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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

FORM 10-K

 

 ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

FOR THE FISCAL YEAR ENDED DECEMBER 31, 2024

 

OR

 

 TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

FOR THE TRANSITION PERIOD FROM ____________ TO ____________

 

Commission File Number: 001-37714

 

Sensus Healthcare, Inc.

(Exact name of registrant as specified in its charter)

 

Delaware   27-1647271
(State or other jurisdiction of
incorporation or organization)
  (I.R.S. Employer
Identification No.)

 

851 Broken Sound Pkwy., NW #215, Boca Raton,
Florida
  33487
(Address of principal executive office)   (Zip Code)

 

(561) 922-5808

(Registrant’s telephone number, including area code)

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class   Trading symbol(s)   Name of each exchange on which registered
Common Stock, par value $0.01 per share   SRTS   The NASDAQ Stock Market, LLC (Nasdaq Capital Market)

 

Securities registered pursuant to Section 12(g) of the Act: None

 

Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☐ No

 

Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes ☐ No

 

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐

 

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐

 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

 

Large accelerated filer ☐ Accelerated filer ☐        Non-accelerated filer  ☒         Smaller reporting company Emerging growth company

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

 

Indicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report. ☐

 

If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the filing reflect the correction of an error to previously issued financial statements.

 

Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation received by any of the registrant’s executive officers during the relevant recovery period pursuant to §240.10D-1(b). ☐

 

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No

 

The aggregate market value of the common equity held by non-affiliates of the registrant on June 30, 2024, the last business day of the registrant’s most recently completed second quarter, was $79,995,039, based on the closing price of $5.33 per share of common stock on the Nasdaq Capital Market on that date. For this purpose, all outstanding shares of common stock have been considered held by non-affiliates, other than the shares beneficially owned by directors and officers of the registrant.

 

As of February 12, 2025, there were 16,495,396 shares of the registrant’s common stock outstanding.

 

DOCUMENTS INCORPORATED BY REFERENCE

 

Portions of our Proxy Statement for the Annual Meeting of Stockholders to be held on May 30, 2025, are incorporated by reference in Part III. 

 

 

 

 

SENSUS HEALTHCARE, INC.

ANNUAL REPORT ON FORM 10-K

TABLE OF CONTENTS

 

    PAGE
PART I   1
     
Item 1. Business 1
Item 1A. Risk Factors 11
Item 1B. Unresolved Staff Comments 21
Item 1C.    Cybersecurity 21
Item 2. Properties 22
Item 3. Legal Proceedings 22
Item 4. Mine Safety Disclosure 22
     
PART II   23
     
Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 23
Item 6. Reserved 23
Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations 24
Item 7A. Quantitative and Qualitative Disclosures About Market Risk 27
Item 8. Financial Statements and Supplementary Data F-1
Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure 28
Item 9A. Controls and Procedures 28
Item 9B. Other Information 29
Item 9C. Disclosures Regarding Foreign Jurisdiction that Prevent Inspections 29
     
PART III   30
     
Item 10. Directors, Executive Officers and Corporate Governance 30
Item 11. Executive Compensation 30
Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters 30
Item 13. Certain Relationships and Related Transactions, and Director Independence 30
Item 14. Principal Accountant Fees and Services 30
     
PART IV   31
     
Item 15. Exhibits and Financial Statement Schedules 31
Item 16 Form 10-K Summary 31
  Signatures 35

 

i

 

 

INTRODUCTORY NOTE

Forward-Looking Statements

 

This report includes statements that are, or may be deemed, “forward-looking statements.” In some cases, these statements can be identified by the use of forward-looking terminology such as “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “approximately,” or “potential,” or negative or other variations of those terms or comparable terminology, although not all forward-looking statements contain these words.

 

Forward-looking statements involve risks and uncertainties because they relate to events, developments, and circumstances relating to Sensus Healthcare, Inc., our industry, and/or general economic or other conditions that may or may not occur in the future or may occur on longer or shorter timelines or to a greater or lesser degree than anticipated. In addition, even if future events, developments and circumstances are consistent with the forward-looking statements contained in this report, they may not be predictive of results or developments in future periods. Although we believe that we have a reasonable basis for each forward-looking statement contained in this report, forward-looking statements are not guarantees of future performance, and our actual results of operations, financial condition and liquidity, and the development of the industry in which we operate, may differ materially from the forward looking statements contained in this report as a result of the following factors, among others: the possibility that inflationary pressures continue to impact our sales; the level and availability of government and/or third party payor reimbursement for clinical procedures using our products, and the willingness of healthcare providers to purchase our products if the level of reimbursement declines; concentration of our customers in the U.S. and China, including the concentration of sales to one particular customer in the U.S.; the development by others of new products, treatments, or technologies that render our technology partially or wholly obsolete; the regulatory requirements applicable to us and our competitors; our ability to efficiently manage our manufacturing processes and costs; the risks arising from doing business in China and other foreign countries; legislation, regulation, or other governmental action that affects our products, taxes, international trade regulation (including the possibility of tariffs on equipment we export or materials we import), or other aspects of our business; the performance of the Company’s information technology systems and its ability to maintain data security; our ability to obtain and maintain the intellectual property needed to adequately protect our products, and our ability to avoid infringing or otherwise violating the intellectual property rights of third parties; and other risks described from time to time in our filings with the Securities and Exchange Commission.

 

To date, the Middle East conflict, the Russian invasion of Ukraine, and other geopolitical uncertainties have not had any significant impact on our business, but we continue to monitor developments and will address them in future disclosures, if applicable.

 

Any forward-looking statements that we make in this report speak only as of the date of such statement, and we undertake no obligation to update such statements to reflect events or circumstances after the date of this report, except as may be required by applicable law. 

 

ii

 

 

PART I.

 

Item 1. BUSINESS

 

Overview

 

Sensus Healthcare, Inc. (together, with its subsidiaries, Sensus Medical Devices Ltd. and Sensus Healthcare Services, LLC, unless the context otherwise indicates, “Sensus,” “we,” “us,” “our,” or the “Company”) is a medical device company committed to providing highly effective, non-invasive, and cost-effective treatments for both oncological and non-oncological skin conditions. The Company uses a proprietary low-energy X-ray technology known as superficial radiation therapy (“SRT”), which is based on over a decade of dedicated research and development, and has successfully incorporated SRT into a portfolio of treatment devices: the SRT-100TM, SRT-100+TM and SRT-100 VisionTM. To date, SRT technology has been used to effectively and safely treat oncological and non-oncological skin conditions in hundreds of thousands of patients around the world.

 

Our business was organized in 2010 and the Company, incorporated in Delaware, completed its initial public offering in 2016. The Company operates as one segment from its corporate headquarters located in Boca Raton, Florida. In February 2024, the Company formed Sensus Healthcare Services, LLC, a wholly-owned subsidiary that provides operational healthcare services to dermatology clinics. For further information see Note 1, Organization and Summary of Significant Accounting Policies - Description of the Business, in the notes to the consolidated financial statements in Part II, Item 8.

 

Our Products and Services

 

SRT is the Company’s core technology. As of December 31, 2024, the Company had installed 867 units in 21 countries, primarily in the United States.

 

SRT-100

 

The SRT-100 is a photon x-ray low energy SRT system that provides patients an alternative to surgery for treating non-melanoma skin cancers, including basal cell and squamous cell skin cancers and other skin conditions such as keloids. The SRT-100 is especially effective in treating primary lesions that would otherwise be difficult to treat or require extensive surgery involving sensitive areas of the head and neck regions, such as the fold in the nose, eyelids, lips, corner of the mouth, and the lining of the ear, that would otherwise lead to a less than desirable cosmetic outcome. SRT treatment procedures do not require the use of anesthetics and eliminate the need for skin grafting. The Company believes that the SRT-100 provides healthcare providers and patients with a safe, virtually painless, and substantially non-scarring treatment option for non-melanoma skin cancer and other skin conditions, such as keloids. It allows dermatologists to retain non-melanoma skin cancer patients, rather than referring them to specialists, while offering radiation oncologists an alternative to costly linear accelerator–based treatments with a process that is less invasive, more time-efficient, and improves practice economics. The SRT-100 provides the following clinical and functional advantages:

 

  Easy touch automatic set-up procedure, including automatic x-ray tube warm-up procedures;
     
  Specially designed control console for medical physicists and service technicians, providing integrated safety and back-up timer controls, automatic system conditioning procedures, calibration, x-ray output verification and system parameters, including last treatment status information;
     
  Advanced patient record management with integrated enterprise workflow management;
     
  Compact mobile design with a small 30” x 30” footprint and unique scissor x-ray tube arm movements, providing a large range of motion for patient access and treatment; and

 

 1

 

 

  High reliability and MTBF (“mean time between failures”) performance that provides availability for patients and practitioners and lowers the total cost of ownership.

 

SRT-100 Vision

 

The SRT-100 Vision provides customers with additional options compared to the SRT-100 base model. These additional options allow for dedicated treatment planning and full treatment progression documentation in a patient’s record. The SRT-100 Vision provides the user with a unique SRT-tailored treatment planning application that integrates an embedded high frequency ultrasound imaging module, volumetric tumor analysis, beam margins planning, and comprehensive dosimetry parameters. This allows the user to precisely and more accurately plan and prescribe the patient-specific treatment course to maximize patient outcomes and workflow efficiency. The SRT-100 Vision also offers a comprehensive control console and workflow management that provides full record and treatment tracing, operator-level access and functional control, audio-visual patient and treated lesion monitoring, and advanced dosimetry setting and tracing.

 

SRT-100+

 

The SRT-100+ offers all the same features as the SRT-100, with the addition of:

 

  An expanded energy range for customized, more precise treatment
     
  Remote diagnostics, including operation tracking
     
  New X-ray tube with extended functionality and performance
     
  Advanced console and enhanced system mobility to optimize clinical practice

 

Sentinel service program

 

The Company offers the Sentinel service program, which provides customers comprehensive protection for their systems. The Sentinel service program covers all parts and labor for the period of the contract and one annual preventive maintenance session that includes cooling system maintenance, high-voltage loop maintenance, filters and system cleaning, and system touch-ups, should these be required during the preventative maintenance session.

 

Sensus also provides, through the program, turnkey pre-and post-sale services that include the following:

 

  Providing a pre-install kit for the contractors to prepare the treatment room;
     
  Room retrofit and shielding;
     
  System shipping coordination and installation;
     
  System commissioning by a medical physicist (through a national physics network);
     
  System registration with the state and daily workflow documentation preparation;
     
  Clinical applications training with the customer’s SRT staff; and
     
  Treating the first scheduled patients with our customers (onsite applications training).

 

 2

 

 

Other products

 

Transdermal Infusion (TDI)

 

TransDermal Infusion is a biophysical alternative to infuse high weight molecule modalities into the dermis for medical and aesthetic purposes without the use of needles. In 2022, the Company sourced the product from a manufacturer in Italy. The Company started developing its own TDI system in 2023, which is pending approval from the FDA. The Company is not currently offering TDI.

 

Lasers

 

Sensus also distributes laser devices, for the aesthetic dermatology market, which includes applications for hair removal, vascular lesions, acne treatment, epidermal pigment removal (including removal of spots, freckles, and tattoos), skin toning, and skin rejuvenation.

 

Other services

 

Sensus provides Operational Healthcare Services in the form of Radiation Oncology and Physics oversight in addition Radiotherapy Technologist for dermatology clinics.

 

Consumables

 

The Company sells disposable lead shielding replacements, disposable radiation safety items, such as aprons and eye shields, ultrasound probe film, and disposable applicator tips, which are used to treat various sized lesions and different areas of the body.

 

Competition

 

The medical device industry is highly competitive and subject to rapid technological change and is significantly affected by new product introductions and market activities of other participants. Current marketed products, and any future products that the Company commercializes, will compete against healthcare providers who use other methods of treatment for the same disease or condition.  

 

In order to grow its business, Sensus must be able to compete effectively for market acceptance of its products. Key competitive factors include improved outcomes for medical conditions, acceptance by doctors treating non-melanoma skin cancer and keloids, acceptance by the patient community, ease of use and reliability, product price and qualification for reimbursement, technical leadership and superiority, effective marketing and distribution, speed to market, and quality of client service.

 

Sales and Marketing

 

The Company’s focus is mainly on two primary markets, private dermatology practices and radiation oncologists in both private and hospital settings. The Company currently employs a multi-tier sales strategy to optimize geographic coverage and focus on its key markets. This multi-tier sales model uses a direct sales force in the U.S., as well as international dealers and distributors. Sensus plans to continue selling and marketing the Company’s products to both the dermatology and radiation oncology markets concurrently.

 

Dermatology Market

 

Private dermatology practices in the U.S. represent the point of entry for most non-melanoma skin cancer patients. The Company believes its SRT products offer dermatologists a competitive advantage by allowing them to retain patients for the treatment of non-melanoma skin cancer, rather than having to refer them to other professionals. In addition to non-melanoma skin cancers, the Company has had an FDA clearance to treat keloid scars since 2014. The Company’s SRT has been used by over 100 U.S. dermatology practices in the treatment of keloids. It has also been used to treat keloids in China since 2017.

 

 3

 

 

Radiation Oncology Market

 

For licensed radiation oncologists in the U.S., the Company believes its SRT products offer a simpler, faster method of treatment with a better overall patient experience. SRT offers oncologists the ability to free up more expensive radiation equipment, such as linear accelerators, for more complex procedures while providing patients with effective, non-invasive treatment options for non-melanoma skin cancer.

 

Other Markets

 

Sensus believes that the plastic surgery and laser aesthetic markets present growth opportunities. With FDA clearance to treat keloids through SRT, plastic surgeons are recognizing the opportunity to be able to provide an effective treatment solution for this benign tumor. Additionally, the Company believes that plastic surgeons view the non-melanoma skin cancer market as a growth opportunity that can supplement their existing services. 

 

Manufacturing and Supply

 

The Company currently uses third parties located in the U.S. to manufacture products. In 2010, the Company entered into a manufacturing agreement with RbM Services, LLC (“RbM”) pursuant to which RbM agreed to manufacture SRT-100 products. Under this agreement, the Company pays a fixed price per unit, subject to annual adjustments due to changes in the cost of materials. The agreement renews for successive one-year periods unless either party notifies the other party in writing, at least 60 days prior to the anniversary date of the agreement, that it will not renew the agreement. The Company or manufacturer may terminate the agreement upon 90 days’ prior written notice.

 

The Company maintains internal policies, procedures, and supplier management processes designed to ensure that RbM meets applicable quality standards, including FDA and International Organization for Standardization, or ISO, requirements. To date, Sensus has not experienced any difficulty in locating and obtaining the materials necessary to meet the demand for our products, and believes manufacturing capacity is sufficient to meet global market demand for our products for the foreseeable future.

 

The Company believes this third-party manufacturing relationship allows us to work with a supplier that has well-developed specific competencies while minimizing our capital investment, controlling costs, and shortening cycle times, all of which has allowed us to compete effectively with our competitors. Sensus also works with other third parties that it believes could be relied upon if we needed to change suppliers.

 

The Company has a single preferred supplier for the x-ray tubes and other major components used in its products. The Company believes this supplier has superior products; however, products of alternate suppliers would be adequate for Sensus’s products and therefore the Company does not anticipate any material disruptions to the supply of major components if there were a change in suppliers.

 

Intellectual Property

 

The Company actively seeks to protect the intellectual property that is important to our business, including seeking and maintaining patents that cover Sensus’s products. The Company also relies on trademarks to enhance, build, and maintain the integrity of the Sensus brand. 

 

The Company possesses eight issued U.S. and Global patents. The patents relate to technology that is pertinent to the Company.

 

The following patents were issued between August 2007 and September 2008:

 

  U.S. Patent No. 7,372,940: Radiation therapy system featuring rotatable filter assembly (expires September 30, 2025)

 

 4

 

 

  U.S. Patent No. 7,263,170: Radiation therapy system featuring rotatable filter assembly (expires September 30, 2025)

 

The following patents were issued to us in 2017:

 

  Russia Patent No. 2633322: Hybrid Ultrasound-Guided Superficial Radiotherapy System and Method (expires January 12, 2033)
     
  China Patent No. ZL201380013491.7: Hybrid Ultrasound-Guided Superficial Radiotherapy System and Method (expires January 12, 2033)

 

The following patents were issued to Sensus in 2020:

 

  U.S. Patent No. 10,596,392: Dermatology Radiotherapy System with hybrid Imager (expires July 28, 2038)
     
  China Patent No. ZL201710929838.2 Hybrid Ultrasound-Guided Superficial Radiotherapy System and Method (expires August 14, 2038)

 

The following patent was issued to Sensus in 2021:

 

  U.S. Patent No. 11,027,149: Hybrid Ultrasound-Guided Superficial Radiotherapy System and Method (expires July 7, 2034)

 

The following patent was issued to Sensus in 2024:

 

  U.S. Patent No. 11,894,123: Radiotherapy Mobile and Wireless Device Workflow Management System (expires June 20, 2039)

 

The Company also owns eight U.S. trademark registrations (expiring from 2025 through 2031).

 

The Company also relies on trade secrets and other unpatented proprietary rights to develop and maintain a competitive position. The Company seeks to protect unpatented proprietary rights through a variety of methods, including confidentiality agreements with employees, consultants and others who may have access to this proprietary information. The Company requires all employees to execute invention assignment agreements with respect to inventions arising from their employment.

 

The Company can provide no assurance that any patents or trademarks will be issued or registered as a result of our pending or future applications for such intellectual property. Even if any such patents or trademarks are ultimately issued or registered, they, or any of the Company’s other intellectual property, may not provide any meaningful protection or competitive advantage. Intellectual property could be challenged, invalidated, circumvented, infringed upon, or misappropriated. In addition, third parties have claimed, and in the future may claim, that the Company or customers, licensees, or other parties indemnified by the Company are infringing upon their intellectual property rights.

 

Government Regulation

 

Sensus’s business is subject to extensive federal, state, local, and foreign laws and regulations, including those relating to the protection of the environment, health, and safety. Some of the pertinent laws and regulations have not been definitively interpreted by the regulatory authorities or the courts, and their provisions are open to a variety of subjective interpretations. In addition, these laws and regulations and their interpretations are subject to change, and new laws may be enacted. Both federal and state governmental agencies continue to subject the healthcare industry to intense regulatory scrutiny, including heightened civil and criminal enforcement efforts. The Company believes that its business operations and relationships with customers and suppliers are structured to comply with all applicable legal requirements. However, it is possible that governmental entities or other third parties could interpret these laws and regulations differently and assert otherwise. Discussed below are statutes and regulations that are most relevant to the Company’s business. For the year ended December 31, 2024, we incurred $0.9 million in expenses related to regulatory compliance and quality standards.

 

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FDA Regulation of Medical Devices

 

The Federal Food, Drug and Cosmetic Act (“FDCA”) and FDA regulations establish a comprehensive system for the regulation of medical devices intended for human use. Sensus’s medical device products are subject to these regulations, as well as other federal, state, and local laws and regulations. The FDA is also responsible for the overall enforcement of quality, regulatory, and statutory requirements governing medical devices.

 

FDA classifies medical devices into one of three classes — Class I, Class II, or Class III — depending on their level of risk and the types of controls that are necessary to assure device safety and effectiveness. The class assignment determines the type of premarketing submission or application, if any, that will be required before marketing in the U.S. The Company’s medical devices are Class II devices under the FDA’s classification system.  Class II devices are deemed to present a moderate risk and are devices for which general controls alone are not sufficient to provide a reasonable assurance of safety and effectiveness. Medical devices in Class II are subject to both general controls and “special controls” — e.g., special labeling, compliance with industry standards, and post market surveillance. Unless exempted, Class II devices typically require FDA clearance before marketing, through the premarket notification (“510(k)”) process, in accordance with 21 CFR, Part 807 requirements.

 

Unless it is exempt from premarket review requirements, a medical device must receive marketing authorization from the FDA prior to being commercially distributed in the U.S. For Class II devices, 510(k) is the most common pathway to obtain market authorization in the US.

 

510(k) pathway

 

We have previously received FDA 510(k) clearances for our SRT-100, SRT-100 Vision, and SRT-100+ (Class II) products through the 510(k) pathway due to the requirement for special controls. To date, other available US regulatory pathways (i.e., Self-certification (Class I), Pre-market Authorization Class III, or de novo) have not been appropriate for our developed products and may involve extended review periods.

 

Ongoing FDA regulation

 

After a device is entered into commerce in the U.S., regardless of its classification or premarket pathway, numerous additional FDA requirements generally apply. These include:

 

  Establishment registration and device listing requirements, in accordance with 21 CFR, Part 807;
     
  Quality System Regulation requirements, which govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, storage, installation, and servicing of finished devices, in accordance with 21 CFR, Part 820;

 

  Labeling requirements, which mandate the inclusion of certain content in device labels and labeling, and which also prohibit the promotion of products for uncleared or unapproved (i.e., “off-label”) uses;
     
  Medical Device Reporting regulation, which requires that manufacturers and importers report to the FDA if their device may have caused or contributed to a death or serious injury or malfunctioned in a way that would likely cause or contribute to a death or serious injury if it were to recur, in accordance with 21 CFR, Part 803; and
     
  Reports of Corrections and Removals regulation, which requires that manufacturers and importers (a) report to the FDA recalls (i.e., corrections or removals) if undertaken to reduce a risk to health posed by the device or to remedy a violation of the FDCA that may present a risk to health, and (b) keep records of recalls that they determine to be not reportable, all in accordance with 21 CFR, Part 806.

 

 6

 

 

The FDA enforces these requirements by inspection and market surveillance. Failure to comply with applicable regulatory requirements can result in enforcement action by the FDA, which may include, but is not limited to, the following sanctions:

 

  Issuance of Form 483 observations (also known as “minor non-conformances”) during a facilities inspection;

 

  Untitled letters or warning letters;

 

  Fines, injunctions, and civil penalties;
     
  Consent Decrees, which forces improvements in the quality management system through the use of the federal courts;
     
  Recall or seizure of products;
     
  Operating restrictions, partial suspension or total shutdown of production;
     
  Refusing 510(k) clearance or premarket approval of new products;
     
  Withdrawing 510(k) clearance or premarket approvals that are already granted; and
     
  Criminal prosecution.

 

The Company is subject to unannounced establishment inspections by the FDA, as well as other regulatory agencies overseeing the implementation of and compliance with applicable state public health regulations. These inspections may include our suppliers’ facilities.

 

International Regulations

 

International sales of medical devices are subject to foreign government regulations, which vary substantially from country to country. In order to market our products in other countries, the Company must obtain regulatory approvals and comply with safety and quality regulations. The time required to obtain approval by a foreign country may be longer or shorter than that required for FDA clearance or approval, and the requirements may differ. The European Union/European Economic Area, or EU/EEA, requires a CE conformity mark in order to market medical devices. The UK, due to Brexit, also requires a separate clearance. Many other countries, such as Australia, India, New Zealand, Pakistan, and Sri Lanka, accept CE or FDA clearance or approval, although others, such as China, Brazil, Canada and Japan, require separate regulatory filings.

 

In the EU/EEA, existing Sensus devices are required to comply with the essential requirements of the EU Medical Devices Directive (93/42/EEC), while any new products placed in the EU/EEA must comply with the EU Medical Device Regulation (2017/745). Compliance with these requirements entitles the Company to affix the CE marking of conformity to our medical devices, without which they cannot be commercialized in the EU/EEA. To demonstrate compliance with the essential requirements and obtain the right to affix the CE marking of conformity, the Company must undergo a conformity assessment procedure, which varies according to the type of medical device and its classification. Except for low-risk medical devices (Class I), where the manufacturer can issue an EC Declaration of Conformity based on a self-assessment of the conformity of its products with the essential requirements of the Medical Devices Directive (existing products) or Medical Device Regulation (new products), a conformity assessment procedure requires the intervention of a Notified Body, which is an organization accredited by a Member State of the EU/EEA to conduct conformity assessments. The Notified Body typically audits and examines the quality system for the manufacture, design, and final inspection of devices before issuing a certification demonstrating compliance with the essential requirements. Based on this certification, we can draw up an EU Declaration of Conformity which allows us to affix the CE mark to our products.

 

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Further, the advertising and promotion of Sensus’s products in the EU/EEA is subject to the laws of individual EEA Member States implementing the EU Medical Devices Directive, Directive 2006/114/EC concerning misleading and comparative advertising, and Directive 2005/29/EC on unfair commercial practices, as well as other EU/EEA Member State laws governing the advertising and promotion of medical devices. These laws may limit or restrict the advertising and promotion of our products to the general public and may impose limitations on our promotional activities with healthcare professionals.

 

The Company has obtained approval to sell our products in Australia, Canada, China, Hong Kong, European Union, United Kingdom, Israel, Mexico, Russia, South Africa, South Korea, Vietnam, Taiwan, and Guatemala, and is currently seeking approval in several other countries.

 

Sales and Marketing Commercial Compliance

 

Federal anti-kickback laws and regulations prohibit, among other things, persons from knowingly and willfully soliciting, receiving, offering, or paying remuneration, directly or indirectly, in exchange for, or to induce either the referral of an individual, or the purchase, order, or recommendation of, any good or service paid for under federal healthcare programs such as the Medicare and Medicaid programs. Possible sanctions for violation of these anti-kickback laws include monetary fines, civil and criminal penalties, exclusion from Medicare and Medicaid programs, and forfeiture of amounts collected in violation of such prohibitions.

 

In addition, federal false claims laws prohibit any person from knowingly presenting, or causing to be presented, a false claim for payment to the federal government, or knowingly making, or causing to be made, a false statement to get a false claim paid. Off-label promotion has been pursued as a violation of the federal false claims laws. Pursuant to FDA regulations, we can only market our products for cleared or approved uses. Although surgeons are permitted to use medical devices for indications other than those cleared or approved by the FDA based on their medical judgment, we are prohibited from promoting products for such off-label uses. Additionally, the majority of states in which we market our products have similar anti-kickback, false claims, anti-fee splitting, and self-referral laws, which may apply to items or services reimbursed by any third-party payor, including commercial insurers. Violations of these laws may result in substantial civil and criminal penalties.

 

To enforce compliance with the federal laws, the U.S. Department of Justice, or DOJ, has increased its scrutiny of interactions between healthcare companies and healthcare providers, which has led to an unprecedented level of investigations, prosecutions, convictions and settlements in the healthcare industry. Dealing with investigations can be time- and resource-consuming. Additionally, if a healthcare company settles an investigation with the DOJ or other law enforcement agencies, the company may be required to agree to additional compliance and reporting requirements as part of a consent decree or corporate integrity agreement.

 

U.S. and foreign government regulators have increased regulation, enforcement, inspections, and governmental investigations of the medical device industry, including increased U.S. government oversight and enforcement of the Foreign Corrupt Practices Act. Whenever a governmental authority concludes that a company is not in compliance with applicable laws or regulations, that authority can impose fines, delay or suspend regulatory clearances, institute proceedings to detain or seize the company’s products, issue a recall, impose operating restrictions, enjoin future violations, assess civil penalties against the company, or its officers or employees, and recommend criminal prosecution. Moreover, governmental authorities can ban or request the recall, repair, replacement, or refund of the cost of devices the company distributes.

 

Additionally, the commercial compliance environment is continually evolving in the healthcare industry as some states, including California, Massachusetts and Vermont, mandate implementation of corporate compliance programs, along with the tracking and reporting of gifts, compensation, and other remuneration to physicians. The Affordable Care Act also imposes reporting and disclosure requirements on device manufacturers for any “transfer of value” made or distributed to prescribers and other healthcare providers. Device manufacturers are also required to report and disclose any investment interests held by physicians and their family members during the preceding calendar year. Failure to submit required information may result in civil monetary penalties of up to an aggregate of $150,000 per year (and up to an aggregate of $1 million per year for “knowing failures”), for all payments, transfers of value or ownership or investment interests not reported in an annual submission. The shifting compliance environment and the need to build and maintain robust and expandable systems to comply in multiple jurisdictions with different compliance or reporting requirements increases the possibility that a healthcare company may run afoul of one or more of the requirements. The Company has implemented policies and procedures related to commercial compliance including with respect to compliance in connection with sales and marketing.

 

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Healthcare Fraud and Abuse

 

Healthcare fraud and abuse laws apply to Sensus’s business when a customer submits a claim for an item or service that is reimbursed under Medicare, Medicaid, or most other federally funded healthcare programs. The federal anti-kickback statute (the “Anti-Kickback Statute”) prohibits unlawful inducements for the referral of business reimbursable under federally funded healthcare programs, such as remuneration provided to physicians to induce them to use certain tissue products or medical devices reimbursable by Medicare or Medicaid. The Anti-Kickback Statute is subject to evolving interpretations. For example, the government has enforced the Anti-Kickback Statute to reach large settlements with healthcare companies based on sham consultant arrangements with physicians. The majority of states also have anti-kickback laws which establish similar prohibitions that may apply to items or services reimbursed by any third-party payor, including commercial insurers. Further, recently enacted amendments to the Affordable Care Act, among other things, amend the intent requirement of the Anti-Kickback Statute and criminal healthcare fraud statute. A person or entity no longer needs to have actual knowledge of this statute or specific intent to violate it. In addition, the Affordable Care Act provides that the government may assert that a claim including items or services resulting from a violation of the Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of false claims statutes. If a governmental authority were to conclude that we are not in compliance with applicable laws and regulations, we and our officers and employees could be subject to severe criminal and civil penalties including, for example, exclusion from participation as a supplier of product to beneficiaries covered by Medicare or Medicaid. In addition to the Anti-Kickback Statute, the federal physician self-referral statute, commonly known as the Stark Law, prohibits physicians who have a financial relationship with an entity, including an investment, ownership, or compensation relationship, from referring Medicare patients for designated health services, which include clinical pathology services, unless an exception applies. Similarly, entities may not bill Medicare or any other party for services furnished pursuant to a prohibited referral. Many states have their own self-referral laws as well, which in some cases apply to all third-party payors, not just Medicare and Medicaid. If a governmental authority were to conclude that we are not in compliance with the Stark Law or state self-referral laws and regulations, our business could be subject to severe financial consequences, including the obligation to refund amounts billed to third-party payors in violation of such laws, civil penalties, and potentially exclusion from participation in government healthcare programs like Medicare and Medicaid. The Stark Law often is enforced through lawsuits brought under the Federal False Claims Act, violations of which trigger significant monetary penalties and treble damages.

 

Additionally, the civil False Claims Act prohibits knowingly presenting or causing the presentation of a false, fictitious, or fraudulent claim for payment to the U.S. government. Actions under the False Claims Act may be brought by the Attorney General or as a qui tam action by a private individual in the name of the government. Violations of the False Claims Act can result in very significant monetary penalties and treble damages. The federal government is using the False Claims Act, and the accompanying threat of significant liability, in its investigations of healthcare providers and suppliers throughout the country for a wide variety of Medicare billing practices, obtaining multi-million and multi-billion dollar settlements in addition to individual criminal convictions. Given the significant size of actual and potential settlements, it is expected that the government will continue to devote substantial resources to investigating healthcare providers’ and suppliers’ compliance with the healthcare reimbursement rules and fraud and abuse laws. The Company has implemented policies and procedures related to compliance with applicable regulations design to prevent healthcare fraud and abuse.

 

Health Information Privacy

 

The federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, or HITECH, and their respective implementing regulations, impose requirements on certain covered healthcare providers, health plans, and healthcare clearinghouses, known as covered entities, as well as their business associates that perform services for them that involve individually identifiable health information. The HIPAA privacy and security regulations, including the expanded requirements under HITECH, establish comprehensive federal standards with respect to the use and disclosure of protected health information by covered entities and their business associates, in addition to setting standards to protect the confidentiality, integrity, and security of protected health information.

 

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The Company has implemented policies and procedures related to compliance with the HIPAA privacy and security regulations, as required by law. The privacy and security regulations establish a “floor” and do not supersede state laws that are more stringent. Therefore, we are required to comply with both federal privacy and security regulations and varying state privacy and security laws. In addition, for healthcare data transfers from other countries relating to citizens of those countries, the Company must comply with the laws of those other countries. The federal privacy regulations restrict the ability to use or disclose patient identifiable laboratory data, without patient authorization, for purposes other than payment, treatment, or healthcare operations (as defined by HIPAA), except for disclosures for various public policy purposes and other permitted purposes outlined in the privacy regulations. HIPAA, as amended by HITECH, provides for significant fines and other penalties for wrongful use or disclosure of protected health information in violation of the privacy and security regulations, including potential civil and criminal fines and penalties. If the Company does not comply with existing or new laws and regulations related to protecting the privacy and security of health information, it could be subject to monetary fines, civil penalties, or criminal sanctions. In addition, other federal and state laws that protect the privacy and security of patient information may be subject to enforcement and interpretations by various governmental authorities and courts resulting in complex compliance issues. The Company could incur damages under state laws pursuant to an action brought by a private party for the wrongful use or disclosure of confidential health information or other private personal information. If the Company were to experience a breach of protected health information, it could be subject to significant adverse publicity in addition to possible enforcement sanctions and civil damages lawsuits. Finally, the Company may be required to incur additional costs related to ongoing HIPAA compliance as may be necessary to address evolving interpretations and enforcement of HIPAA and other health information privacy and security laws, the enactment of new laws or regulations, emerging cybersecurity threats, and other factors.

 

Research and Development

 

Research and development costs related to development and quality and regulatory costs are expensed as incurred. For the years ended December 31, 2024 and 2023, the Company incurred research and development expenses of $4.2 million and $3.7 million, respectively. The Company expects research and development expenses in 2025 to be generally consistent with 2024.

 

Employees and Human Capital

 

At December 31, 2024, the Company had 54 employees. None of the Company’s employees are represented by a labor union or covered by a collective bargaining agreement.

 

The Company believes that its success depends on the ability to attract, develop, and retain key personnel. It also believes that the skills, experience, and industry knowledge of its key employees significantly benefits its operations and performance. The Company believes that it offers competitive compensation and other means of attracting and retaining key personnel.

 

Employee levels are managed to align with the pace of business and management believes it has sufficient human capital to operate its business successfully.

 

Available Information

 

Sensus files annual, quarterly, and current reports, proxy statements, and all amendments to these reports and other information with the SEC. Sensus makes available free-of-charge, on or through its website at http://www.sensushealthcare.com, Sensus’s Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K, proxy statements and all amendments to those filings, as soon as reasonably practicable after such material is electronically filed with or furnished to the SEC . The information on Sensus’s website is not incorporated by reference in this Annual Report on Form 10-K. Reports, proxy statements, and other information regarding issuers that file electronically with the SEC, including Sensus’s filings, are also available to the public from the SEC’s website at http://www.sec.gov.

 

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Item 1A.  RISK FACTORS

 

An investment in Sensus’s common stock contains a high degree of risk. Investors should carefully consider the following risks and uncertainties before making an investment decision with respect to our common stock. Our business, including our operating results and financial conditions, could be harmed if any of these risks, as well as other risks not currently known to us or that we currently deem immaterial, were to materialize. The trading price of Sensus’s common stock could decline due to the occurrence of any of these risks. In assessing these risks, investors should also refer to the other information included in our filings with the SEC, including our financial statements and the related notes.

 

Risks Related to our Business

 

If third-party payors do not provide coverage and adequate reimbursement for the use of our products, it is unlikely that our products will be widely used, and our revenue will be negatively impacted.

 

In the U.S., the commercial success of Sensus’s existing products and any future products will depend, in part, on the extent to which governmental payors at the federal and state levels, including Medicare and Medicaid, private health insurers, and other third-party payors provide coverage for and establish adequate reimbursement levels for procedures using these products. Neither hospitals nor physicians are likely to use Sensus’s products if they do not receive adequate reimbursement payments for the procedures using these products.

 

Some private payors in the U.S. may base their reimbursement policies on the coverage decisions determined by the Center for Medicare & Medical Services, or CMS, which administers the Medicare program and works in partnership with state governments to administer the Medicaid program. Others may adopt different coverage or reimbursement policies for procedures performed using Sensus’s products, while some governmental programs, such as Medicaid, have reimbursement policies that vary from state to state, some of which may not pay an amount that supports the selling price of Sensus’s products, if at all. A Medicare national or local coverage decision denying coverage for any of the procedures performed using the Company’s products could result in private and other third-party payors also denying coverage. Medicare (Part B) and a number of private insurers in the U.S. currently cover and pay for both non-melanoma skin cancer and keloid treatments using the SRT-100. A withdrawal, or even contemplation of a withdrawal, by CMS, Medicaid or private payors of reimbursements, or any other unfavorable coverage or reimbursement decisions by government programs or private payors, could have a material adverse effect on the Company’s revenues and business.

 

Reimbursement systems in international markets vary significantly by country and by region within some countries, and reimbursement approvals must be obtained on a country-by-country basis. In many international markets, a product must be approved for reimbursement before it can be cleared for sale in that country. Further, many international markets have government-managed healthcare systems that control reimbursement for new devices and procedures. In most markets there are private insurance systems as well as government-managed systems. Sensus’s products may not be considered cost-effective by international third-party payors or governments managing healthcare systems. Furthermore, reimbursement may not be available or, if available, third-party payors’ reimbursement policies may adversely affect the Company’s ability to sell products profitably. If sufficient coverage and reimbursement are not available for Sensus’s products, in either the U.S. or internationally, the demand for these products and, consequently, the Company’s revenues and business, will be adversely affected.

 

Substantially all of the Company’s revenue is generated from the sale of the SRT-100 and related products, and any decline in the sales of these products will negatively impact the Company’s business, financial condition, and results of operations.

 

The Company is focused heavily on the development and commercialization of a limited number of products for the treatment of non-melanoma skin cancer and other skin conditions with SRT. From the Company’s inception in 2010 through December 31, 2024, revenue has primarily been derived from sales of the SRT-100 product line and related services and ancillary products. Although the Company has introduced new products, the Company expects most of revenue in the near to medium term to be derived from or related to sales of the SRT-100 product line. Because of this, any decline in the sales of these products will negatively impact the Company’s business, financial condition, and results of operations.

 

 11

 

 

The Company’s technology could be superseded by new products, treatments, or technologies that gain wider acceptance among doctors and patients, which could adversely affect the Company. 

 

The medical device industry is highly competitive and subject to rapid technological change, and is significantly affected by the introduction of new products and treatment options. The Company’s products, some of which use technologies that have been available for many years, compete for market acceptance against those of healthcare providers who use other methods of treatment for similar diseases and conditions. Our success depends on our ability to keep pace with rapid technological changes affecting the development of our products and our operations. Emerging technological trends such as artificial intelligence, machine learning, and automation are impacting many industries and business operations, including ours. If we do not adequately invest in new technology, appropriately implement new technologies, or evolve our business at sufficient speed and scale in response to such developments, or if we do not make the right strategic investments to respond to these developments, our products, results of operations, and ability to develop and maintain our business could be negatively affected. Such investments could require substantial expenditures to the extent we were to modify or adapt our existing products and services to keep pace with such new technologies. If new products, treatments, and/or technologies are developed by our competitors or other third parties more quickly or more successfully than us that gain wide acceptance among doctors and patients, including products or treatments developed by our significant customers, it could take market share away from the Company, which could adversely affect the Company’s render the Company’s products obsolete, which could impair our ability to compete effectively and adversely affect our results of operations.

 

The Company’s customers, including one U.S. customer accounting for a significant portion of our sales, are concentrated in the U.S., and economic difficulties or changes in the purchasing policies or patterns of the Company’s customers in the U.S. could have a significant impact on our business and operating results.

 

Most of the Company’s sales have been made to customers located in the U.S. (96% and 91% in the years ended December 31, 2024 and 2023, respectively). Additionally, a single customer in the U.S. accounted for 73% and 61% of revenues for the years ended December 31, 2024, and December 31, 2023, respectively. Because of these concentrations, revenue could fluctuate significantly due to changes in economic conditions, competitive products (including any developed by our significant customers), or the loss of, reduction of business with, or less favorable terms with, our significant customer or other U.S. customers. A reduction or delay in orders for the Company’s products for these or other reasons could materially harm business and results of operations.

 

The Company has a single preferred supplier for the x-ray tubes and other major components used in the Company’s products and the loss of this preferred supplier could adversely affect the Company.

 

The Company has a single preferred supplier for the x-ray tubes and other major components used in the Company’s products. Although other suppliers exist in the market, the Company believes that our preferred supplier’s products are of a superior quality. The loss of the preferred supplier, or its inability to supply the Company with an adequate supply of these components, could hinder the Company’s ability to effectively produce the Company’s products to meet existing demand levels, especially if the Company were unable to timely procure them from other suppliers in the market, which could adversely affect the Company’s ability to commercialize products and to maintain or increase revenues.

 

The Company’s operations may be impaired if our information technology systems fail to perform adequately or are the subject of a data breach or cyberattack.

 

The Company’s information technology systems are critically important to operating business efficiently. The Company relies on information technology systems to manage business data, communications, employee information, and other business processes. The Company outsources certain business process functions to third-party providers and similarly relies on these third parties to maintain and store confidential information on their systems. The failure of these information technology systems to perform as the Company anticipates could disrupt business and could result in transaction errors, processing inefficiencies, and the loss of sales and customers, causing business and results of operations to suffer.

 

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The Company has experienced, and expects to continue to experience, cyber security threats and incidents, none of which have been material to the Company to date. Although the Company protects its information technology systems, the Company has experienced varying degrees of cyber security threats incidents in the normal conduct of business, which include the use of computer malware, ransomware, computer hacking, viruses, worms, phishing, and other malicious activities that could result in unauthorized access, theft, misuse, loss, release, or destruction of data, account takeovers, unavailability of services, or other events. These types of threats may derive from human error, fraud, or malice on the part of external or internal parties or may result from accidental technological failure. Further, these types of threats may be exacerbated by recent developments in artificial intelligence and its increased use to produce sophisticated malware, phishing schemes, and other fraudulent activities. The development and maintenance of measures to mitigate against cyber security risks is costly and time-consuming, requiring continuous monitoring as technologies change and efforts to overcome security measures evolve.

 

Although there have been no serious consequences to date, cyber security incidents or other significant disruption of our information systems or those of our customers or third-party vendors could occur, and, if they do, they could (i) disrupt the proper functioning of our networks and systems and therefore our operations; (ii) result in the unauthorized access to, and destruction, loss, theft, misappropriation, or release of confidential, sensitive, or otherwise valuable information of ours; (iii) result in a violation of applicable privacy, data protection, and other laws, subjecting us to additional regulatory scrutiny and exposing us to civil litigation, enforcement actions, governmental fines, and possible financial liability; (iv) require significant management attention and resources to remedy the damages that result; or (v) harm our reputation. The occurrence of any of the foregoing could have a material adverse effect on our business, financial condition, and results of operations. Furthermore, in the event of a cyber-related incident, we may be delayed in identifying or responding to the incident, which could increase the negative impact of the incident on our business, financial condition, and results of operations.

 

The Company carries insurance against cyber-related incidents risks, performs penetration tests from time to time, and designs business processes to attempt to mitigate the risk of such incidents. While our cyber insurance coverage would apply in the event of certain cyber-related incidents, the amount of coverage may not be adequate depending on the magnitude of the incident. Furthermore, because cyber-related incidents are inherently difficult to predict and can take many forms, some incidents may not be covered under our cyber insurance coverage.

 

Sensus may be required to obtain additional funds in the future, and these funds may not be available on acceptable terms or at all.

 

Sensus’s operations have consumed substantial amounts of cash since its inception. Sensus may need to seek additional capital, as our existing financial resources including our revolving line of credit (which restricts the ability to incur certain indebtedness or permit certain encumbrances on assets without the prior written consent of the lender), may not allow us to conduct all of the activities that would be beneficial for future growth. If Sensus is unable to raise funds on favorable terms, or at all, it may not be able to support commercialization efforts, increase research and development activities, compete effectively, or meet debt and other contractual obligations, and the growth of our business may be negatively impacted.

 

The Company’s cash requirements in the future may be significantly different from current estimates and depend on many factors, including:

 

  the results of commercialization efforts for products;
     
  the need for additional capital to fund development programs;
     
  the costs involved in obtaining and enforcing patents or any litigation by third parties regarding intellectual property;
     
  the establishment of high-volume manufacturing and increased sales, marketing, and distribution capabilities; and
     
  success in entering into collaborative relationships with other parties.

 

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To the extent that Sensus raises additional capital through the sale of equity or convertible debt securities, the ownership interests of the existing stockholders will be diluted. Moreover, the terms of newly issued securities may include liquidation or other preferences that adversely affect common stockholders’ rights. Debt financing, if available, may involve covenants limiting or restricting our ability to take specific actions such as incurring additional debt, making capital expenditures, or declaring distributions or dividends. If Sensus raises additional funds through collaboration and licensing arrangements with third parties, the Company may have to relinquish valuable rights to technologies or products or to grant licenses on terms that are not favorable. Any of these events could adversely affect Sensus’s ability to declare dividends on its common stock and to achieve future product development and commercialization goals and could have a material adverse effect on our business, financial condition, and results of operations.

 

Consolidation in the healthcare industry could adversely affect the Company’s future revenues and operating income.

 

The medical technology industry has experienced a significant amount of consolidation, resulting in companies with greater market presence. Health care systems and other health care companies are also consolidating, resulting in greater purchasing power for the combined companies. The disruption in the healthcare industry caused by consolidation may lead to further competition among medical device suppliers to provide goods and services, which could adversely affect the Company’s future revenues and operating income.

 

Pandemics, natural disasters, global climate change, acts of terrorism and global conflicts may have a negative impact on our business and operations.

 

Pandemics (such as the COVID-19 pandemic), natural disasters, global climate change, acts of terrorism, global conflicts or other similar events have in the past, and may in the future have, a negative impact on our business and operations. These events impact us negatively to the extent that they result in disruptions in the global and national economies and certain industries and geographies in which we operate. In addition, these or similar events may impact economic growth negatively, which could have an adverse effect on our business and operations and may have other adverse effects on us in ways that we are unable to predict.

 

Risks Related to our Regulatory Environment

 

Sensus is subject to various federal, state, and foreign healthcare laws and regulations, and a finding of failure to comply with these laws and regulations could have a material adverse effect on its business.

 

Sensus’s operations are, and will continue to be, directly and indirectly affected by various federal, state, and foreign healthcare laws, including, but not limited to, those described below.

 

  The Anti-Kickback Statute, which prohibits any person or entity from knowingly and willfully offering, paying, soliciting, or receiving any remuneration, directly or indirectly, in cash or in kind, in return for or to induce the referring, ordering, leasing, purchasing, or arranging for or recommending the referring, ordering, purchasing, or leasing of any good, facility, item, or service, for which payment may be made, in whole or in part, under federal healthcare programs, such as the Medicare and Medicaid programs.
     
  The Federal “Sunshine” law, which requires us to track and report annually to CMS information related to certain payments and other “transfers of value” provided to physicians (defined to include doctors, dentists, optometrists, podiatrists, and chiropractors) and teaching hospitals and to report annually to CMS ownership and investment interests held by physicians and their immediate family members. We are also subject to similar foreign “sunshine” laws or codes of conduct, which vary country by country.
     
  Federal civil and criminal false claims laws and civil monetary penalty laws, which prohibit, among other things, persons or entities from knowingly presenting, or causing to be presented, a false or fraudulent claim to, or the knowing use of false records or statements to obtain payment from, or approval by, the federal government. Suits filed under the False Claims Act, known as “qui tam” actions, can be brought by any individual on behalf of the government and such individuals, commonly known as “whistleblowers,” may share in any amounts paid by the entity to the government in fines or settlement. When an entity is determined to have violated the False Claims Act, it may be required to pay up to three times the actual damages sustained by the government, plus civil penalties for each separate false claim. Many of the physicians that use our products will file for reimbursement from governmental programs such as Medicare and Medicaid. As a result, we may be subject to the False Claims Act if we knowingly cause the filing of false claims.

 

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  HIPAA, which, among other things, created federal criminal laws that prohibit knowingly and willfully executing, or attempting to execute, a scheme or artifice to defraud any healthcare benefit program and knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false, fictitious or fraudulent statements in connection with the delivery of or payment for healthcare benefits, items or services.

 

Additionally, HIPAA, as amended by HITECH, and applicable implementing regulations, impose certain requirements relating to the privacy, security, and transmission of individually identifiable health information without appropriate authorization on entities subject to the law, such as health plans, clearinghouses, and healthcare providers and their business associates. Internationally, substantially every jurisdiction in which we operate has established its own data security and privacy legal framework with which we must comply, including the Data Protection Directive 95/46/EC and national implementation of the Directive in the member states of the European Union.

 

Many states have also adopted laws similar to each of the above federal laws, such as anti-kickback and false claims laws, which may be broader in scope and apply to items or services reimbursed by any third-party payor, including commercial insurers, as well as laws that restrict our marketing activities with healthcare professionals and entities, and require the Company to track and report payments and other transfers of value, including consulting fees, provided to healthcare professionals and entities. Some states mandate implementation of compliance programs to ensure compliance with these laws. Additionally, certain states require a certificate of need prior to the installation of a radiation device, such as the SRT-100. The Company is also subject to foreign fraud and abuse laws, which vary by country.

 

If the Company’s operations are found to be in violation of any of the laws or regulations described above or any other governmental laws or regulations that apply now or in the future, it may be subject to penalties, including administrative, civil, and criminal penalties; damages; fines; disgorgement; individual imprisonment; contractual damages; reputational harm; exclusion from governmental healthcare programs; and the curtailment or restructuring of its operations. Any of the foregoing could adversely affect the Company’s ability to operate its business and financial results.

 

Sensus is required to comply with medical device reporting requirements and must report certain malfunctions, deaths, and serious injuries associated with its products, which can result in voluntary corrective actions or agency enforcement actions.

 

Under the FDA’s medical device reporting regulations (21 CFR 803), medical device manufacturers are required to submit information to the U.S. Food and Drug Administration when they receive a report or become aware that a device has or may have caused or contributed to a death or serious injury or has or may have a malfunction that would likely cause or contribute to death or serious injury if the malfunction were to recur. All manufacturers placing medical devices on the market in the European Economic Area are legally bound to report any serious or potentially serious incidents involving devices they produce or sell (MEDDEV 2.12-1) to the competent authority in whose jurisdiction the incident occurred through the “European Vigilance” process.

 

If an event subject to medical device reporting requirements occurs, Sensus will need to comply with the reporting requirements, which would adversely affect its reputation and subject Sensus to actions by regulatory authorities, such as ordering recalls, imposing fines, or seizing the affected products. Furthermore, any corrective action, whether voluntary or involuntary, will require the dedication of time and capital and will distract management from business operations. Any of the foregoing would negatively impact Sensus’s reputation, business, and financial results.

 

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Healthcare policy changes may have a material adverse effect on Sensus’s business.

 

The Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act, included, among other things, comparative effectiveness research, an independent payment advisory board, payment system reforms (including shared savings pilots), and other provisions, one or more of which may significantly affect the payment for, and the availability of, healthcare services and may result in fundamental changes to federal healthcare reimbursement programs, any of which may materially affect numerous aspects of our business.

 

Other healthcare reform measures may result in more rigorous coverage criteria and in additional downward pressure on the reimbursement received for procedures utilizing our products. In addition, other legislative changes have been proposed and adopted since the law discussed above was enacted that may adversely affect Sensus’s revenues. Changes to existing laws may result in additional reductions in Medicare and other healthcare funding, which could have a material adverse effect on Sensus’s business and financial operations. Any reduction in reimbursement from Medicare or other government programs may result in a reduction in payments from private payors. The implementation of cost containment measures or other healthcare reforms may prevent Sensus from being able to increase revenue, attain profitability, or commercialize its devices. In addition, other legislative changes may be enacted or existing regulations, guidance, or interpretations may be changed, each of which may adversely affect our operations.

 

Risks Related to our Intellectual Property

 

If Sensus’s patents and other intellectual property rights do not adequately protect its products, it may lose market share to competitors and be unable to operate business profitably.

 

Sensus’s success significantly depends on its ability to protect proprietary rights to the technologies used in its products. Sensus relies on three U.S. patents and two foreign patents, as well as a combination of copyright, trade secret, and trademark laws, and nondisclosure, confidentiality, and other contractual restrictions, to protect its proprietary technology. Sensus also has patent applications currently pending and in the process of being submitted. However, these legal means afford only limited protection and may not adequately protect its rights or permit Sensus to gain or keep any competitive advantage. For example, some or all of the pending patent applications or any future pending applications may be unsuccessful. The U.S. Patent and Trademark Office may deny or require significant narrowing of claims in the pending patent applications or future patent applications, and patents issued as a result of these patent applications, if any, may not provide Sensus with significant commercial protection or be issued in a form that is advantageous. Sensus could also incur substantial costs in proceedings before the U.S. Patent and Trademark Office. These proceedings could result in adverse decisions as to the priority of its inventions and the narrowing or invalidation of claims in its issued patents. Third parties may successfully challenge issued patents and those that may be issued in the future, which would render these patents invalid or unenforceable, which in turn could limit Sensus’s ability to stop competitors from marketing and selling related products. In addition, pending patent applications include claims to aspects of Sensus’s products and procedures that are not currently protected by issued patents, and third parties may successfully patent those aspects before us or otherwise challenge our rights to these aspects.

 

Both the patent application process and the process of managing patent disputes can be time consuming and expensive. Competitors may be able to design around Sensus’s patents or develop products that provide outcomes that are comparable to Sensus’s products. Although Sensus has entered into confidentiality agreements and intellectual property assignment agreements with certain of its employees, consultants, and advisors in order to protect our intellectual property and other proprietary technology, these agreements may not be enforceable or may not provide meaningful protection for trade secrets or other proprietary information in the event of unauthorized use or disclosure or other breaches of the agreements. In addition, Sensus has not sought patent protection in all countries where it sells products. If Sensus fails to timely file a patent application in any such country or major market, Sensus may be precluded from doing so at a later date. Competitors may use Sensus’s technologies in jurisdictions where Sensus has not obtained patent protection to develop their own products and, further, may export otherwise infringing products to territories in which Sensus has patent protection that may not be sufficient to terminate infringing activities. Furthermore, the laws of some foreign countries may not protect intellectual property rights to the same extent as the laws of the U.S., if at all.

 

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In the event a competitor infringes upon one of Sensus’s patents or other intellectual property rights, enforcing those patents and rights may be difficult and time consuming. Even if successful, litigation to defend these patents against challenges or to enforce Sensus’s intellectual property rights could be expensive and time consuming and could divert management’s attention. Moreover, Sensus may not have sufficient resources to defend patents against challenges or to enforce intellectual property rights, any of which would adversely affect its ability to compete. Any of the foregoing would negatively impact Sensus’s business, operations, and financial results.

 

If Sensus’s trademarks or trade names are not adequately protected, then Sensus may be unable to build name recognition in markets of interest and its business may be adversely affected.

 

Sensus’s registered or unregistered trademarks or trade names may be challenged, infringed, circumvented, declared generic, or determined to infringe other marks. Sensus may be unable to protect the rights to these trademarks and trade names, which it needs to build name recognition by potential partners or customers in markets of interest. If these trademarks are challenged, infringed upon, circumvented, or declared generic or infringing, or if Sensus is unable to establish name recognition based on these trademarks and trade names, then it may be unable to compete effectively and Sensus’s business may be adversely affected.

 

The medical device industry is characterized by extensive patent litigation, and if Sensus becomes subject to litigation, it could be costly, result in the diversion of management’s attention, require us to pay significant damages or royalty payments, or prevent us from marketing and selling existing or future products.

 

The medical device industry is characterized by extensive litigation and administrative proceedings over patent and other intellectual property rights. Determining whether a product infringes a patent involves complex legal and factual issues. As the number of participants in the market for skin cancer and general oncology devices and treatments increases, the possibility of patent infringement claims against Sensus increases. Any infringement claims, litigation or other proceedings would place a significant strain on Sensus’s financial resources, divert the attention of management from the core business and harm Sensus’s reputation. Any of the foregoing could negatively impact Sensus’s business, operations, and financial results.

 

Adverse outcomes in litigation or similar proceedings could adversely impact business.

 

Sensus may in the future be named as a party to litigation or other similar legal proceedings. Adverse outcomes in any or all of these proceedings could result in monetary damages or injunctive relief that could adversely affect its ability to continue conducting business. If an unfavorable final outcome in any such matter becomes probable and reasonably estimable, the Company’s financial condition could be materially and adversely affected.

 

Risks Related to the Ownership of Sensus’s Securities

 

We have a history of net losses prior to 2021. If we do not maintain profitability, our financial condition and the value of our common stock could suffer.

 

The Company has a history of net losses. The historical losses from inception through December 31, 2021 totaled $17.8 million. The Company reported net income of $6.6 million and $0.5 million, respectively, during the years ended December 31, 2024 and 2023. The accumulated net loss was mainly related to the research and development expenses in the early stage of the Company. The Company is continuously managing expenses. However, there can be no assurances that this and other actions will result in the Company’s continued profitability.

 

Limited trading activity for shares of Sensus’s common stock may contribute to price volatility.

 

While Sensus’s common stock is listed and traded on the Nasdaq Capital Market, there has been limited trading activity in the Company’s shares. Due to the limited trading activity of Sensus’s common stock, relativity small trades may have a significant impact on the price of our common stock.  

 

The Company does not anticipate paying dividends for the foreseeable future. As a result, investors must rely on price appreciation of the Company’s common stock for a return on its investment in the foreseeable future. 

 

The Company expects to retain any funds and future earnings to support the operation, growth, and development of its business and does not anticipate paying any cash dividends on its common stock in the foreseeable future. As a result, a return on an investor’s investment in the near future will occur only if the Company’s share price appreciates. The Company’s common stock price may not appreciate in value or maintain the price at which an investor purchased these securities, and in either case, may not realize a return on investment or could lose all or part of an investment in the Company’s securities.

 

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Any future determination to declare cash dividends will be made at the discretion of the Company’s Board of Directors (the “Board of Directors”) and will be subject to compliance with applicable laws and covenants under any credit facilities, which may restrict or limit the Company’s ability to pay dividends. For example, the Company’s current revolving line of credit restricts the ability to pay dividends or make any distributions or payments or redeem, retire, or purchase any capital stock without the prior written consent of the lender, provided that the Company may pay dividends solely in common stock and, so long as no default has occurred under the line of credit, the Company may make certain redemptions of its common stock and pay certain tax distributions to its shareholders. Also, the form, frequency, and amount of dividends will depend upon the Company’s future operations and earnings, capital requirements and surplus, general financial condition, contractual restrictions, and other factors that the Board of Directors may deem relevant. Sensus may not pay dividends as a result of any of the foregoing, and in these cases, an investor would need to rely on price appreciation of the Company’s common stock for a return on investment.

 

Sensus is a “smaller reporting company,” and the reduced reporting requirements applicable to smaller reporting companies may make Sensus’s common stock less attractive to investors.  

 

As a smaller reporting company, Sensus can take advantage of certain reduced governance and disclosure requirements, including not being required to comply with the auditor attestation requirements in the assessment of internal control over financial reporting. As a result, investors and others may be less comfortable with the effectiveness of Sensus’s internal controls and the risk that material weaknesses or other deficiencies in internal controls go undetected may increase. In addition, as a smaller reporting company, Sensus takes advantage of the ability to provide certain other less comprehensive disclosures in our SEC filings, including, among other things, providing only two years of audited financial statements in annual reports and simplified executive compensation disclosures. Consequently, it may be more challenging for investors to analyze Sensus’s results of operations and financial prospects, as the information provided to stockholders may be different from what one might receive from other public companies in which one holds shares.

 

Sensus’s executive officers and directors may exert control over the Company and may exercise influence over matters subject to stockholder approval. 

 

Sensus’s executive officers and directors, together with their respective affiliates, beneficially owned approximately 8.5% of our outstanding common stock as of February 12, 2025. Accordingly, these stockholders, if they act together, may exercise substantial influence over matters requiring stockholder approval, including the election of directors and approval of corporate transactions, such as a merger. This concentration of ownership could have the effect of delaying or preventing a change in control or otherwise discourage a potential acquirer from attempting to obtain control over Sensus, which in turn could have a material adverse effect on the market value of Sensus’s common stock.

 

If securities or industry analysts do not publish research or publish unfavorable or inaccurate research about Sensus, the price of Sensus’s securities and trading volume could decline. 

 

The trading market for Sensus’s securities depends, in part, on the research and reports that securities or industry analysts publish about us. Sensus may be unable to attract or sustain coverage by well-regarded securities and industry analysts. If either none or only a limited number of securities or industry analysts cover Sensus, or if these securities or industry analysts are not widely respected within the general investment community, the trading price for Sensus’s securities would be materially and negatively impacted. In the event Sensus obtains securities or industry analyst coverage, if one or more of the analysts who cover Sensus downgrades the securities or publishes inaccurate or unfavorable research about the Company, the price of Sensus’s securities would likely decline. If one or more of these analysts cease coverage of Sensus, or fail to publish reports on Sensus regularly, demand for the Sensus’s securities could decrease, which might cause the price of its securities and trading volume to decline.

 

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The Company’s certificate of incorporation and bylaws, and Delaware law contain provisions that could discourage another company from acquiring the Company and may prevent attempts by the Company’s stockholders to replace or remove the current directors and management. 

 

Provisions of the Delaware General Corporation Law (“DGCL”) and the Company’s certificate of incorporation and bylaws may discourage, delay, or prevent a merger or acquisition that stockholders may consider favorable, including transactions in which an investor might otherwise receive a premium for its stock. In addition, these provisions may frustrate or prevent any attempts by the Company’s stockholders to replace or remove the current management by making it more difficult for stockholders to replace or remove directors from the Board of Directors. These provisions include:

 

  authorizing the issuance of “blank check” preferred stock without any need for action by stockholders;
     
  requiring supermajority stockholder voting to effect any merger or sale of all or substantially all of the Company’s stock and assets;
     
  eliminating the ability of stockholders to call and bring business before special meetings of stockholders;

 

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  prohibiting stockholder action by written consent;
     
  establishing advance notice requirements for nominations for election to the Board of Directors or for proposing matters that can be acted on by stockholders at stockholder meetings;
     
  dividing the Board of Directors into three classes so that only one third of the directors will be up for election in any given year; and
     
  providing that the Company’s directors may be removed only by the affirmative vote of at least 75% of the Company’s then-outstanding common stock and only for cause.

 

In addition, the Company is subject to Section 203 of the DGCL, which may have an anti-takeover effect with respect to transactions not approved in advance by the Board of Directors, including discouraging takeover attempts that could result in a premium over the market price for shares of the Company’s common stock. These provisions will apply even if a takeover offer may be considered beneficial by some stockholders and could delay or prevent an acquisition that the Board of Directors determines is not in the best interests of the Company and its stockholders and could also affect the price that some investors are willing to pay for the Company’s common stock.

 

The Company’s certificate of incorporation provides that the Court of Chancery of the State of Delaware is the exclusive forum for substantially all disputes between the Company and its stockholders, which could limit a stockholder’s ability to obtain a favorable judicial forum for disputes with the Company or its directors, officers, or employees. 

 

The Company’s certificate of incorporation provides that, unless the Company consents in writing to the selection of an alternative forum, the Court of Chancery of the State of Delaware is the exclusive forum for: any derivative action or proceeding brought on behalf of the Company; any action asserting a breach of fiduciary duty; any action asserting a claim against the Company arising pursuant to the DGCL, the Company’s certificate of incorporation, or bylaws; or any action asserting a claim against the Company that is governed by the internal affairs doctrine. This choice of forum provision may limit a stockholder’s ability to bring a claim in a judicial forum that it finds favorable for disputes with the Company or its directors, officers, or other employees, which may discourage these lawsuits against the Company and its directors, officers, and other employees. If a court were to find the choice of forum provision contained in the Company’s certificate of incorporation to be inapplicable or unenforceable in an action, the Company may incur additional costs associated with resolving the action in other jurisdictions, which could harm business and financial condition.

 

If the Company fails to maintain proper and effective internal controls, the Company’s ability to produce accurate and timely financial statements could be impaired and investors’ views of the Company or its business could be harmed, resulting in a decrease in value of the Company’s common stock. 

 

As a public company, the Company is required to maintain internal control over financial reporting and to report any material weaknesses in the Company’s internal controls. In addition, the Company is required to furnish a report by management on the effectiveness of the internal control over financial reporting pursuant to Section 404 of the Sarbanes-Oxley Act. In addition, the Company’s independent registered public accounting firm will be required to attest to the effectiveness of the internal control over financial reporting beginning with the Company’s annual report on Form 10-K following the date on which the Company no longer qualifies as a smaller reporting company. Compliance with Section 404 of the Sarbanes-Oxley Act will require the Company to incur substantial accounting expense and expend significant management efforts. If the Company is unable to comply with the requirements of Section 404 in a timely manner, or the Company and the independent registered public accounting firm identify deficiencies in the internal control over financial reporting that are deemed to be material weaknesses, the market price of the Company’s common stock could decline and the Company could be subject to sanctions or investigations by Nasdaq, the SEC, or other regulatory authorities, which would require additional financial and management resources.

 

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In connection with the preparation of our Quarterly Report on Form 10-Q for the quarter ended June 30, 2024, we identified a material weakness in our internal control over financial reporting. A material weakness is a deficiency, or a combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of our annual or interim financial statements will not be prevented or detected on a timely basis. We have since enhanced our internal control environment and remediated this material weakness. However, we cannot guarantee that we will not identify different material weaknesses in the future.

 

Item 1B. UNRESOLVED STAFF COMMENTS

 

The Company has no unresolved comments from the SEC staff relating to the Company’s periodic or current reports filed with the SEC pursuant to the Securities Exchange Act of 1934, as amended (the “Exchange Act”).

 

Item 1C. CYBERSECURITY

 

Cybersecurity Risk Management and Processes

 

Sensus is actively working towards the integration of a cybersecurity risk management program into its comprehensive risk management framework to protect the confidentiality, integrity, and availability of its critical systems and information.

 

Our cybersecurity risk management program is being designed based on various cybersecurity frameworks, including National Institute of Standards and Technology and the Center for Internet Security, as well as information security standards issued by the International Organization for Standardization, including ISO 27001 and ISO 27002. The Company uses these frameworks and information security standards as a guide to identify, assess, and management cybersecurity risks relevant to the business.

 

The Company has implemented or is implementing the following key elements into the cybersecurity risk management program:

 

  Formalization and implementation of robust IT security policies;

 

  Conducting vulnerability assessments;

 

  Revision of user access request documentation to clearly define the roles and permissions assigned to users;

 

  Thorough review of the accuracy and completeness of user listings and access;

 

  Preservation of evidence related to system modifications; and

 

  Continued collaboration with external specialists to aid in the ongoing evaluation of existing policies and procedures.

 

In addition, the Company has a strategic plan, which encompasses the following key elements:

 

  Establishment of a dedicated cybersecurity governance committee;

 

  Standardization of cybersecurity incident response procedures and formats;

 

  Conducting penetration tests on a quarterly basis;

 

  Enhancement of segregation of duties to mitigate the risk of self-review of transactions within the system;

 

The Company has not identified any risks from known cybersecurity threats and did not have any cybersecurity incidents that have materially affected or are reasonably likely to materially affect the Company. For a discussion of whether and how any risks from cybersecurity threats are reasonably likely to materially affect us, refer to Item 1A. Risk Factors – “The Company’s operations may be impaired if our information technology systems fail to perform adequately or are the subject of a data breach or cyberattack,” which is incorporated by reference into this Item 1C.

 

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Cybersecurity Governance

 

The Board of Directors actively collaborates with management to supervise cybersecurity risks. The Chief Technology Officer (“CTO”), with over 10 years’ experience in cybersecurity, leads the Company’s overall cybersecurity function and monitors cybersecurity risks. The CTO works with internal personnel and third-party consultants to design and implement the controls on the prevention, detection, mitigation, and remediation of cybersecurity risks. The CTO maintains regular communication with the Board on matters related to cybersecurity and provides updates to management on a quarterly basis. In the event of a cybersecurity incident, the Board is to be promptly notified.

 

Management considers cybersecurity risk as part of its risk oversight function and is in the process of establishing a cybersecurity governance committee. The cybersecurity governance committee will oversee the management’s implementation of the cybersecurity risk management program.

 

Item 2. PROPERTIES

 

The Company’s corporate headquarters is located in Boca Raton, Florida and occupies a total of 10,356 square feet of space under a lease and a sublease that both expire in September 2027. The Company believes that the current facilities are suitable and adequate to meet the Company’s current needs and that suitable additional space will be available as and when needed. The Company’s main manufacturing function is physically located at our third-party manufacturer’s facility in Oak Ridge, Tennessee. Additional disclosures have been included within Note 6, Commitments and Contingencies, of the consolidated financial statements.

 

Item 3. LEGAL PROCEEDINGS

 

From time to time, Sensus is party to certain legal proceedings in the ordinary course of business. Management, after consultation with legal counsel, currently does not anticipate that the aggregate liability arising out of these legal proceedings will have a material effect on Sensus’s results of operations, financial position, or cash flows and have assessed that there is no need to record a liability for these legal proceedings and related contingencies. Additional disclosures have been included within Note 6, Commitments and Contingencies, of the consolidated financial statements.

 

Item 4. MINE SAFETY DISCLOSURE

 

Not applicable. 

 

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PART II.

 

Item 5. MARKET FOR THE REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES

 

Market Information

 

The Company’s Class A common stock is publicly traded on the NASDAQ Capital Market under the symbol “SRTS.”

 

Holders

 

At the close of business on February 13, 2025, there were 17 common stockholders of record. This does not include “street name” or beneficial owners, whose shares are held of record by banks, brokers, and other financial institutions.

 

Dividends

 

The Company has never declared or paid any dividends on its common stock and anticipates that for the foreseeable future all earnings will be retained for use rather than paid out as dividends. Any future payment of cash dividends will be dependent upon the Company’s financial condition, results of operations, current and anticipated cash requirements, and plans for expansion, as well as other factors that the Board of Directors deems relevant. Additionally, certain contractual agreements and provisions of Delaware law impose restrictions on our ability to pay dividends. For example, the Company’s current revolving line of credit restricts the ability to pay dividends or make any distributions or payments or redeem, retire, or purchase any capital stock without the prior written consent of the lender, provided that the Company may pay dividends solely in common stock without prior consent. Additionally, Section 170(a) of the DGCL only permits dividends to be paid out of two legally available sources: (1) out of surplus, or (2) if there is no surplus, out of net profits for the year in which the dividend is declared or the preceding year (so-called “nimble dividends”). However, dividends may not be declared or paid out of net profits if “the capital of the corporation, computed in accordance with sections 154 and 244 of the DGCL, shall have been diminished by depreciation in the value of its property, or by losses, or otherwise, to an amount less than the aggregate amount of the capital represented by the issued and outstanding stock of all classes having a preference upon the distribution of assets.” Contractual obligations and applicable law will restrict the ability to declare and pay dividends in the future.

 

Unregistered Sales of Securities

 

There were no unregistered sales of securities during the year ended December 31, 2024.

 

Purchases of Equity Securities by the Registrant and Affiliated Purchasers

 

In August 2023, the Company announced that its Board of Directors had authorized a program to purchase up to $3,000,000 of shares of its common stock. Purchases may be made in a variety of methods, including open market, from time to time, depending upon market conditions, including the market price of the common stock, and other factors. The program has no time limit and may be modified, suspended, or discontinued at any time. No purchases were made during the fourth quarter of 2024 by or on behalf of the Company.

 

Item 6. RESERVED

 

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Item 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

 

You should read the following management’s discussion and analysis (“MD&A”) in conjunction with the information set forth within the financial statements and related notes included in this Annual Report on Form 10-K.

 

Overview

 

As discussed elsewhere in this Report, Sensus achieved profitability for the first time in 2021, maintained profitability in 2023 and 2024, and seeks to maintain and increase profitability in 2025 by, among other things, increasing sales and managing operational expenses where necessary in order to continue to invest in research and development of new products and marketing initiatives to promote the Company’s products. However, Sensus faces a number of uncertainties in 2025 that could impact our ability to achieve this goal. These include inflation and international trade issues. Either of these matters could adversely affect the Company’s ability to do business in a number of countries and geographic regions, including China.

 

Components of our results of operations

 

Sensus manages its business globally within one reportable segment, which is consistent with how management views the business, prioritizes investment and resource allocation decisions, and assesses operating performance.

 

Results of Operations

 

   For the Years Ended 
   December 31, 
(in thousands, except shares and per share data)  2024   2023 
         
Revenues  $41,807   $24,405 
Cost of sales   17,376    10,345 
Gross profit   24,431    14,060 
Operating expenses          
General and administrative   7,147    5,156 
Selling and marketing   4,978    5,608 
Research and development   4,216    3,678 
Total operating expenses   16,341    14,442 
Income (loss) from operations   8,090    (382)
Other income:          
Gain on sale of assets       42 
Interest income   932    992 
Other income, net   932    1,034 
Income before income tax   9,022    652 
Provision for income taxes   2,375    167 
Net income  $6,647   $485 
Net income per share – basic  $0.41   $0.03 
diluted  $0.41   $0.03 
Weighted average number of shares used in computing net income per share – basic   16,312,351    16,259,254 
diluted   16,359,616    16,266,139 

 

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2024 Compared with 2023

 

Revenues of $41.8 million in 2024 increased by $17.4 million, or 71%, from $24.4 million in 2023. The increase was primarily driven by a higher number of units sold, with 115 units sold in the year ended December 31, 2024 compared to 67 units sold in the year ended December 31, 2023.

 

Cost of sales of $17.4 million in 2024 increased by $7.1 million, or 69%, from $10.3 million in 2023. The increase in cost of sales was primarily related to a higher number of units sold in the year ended December 31, 2024 compared to the year ended December 31, 2023.

 

Gross profit of $24.4 million, or 58.4% of revenue, in 2024 increased by $10.3 million, or 73%, from $14.1 million, or 57.8% of revenue, in 2023. The increase in gross profit was primarily driven by a higher number of units sold in the year ended December 31, 2024 compared to the year ended December 31, 2023.

 

General and administrative expenses of $7.1 million in 2024 increased by $1.9 million, or 37%, from $5.2 million in 2023. The net increase in general and administrative expense was primarily due to higher compensation, professional fees and bad debt expense, which were offset by a reduction in bank fees and insurance expense.

 

Selling and marketing expenses of $5.0 million in 2024 decreased by $0.6 million, or 11%, from $5.6 million in 2023. The decrease was primarily attributable to the decrease in marketing agency expense, travel expense, and payroll cost due to lower headcount. 

 

Research and development expenses of $4.2 million in 2024 increased by $0.5 million, or 14%, from $3.7 million in 2023. The increase was primarily due to higher compensation expenses and existing product development cost offset by a decrease in expenses related to a project to develop a drug delivery system for aesthetic use during 2024. 

 

Other income, net of $0.9 million and $1.0 million in the years ended December 31, 2024 and 2023, respectively, relate primarily to interest income.

 

Cash and cash equivalents of $22.1 million at December 31, 2024 decreased by $1.0 million, or 4%, from $23.1 million at December 31, 2023. See Cash flows for details on the change in cash and cash equivalents during the year ended December 31, 2024.

 

Accounts receivable, net of $19.7 million at December 31, 2024 increased by $9.1 million, or 86%, from $10.6 million at December 31, 2023, primarily due to the increase in sales to the Company’s primary customer that is subject to extended payment terms.

 

Inventories of $10.1 million at December 31, 2024 decreased by $1.8 million, or 15%, from $11.9 million at December 31, 2023, primarily due to a shipments of units sold during the year ended December 31, 2024.

 

Liabilities

 

There were no borrowings under our revolving lines of credit at December 31, 2024 or December 31, 2023. See Note 3, Debt, to the consolidated financial statements for further discussion.

 

 25

 

 

Liquidity and Capital Resources

 

Overview

 

In general terms, liquidity is a measurement of the Company’s ability to meet its cash needs. For the year ended December 31, 2024, funding was derived primarily from cash generated by the sale of equipment to our customers in the ordinary course of business. The Company believes that proceeds from maturing cash equivalents, as well as the Company’s borrowing capacity under its existing line of credit and access to capital resources are sufficient to meet operating capital and funding requirements for the next 12 months from the date of this annual report. Please see Note 3, Debt, to the consolidated financial statements for a discussion regarding the Company’s revolving credit facility with Comerica Bank. The Company’s liquidity position and capital requirements may be impacted by a number of factors, including the following:

 

  ability to generate and increase revenue; and
     
  fluctuations in gross margins, operating expenses, and net results.

 

The Company’s primary short-term capital needs, which are subject to change, include expenditures related to:

 

  expansion of sales and marketing activities; and
     
  continuation of research and development activities.

  

Sensus’s management regularly evaluates cash requirements for current operations, commitments, capital requirements, and business development transactions, and may seek to raise additional funds for these purposes in the future. However, there can be no assurance that it will be able to raise such funds or the terms on which such funds may be raised, if at all.

 

Cash flows

 

The following table provides a summary of the Company’s cash flows for the periods indicated:

 

   For the Years Ended 
    December 31 
(in thousands)  2024   2023 
Net cash provided by (used in):          
Operating activities  $(831)  $(2,145)
Investing activities   (276)   (187)
Financing activities   15    (40)
Total  $(1,092)  $(2,372)

 

Cash flows from operating activities 

 

Net cash used in operating activities was $0.8 million for the year ended December 31, 2024, consisting of net income of $6.6 million and non-cash charges of $1.1 million, offset by an increase in net operating assets of $8.5 million. Cash flows provided by operating activities primarily include the receipt of revenues offset by the payment of operating expenses incurred in the normal course of business. Non-cash items consisted of credit loss expense, deferred income taxes, stock-based compensation expense, provision for product warranties, amortization of right-of-use asset and depreciation and amortization of property and equipment. Net cash used in operating activities was $2.1 million for the year ended December 31, 2023, consisting of net income of $0.5 million and non-cash charges of $1.0 million, offset by a decrease in net operating liabilities of $3.6 million. Non-cash charges consisted of credit loss expense, deferred income taxes, stock-based compensation expense, provision for product warranties, amortization of right-of-use asset, depreciation and amortization of property and equipment and gain on sale of assets.

 

 26

 

 

Cash flows from investing activities

 

Net cash used in investing activities during the year ended December 31, 2024 reflected $0.3 million of purchases of property and equipment. Net cash used in investing activities during the year ended December 31, 2023 mainly reflected $0.2 million of purchases of property and equipment.

 

Cash flows from financing activities

 

Net cash provided by financing activities during the year ended December 31, 2024 reflected $67 thousand of exercised stock options, offset by $52 thousand of withholding taxes on stock-based compensation. Net cash used in financing activities during the year ended December 31, 2023 reflected $27 thousand of repurchases of common stock and $59 thousand of withholding taxes on stock-based compensation, offset by $46 thousand of exercised stock options.

 

Inflation

 

During 2024, increased commodity and shipping prices and energy and labor costs resulted in inflationary pressures across various parts of our business and operations, including on our customers, partners, and suppliers. We continue to monitor the impact of inflation and we are taking actions, such as ordering inventory in advance, to minimize its effects on our product cost and sales.

 

Indebtedness

 

Please see Note 3, Debt, to the consolidated financial statements.

 

Contractual Obligations and Commitments

 

Please see Note 6, Commitments and Contingencies, to the consolidated financial statements.

 

Critical Accounting Policies and Estimates

 

The preparation of the consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the consolidated financial statements and the reported amounts of revenue and expense during the reporting periods. Management has not applied any critical accounting estimates but has identified certain accounting policies as critical to understanding the financial condition and results of operations. For a detailed discussion on the application of these and other accounting policies, see the notes to the consolidated financial statements included in this Annual Report on Form 10-K.

 

Item 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURE ABOUT MARKET RISK

 

Not applicable.

 

 27

 

 

Item 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA

 

FINANCIAL STATEMENTS OF SENSUS HEALTHCARE, INC.

 

CONTENTS

 

Report of Independent Registered Public Accounting Firm (PCAOB ID 52)   F-2
Report of Independent Registered Public Accounting Firm (PCAOB ID 688)   F-4
Financial Statements    
Consolidated Balance Sheets as of December 31, 2024 and 2023   F-6
Consolidated Statements of Income for the years ended December 31, 2024 and 2023   F-7
Consolidated Statements of Stockholders’ Equity for the years ended December 31, 2024 and 2023   F-8
Consolidated Statements of Cash Flows for the years ended December 31, 2024 and 2023   F-9
Notes to the Consolidated Financial Statements   F-10

 

F-1

 

 

 

 

REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

 

To the Board of Directors and
Stockholders of Sensus Healthcare, Inc. and Subsidiaries

 

Opinion on the Financial Statements

 

We have audited the accompanying consolidated balance sheet of Sensus Healthcare, Inc. and Subsidiaries (the “Company”) as of December 31, 2024, and the related consolidated statement of income, stockholders’ equity, and cash flows for the year then ended, and the related notes (collectively referred to as the “consolidated financial statements”). In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2024, and the results of its operations and its cash flows for the year then ended, in conformity with accounting principles generally accepted in the United States of America.

 

As described in Notes 1 and 12, the Company adopted Accounting Standards Update No. 2023-07, “Segment Reporting ("Topic 280"): Improvements to Reportable Segment Disclosures,” as of January 1, 2024, which is retrospectively applied to January 1, 2023. Except for the effects of the retrospective presentation for the adoption of Topic 280, we were not engaged to audit, review, or apply any procedures to the financial position of the Company as of December 31, 2023, and the results of its operations and its cash flows for the year then ended, other than as stated above and, accordingly, we do not express an opinion or any other form of assurance about whether such financial position has been fairly stated as of December 31, 2023 and for the year then ended. Those balances were audited by the predecessor auditor.

 

Basis for Opinion

 

These consolidated financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s consolidated financial statements based on our audit. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.

 

We conducted our audit in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the consolidated financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audit, we are required to obtain an understanding of internal control over financial reporting, but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.

 

Our audit included performing procedures to assess the risks of material misstatement of the consolidated financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the consolidated financial statements. Our audit also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the consolidated financial statements. We believe that our audit provides a reasonable basis for our opinion.

 

MIAMI    |    FT. LAUDERDALE    |    BOCA RATON    |    WEST PALM BEACH    |    NEW YORK CITY

 

F-2

 

 

Critical Audit Matters

 

Critical audit matters are matters arising from the current period audit of the financial statements that were communicated or required to be communicated to the audit committee and that: (1) relate to accounts or disclosures that are material to the financial statements and (2) involved our especially challenging, subjective, or complex judgments. We determined that there are no critical audit matters.

 

/s/ Berkowitz Pollack Brant, Advisors + CPAs

   
We have served as the Company’s auditor since 2024.
   
West Palm Beach, FL
   
March 5, 2025  

 

F-3

 

 

REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

 

To the Stockholders and Board of Directors of

Sensus Healthcare, Inc.

 

Opinion on the Financial Statements

 

We have audited, before the effects of the retrospective presentation adjustments for the adoption of ASU No. 2023-07, Segment Reporting, discussed in Note 1 and 12 to the consolidated financial statements, the accompanying consolidated balance sheet of Sensus Healthcare, Inc. (the “Company”) as of December 31, 2023, the related consolidated statements of income, stockholders’ equity and cash flows for the year ended December 31, 2023 and the related notes (collectively referred to as the “consolidated financial statements”). In our opinion, before the effects of the retrospective presentation adjustments for the adoption of ASU No. 2023-07, Segment Reporting, discussed in Note 1 and 12 to the consolidated financial statements, the financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2023, and the results of its operations and its cash flows for the year ended December 31, 2023, in conformity with accounting principles generally accepted in the United States of America.

 

We were not engaged to audit, review, or apply any procedures to the retrospective presentation adjustments for the adoption of ASU No. 2023-07, Segment Reporting discussed in Note 1 and 12 to the consolidated financial statements, and accordingly, we do not express an opinion or any other form of assurance about whether such retrospective presentation adjustments are appropriate and have been properly applied. Those retrospective presentation adjustments were audited by other auditors.

 

Basis for Opinion

 

These financial statements are the responsibility of the Company's management. Our responsibility is to express an opinion on the Company's financial statements based on our audit. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) ("PCAOB") and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.

 

We conducted our audit in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audit we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company's internal control over financial reporting. Accordingly, we express no such opinion.

 

F-4

 

 

Sensus Healthcare, Inc.

March 15, 2024

Page 2

 

Our audit included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements. Our audit also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that our audit provides a reasonable basis for our opinion.

 

Critical Audit Matters

 

Critical audit matters are matters arising from the current period audit of the financial statements that were communicated or required to be communicated to the audit committee and that: (1) relate to accounts or disclosures that are material to the financial statements and (2) involved our especially challenging, subjective, or complex judgments. We determined that there are no critical audit matters.

 

Marcum LLP

 

We served as the Company’s auditor from 2012 through 2024.

 

Tampa, Florida 

March 15, 2024

 

F-5

 

 

SENSUS HEALTHCARE, INC.
CONSOLIDATED BALANCE SHEETS

 

   As of   As of 
   December 31,   December 31, 
(in thousands, except shares and per share data)  2024   2023 
           

Assets 

          
Current assets          
Cash and cash equivalents  $22,056   $23,148 
Accounts receivable, net   19,731    10,645 
Inventories   10,097    11,861 
Prepaid inventory   3,347    2,986 
Other current assets   1,507    888 
Total current assets   56,738    49,528 
Property and equipment, net   1,997    464 
Deferred tax asset   2,197    2,140 
Operating lease right-of-use asset, net   581    774 
Other noncurrent assets   652    804 
Total assets  $62,165   $53,710 
Liabilities and stockholders’ equity          
Current liabilities          
Accounts payable and accrued expenses  $4,811   $2,793 
Product warranties   329    538 
Operating lease liability, current portion   204    187 
Income tax payable       37 
Deferred revenue, current portion   541    657 
Total current liabilities   5,885    4,212 
Operating lease liability   398    596 
Deferred revenue, net of current portion   55    60 
Total liabilities   6,338    4,868 
Commitments and contingencies          
Stockholders’ equity          
Preferred stock, 5,000,000 shares authorized and none issued and outstanding        
Common stock, $0.01 par value – 50,000,000 authorized; 17,036,845 issued and 16,495,396 outstanding at December 31, 2024; 16,907,095 issued and 16,374,171 outstanding at December 31, 2023   169    169 
Additional paid-in capital   45,795    45,405 
Treasury stock, 541,449 and 532,924 shares at cost, at December 31, 2024 and December 31, 2023, respectively    (3,571)   (3,519)
Retained earnings   13,434    6,787 
Total stockholders’ equity   55,827    48,842 
Total liabilities and stockholders’ equity  $62,165   $53,710 

  

See accompanying notes to the consolidated financial statements.

 

F-6

 

 

SENSUS HEALTHCARE, INC.
CONSOLIDATED STATEMENTS OF INCOME

 

             
   For the Years Ended 
   December 31, 
(in thousands, except shares and per share data)  2024   2023 
         
Revenues  $41,807   $24,405 
Cost of sales   17,376    10,345 
Gross profit   24,431    14,060 
Operating expenses          
General and administrative   7,147    5,156 
Selling and marketing   4,978    5,608 
Research and development   4,216    3,678 
Total operating expenses   16,341    14,442 
Income (loss) from operations   8,090    (382)
Other income:          
Gain on sale of assets       42 
Interest income, net   932    992 
Other income, net   932    1,034 
Income before income tax   9,022    652 
Provision for income taxes   2,375    167 
Net income  $6,647   $485 
Net income per share – basic  $0.41   $0.03 
diluted  $0.41   $0.03 
Weighted average number of shares used in          
computing net income per share – basic   16,312,351    16,259,254 
diluted   16,359,616    16,266,139 

 

See accompanying notes to the consolidated financial statements.

 

F-7

 

 

SENSUS HEALTHCARE, INC.
CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY

 

FOR THE YEARS ENDED DECEMBER 31, 2024 AND 2023

 

                                     
(in thousands,  Common Stock   Additional Paid-In   Treasury Stock   Retained     
except shares)  Shares   Amount   Capital   Shares   Amount   Earnings   Total 
                             
December 31, 2022   16,902,761   $169   $45,031    (512,342)  $(3,433)  $6,302   $48,069 
Stock-based compensation   10,000        359                359 
Exercise of stock options   8,334        46                46 
Stock repurchase               (9,427)   (27)       (27)
Forfeiture of restricted stock units   (14,000)       (31)                 (31)
Surrender of shares for tax withholding on stock-based compensation               (11,155)   (59)       (59)
Net income                       485    485 
December 31, 2023   16,907,095   $169   $45,405    (532,924)  $(3,519)  $6,787   $48,842 
Stock-based compensation   120,000        325                325 
Exercise of stock options   12,000        67                67 
Forfeiture of restricted stock units   (2,250)       (2)               (2)
Surrender of shares for tax withholding on stock-based compensation               (8,525)   (52)       (52)
Net income                        6,647    6,647 
December 31, 2024   17,036,845   $169   $45,795    (541,449)  $(3,571)  $13,434   $55,827 

 

See accompanying notes to the consolidated financial statements. 

 

F-8

 

 

SENSUS HEALTHCARE, INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS

 

             
   For the Years Ended
December 31,
 
(in thousands)  2024   2023 
Cash flows from operating activities        

Net income

  $6,647   $485 
Adjustments to reconcile net income to net cash and cash equivalents used in operating activities:          
Credit loss expense   123    7 
Depreciation and amortization   239    275 
Gain on sale of assets       (42)
Amortization of right-of-use asset   193    186 
Provision for product warranties   255    603 
Stock-based compensation   323    328 
Deferred income taxes   (57)   (427)
Changes in operating assets and liabilities:          
Accounts receivable   (9,209)   6,647 
Inventories   268    (8,577)
Prepaid inventory   (361)   3,275 
Other current assets   (619)   (228)
Other noncurrent assets   152    (312)
Accounts payable and accrued expenses   2,018    (2,728)
Operating lease liability   (181)   (201)
Income tax payable   (37)   (853)
Deferred revenue   (121)   (115)
Product warranties   (464)   (468)
Net cash used in operating activities   (831)   (2,145)
Cash flows from investing activities          
Acquisition of property and equipment   (276)   (229)
Proceeds from sale of assets       42 
Net cash used in investing activities   (276)    (187) 
Cash flows from financing activities          
Repurchase of common stock       (27)
Withholding taxes on stock-based compensation   (52)   (59)
Exercise of stock options   67    46 
Net cash provided by (used in) financing activities   15    (40) 
Net decrease in cash and cash equivalents   (1,092)   (2,372)
Cash and cash equivalents – beginning of year   23,148    25,520 
Cash and cash equivalents – end of year  $ 22,056   $ 23,148 
Supplemental disclosure of cash flow information:          
Interest paid  $   $ 
Income tax paid  $2,582   $1,440 
Supplemental schedule of noncash investing and financing transactions:          
Transfer of inventory to property and equipment  $1,496   $217 

 

See accompanying notes to the consolidated financial statements. 

 

F-9

 

 

SENSUS HEALTHCARE, INC.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS

 

Note 1 — Organization and Summary of Significant Accounting Policies

 

Description of the Business

 

Sensus Healthcare, Inc. (together, with its subsidiaries, unless the context otherwise indicates, “Sensus” or the “Company”) is a manufacturer of radiation therapy devices and sells the devices to healthcare providers globally through its distribution and marketing network. The Company operates from its corporate headquarters located in Boca Raton, Florida.

 

In 2024, the Company formed Sensus Healthcare Services, LLC, a wholly-owned subsidiary that provides operational healthcare services in the form of equipment, radiation oncology and physics oversight, including radiotherapy technologists for dermatology clinics.

 

Basis of Presentation and Principles of Consolidation

 

These consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States (“GAAP”) and include the accounts of the Company and its subsidiaries. Accounts and transactions between consolidated entities have been eliminated.

 

Use of Estimates

 

The preparation of consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, including disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenue and expense during the reporting periods. Actual results could differ from those estimates.

 

Change in Accounting Estimate

 

In the fourth quarter of 2023, the Company changed its estimate that it was probable that it would make commission payments to certain of its employees as compensation expense. As it was no longer probable that the payments would be made, the Company reversed the accrued compensation expense, which was included in accounts payable and accrued expenses in the consolidated balance sheets, related to these payments. This change in estimate resulted in a decrease in selling and marketing expenses of $853,500, or $0.05 per share (basic and diluted) for the year ended December 31, 2023.

 

Revenue Recognition

 

The Company’s revenue is derived from sales of the Company’s devices and services related to operating, maintaining and repairing the devices as part of a contract or on an ad-hoc basis without a service contract.

 

The Company provides warranties, generally for one year, in conjunction with the sale of its products. These warranties entitle the customer to repair, replacement, or modification of the defective product, subject to the terms of the relevant warranty. The Company has determined that these warranties do not represent separate performance obligations, as the customer does not have the option to purchase the warranty separately and the warranty does not provide the customer with a service in addition to the assurance that the product complies with agreed-upon specifications. The Company records an estimate of future warranty claims at the time it recognizes revenue from the sale of the device based upon management’s estimate of the future claims rate.

 

Revenue is recognized upon transfer of control of promised goods or services to customers when the product is shipped or the service is rendered, based on the amount the Company expects to receive in exchange for those goods or services. The Company enters into contracts that can include multiple services, which are accounted for separately if they are determined to be distinct.

 

F-10

 

 

To determine the transaction price for contracts in which a customer promises consideration in a form other than cash, the Company measures the estimated fair value of the noncash consideration at contract inception. If the Company cannot reasonably estimate the fair value of the noncash consideration, the Company measures the consideration indirectly by reference to the stand-alone selling price of the products promised to the customer or class of customer in exchange for the consideration.

 

Our service contracts include maintenance or repair service for device purchases and personnel service contracts to assist in the use and operation of leased-out equipment under lease agreements where the Company is the lessor.

 

The revenues from maintenance or repair service contracts are recognized over the service contract period on a straight-line basis. In the event that a customer does not sign a service contract, but requests maintenance or repair services after the warranty expires, the Company recognizes revenue when the service is rendered. There is no termination provision in the service contract or any penalties in practice for cancellation of the service contract.

 

The revenues from personnel service contracts are recognized in the period that the work is performed, as the Company has elected the practical expedient under Accounting Standards Codification ("ASC") 606, Revenue from Contracts with Customers, to recognize revenue in the amount to which the entity has a right to invoice. The service contracts can be terminated by mutual written agreement.

 

The Company has determined that in practice no significant discount is given on service contracts when offered with the device purchase or equipment lease as compared to when sold on a stand-alone basis. The service level provided is identical whether the service contract is purchased on a stand-alone basis or together with the device purchase or equipment lease. The Company may also incur preparation cost to ensure the customer’s space meets the requirements and specifications for the operation of the equipment. The preparation cost is expensed as incurred.

 

The components of disaggregated revenue for the years ended December 31, 2024 and 2023 were as follows: 

 

   For the Years Ended 
   December 31, 
(in thousands)  2024   2023 
Product Revenue - recognized at a point in time  $36,398   $20,347 
Product Revenue - recognized over time   247     
Service Revenue - recognized at a point in time   1,961    1,261 
Service Revenue - recognized over time   3,201    2,797 
Total Revenue  $41,807   $24,405 

 

The Company operates in a highly regulated environment, primarily in the U.S. dermatology market, in which state regulatory approval is sometimes required prior to the customer being able to use the product. In cases where such regulatory approval is pending, revenue is deferred until such time as regulatory approval is obtained.

 

F-11

 

 

Deferred revenue activity for 2024 and 2023 was as follows:

 

(in thousands)   Product   Service   Total 
December 31, 2022  $45   $787   $832 
Revenue recognized   (45)   (2,797)   (2,842)
Amounts invoiced   36    2,691    2,727 
December 31, 2023  $36   $681   $717 
Revenue recognized   (300)   (3,201)   (3,501)
Amounts invoiced   345    3,035    3,380 
December 31, 2024  $81   $515   $596 

 

Remaining performance obligations related to deposits for products have original expected durations of one year or less. Estimated service revenue to be recognized in the future related to the performance obligations that are unsatisfied (or partially unsatisfied) as of December 31, 2024 is as follows:

 

Year   Service Revenue 
2025    461 
2026    44 
2027    10 
Total   $515 

  

For the years ended December 31, 2024 and 2023, the Company paid commissions for certain equipment sales. Because the recovery of commissions is expected to occur from product revenue within one year, the Company charges commissions to expense as incurred.

 

In addition, the Company incurs commissions associated with equipment lease agreements, which are accounted for as initial direct costs and recorded in other noncurrent assets in the consolidated balance sheets. The commission is capitalized at the commencement of the lease and recognized as an expense in selling and marketing expenses over the lease term.

 

Shipping and handling costs are expensed as incurred and are included in cost of sales.

 

Concentration

 

Financial instruments that potentially subject the Company to concentration of credit risk consist primarily of cash and cash equivalents and accounts receivable.

 

The Company maintains cash balances at financial institutions in excess of federally insured limits. The Company has not experienced any losses related to these balances. The Federal Deposit Insurance Corporation insures eligible accounts up to $250,000 per depositor at each financial institution. The Company holds cash at well-known banks and does not believe that it is exposed to any significant credit risks on its cash.

 

One customer in the U.S. accounted for 73% and 61% of revenue for the years ended December 31, 2024 and 2023, respectively, and 86% and 85% of accounts receivable as of December 31, 2024 and 2023, respectively.

 

F-12

 

 

Geographical Information

 

The following table illustrates total revenue for the years ended December 31, 2024 and 2023 by geographic region.

 

   For the Years Ended 
   December 31, 
(in thousands)  2024   2023 
United States  $40,180    96%  $22,279    91%
China   1,445    3%   1,491    6%
Israel   172    1%   43    0%
Turkey       0%   265    1%
Guatemala       0%   190    1%
Ireland       0%   135    1%
Other   10    0%   2    0%
Total Revenue  $41,807    100%  $24,405    100%

 

Fair Value of Financial Instruments

 

Carrying amounts of cash equivalents, accounts receivable, accounts payable and the revolving credit facility approximate fair value due to their relative short maturities.

 

Fair Value Measurements

 

The Company uses a fair value hierarchy that prioritizes inputs to valuation approaches used to measure fair value. The fair value hierarchy gives the highest priority to quoted prices (unadjusted) in active markets for identical assets or liabilities and the lowest priority to unobservable inputs. Assets and liabilities measured and reported at fair value are classified and disclosed in one of the following categories:

 

Level 1 Inputs:

 

Quoted prices (unadjusted) in active markets for identical assets or liabilities at the reporting date.

 

  Level 1 assets may include listed mutual funds, ETFs and listed equities

 

Level 2 Inputs:

 

Quoted prices for similar assets or liabilities in active markets; quoted prices for identical or similar assets or liabilities that are not active; quotes from pricing services or brokers for which the Company can determine that orderly transactions took place at the quoted price or that the inputs used to arrive at the price are observable; and inputs other than quoted prices that are observable, such as models or other valuation methodologies. 

 

  Level 2 assets may include debt securities and foreign currency exchange contracts that have inputs to the valuations that generally can be corroborated by observable market data.

 

Level 3 Inputs:

 

Unobservable inputs for the valuation of the asset or liability, which may include nonbinding broker quotes.

 

  Level 3 assets include investments for which there is little, if any, market activity. These inputs require significant management judgment or estimation.

 

Significance of Inputs: The Company’s assessment of the significance of a particular input to the fair value measurement in its entirety requires judgment and considers factors specific to the financial instrument.

 

F-13

 

 

Foreign Currency

 

The Company’s foreign operation functional currency is the U.S. dollar. The Company considers its Israel subsidiary an extension of the parent company operations in the United States. The cash flow in the foreign operation depends primarily on the funding by the parent company.

 

Cash and Cash Equivalents

 

Cash and cash equivalents primarily consists of cash, money market funds and short-term, highly liquid investments with original maturities of three months or less.

 

Accounts Receivable

 

On January 1, 2023, the Company adopted Accounting Standards Update (ASU) 2016-13, Financial Instruments – Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments. The amendments in this ASU replace the incurred loss model for recognition of credit losses with a methodology that reflects expected credit losses over the life of the loan and requires consideration of a broader range of reasonable and supportable information to calculate credit loss estimates. This update did not have a significant impact on the Company’s consolidated financial statements.

 

The Company does business and extends credit based on an evaluation of each customer’s financial condition, generally without requiring collateral. Exposure to losses on receivables is expected to vary by customer due to the financial condition of each customer. The Company estimates future credit losses based on the age of customer receivable balances, collection history and forecasted economic trends. Future collections can be significantly different from historical collection trends or current estimates. The Company monitors exposure to credit losses and maintains allowances for anticipated losses considered necessary under the circumstances. The allowance for expected credit losses was $0.1 million and $0 as of December 31, 2024 and 2023, respectively. Credit loss expense for the years ended December 31, 2024 and 2023 was $0.1 million and $7 thousand, respectively.

 

Inventories

 

Inventories consist of finished product and components and are stated at the lower of cost or net realizable value, determined using the first-in-first-out method.

 

Property and Equipment

 

Property and equipment are stated at cost less accumulated depreciation. Depreciation on property and equipment is calculated on the straight-line basis over the estimated useful life of each asset. Maintenance and repairs are expensed as incurred; expenditures that enhance the value of property or extend their useful lives are capitalized. When assets are sold or returned, the cost and related accumulated depreciation are removed from the accounts and the resulting gain or loss is included in other income in the consolidated statements of income.

 

Inventory units designated for customer demonstrations, as part of the sales process, are reclassified to property and equipment and the depreciation is recorded in selling and marketing expense. Property and equipment that were reclassified to or from inventory were $1.5 million and $0.2 million for the years ended December 31, 2024 and 2023, respectively. These property and equipment were for demonstrations and the leasing program where the Company is the lessor.

 

Research and Development

 

Research and development costs related to products under development by the Company and quality and regulatory costs and are expensed as incurred.

 

Earnings Per Share

 

Basic net income per share is calculated by dividing the net income by the weighted-average number of common shares outstanding for the period using the treasury stock method for options, restricted stocks and warrants. Diluted net income per share is computed by giving effect to all potential dilutive common share equivalents outstanding for the period.

 

F-14

 

 

The factors used in the earnings per share computation are as follows:

 

   For the Years Ended 
   December 31, 
(in thousands)  2024   2023 
Basic        
Net income  $6,647   $485 
Weighted average number of shares used in computing net income per share – basic   16,312    16,259 
Net income per share - basic  $0.41   $0.03 
Diluted          
Net income  $6,647   $485 
Weighted average number of shares used in computing net income per share – basic   16,312    16,259 
Dilutive effects of:          
Stock options   7    5 
Restricted stock awards   41    2 
Weighted average number of shares used in computing net income per share – diluted   16,360    16,266 
Net income per share - diluted  $0.41   $0.03 
           
The full shares listed below were not included in the computation of diluted net income          
per share because to do so would have been antidilutive for the periods presented:          
Restricted stock awards       57,250 

  

Diluted net income per share for the year ended December 31, 2024 includes the dilutive effect of stock options and restricted stock awards that were issued in December 2022, January 2024, and December 2024 to directors, officers, and employees.

 

Diluted net income per share for the year ended December 31, 2023 includes the dilutive effect of stock options and restricted stock awards that were issued in July 2021. The stock options and 89,750 restricted stock awards were not in the money as the average price of common stock during the second to fourth quarter was less than the exercise prices. The assumed proceeds of stock options and the restricted stock awards for the treasury stock method is the amount the grantee pays on exercise plus the average amount of unrecognized compensation expense.

 

Equity-Based Compensation

 

Pursuant to relevant accounting guidance related to accounting for equity-based compensation, the Company is required to recognize all share-based payments to non-employees and employees in the financial statements based on grant-date fair values. The Company has accounted for issuances of shares and options in accordance with the guidance, which requires the recognition of expense, based on grant-date fair values, over the service period, which is generally the period over which the shares and options vest.

 

Advertising Costs

 

Advertising and promotion costs are charged to expense as incurred. Advertising and promotion costs included in selling and marketing expense in the accompanying statements of income amounted to $1.2 million for both the years ended December 31, 2024 and 2023.

 

Leases

 

The Company evaluates arrangements at inception to determine if an arrangement is or contains a lease. Operating lease assets represent the Company’s right to control an underlying asset for the lease term, and operating lease liabilities represent the Company’s obligation to make lease payments arising from the lease. Control of an underlying asset is conveyed to the Company if the Company obtains the rights to direct the use of and to obtain substantially all of the economic benefits from using the underlying asset. Operating lease assets and liabilities are recognized at the commencement date of the lease based upon the present value of lease payments over the lease term. When determining the lease term, the Company includes options to extend or terminate the lease when it is reasonably certain that the Company will exercise that option. The Company uses an incremental borrowing rate that the Company would expect to incur for a fully collateralized loan over a similar term under similar economic conditions to determine the present value of the lease payments. The Company has lease agreements which include lease and non-lease components, which the Company has elected to account for as a single lease component for all classes of underlying assets.

 

F-15

 

 

The lease payments used to determine the Company’s operating lease assets may include lease incentives, and stated rent increases are recognized in the Company’s operating lease assets in the Company’s consolidated balance sheets. Operating lease assets are amortized to rent expense over the lease term and included in operating expenses in the consolidated statements of income.

 

For leases in which the Company is the lessor, the Company identifies the lease and non-lease components and allocates the contract consideration to the different components on a relative stand-alone selling price basis at lease inception. The Company uses a residual approach for the components when the stand-alone selling price is not directly observable or those for which the Company has not established a price.

 

The Company has elected the practical expedient to combine lease and non-lease components when the components qualify to be combined. Continuous supporting services are the primary non-lease components and are not predominant. As a result, the combined components are accounted for as a lease under ASC 842, Leases. The revenues from non-lease components that are not qualified to be combined are recognized when the services are rendered under ASC 606, Revenue from Contracts with Customers. The revenues from non-lease components were $0.3 million for the year ended December 31, 2024.

 

For operating leases where the Company is the lessor, the Company recognizes the underlying assets and depreciates them over the estimated useful life which is based upon an estimate of the residual value expected at the end of the lease term. Lease income is recognized on a straight-line basis over the lease term when the lease payment is determined. Lease income is not recognized when collection of all contractual rents over the term of the agreement is not probable. When collection is not probable, the Company limits the lease income to the lesser of the revenue recognized on a straight-line basis or cash basis. The lease income is included in revenues in the consolidated statements of income.

 

Variable lease payments associated with the leases are recognized when the event, activity, or circumstance in the lease agreement on which those payments are assessed occurs. Variable lease payments are presented within revenues in the consolidated statements of income.

 

Income Taxes

 

The Company recognizes deferred tax assets and liabilities for the expected future tax consequences of events that have been recognized in the Company’s financial statements or tax returns. Under this method, deferred tax assets and liabilities are determined based on differences between the financial statement carrying amounts and the tax bases of the assets and liabilities using the enacted tax rates in effect in the years in which the differences are expected to reverse. A valuation allowance against deferred tax assets is recorded if, based on the weight of the available evidence, it is more likely than not that some or all of the deferred tax assets will not be realized.

 

Uncertain tax positions are recognized in the consolidated financial statements only if that position is more likely than not to be sustained upon examination by taxing authorities, based on the technical merits of the position. The Company’s practice is to recognize interest and/or penalties related to income tax matters in income tax expense.

 

F-16

 

 

Recent Accounting Pronouncements

 

In March 2020, the Financial Accounting Standard Board (“FASB”) issued ASU 2020-4, Reference Rate Reform (Topic 848): Facilitation of the Effects of Reference Rate Reform on Financial Reporting, to provide temporary optional expedients and exceptions to U.S. GAAP guidance on contract modifications to ease the financial reporting burdens of the expected market transition from the London Interbank Offered Rate, or LIBOR, to alternative reference rates, such as the Secured Overnight Financing Rate. Entities can elect not to apply certain modification accounting requirements to contracts affected by what the guidance calls reference rate reform if certain criteria are met. An entity that makes this election would not have to remeasure the contracts at the modification date or reassess a previous accounting determination. The guidance is effective prospectively as of March 12, 2020 through December 31, 2022 and interim periods within those fiscal years. In December 2022, the FASB issued ASU 2022-06, Deferral of the Sunset Date of Topic 848 which was issued to defer the sunset date of Topic 848 to December 31, 2024. These updates did not have a significant impact on the Company’s consolidated financial statements.

 

In November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures to enhance disclosures about significant segment expenses for public entities reporting segment information under ASC Topic 280. The amendments require public entities to disclose significant expense categories for each reportable segment, other segment items, the title and position of the chief operating decision-maker, and interim disclosures of certain segment-related information previously required only on an annual basis. The amendments clarify that entities reporting single segments must disclose both the new and existing segment disclosures under Topic 280, and a public entity is permitted to disclose multiple measures of segment profit or loss if certain criteria are met. The ASU is effective for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024. The adoption of ASU 2023-07 did not have a significant impact on the Company's consolidated financial statements. See Note 12, Segment Reporting, for the required disclosures.

 

In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures, to enhance transparency into income tax disclosures. The amendments require annual disclosure of certain information relating to the rate reconciliation, income taxes paid by jurisdiction, income (or loss) from continuing operations before income tax expense (or benefit) disaggregated between domestic and foreign, income tax expense (or benefit) from continuing operations disaggregated by federal (national), state, and foreign. The amendments also eliminate certain requirements relating to unrecognized tax benefits and certain deferred tax disclosure relating to subsidiaries and corporate joint ventures. The ASU is effective for fiscal years beginning after December 15, 2024, and interim periods within fiscal years beginning after December 15, 2025. Early adoption is permitted. The Company is currently evaluating the impact of this standard on its consolidated financial statements and related disclosures.

 

In March 2024, the FASB issued ASU 2024-01, Compensation - Stock Compensation (Topic 718): Scope Application of Profits Interest and Similar Awards, to clarify how an entity determines whether a profits interest or similar award is within the scope of Topic 718 or is not a share-based payment arrangement and therefore within the scope of other guidance. ASU 2024-01 provides an illustrative example with multiple fact patterns and also amends certain language in the “Scope” and “Scope Exceptions” sections of Topic 718 to improve its clarity and operability without changing the guidance. The ASU is effective for fiscal years beginning after December 15, 2024, and interim periods within those annual periods. Early adoption is permitted. These updates are not expected to have a significant impact on the Company’s consolidated financial statements. 

 

In November 2024, the FASB issued ASU 2024-03, Income Statement - Reporting Comprehensive Income - Expense Disaggregation Disclosures (“ASU 2024-03”) which requires entities to (i) disclose amounts of (a) purchase of inventory, (b) employee compensation, (c) depreciation, (d) intangible asset amortization, and, (e) depreciation, depletion, and amortization recognized as part of oil-and gas-producing activities, (ii) include certain amounts that are already required to be disclosed under current U.S. GAAP in the same disclosures as other disaggregation requirements, (iii) disclose a qualitative description of the amounts remaining in relevant expense captions that are not necessarily disaggregated quantitatively, and (iv) disclose the total amount of selling expenses, in annual reporting periods, an entity’s definition of selling expense. ASU 2024-03 is effective for annual reporting periods beginning after December 15, 2026 and interim reporting periods beginning after December 15, 2027.  Early adoption is permitted. The Company is currently evaluating ASU 2024-03 to determine the impact it may have on its consolidated financial statements.

 

F-17

 

 

Note 2 — Property and Equipment

 

Property and equipment consists of the following:

 

(in thousands)  As of December 31, 2024   As of December 31, 2023   Estimated Useful Lives 
             
Operations equipment  $940   $1,018   3-10 years 
Equipment leased to customers   1,597       10 years 
Tradeshow and demo equipment   1,184    1,184   3 years 
Computer equipment   168    145   3 years 
Subtotal   3,889    2,347     
Construction in progress   228         
Less accumulated depreciation   (2,120)   (1,883)    
Property and Equipment, Net  $1,997   $464     

 

Depreciation expense was $0.2 million and $0.2 million for the years ended December 31, 2024 and 2023, respectively.

 

Note 3 — DEBT

 

On September 11, 2023, the Company entered into a new revolving credit facility (the “Credit Facility”) with Comerica Bank (“Comerica”), replacing the prior facility with Silicon Valley Bank, that provided for maximum borrowings of $10 million. The Credit Facility may be terminated by the Company or Comerica at any time without penalty. At December 31, 2024, the available borrowings under this facility were $10 million. Any borrowings bear interest at the Secured Overnight Financing Rate plus 2.50% (or 6.99% at December 31, 2024) and would be due upon demand by Comerica. The Credit Facility is secured by all of the Company’s assets. In October 2024, the Credit Facility was amended to extend the term of the Credit Facility to November 1, 2026 and to increase the maximum borrowings to $15.0 million. The amended Credit Facility includes updated covenants requiring that the Company maintain (1) unencumbered liquid assets having a minimum value of $10.0 million in a Comerica account; (2) minimum profitability of $1 on a trailing 12-month basis; and (3) the contractual relationship with the manufacturer of the SRT-100 discussed in Note 6, Commitments and Contingencies – Manufacturing Agreement. There were no other significant changes to the terms of the Credit Facility.

 

The Company was in compliance with its financial covenants under the respective facilities as of December 31, 2024 and December 31, 2023. There were no borrowings outstanding under either facility at December 31, 2024 or December 31, 2023.

 

F-18

 

 

Note 4 — Product Warranties

 

Changes in product warranty liability were as follows for the years ended December 31, 2024 and 2023:

 

(in thousands)    
Balance, December 31, 2022  $403 
Warranties accrued during the period   603 
Payments on warranty claims   (468)
Balance, December 31, 2023  $538 
Warranties accrued during the period   255 
Payments on warranty claims   (464)
Balance, December 31, 2024  $329 

 

Note 5 — Leases

 

Operating Lease Agreements

 

The Company leases its headquarters office from an unrelated third party under a lease expiring in September 2027. The amortization expense of the right of use lease asset was $0.2 million and $0.2 million for the years ended December 31, 2024 and 2023, respectively. In January 2025, the Company entered into a sublease agreement with an unrelated third party to lease a new office space which is adjacent to the current headquarters office. The sublease will be effective from January 2025 to September 2027.

 

The following table presents information about the amount, timing and uncertainty of cash flows arising from the Company’s operating leases as of December 31, 2024.

 

Maturity of Operating Lease Liability  Amount 
2025  $229 
2026   236 
2027   181 
Total undiscounted operating leases payments  $646 
Less: Imputed interest   (44)
Present Value of Operating Lease Liability  $602 
Operating lease liability, current portion  $204 
Operating lease liability, net of current portion  $398 
      
Other Information     
Weighted-average remaining lease term    2.75 years  
Weighted-average discount rate   5%

 

Cash paid for amounts included in the measurement of operating lease liabilities was $0.2 million and $0.2 million for the years ended December 31, 2024 and 2023, respectively, and is included in cash flows from operating activities in the accompanying consolidated statements of cash flows.

 

Operating lease cost recognized as expense was $0.2 million for the years ended December 31, 2024 and 2023. The financing component for operating lease obligations represents the effect of discounting the operating lease payments to their present value.

 

Lessor Accounting

 

Beginning in the quarter ended June 30, 2024, the Company, through its subsidiary, Sensus Healthcare Services, LLC, leases superficial radiotherapy equipment to dermatology clinics. These leases generally have an initial lease term of 60 months and automatically renew for a one-year period upon the expiration of the initial lease term. Payments due under the leases may be fixed or variable payments.

 

F-19

 

 

The components of lease income for the year ended December 31, 2024 are as follows:

 

     For the 
     Year Ended 
(in thousands)    December 31, 2024 
Lease income - operating leases - fixed payments    $192 
Lease income - operating leases - variable payments     55 
Total    $247 

 

The future minimum fixed lease payments to be received under the lease agreements as of December 31, 2024 are as follows:

 

(in thousands)   Amount 
2025   $256 
2026    256 
2027    256 
2028    256 
2029    256 
Thereafter    87 
Total    $1,367 

 

Note 6 — Commitments and Contingencies

 

Manufacturing Agreement

 

The Company has a contract manufacturing agreement with an unrelated third party for the production and manufacture of the SRT-100 (and subsequently the SRT-100 Vision and the SRT-100+), in accordance with the Company’s product specifications. The agreement renews for successive one-year periods unless either party notifies the other party in writing, at least 60 days prior to the anniversary date of the agreement, that it will not renew the agreement. The Company or the manufacturer may terminate the agreement upon 90 days’ prior written notice.

 

The Company pays this manufacturer for finished goods in advance of the inventory being received. The Company paid this manufacturer $9.9 million and $10.3 million for finished goods for the years ended December 31, 2024 and 2023, respectively. Approximately $10.3 million and $12.7 million of finished goods was received from this manufacturer for the years ended December 31, 2024 and 2023, respectively. As of December 31, 2024 and December 31, 2023, a prepayment related to these finished goods of $3.3 million and $3.0 million, respectively, was presented in prepaid inventory in the accompanying consolidated balance sheets. 

 

Legal contingencies

 

The Company is party to certain legal proceedings in the ordinary course of business. The Company assesses, in conjunction with its legal counsel, the need to record a liability for litigation and related contingencies.

 

In 2015, the Company learned that the Department of Justice (the “Department”) had commenced an investigation of the billing to Medicare by a physician who had treated patients with the Company’s SRT-100. The Department subsequently advised the Company that it was considering expanding the investigation to determine whether the Company had any involvement in physician’s use of certain reimbursements codes. The Company has received two Civil Investigative Demands from the Department seeking documents and written responses in connection with its investigation. The Company has fully cooperated with the Department. The Company disputes that it has engaged in any wrongdoing with respect to such reimbursement claims; among other considerations, the Company does not submit claims for reimbursement or provide coding or billing advice to physicians. To the Company’s knowledge, the Department has made no determination as to whether the Company engaged in any wrongdoing, or whether to pursue any legal action against the Company. Should the Department decide to pursue legal action, the Company believes it has strong and meritorious defenses and will vigorously defend itself. As of December 31, 2024, the Company was unable to estimate the cost associated with this matter. 

 

F-20

 

 

Note 7 — Employee Benefit Plans

 

The Company sponsors a 401(k) defined contribution retirement plan that allows eligible employees to contribute a portion of their compensation, as defined by the plan and subject to Internal Revenue Code limitations. The Company makes contributions to the plan which include matching a percentage of the employees’ contributions up to certain limits. Expenses related to this plan totaled $0.1 million for each of the years ended December 31, 2024 and 2023.

 

Note 8 — Stockholders’ Equity

 

Preferred Stock

 

The Company has authorized 5 million shares of preferred stock. No shares of preferred stock were issued or outstanding at December 31, 2024 or December 31, 2023.

 

Treasury Stock

 

Treasury stock includes shares surrendered by employees for tax withholding on the vesting of restricted stock awards and shares repurchased in open market transactions. 8,525 and 11,155 shares were surrendered by employees for tax withholding for the years ended December 31, 2024 and 2023, respectively. During the years ended December 31, 2024 and 2023, the Company repurchased 0 and 9,427 shares, respectively, in open market transactions.

 

Note 9 — Equity-based Compensation

 

2016 and 2017 Equity Incentive Plans

 

The Company’s 2016 Equity Incentive Plan and the 2017 Incentive Plan, as amended in June 2023 (collectively, the “Plans”), provide for the issuance of up to 397,473 shares and 750,000 shares, respectively. In addition, unless the Compensation Committee specifically determines otherwise, the maximum number of shares available under the Plans and the awards granted under the Plans will be subject to appropriate adjustment in the case of any stock dividends, stock splits, recapitalizations, reorganizations, mergers, consolidations, exchanges or other changes in capitalization affecting the Company’s common stock. The awards may be made in the form of restricted stock awards or stock options, among other things. As of December 31, 2024 and 2023, 195,223 and 312,973 shares were available to be granted in the Plans, respectively.

 

On February 1, 2020, a total of 35,000 shares of restricted stock were issued to employees. The restricted shares vested 25% per year over a four-year period. The grant date fair value of $4.11 per share was recognized as expense on a straight-line basis over the vesting period. During the year ended December 31, 2024, 2,500 shares of common stock vested. During the year ended December 31, 2023, 5,000 shares of common stock vested, and 10,000 shares of unvested common stock were forfeited due to the termination of three employees. As of December 31, 2024, the shares issued on February 1, 2020 were fully vested.

 

On July 21, 2021, a total of 130,000 shares of restricted stock were issued to employees and board members. The restricted shares vested 25% at grant date and 25% per year over a three-year period. The grant date fair value of $3.84 per share was being recognized as expense on a straight-line basis over the vesting period. During each of the years ended December 31, 2024 and 2023, 32,500 shares of common stock vested. As of December 31, 2024, the shares issued on July 21, 2021 were fully vested.

 

F-21

 

 

On December 19, 2022, a total of 77,000 shares of restricted stock were issued to employees. The restricted shares vest 25% per year over a four-year period. The fair value of $6.40 per share, the stock price on grant date, is being recognized as expense on a straight-line basis over the vesting period. During the year ended December 31, 2024, 17,500 shares of common stock vested, and 2,250 shares of unvested common stock were forfeited due to the termination of three employees. During the year ended December 31, 2023, 18,250 shares of common stock vested, and 4,000 shares of unvested common stock were forfeited due to the termination of four employees.

 

On January 26, 2023, 10,000 shares of common stock were issued to an employee and were recorded at the fair value of $8.96 per share, the stock price on the grant date. The shares were fully vested on the grant date.

 

On January 11, 2024, 20,000 shares of common stock with a fair value of $2.65 per share, the stock price on the grant date, were issued to an employee. 10,000 of the shares vested and the expense related to these shares was recognized on the grant date. The remaining 10,000 shares vested in January 2025. The grant date fair value of $2.65 per share is being recognized as expense on a straight-line basis over the vesting period.

 

On December 17, 2024, 100,000 shares of common stock with a fair value of $7.78 per share, the stock price on the grant date, were issued to employees and directors. 10,000 of the shares issued to one individual vested and the expense related to these shares was recognized on the grant date. The remaining 30,000 shared issued to the same individual vest over a three-year period. The remaining 60,000 shares issued to other individuals vest 25% per year over a four-year period. The grant date fair value of $7.78 per share is being recognized as expense on a straight-line basis over the vesting period.

 

Restricted Stock

 

Restricted stock activity for the years ended December 31, 2024 and 2023 is summarized below:

 

Outstanding at  Restricted Stock   Weighted-Average Grant Date Fair Value 
December 31, 2022   159,500   $5.11 
Granted   10,000    8.96 
Vested   (65,750)   5.35 
Forfeited   (14,000)  $4.76 
December 31, 2023   89,750   $5.41 
Granted   120,000    6.93 
Vested   (72,500)   4.85 
Forfeited   (2,250)  $6.40 
December 31, 2024   135,000   $7.04 

  

The Company recognizes forfeitures as they occur. The reduction of stock compensation expense related to the forfeitures was $2 thousand and $31 thousand for the years ended December 31, 2024 and 2023, respectively.

 

Stock compensation expense related to restricted stock, excluding the recognition of forfeitures, was $0.3 million and $0.4 million for the years ended December 31, 2024 and 2023, respectively.

 

Unrecognized stock compensation expense was $0.9 million as of December 31, 2024, which will be recognized over a weighted-average period of 3.4 years.

 

F-22

 

 

Stock Options

 

Stock options expire 10 years after the grant date. Options that have been granted are exercisable and vest based on the terms of the related agreements.

 

The following table summarizes the Company’s stock options activity for the years ended December 31, 2024 and 2023:

 

    Number of Options   Weighted-Average Exercise Price   Weighted-Average Remaining Contractual Term  (In Years) 
Outstanding - December 31, 2022    97,884   $5.55    5.08 
Granted             
Exercised    (8,334)   5.55     
Expired             
Outstanding - December 31, 2023    89,550   $5.55    4.08 
Granted             
Exercised    (12,000)   5.55     
Expired             
Outstanding - December 31, 2024    77,550   $5.55    3.08 
Exercisable – December 31, 2023    89,550   $5.55    4.08 
Exercisable – December 31, 2024    77,550   $5.55    3.08 

  

As of December 31, 2024, the stock options have been fully vested. The stock options outstanding had an intrinsic value of $0.1 million and $0 as of December 31, 2024 and 2023, respectively.

 

Note 11 — Income Taxes

 

The provision for income taxes consisted of the following:

 

             
   For The Years Ended 
   December 31, 
(in thousands)  2024   2023 
Current - Federal  $1,576   $249 
Current - State   856    345 
Deferred - Federal   (71)   (369)
Deferred - State   14    (58)
Income tax provision  $2,375   $167 

  

F-23

 

 

For the years ended December 31, 2024 and 2023, the expected tax expense based on the statutory rate is reconciled with the actual tax expense as follows:

 

             
   For The Years Ended 
   December 31, 
   2024   2023 
U.S. federal statutory rate   21.0%   21.0%
State taxes, net of federal benefit   8.0%   9.7%
Permanent differences   (0.4%)   6.3%
Change in tax rates   (0.4%)   9.0%
Return-to-provision adjustments   (0.5%)   1.9%
Tax credits   (1.5%)   (22.3%)
Income tax provision   26.2%   25.6%

 

As of December 31, 2024 and December 31, 2023, the Company’s net deferred tax asset consisted of the effects of temporary differences attributable to the following:

 

             
   As of December 31, 
(in thousands)  2024   2023 
Deferred tax assets:   -      
Net operating losses  $647   $814 
Stock-based compensation   115    103 
Depreciation and amortization   942    762 
Accrued expenses and reserves   243    257 
Inventory capitalization   165       
Customer deposits   18    37 
Tax credits   267    367 
Lease accounting, net   6    2 
Gross deferred tax assets   2,403    2,342 
Valuation allowance   (185)   (185)
Total deferred tax assets   2,218    2,157 
Deferred tax liabilities   -      
Prepaid expenses   (21)   (17)
Total deferred tax liabilities   (21)   (17)
Net deferred tax assets  $2,197   $2,140 

 

The Company has state net operating loss carryforwards (each, an “NOL”) spread across various jurisdictions with a combined total of approximately $6.3 million as of December 31, 2024. A majority of the state NOL’s are attributed to the State of Illinois which begin to expire in 2037. Additionally, the Company also has federal and state tax credit carryforwards of approximately $0.3 million as of December 31, 2024. These credit carryforwards do not expire.

 

In assessing the realization of deferred tax assets, management considers whether it is more likely than not that some or all of the deferred tax assets will be realized. The ultimate realization of deferred tax assets is dependent upon the future generation of taxable income during the periods in which those temporary differences become deductible. Management considers the ability to carryback taxable income, future reversals of existing taxable temporary differences, tax-planning strategies, and future taxable income exclusive of reversing temporary differences and carryforwards in making this assessment. As of each reporting date, management considers new evidence, both positive and negative, that could affect its view of the future realization of deferred tax assets. As of December 31, 2024, management determined there continues to be sufficient positive evidence that it is more likely than not that the net deferred tax assets (other than foreign net operating losses) are realizable.

 

F-24

 

 

Management has evaluated and concluded that there were no material uncertain tax positions requiring recognition in the Company’s consolidated financial statements as of December 31, 2024 and 2023. The Company does not expect any significant changes in its unrecognized tax benefits within 12 months of the reporting date. The Company has U.S. federal and certain state tax returns subject to examination by tax authorities beginning with those filed for the year ended December 31, 2017.

 

Note 12 — Segment Reporting

 

The Company has a single reportable segment focused around sale of similar products and related services. This reportable segment derives revenues from customers by selling medical devices which are used to treat oncological and non-oncological skin conditions with SRT technology and providing services related to operating, maintaining, and repairing these devices.

 

The Company’s chief operating decision-maker (the “CODM”), who is the chief executive officer, assesses performance for the reportable segment and decides how to allocate resources using net income as the primary measure of profitability. The CODM is not regularly provided with specific segment expenses, but focuses on revenue, gross profit, and net income. Expense information, including cost of sales can be easily computed from the provided information. These segment (and consolidated) measures of profitability are shown in the consolidated statements of income. The measure of segment assets is reported on the consolidated balance sheets as total assets.

 

Note 13 — Subsequent Events

 

The Company has evaluated subsequent events and transactions that occurred after the balance sheet date up to the date that the financial statements were issued for potential recognition or disclosure. The Company did not identify any subsequent events that would have required adjustment or disclosure in the consolidated financial statements.

 

F-25

 

 

Item 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE

 

There have been no disagreements on accounting and financial disclosure matters.

 

Item 9A. CONTROLS AND PROCEDURES

 

Evaluation of Disclosure Control and Procedures

 

As of December 31, 2024, the end of the year covered by this Annual Report on Form 10-K, our management, including our Chief Executive Officer and Chief Financial Officer, evaluated the effectiveness of our disclosure controls and procedures (as defined in Rule 13a-15(e)) under the Exchange Act). Based upon that evaluation, our Chief Executive Officer and Chief Financial Officer each concluded that as of December 31, 2024, the end of the year covered by this Annual Report on Form 10-K, we did maintain effective disclosure controls and procedures, and that the previously disclosed material weakness around information technology general controls has been remediated. 

 

Management’s Report on Internal Control Over Financial Reporting

 

Our management is responsible for establishing and maintaining adequate internal control over financial reporting as defined in Rule 13a-15(f) and 15d-15(f) under the Exchange Act. We have performed an evaluation under the supervision and with the participation of our management, including our Chief Executive Officer and our Chief Financial Officer, of the effectiveness of our internal control over financial reporting. Our management used the Internal Control-Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission to perform this evaluation. Based on that evaluation, our management, including our Chief Executive Officer and Chief Financial Officer, concluded that our internal control over financial reporting was effective as of December 31, 2024.

 

As a smaller reporting company, our independent registered accounting firm is not required to issue an attestation report on our internal control over financial reporting.

 

Management’s Remediation Measures

 

As disclosed in our Quarterly Report on Form 10-Q for the quarter ended June 30, 2024, management identified a material weakness in the control environment as discussed below.

 

Information technology general controls were not designed and operating effectively to ensure that access to applications and data were adequately restricted to appropriate personnel, ensure segregation of duties, and appropriately monitor the activities of the individuals with access to modify data.

 

The Company remediated the material weakness by implementing new and enhanced controls designed to ensure that access to information technology applications and data is adequately restricted to appropriate personnel, ensure segregation of duties, and appropriately monitor the activities of the individuals with access to modify data.

 

28

 

 

Changes in Internal Control Over Financial Reporting

 

Except for the remediation efforts described above, there have been no significant changes in our internal control over financial reporting during the three months ended December 31, 2024 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

 

Item 9B. OTHER INFORMATION

 

The Company is furnishing no other information in this Form 10-K.

 

Item 9C. DISCLOSURES REGARDING FOREIGN JURISDICTION THAT PREVENT INSPECTIONS

 

Not applicable.

 

29

 

 

PART III.

 

Item 10. DIRECTORS, EXECUTIVE OFFICERS, AND CORPORATE GOVERNANCE

 

The information required by this item will be set forth in the Proxy Statement for our 2025 Annual Meeting and is incorporated into this report by reference.

 

Item 11. EXECUTIVE COMPENSATION

 

The information required by this item will be set forth in the Proxy Statement for our 2025 Annual Meeting and is incorporated into this report by reference. 

 

Item 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS

 

The information required by this item will be set forth in the Proxy Statement for our 2025 Annual Meeting and is incorporated into this report by reference.

 

Item 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE

 

The information required by this item will be set forth in the Proxy Statement for our 2025 Annual Meeting and is incorporated into this report by reference. 

 

Item 14. PRINCIPAL ACCOUNTANT FEES AND SERVICES

 

The information required by this item will be set forth in the Proxy Statement for our 2025 Annual Meeting and is incorporated into this report by reference. 

 

30

 

 

PART IV

 

Item 15. EXHIBITS AND FINANCIAL STATEMENT SCHEDULES

 

The following documents are filed as a part of this report:

 

  1. Financial Statements

 

The Company’s consolidated financial statements included beginning on page F-1.

 

  2. Financial Statement Schedules

 

Financial statement schedules have been omitted because they are not applicable, not required or the information required is included in the Company’s consolidated financial statements or note thereto.

 

  3. Exhibits Required to be Filed by Item 601 of Regulation S-K

 

The Exhibit Index beginning on page 29 of this Annual Report on Form 10-K is incorporated by reference to this Item 15.

 

Item 16. FORM 10-K SUMMARY

 

None.

 

31

 

 

EXHIBIT INDEX

 

Exhibit No.   Description
2.1   Agreement and Plan of Merger, dated as of December 12, 2011, by and between Sensus Healthcare, LLC and Sensus Healthcare, LLC – incorporated by reference to Exhibit 2.1 of the Company’s Registration Statement on Form S-1 (filed 2/10/16)(No. 333-209451).
     
2.2   Plan of Conversion of Sensus Healthcare, LLC – incorporated by reference to Exhibit 2.2 of the Company’s Registration Statement on Form S-1 (filed 2/10/16)(No. 333-209451).
     
2.3   Asset Purchase Agreement between Sensus Healthcare, Inc. and Empyrean Medical Systems, Inc., dated as of February 25, 2022 – incorporated by reference to Exhibit 2.3 of the Company’s Annual Report on Form 10-K (filed 3/25/22) (No. 001-37714)
     
3.1  

Amended and Restated Certificate of Incorporation of Sensus Healthcare, Inc. – incorporated by reference to Exhibit 3.1 to the Company’s Quarterly Report on Form 10-Q (filed 8/13/24)(No. 333-209451). 

     
3.2   Bylaws of Sensus Healthcare, Inc. – incorporated by reference to Exhibit 3.2 of the Company’s Registration Statement on Form S-1 (filed 2/10/16)(No. 333-209451).
     
4.1   Form of Representatives’ Warrant to Purchase Units – incorporated by reference to Exhibit 4.7 of the Company’s Amendment No. 4 to Registration Statement on Form S-1 (filed 5/19/16) (No. 333-209451).
     
4. 2   Description of Company’s Common Stock – incorporated by reference to Exhibit 4.4 of the Company’s Annual Report on Form 10-K (filed 3/6/20) (No.001-37714).
     
     
10.1+   Sensus Healthcare, Inc. 2016 Equity Incentive Plan – incorporated by reference to Exhibit 10.14 of the Company’s Amendment No. 1 to Registration Statement on Form S-1 (filed 3/10/16)(No. 333-209451).
     
10.2+   Form of Non-Qualified Option Grant Agreement – incorporated by reference to Exhibit 10.8 of the Company’s Registration Statement on Form S-1 (filed 2/10/16)(No. 333-209451).
     
10.3+   Employment Agreement between Sensus Healthcare, Inc. and Joseph C. Sardano – incorporated by reference to Exhibit 10.10 of the Company’s Registration Statement on Form S-1 (filed 2/10/16)(No. 333-209451).
     
10.4#  

Manufacturing Agreement, dated as of July 20, 2010, by and between RbM Services, LLC and Sensus Healthcare, LLC – incorporated by reference to Exhibit 10.13 of the Company’s Registration Statement on Form S-1 (filed 2/10/16)(No. 333-209451).

     
10.5+   Sensus Healthcare, Inc. 2017 Equity Incentive Plan – incorporated by reference to Appendix A of the Company’s Definitive Proxy Statement (filed 5/1/2023)(No. 001-37714).
     
10.6+   Form of Restricted Stock Award Agreement incorporated by reference to Exhibit 10.2 of the Company’s Registration Statement on Form S-8 (filed 11/6/17)(No. 333-221372).
     
10.7+   Employment Agreement between Sensus Healthcare, Inc. and Michael Sardano – incorporated by reference to Exhibit 10.1 of the Company’s Quarterly Report on Form 10-Q (filed 5/8/18) (No. 333-209451).

 

32

 

 

10.8+   Employment Agreement between Sensus Healthcare, Inc. and Javier Rampolla – incorporated by reference to Exhibit 10.1 of the Company’s Quarterly Report on Form 10-Q (filed 8/11/23) (No. 001-37714).
     
10.9   Credit Agreement, dated as of September 11, 2023, by and between the Company and Comerica – incorporated by reference to Exhibit 10.1 of the Company’s Report on Form 8-K (filed 9/14/23) (No. 001-37714).
     
10.10   Master Revolving Note, dated as of September 11, 2023, made by the Company in favor of Comerica – incorporated by reference to Exhibit 10.2 of the Company’s Report on Form 8-K (filed 9/14/23) (No. 001-37714).
     
10.11   Security Agreement, dated as of September 11, 2023, made by the Company in favor of Comerica – incorporated by reference to Exhibit 10.3 of the Company’s Report on Form 8-K (filed 9/14/23) (No. 001-37714).
     
10.12

Amendment No.1 to Credit Agreement between the Company and Comerica Bank, dated as of October 16, 2024 – incorporated by reference to Exhibit 10.1 of the Company’s Quarterly Report on Form 10-Q (filed 11/14/24)

     
10.13  

Amendment No.1 to Master Revolving Note between the Company and Comerica Bank, dated as of October 16, 2024 – incorporated by reference to Exhibit 10.2 of the Company’s Quarterly Report on Form 10-Q (filed 11/14/24)

     
14.1   Sensus Healthcare, Inc. Code of Ethics – incorporated by reference to Exhibit 14.1 of the of the Company’s Amendment No. 1 to Registration Statement on Form S-1 (filed 3/10/16)(No. 333-209451).
     
19.1*   Sensus Healthcare, Inc. Insider Trading Policy
     
23.1*   Consent of Marcum LLP, Independent Registered Public Accounting Firm
     
23.2*   Consent of Berkowitz Pollack Brant Advisors + CPAs, LLP, Independent Registered Public Accounting Firm
     
31.1*   Certification of Joseph C. Sardano, Chairman and Chief Executive Officer of Sensus Healthcare, Inc., Pursuant to Rule 13a-14(a) of the Securities Exchange Act of 1934.
     
31.2*   Certification of Javier Rampolla, Chief Financial Officer of Sensus Healthcare, Inc., Pursuant to Rule 13a-14(a) of the Securities Exchange Act of 1934.
     
32.1*   Certification of Joseph C. Sardano, Chairman and Chief Executive Officer of Sensus Healthcare, Inc., Pursuant to 18 U.S.C. Section 1350.
     
32.2*   Certification of Javier Rampolla, Chief Financial Officer of Sensus Healthcare, Inc., Pursuant to 18 U.S.C. Section 1350.
     

97   Sensus Healthcare, Inc. Clawback Policy – incorporated by reference to Exhibit 97.1 of the Company’s Annual Report on Form 10-K (filed 3/15/24) (No.001-37714).

 

33

 

 

101.INS*   Inline XBRL Instance Document.
     
101.SCH*   Inline XBRL Taxonomy Extension Schema Document.
     
101.CAL*   Inline XBRL Taxonomy Extension Calculation Linkbase Document.
     
101.LAB*   Inline XBRL Taxonomy Extension Label Linkbase Document.
     
101.PRE*   Inline XBRL Taxonomy Extension Presentation Linkbase Document.
     
101.DEF*   Inline XBRL Taxonomy Extension Definition Linkbase Document.
     
104.*   Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101).

 

+ Indicates a management contract or compensatory plan.
   
# Portions of exhibit have been omitted.
   
* Filed electronically herewith.

 

  Instruments defining the rights of holders of unregistered long-term debt of the issuer and its subsidiaries have been omitted from this exhibit index because the amount of debt authorized under any such instrument does not exceed 10% of the total assets of the issuer and its consolidated subsidiaries. The issuer agrees to furnish a copy of any such instrument to the Commission upon request.

 

34

 

 

SIGNATURES

 

Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

 

  SENSUS HEALTHCARE, INC.
   
Date: March 5, 2025 /s/ Joseph C. Sardano
  Joseph C. Sardano
  Chief Executive Officer
  (Principal Executive Officer)

 

Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the Registrant and in the capacities and on the dates indicated.

 

Name   Title   Date
         
/s/ Joseph Sardano   Chief Executive Officer and Chairman   March 5, 2025
Joseph Sardano   (Principal Executive Officer)    
         
/s/ Javier Rampolla   Chief Financial Officer   March 5, 2025
Javier Rampolla   (Principal Financial and Accounting Officer)    
         
/s/ Megan Cornish   Director   March 5, 2025
Megan Cornish        
         
/s/ William H. McCall   Director   March 5, 2025
William H. McCall        
         
/s/ Anthony B. Petrelli   Director   March 5, 2025
Anthony B. Petrelli        
         
/s/ Michael C. Sardano   Director   March 5, 2025
Michael C. Sardano        

 

35

 

 

Exhibit 19.1

 

Sensus Healthcare, Inc.

Insider Trading Policy

 

This Insider Trading Policy describes the standards of Sensus Healthcare, Inc. on trading in securities of the Company, and securities of certain other publicly traded companies while in possession of material, non-public information about the Company or such other companies. It also prohibits communicating any confidential information about the Company and such other companies. This Policy is divided into three parts:

 

Part I prohibits trading in certain circumstances and communicating material, non-public information and applies to all directors, officers and employees of the Company and their respective immediate family members (collectively “Covered Persons”);

 

Part II imposes additional trading restrictions on (i) directors of the Company, and (ii) executive officers of the Company (collectively, “Key Persons”); and

 

Part III provides general information applicable to both Covered Persons and Key Persons.

 

The federal securities laws prohibit so-called “insider trading.” Simply stated, insider trading occurs when a person engages in transactions in securities while in possession of material non-public information about the issuer of those securities.

 

PART I

 

1. Applicability of this Policy

 

This Policy applies to all trading or other transactions in the Company’s securities. Note that:

 

“Trading or other transactions” includes not only buying and selling, but also donating, gifting and any other transfer of ownership.

“The Company’s securities” include common stock, options and any other securities that the Company may issue, such as preferred stock, notes, bonds and convertible securities, as well as derivative securities (such as puts and calls) relating to any of the Company’s securities, whether or not issued by the Company.

 

2. General Policy: No Trading While in Possession of Material Non-public Information and No Communication of Material Non-Public Information

 

If you are a Covered Person, you may not:

 

a)     Purchase, sell or otherwise transfer, or offer to purchase, sell or otherwise transfer, any Company security, whether or not issued by the Company, while in possession of material non-public information about the Company.

 

 

 

 

b)     Purchase, sell or otherwise transfer any security of any other company while in possession of material non-public information about that company that was obtained in the course of your service to the Company.

 

c)     Communicate any material non-public information in your possession about the Company or any company referred to in clause (b) above to any other person (such communication, a “tip”), including family members and friends, or otherwise disclose such information without the Company’s authorization.

 

Twenty-Twenty Hindsight. Remember, if your securities transactions or those of your immediate family members or others you know become the subject of scrutiny, they will be viewed after the fact, with the benefit of 20/20 hindsight. As a result, always err on the side of caution when trading or communicating sensitive information.

 

3. Important Definitions

 

a)     Material. Information is generally regarded as “material” if it has market significance -- that is, if its public dissemination is likely to affect the market price of securities, or if it otherwise is information that a reasonable investor would want to know before making an investment decision. Materiality involves a relatively low threshold. By way of example, information relating to the following subjects would likely be deemed material in particular situations (but note that this list is not exhaustive):

 

(i) significant changes in the Company’s prospects;

 

(ii) significant write-downs in assets or increases in reserves;

 

(iii) developments regarding significant litigation or government agency investigations;

 

(iv) liquidity problems;

 

(v) changes in earnings estimates or unusual gains or losses in major operations;

 

(vi) major changes in management;

 

(vii) extraordinary borrowings;

 

(viii) award or loss of a significant contract;

 

(ix) changes in debt ratings;

 

(x) proposals, plans or agreements, even if preliminary in nature, involving mergers, acquisitions, divestitures, recapitalizations, strategic alliances, licensing arrangements, or purchases or sales of substantial assets;

 

(xi) offerings of Company securities; and

 

 

 

 

(xiii) pending statistical reports (such as, consumer price index, money supply and retail figures, or interest rate developments).

 

Material information is not limited to historical facts but may also include projections and forecasts. It also can be negative or positive. With respect to a future event, such as a merger, acquisition or introduction of a new product, the point at which negotiations or product development are determined to be material is determined by balancing the probability that the event will occur against the magnitude of the effect the event would have on a company’s operations or stock price should it occur. Thus, information concerning an event that would have an effect on stock price, such as a merger, may be material even if the possibility that the event will occur is relatively small. When in doubt about whether particular non-public information is material, you should presume it is material. If you are unsure whether information is material, you should consult the Compliance Officer before making any decision to disclose such information (other than to persons who need to know it) or to trade in or recommend securities to which that information relates.

 

b)     Non-public. “Public” information is information that has been disseminated in a manner designed to reach investors generally, after investors and the market generally have had the opportunity to absorb the information. Even after public disclosure of information about the Company, you must wait until the close of business on the second trading day after the information was publicly disclosed before you can treat the information as public. Note that the fact that information has been disclosed to a few members of the public does not make it public for insider trading purposes. By way of example, but not by limitation, non-public information may include:

 

(i) information available to a select group of analysts or brokers or institutional investors;

 

(ii) undisclosed facts that are the subject of rumors, even if the rumors are widely circulated; and

 

(iii) information that has been entrusted to the Company on a confidential basis until a public announcement of the information has been made and enough time has elapsed for the market to respond to a public announcement of the information (normally two trading days).

 

As with questions of materiality, if you are not sure whether information is considered public, you should either consult with the Compliance Officer or assume that the information is non-public and treat it as confidential.

 

 

 

 

PART II

 

1. Blackout Periods

 

If you are a Key Person, you are prohibited from trading in the Company’s securities during any Blackout Period.

 

a)     Quarterly Blackout Periods. As a Key Person, you are prohibited from trading in the Company’s securities during the period beginning at the close of the market on the fourteenth day prior to the end of each fiscal quarter and ending at the close of business on the second trading day following the release of the Company’s quarterly or annual financial results for the particular period. During these periods, you generally possess or are presumed to possess material non-public information about the Company’s financial results.

 

b)     Other Blackout Periods. From time to time, other types of material non-public information regarding the Company (such as possible mergers, acquisitions or dispositions or new product developments) may be pending and not publicly disclosed. At such times, the Company may impose special Blackout Periods during which you, as a Key Person, are prohibited from trading in the Company’s securities. If the Company imposes a special blackout period, it will notify you.

 

c)     Exceptions. Any exceptions to the foregoing may be granted only by the Compliance Officer and must be granted before any activity contrary to the above requirements takes place.

 

2. Trading Windows

 

Subject to the pre-clearance process described below, if you are a Key Person, you are generally permitted to trade in the Company’s securities when no blackout period is in effect. However, even during this trading window, if you are in possession of any material non-public information, then you should not trade in the Company’s securities until the information has been made publicly available or is no longer material. In addition, the Company may close this trading window if a special blackout period is imposed and will re-open the trading window once the special blackout period has ended.

 

3. Pre-clearance of Securities Transactions

 

a)     Because you, as a Key Person, are likely to obtain material non-public information on a regular basis, the Company requires you to refrain from trading, even during a trading window, without first pre-clearing all transactions in the Company’s securities with the Compliance Officer.

 

b)     You may not, directly or indirectly, purchase or sell (or otherwise make any transfer, gift, pledge or loan of) any Company security at any time without first obtaining prior approval from the Compliance Officer. These procedures also apply to transactions by your spouse, other persons living in your household and minor children and to transactions by entities over which you exercise control.

 

c)     The Compliance Officer shall record the date a request is received and the date and time a request is approved or disapproved. Any grant of permission shall be on such terms and subject to such conditions as may be approved by the Compliance Officer; provided that unless otherwise specified by the Compliance Officer, (i) a grant of permission shall remain valid until the close of trading two business days following the day on which it was granted, unless earlier revoked, and (ii) if the transaction does not occur during the two-day period, such grant will terminate and pre-clearance of the transaction must be re-requested.

 

 

 

 

4. Prohibited Transactions

 

a)     If you are a director or executive officer of the Company, then you are prohibited from trading in the Company’s equity securities during a blackout period imposed under an “individual account” retirement or pension plan of the Company, during which at least 50% of the plan participants are unable to purchase, sell or otherwise acquire or transfer an interest in equity securities of the Company, due to a temporary suspension of trading by the Company or the plan fiduciary.

 

b)     If you are a Key Person, then you (including your spouse, other persons living in your household and your minor children and entities over which you exercise control) are prohibited from engaging in the following transactions in the Company’s securities unless advance written approval is obtained from the Compliance Officer:

 

(i) Short-term trading. Purchasing any Company securities and selling securities of the same class at any time within six months before or after the purchase;

 

(ii) Short sales. Selling the Company’s securities short;

 

(iii) Options trading. Buying or selling puts or calls or other derivative securities on the Company’s securities;

 

(iv) Trading on margin or pledging. Holding Company securities in a margin account or pledging Company securities as collateral for a loan; and

 

(v) Hedging. Entering into hedging or monetization transactions or similar arrangements with respect to Company securities.

 

Part III

 

1. Compliance Officer

 

The Company has appointed its In-House Corporate Counsel as the Compliance Officer for this Policy. The duties of the Compliance Officer include, but are not limited to, the following:

 

(i) assisting with implementation and enforcement of this Policy;

 

(ii) circulating this Policy to all employees and others, as deemed appropriate, and overseeing the amendment of this Policy as necessary to remain in compliance with applicable laws; and

 

(iii) pre-clearing all trading in securities of the Company by Key Persons.

 

 

 

 

2. Exceptions

 

Any exceptions to the Policy, if permitted, may be granted only by the Compliance Officer and must be granted before any activity contrary to the requirements of this Policy takes place.

 

3. Penalties for Violations

 

a) SEC-Imposed Penalties. Penalties imposed by the SEC for trading on or communicating material non-public information can be severe, both for individuals involved in such unlawful conduct and their employers and supervisors, and may include prison terms, fines, other criminal or civil penalties (including injunctions) and disgorgement of insider trading profits. Given the severity of the potential penalties, compliance with this Policy is absolutely mandatory.

 

It is important to note that a person who “tips” material non-public information to others may also be liable for transactions by the “tippees” to whom the material non-public information is given. Tippers can be subject to the same penalties and sanctions as the tippees, and the SEC has imposed large penalties even when the tipper did not profit from the transaction.

 

The SEC can also seek substantial penalties from any person who, at the time of an insider trading violation, “directly or indirectly controlled the person who committed such violation,” which would apply to the Company and its management and supervisory personnel. These control persons may be held liable for up to the greater of $1 million or three times the amount of the profits gained or losses avoided. The SEC can even seek penalties for violations that result in a small or no profit.

 

b) Company-Imposed Penalties. Covered Persons and Key Persons who violate this Policy may be subject to disciplinary action by the Company, including dismissal for cause.

 

4. Inquiries

 

If you have any questions regarding any of the provisions of this Policy, please contact the Compliance Officer.

 

Adopted June 2, 2016

 

 

 

 

ACKNOWLEDGMENT AND CERTIFICATION

 

The undersigned does hereby acknowledge receipt of the Company’s Insider Trading Policy. The undersigned has read and understands (or has had explained, if so requested) such Policy and agrees to be governed by such Policy at all times in connection with the purchase and sale of securities and the confidentiality of non-public information.

 

   
  (Signature)
   
   
  (Please print name)
   
Date: ________________________  

 

 

Exhibit 23.1

 

Independent Registered Public Accounting Firm’s Consent

 

We consent to the incorporation by reference in the Registration Statement of Sensus Healthcare, Inc. on Form S-8 (File Nos. 333-221372, 333-212195, and 333-273922) of our report dated March 15, 2024 with respect to our audit of the consolidated financial statements of Sensus Healthcare, Inc. as of December 31, 2023 and for the year then ended, which report is included in this Annual Report on Form 10-K of Sensus Healthcare, Inc. for the year ended December 31, 2024.

 

/s/ Marcum llp

 

Marcum llp 

Tampa, Florida 

March 5, 2025

 

 

 

 

 Exhibit 23.2

 

CONSENT OF REGISTERED INDEPENDENT PUBLIC ACCOUNTING FIRM
 

We consent to the incorporation by reference in the Registration Statement on Form S-8 (File Nos. 333-221372, 333-212195 and 333-273922) of Sensus Healthcare, Inc. and Subsidiaries of our report dated March 5, 2025 on the consolidated financial statements of Sensus Healthcare, Inc. and Subsidiaries as of December 31, 2024 and for the year then ended, which report is included herein in the Annual Report on Form 10-K of Sensus Healthcare, Inc. for the year ended December 31, 2024.

/s/ Berkowitz Pollack Brant, Advisors + CPAs

 

West Palm Beach, FL

March 5, 2025

 
 
 
 
 


 

 

 

 

 

 

Exhibit 31.1

 

Certification of CEO Pursuant to Securities Exchange Act

Rule 13a-14(a)/15d-14(a) as Adopted Pursuant to

Section 302 of the Sarbanes-Oxley Act of 2002

 

I, Joseph C. Sardano, certify that:

 

1. I have reviewed this annual report on Form 10-K of Sensus Healthcare, Inc.;

 

2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

 

3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

 

4. The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

 

a. Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

 

b. Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

 

c. Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

 

d. Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

 

5. The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

 

a. All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

 

b. Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

 

Date: March 5, 2025

 

/s/ Joseph C. Sardano
  Joseph C. Sardano
  Chairman and Chief Executive Officer

 

 

 

 

Exhibit 31.2

 

Certification of CFO Pursuant to Securities Exchange Act

Rule 13a-14(a)/15d-14(a) as Adopted Pursuant to

Section 302 of the Sarbanes-Oxley Act of 2002

 

I, Javier Rampolla, certify that:

 

1. I have reviewed this annual report on Form 10-K of Sensus Healthcare, Inc.;

 

2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

 

3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

 

4. The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

 

a. Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

 

b. Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

 

c. Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

 

d. Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

 

5. The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

 

a. All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

 

b. Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

 

Date: March 5, 2025

 

/s/ Javier Rampolla
  Javier Rampolla
  Chief Financial Officer

 

 

 

 

Exhibit 32.1

 

Certification of CEO Pursuant to 18 U.S.C. Section 1350

 

Pursuant to 18 U.S.C. § 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, the undersigned certifies that:

 

(1) the Annual Report for Sensus Healthcare, Inc. (the “Company”) on Form 10-K for the period ended December 31, 2024, as filed with the Securities and Exchange Commission on the date hereof (this “Report”), fully complies with the requirements of Section 13(a) of the Securities Exchange Act of 1934, as amended; and

 

(2) The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company as of and for the periods covered therein.

 

A signed original of this written statement required by Section 906, or other document authenticating, acknowledging or otherwise adopting the signature that appears in typed form within the electronic version of this written statement, has been provided to the Company and will be retained by the Company and furnished to the Securities and Exchange Commission or its staff upon request.

 

/s/ Joseph C. Sardano  
Joseph C. Sardano  
Chairman and Chief Executive Officer  
   
March 5, 2025  

 

 

  

Exhibit 32.2

 

Certification of CFO Pursuant to 18 U.S.C. Section 1350

 

Pursuant to 18 U.S.C. § 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, the undersigned certifies that:

 

(1) the Annual Report for Sensus Healthcare, Inc. (the “Company”) on Form 10-K for the period ended December 31, 2024, as filed with the Securities and Exchange Commission on the date hereof (this “Report”), fully complies with the requirements of Section 13(a) of the Securities Exchange Act of 1934, as amended; and

 

(2) The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company as of and for the periods covered therein.

 

A signed original of this written statement required by Section 906, or other document authenticating, acknowledging or otherwise adopting the signature that appears in typed form within the electronic version of this written statement, has been provided to the Company and will be retained by the Company and furnished to the Securities and Exchange Commission or its staff upon request.

 

/s/ Javier Rampolla  
Javier Rampolla  
Chief Financial Officer  
   
March 5, 2025  

 

 

 

v3.25.0.1
Cover - USD ($)
12 Months Ended
Dec. 31, 2024
Feb. 12, 2025
Jun. 30, 2024
Cover [Abstract]      
Document Type 10-K    
Amendment Flag false    
Document Annual Report true    
Document Transition Report false    
Document Period End Date Dec. 31, 2024    
Document Fiscal Period Focus FY    
Document Fiscal Year Focus 2024    
Current Fiscal Year End Date --12-31    
Entity File Number 001-37714    
Entity Registrant Name Sensus Healthcare, Inc.    
Entity Central Index Key 0001494891    
Entity Tax Identification Number 27-1647271    
Entity Incorporation, State or Country Code DE    
Entity Address, Address Line One 851 Broken Sound Pkwy.    
Entity Address, Address Line Two NW #215    
Entity Address, City or Town Boca Raton    
Entity Address, State or Province FL    
Entity Address, Postal Zip Code 33487    
City Area Code (561)    
Local Phone Number 922-5808    
Title of 12(b) Security Common Stock, par value $0.01 per share    
Trading Symbol SRTS    
Security Exchange Name NASDAQ    
Entity Well-known Seasoned Issuer No    
Entity Voluntary Filers No    
Entity Current Reporting Status Yes    
Entity Interactive Data Current Yes    
Entity Filer Category Non-accelerated Filer    
Entity Small Business true    
Entity Emerging Growth Company false    
Entity Shell Company false    
Entity Public Float     $ 79,995,039
Entity Common Stock, Shares Outstanding   16,495,396  
Document Financial Statement Error Correction [Flag] false    
Auditor Name Marcum LLP    
Auditor Firm ID 688    
Auditor Location Tampa, Florida    
v3.25.0.1
CONSOLIDATED BALANCE SHEETS - USD ($)
$ in Thousands
Dec. 31, 2024
Dec. 31, 2023
Current assets    
Cash and cash equivalents $ 22,056 $ 23,148
Accounts receivable, net 19,731 10,645
Inventories 10,097 11,861
Prepaid inventory 3,347 2,986
Other current assets 1,507 888
Total current assets 56,738 49,528
Property and equipment, net 1,997 464
Deferred tax asset 2,197 2,140
Operating lease right-of-use asset, net 581 774
Other noncurrent assets 652 804
Total assets 62,165 53,710
Current liabilities    
Accounts payable and accrued expenses 4,811 2,793
Product warranties 329 538
Operating lease liability, current portion 204 187
Income tax payable 37
Deferred revenue, current portion 541 657
Total current liabilities 5,885 4,212
Operating lease liability 398 596
Deferred revenue, net of current portion 55 60
Total liabilities 6,338 4,868
Stockholders’ equity    
Preferred stock, 5,000,000 shares authorized and none issued and outstanding
Common stock, $0.01 par value – 50,000,000 authorized; 17,036,845 issued and 16,495,396 outstanding at December 31, 2024; 16,907,095 issued and 16,374,171 outstanding at December 31, 2023 169 169
Additional paid-in capital 45,795 45,405
Treasury stock, 541,449 and 532,924 shares at cost, at December 31, 2024 and December 31, 2023, respectively (3,571) (3,519)
Retained earnings 13,434 6,787
Total stockholders’ equity 55,827 48,842
Total liabilities and stockholders’ equity $ 62,165 $ 53,710
v3.25.0.1
CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares
Dec. 31, 2024
Dec. 31, 2023
Statement of Financial Position [Abstract]    
Preferred Stock, Shares Authorized 5,000,000 5,000,000
Preferred Stock, Shares Issued 0 0
Preferred Stock, Shares Outstanding 0 0
Common stock, par value (in dollars per share) $ 0.01 $ 0.01
Common stock, authorized 50,000,000 50,000,000
Common stock, issued 17,036,845 16,907,095
Common stock, outstanding 16,495,396 16,374,171
Common stock, par value (in dollars per share) 541,449 532,924
v3.25.0.1
CONSOLIDATED STATEMENTS OF INCOME - USD ($)
$ in Thousands
12 Months Ended
Dec. 31, 2024
Dec. 31, 2023
Income Statement [Abstract]    
Revenues $ 41,807 $ 24,405
Cost of sales 17,376 10,345
Gross profit 24,431 14,060
Operating expenses    
General and administrative 7,147 5,156
Selling and marketing 4,978 5,608
Research and development 4,216 3,678
Total operating expenses 16,341 14,442
Income (loss) from operations 8,090 (382)
Other income:    
Gain on sale of assets 42
Interest income, net 932 992
Other income, net 932 1,034
Income before income tax 9,022 652
Provision for income taxes 2,375 167
Net income $ 6,647 $ 485
Net income per share – basic $ 0.41 $ 0.03
Earnings Per Share, Diluted $ 0.41 $ 0.03
Weighted Average Number of Shares Outstanding, Basic 16,312,351 16,259,254
Weighted Average Number of Shares Outstanding, Diluted 16,359,616 16,266,139
v3.25.0.1
CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY - USD ($)
$ in Thousands
Common Stock [Member]
Additional Paid-in Capital [Member]
Treasury Stock, Common [Member]
Retained Earnings [Member]
Total
Beginning balance, value at Dec. 31, 2022 $ 169 $ 45,031 $ (3,433) $ 6,302 $ 48,069
Beginning balance (in shares) at Dec. 31, 2022 16,902,761   (512,342)    
Stock-based compensation 359 359
Stock-Based Compensation (in shares) 10,000        
Exercise of stock options 46 46
Exercise of stock options (in shares) 8,334        
Stock repurchase $ (27) $ (27)
Stock repurchase (in shares)     (9,427)   9,427
Forfeiture of restricted stock units (31)     $ (31)
Forfeiture of restricted stock units (in shares) (14,000)        
Surrender of shares for tax withholding on stock-based compensation $ (59) (59)
Surrender of shares for tax withholding on stock-based compensation (in shares)     (11,155)    
Net income 485 485
Ending balance, value at Dec. 31, 2023 $ 169 45,405 $ (3,519) 6,787 48,842
Ending balance (in shares) at Dec. 31, 2023 16,907,095   (532,924)    
Stock-based compensation 325 325
Stock-Based Compensation (in shares) 120,000        
Exercise of stock options 67 $ 67
Exercise of stock options (in shares) 12,000        
Stock repurchase (in shares)         0
Forfeiture of restricted stock units (2) $ (2)
Forfeiture of restricted stock units (in shares) (2,250)        
Surrender of shares for tax withholding on stock-based compensation $ (52) (52)
Surrender of shares for tax withholding on stock-based compensation (in shares)     (8,525)    
Net income 6,647 6,647
Ending balance, value at Dec. 31, 2024 $ 169 $ 45,795 $ (3,571) $ 13,434 $ 55,827
Ending balance (in shares) at Dec. 31, 2024 17,036,845   (541,449)    
v3.25.0.1
CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($)
$ in Thousands
12 Months Ended
Dec. 31, 2024
Dec. 31, 2023
Cash flows from operating activities    
Net income $ 6,647 $ 485
Adjustments to reconcile net income to net cash and cash equivalents used in operating activities:    
Credit loss expense 123 7
Depreciation and amortization 239 275
Gain on sale of assets (42)
Amortization of right-of-use asset 193 186
Provision for product warranties 255 603
Stock-based compensation 323 328
Deferred income taxes (57) (427)
Changes in operating assets and liabilities:    
Accounts receivable (9,209) 6,647
Inventories 268 (8,577)
Prepaid inventory (361) 3,275
Other current assets (619) (228)
Other noncurrent assets 152 (312)
Accounts payable and accrued expenses 2,018 (2,728)
Operating lease liability (181) (201)
Income tax payable (37) (853)
Deferred revenue (121) (115)
Product warranties (464) (468)
Net cash used in operating activities (831) (2,145)
Cash flows from investing activities    
Acquisition of property and equipment (276) (229)
Proceeds from sale of assets 42
Net cash used in investing activities (276) (187)
Cash flows from financing activities    
Repurchase of common stock (27)
Withholding taxes on stock-based compensation (52) (59)
Exercise of stock options 67 46
Net cash provided by (used in) financing activities 15 (40)
Net decrease in cash and cash equivalents (1,092) (2,372)
Cash and cash equivalents – beginning of year 23,148 25,520
Cash and cash equivalents – end of year 22,056 23,148
Supplemental disclosure of cash flow information:    
Interest paid
Income tax paid 2,582 1,440
Supplemental schedule of noncash investing and financing transactions:    
Transfer of inventory to property and equipment $ 1,496 $ 217
v3.25.0.1
Pay vs Performance Disclosure - USD ($)
$ in Thousands
12 Months Ended
Dec. 31, 2024
Dec. 31, 2023
Pay vs Performance Disclosure [Table]    
Net Income (Loss) $ 6,647 $ 485
v3.25.0.1
Insider Trading Policies and Procedures
12 Months Ended
Dec. 31, 2024
Insider Trading Policies and Procedures [Line Items]  
Insider Trading Policies and Procedures Adopted true
v3.25.0.1
Organization and Summary of Significant Accounting Policies
12 Months Ended
Dec. 31, 2024
Accounting Policies [Abstract]  
Organization and Summary of Significant Accounting Policies

Note 1 — Organization and Summary of Significant Accounting Policies

 

Description of the Business

 

Sensus Healthcare, Inc. (together, with its subsidiaries, unless the context otherwise indicates, “Sensus” or the “Company”) is a manufacturer of radiation therapy devices and sells the devices to healthcare providers globally through its distribution and marketing network. The Company operates from its corporate headquarters located in Boca Raton, Florida.

 

In 2024, the Company formed Sensus Healthcare Services, LLC, a wholly-owned subsidiary that provides operational healthcare services in the form of equipment, radiation oncology and physics oversight, including radiotherapy technologists for dermatology clinics.

 

Basis of Presentation and Principles of Consolidation

 

These consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States (“GAAP”) and include the accounts of the Company and its subsidiaries. Accounts and transactions between consolidated entities have been eliminated.

 

Use of Estimates

 

The preparation of consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, including disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenue and expense during the reporting periods. Actual results could differ from those estimates.

 

Change in Accounting Estimate

 

In the fourth quarter of 2023, the Company changed its estimate that it was probable that it would make commission payments to certain of its employees as compensation expense. As it was no longer probable that the payments would be made, the Company reversed the accrued compensation expense, which was included in accounts payable and accrued expenses in the consolidated balance sheets, related to these payments. This change in estimate resulted in a decrease in selling and marketing expenses of $853,500, or $0.05 per share (basic and diluted) for the year ended December 31, 2023.

 

Revenue Recognition

 

The Company’s revenue is derived from sales of the Company’s devices and services related to operating, maintaining and repairing the devices as part of a contract or on an ad-hoc basis without a service contract.

 

The Company provides warranties, generally for one year, in conjunction with the sale of its products. These warranties entitle the customer to repair, replacement, or modification of the defective product, subject to the terms of the relevant warranty. The Company has determined that these warranties do not represent separate performance obligations, as the customer does not have the option to purchase the warranty separately and the warranty does not provide the customer with a service in addition to the assurance that the product complies with agreed-upon specifications. The Company records an estimate of future warranty claims at the time it recognizes revenue from the sale of the device based upon management’s estimate of the future claims rate.

 

Revenue is recognized upon transfer of control of promised goods or services to customers when the product is shipped or the service is rendered, based on the amount the Company expects to receive in exchange for those goods or services. The Company enters into contracts that can include multiple services, which are accounted for separately if they are determined to be distinct.

 

 

To determine the transaction price for contracts in which a customer promises consideration in a form other than cash, the Company measures the estimated fair value of the noncash consideration at contract inception. If the Company cannot reasonably estimate the fair value of the noncash consideration, the Company measures the consideration indirectly by reference to the stand-alone selling price of the products promised to the customer or class of customer in exchange for the consideration.

 

Our service contracts include maintenance or repair service for device purchases and personnel service contracts to assist in the use and operation of leased-out equipment under lease agreements where the Company is the lessor.

 

The revenues from maintenance or repair service contracts are recognized over the service contract period on a straight-line basis. In the event that a customer does not sign a service contract, but requests maintenance or repair services after the warranty expires, the Company recognizes revenue when the service is rendered. There is no termination provision in the service contract or any penalties in practice for cancellation of the service contract.

 

The revenues from personnel service contracts are recognized in the period that the work is performed, as the Company has elected the practical expedient under Accounting Standards Codification ("ASC") 606, Revenue from Contracts with Customers, to recognize revenue in the amount to which the entity has a right to invoice. The service contracts can be terminated by mutual written agreement.

 

The Company has determined that in practice no significant discount is given on service contracts when offered with the device purchase or equipment lease as compared to when sold on a stand-alone basis. The service level provided is identical whether the service contract is purchased on a stand-alone basis or together with the device purchase or equipment lease. The Company may also incur preparation cost to ensure the customer’s space meets the requirements and specifications for the operation of the equipment. The preparation cost is expensed as incurred.

 

The components of disaggregated revenue for the years ended December 31, 2024 and 2023 were as follows: 

 

   For the Years Ended 
   December 31, 
(in thousands)  2024   2023 
Product Revenue - recognized at a point in time  $36,398   $20,347 
Product Revenue - recognized over time   247     
Service Revenue - recognized at a point in time   1,961    1,261 
Service Revenue - recognized over time   3,201    2,797 
Total Revenue  $41,807   $24,405 

 

The Company operates in a highly regulated environment, primarily in the U.S. dermatology market, in which state regulatory approval is sometimes required prior to the customer being able to use the product. In cases where such regulatory approval is pending, revenue is deferred until such time as regulatory approval is obtained.

 

Deferred revenue activity for 2024 and 2023 was as follows:

 

(in thousands)   Product   Service   Total 
December 31, 2022  $45   $787   $832 
Revenue recognized   (45)   (2,797)   (2,842)
Amounts invoiced   36    2,691    2,727 
December 31, 2023  $36   $681   $717 
Revenue recognized   (300)   (3,201)   (3,501)
Amounts invoiced   345    3,035    3,380 
December 31, 2024  $81   $515   $596 

 

Remaining performance obligations related to deposits for products have original expected durations of one year or less. Estimated service revenue to be recognized in the future related to the performance obligations that are unsatisfied (or partially unsatisfied) as of December 31, 2024 is as follows:

 

Year   Service Revenue 
2025    461 
2026    44 
2027    10 
Total   $515 

  

For the years ended December 31, 2024 and 2023, the Company paid commissions for certain equipment sales. Because the recovery of commissions is expected to occur from product revenue within one year, the Company charges commissions to expense as incurred.

 

In addition, the Company incurs commissions associated with equipment lease agreements, which are accounted for as initial direct costs and recorded in other noncurrent assets in the consolidated balance sheets. The commission is capitalized at the commencement of the lease and recognized as an expense in selling and marketing expenses over the lease term.

 

Shipping and handling costs are expensed as incurred and are included in cost of sales.

 

Concentration

 

Financial instruments that potentially subject the Company to concentration of credit risk consist primarily of cash and cash equivalents and accounts receivable.

 

The Company maintains cash balances at financial institutions in excess of federally insured limits. The Company has not experienced any losses related to these balances. The Federal Deposit Insurance Corporation insures eligible accounts up to $250,000 per depositor at each financial institution. The Company holds cash at well-known banks and does not believe that it is exposed to any significant credit risks on its cash.

 

One customer in the U.S. accounted for 73% and 61% of revenue for the years ended December 31, 2024 and 2023, respectively, and 86% and 85% of accounts receivable as of December 31, 2024 and 2023, respectively.

 

 

Geographical Information

 

The following table illustrates total revenue for the years ended December 31, 2024 and 2023 by geographic region.

 

   For the Years Ended 
   December 31, 
(in thousands)  2024   2023 
United States  $40,180    96%  $22,279    91%
China   1,445    3%   1,491    6%
Israel   172    1%   43    0%
Turkey       0%   265    1%
Guatemala       0%   190    1%
Ireland       0%   135    1%
Other   10    0%   2    0%
Total Revenue  $41,807    100%  $24,405    100%

 

Fair Value of Financial Instruments

 

Carrying amounts of cash equivalents, accounts receivable, accounts payable and the revolving credit facility approximate fair value due to their relative short maturities.

 

Fair Value Measurements

 

The Company uses a fair value hierarchy that prioritizes inputs to valuation approaches used to measure fair value. The fair value hierarchy gives the highest priority to quoted prices (unadjusted) in active markets for identical assets or liabilities and the lowest priority to unobservable inputs. Assets and liabilities measured and reported at fair value are classified and disclosed in one of the following categories:

 

Level 1 Inputs:

 

Quoted prices (unadjusted) in active markets for identical assets or liabilities at the reporting date.

 

  Level 1 assets may include listed mutual funds, ETFs and listed equities

 

Level 2 Inputs:

 

Quoted prices for similar assets or liabilities in active markets; quoted prices for identical or similar assets or liabilities that are not active; quotes from pricing services or brokers for which the Company can determine that orderly transactions took place at the quoted price or that the inputs used to arrive at the price are observable; and inputs other than quoted prices that are observable, such as models or other valuation methodologies. 

 

  Level 2 assets may include debt securities and foreign currency exchange contracts that have inputs to the valuations that generally can be corroborated by observable market data.

 

Level 3 Inputs:

 

Unobservable inputs for the valuation of the asset or liability, which may include nonbinding broker quotes.

 

  Level 3 assets include investments for which there is little, if any, market activity. These inputs require significant management judgment or estimation.

 

Significance of Inputs: The Company’s assessment of the significance of a particular input to the fair value measurement in its entirety requires judgment and considers factors specific to the financial instrument.

 

 

Foreign Currency

 

The Company’s foreign operation functional currency is the U.S. dollar. The Company considers its Israel subsidiary an extension of the parent company operations in the United States. The cash flow in the foreign operation depends primarily on the funding by the parent company.

 

Cash and Cash Equivalents

 

Cash and cash equivalents primarily consists of cash, money market funds and short-term, highly liquid investments with original maturities of three months or less.

 

Accounts Receivable

 

On January 1, 2023, the Company adopted Accounting Standards Update (ASU) 2016-13, Financial Instruments – Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments. The amendments in this ASU replace the incurred loss model for recognition of credit losses with a methodology that reflects expected credit losses over the life of the loan and requires consideration of a broader range of reasonable and supportable information to calculate credit loss estimates. This update did not have a significant impact on the Company’s consolidated financial statements.

 

The Company does business and extends credit based on an evaluation of each customer’s financial condition, generally without requiring collateral. Exposure to losses on receivables is expected to vary by customer due to the financial condition of each customer. The Company estimates future credit losses based on the age of customer receivable balances, collection history and forecasted economic trends. Future collections can be significantly different from historical collection trends or current estimates. The Company monitors exposure to credit losses and maintains allowances for anticipated losses considered necessary under the circumstances. The allowance for expected credit losses was $0.1 million and $0 as of December 31, 2024 and 2023, respectively. Credit loss expense for the years ended December 31, 2024 and 2023 was $0.1 million and $7 thousand, respectively.

 

Inventories

 

Inventories consist of finished product and components and are stated at the lower of cost or net realizable value, determined using the first-in-first-out method.

 

Property and Equipment

 

Property and equipment are stated at cost less accumulated depreciation. Depreciation on property and equipment is calculated on the straight-line basis over the estimated useful life of each asset. Maintenance and repairs are expensed as incurred; expenditures that enhance the value of property or extend their useful lives are capitalized. When assets are sold or returned, the cost and related accumulated depreciation are removed from the accounts and the resulting gain or loss is included in other income in the consolidated statements of income.

 

Inventory units designated for customer demonstrations, as part of the sales process, are reclassified to property and equipment and the depreciation is recorded in selling and marketing expense. Property and equipment that were reclassified to or from inventory were $1.5 million and $0.2 million for the years ended December 31, 2024 and 2023, respectively. These property and equipment were for demonstrations and the leasing program where the Company is the lessor.

 

Research and Development

 

Research and development costs related to products under development by the Company and quality and regulatory costs and are expensed as incurred.

 

Earnings Per Share

 

Basic net income per share is calculated by dividing the net income by the weighted-average number of common shares outstanding for the period using the treasury stock method for options, restricted stocks and warrants. Diluted net income per share is computed by giving effect to all potential dilutive common share equivalents outstanding for the period.

 

 

The factors used in the earnings per share computation are as follows:

 

   For the Years Ended 
   December 31, 
(in thousands)  2024   2023 
Basic        
Net income  $6,647   $485 
Weighted average number of shares used in computing net income per share – basic   16,312    16,259 
Net income per share - basic  $0.41   $0.03 
Diluted          
Net income  $6,647   $485 
Weighted average number of shares used in computing net income per share – basic   16,312    16,259 
Dilutive effects of:          
Stock options   7    5 
Restricted stock awards   41    2 
Weighted average number of shares used in computing net income per share – diluted   16,360    16,266 
Net income per share - diluted  $0.41   $0.03 
           
The full shares listed below were not included in the computation of diluted net income          
per share because to do so would have been antidilutive for the periods presented:          
Restricted stock awards       57,250 

  

Diluted net income per share for the year ended December 31, 2024 includes the dilutive effect of stock options and restricted stock awards that were issued in December 2022, January 2024, and December 2024 to directors, officers, and employees.

 

Diluted net income per share for the year ended December 31, 2023 includes the dilutive effect of stock options and restricted stock awards that were issued in July 2021. The stock options and 89,750 restricted stock awards were not in the money as the average price of common stock during the second to fourth quarter was less than the exercise prices. The assumed proceeds of stock options and the restricted stock awards for the treasury stock method is the amount the grantee pays on exercise plus the average amount of unrecognized compensation expense.

 

Equity-Based Compensation

 

Pursuant to relevant accounting guidance related to accounting for equity-based compensation, the Company is required to recognize all share-based payments to non-employees and employees in the financial statements based on grant-date fair values. The Company has accounted for issuances of shares and options in accordance with the guidance, which requires the recognition of expense, based on grant-date fair values, over the service period, which is generally the period over which the shares and options vest.

 

Advertising Costs

 

Advertising and promotion costs are charged to expense as incurred. Advertising and promotion costs included in selling and marketing expense in the accompanying statements of income amounted to $1.2 million for both the years ended December 31, 2024 and 2023.

 

Leases

 

The Company evaluates arrangements at inception to determine if an arrangement is or contains a lease. Operating lease assets represent the Company’s right to control an underlying asset for the lease term, and operating lease liabilities represent the Company’s obligation to make lease payments arising from the lease. Control of an underlying asset is conveyed to the Company if the Company obtains the rights to direct the use of and to obtain substantially all of the economic benefits from using the underlying asset. Operating lease assets and liabilities are recognized at the commencement date of the lease based upon the present value of lease payments over the lease term. When determining the lease term, the Company includes options to extend or terminate the lease when it is reasonably certain that the Company will exercise that option. The Company uses an incremental borrowing rate that the Company would expect to incur for a fully collateralized loan over a similar term under similar economic conditions to determine the present value of the lease payments. The Company has lease agreements which include lease and non-lease components, which the Company has elected to account for as a single lease component for all classes of underlying assets.

The lease payments used to determine the Company’s operating lease assets may include lease incentives, and stated rent increases are recognized in the Company’s operating lease assets in the Company’s consolidated balance sheets. Operating lease assets are amortized to rent expense over the lease term and included in operating expenses in the consolidated statements of income.

 

For leases in which the Company is the lessor, the Company identifies the lease and non-lease components and allocates the contract consideration to the different components on a relative stand-alone selling price basis at lease inception. The Company uses a residual approach for the components when the stand-alone selling price is not directly observable or those for which the Company has not established a price.

 

The Company has elected the practical expedient to combine lease and non-lease components when the components qualify to be combined. Continuous supporting services are the primary non-lease components and are not predominant. As a result, the combined components are accounted for as a lease under ASC 842, Leases. The revenues from non-lease components that are not qualified to be combined are recognized when the services are rendered under ASC 606, Revenue from Contracts with Customers. The revenues from non-lease components were $0.3 million for the year ended December 31, 2024.

 

For operating leases where the Company is the lessor, the Company recognizes the underlying assets and depreciates them over the estimated useful life which is based upon an estimate of the residual value expected at the end of the lease term. Lease income is recognized on a straight-line basis over the lease term when the lease payment is determined. Lease income is not recognized when collection of all contractual rents over the term of the agreement is not probable. When collection is not probable, the Company limits the lease income to the lesser of the revenue recognized on a straight-line basis or cash basis. The lease income is included in revenues in the consolidated statements of income.

 

Variable lease payments associated with the leases are recognized when the event, activity, or circumstance in the lease agreement on which those payments are assessed occurs. Variable lease payments are presented within revenues in the consolidated statements of income.

 

Income Taxes

 

The Company recognizes deferred tax assets and liabilities for the expected future tax consequences of events that have been recognized in the Company’s financial statements or tax returns. Under this method, deferred tax assets and liabilities are determined based on differences between the financial statement carrying amounts and the tax bases of the assets and liabilities using the enacted tax rates in effect in the years in which the differences are expected to reverse. A valuation allowance against deferred tax assets is recorded if, based on the weight of the available evidence, it is more likely than not that some or all of the deferred tax assets will not be realized.

 

Uncertain tax positions are recognized in the consolidated financial statements only if that position is more likely than not to be sustained upon examination by taxing authorities, based on the technical merits of the position. The Company’s practice is to recognize interest and/or penalties related to income tax matters in income tax expense.

 

 

Recent Accounting Pronouncements

 

In March 2020, the Financial Accounting Standard Board (“FASB”) issued ASU 2020-4, Reference Rate Reform (Topic 848): Facilitation of the Effects of Reference Rate Reform on Financial Reporting, to provide temporary optional expedients and exceptions to U.S. GAAP guidance on contract modifications to ease the financial reporting burdens of the expected market transition from the London Interbank Offered Rate, or LIBOR, to alternative reference rates, such as the Secured Overnight Financing Rate. Entities can elect not to apply certain modification accounting requirements to contracts affected by what the guidance calls reference rate reform if certain criteria are met. An entity that makes this election would not have to remeasure the contracts at the modification date or reassess a previous accounting determination. The guidance is effective prospectively as of March 12, 2020 through December 31, 2022 and interim periods within those fiscal years. In December 2022, the FASB issued ASU 2022-06, Deferral of the Sunset Date of Topic 848 which was issued to defer the sunset date of Topic 848 to December 31, 2024. These updates did not have a significant impact on the Company’s consolidated financial statements.

 

In November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures to enhance disclosures about significant segment expenses for public entities reporting segment information under ASC Topic 280. The amendments require public entities to disclose significant expense categories for each reportable segment, other segment items, the title and position of the chief operating decision-maker, and interim disclosures of certain segment-related information previously required only on an annual basis. The amendments clarify that entities reporting single segments must disclose both the new and existing segment disclosures under Topic 280, and a public entity is permitted to disclose multiple measures of segment profit or loss if certain criteria are met. The ASU is effective for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024. The adoption of ASU 2023-07 did not have a significant impact on the Company's consolidated financial statements. See Note 12, Segment Reporting, for the required disclosures.

 

In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures, to enhance transparency into income tax disclosures. The amendments require annual disclosure of certain information relating to the rate reconciliation, income taxes paid by jurisdiction, income (or loss) from continuing operations before income tax expense (or benefit) disaggregated between domestic and foreign, income tax expense (or benefit) from continuing operations disaggregated by federal (national), state, and foreign. The amendments also eliminate certain requirements relating to unrecognized tax benefits and certain deferred tax disclosure relating to subsidiaries and corporate joint ventures. The ASU is effective for fiscal years beginning after December 15, 2024, and interim periods within fiscal years beginning after December 15, 2025. Early adoption is permitted. The Company is currently evaluating the impact of this standard on its consolidated financial statements and related disclosures.

 

In March 2024, the FASB issued ASU 2024-01, Compensation - Stock Compensation (Topic 718): Scope Application of Profits Interest and Similar Awards, to clarify how an entity determines whether a profits interest or similar award is within the scope of Topic 718 or is not a share-based payment arrangement and therefore within the scope of other guidance. ASU 2024-01 provides an illustrative example with multiple fact patterns and also amends certain language in the “Scope” and “Scope Exceptions” sections of Topic 718 to improve its clarity and operability without changing the guidance. The ASU is effective for fiscal years beginning after December 15, 2024, and interim periods within those annual periods. Early adoption is permitted. These updates are not expected to have a significant impact on the Company’s consolidated financial statements. 

 

In November 2024, the FASB issued ASU 2024-03, Income Statement - Reporting Comprehensive Income - Expense Disaggregation Disclosures (“ASU 2024-03”) which requires entities to (i) disclose amounts of (a) purchase of inventory, (b) employee compensation, (c) depreciation, (d) intangible asset amortization, and, (e) depreciation, depletion, and amortization recognized as part of oil-and gas-producing activities, (ii) include certain amounts that are already required to be disclosed under current U.S. GAAP in the same disclosures as other disaggregation requirements, (iii) disclose a qualitative description of the amounts remaining in relevant expense captions that are not necessarily disaggregated quantitatively, and (iv) disclose the total amount of selling expenses, in annual reporting periods, an entity’s definition of selling expense. ASU 2024-03 is effective for annual reporting periods beginning after December 15, 2026 and interim reporting periods beginning after December 15, 2027.  Early adoption is permitted. The Company is currently evaluating ASU 2024-03 to determine the impact it may have on its consolidated financial statements.

v3.25.0.1
Property and Equipment
12 Months Ended
Dec. 31, 2024
Property, Plant and Equipment [Abstract]  
Property and Equipment

Note 2 — Property and Equipment

 

Property and equipment consists of the following:

 

(in thousands)  As of December 31, 2024   As of December 31, 2023   Estimated Useful Lives 
             
Operations equipment  $940   $1,018   3-10 years 
Equipment leased to customers   1,597       10 years 
Tradeshow and demo equipment   1,184    1,184   3 years 
Computer equipment   168    145   3 years 
Subtotal   3,889    2,347     
Construction in progress   228         
Less accumulated depreciation   (2,120)   (1,883)    
Property and Equipment, Net  $1,997   $464     

 

Depreciation expense was $0.2 million and $0.2 million for the years ended December 31, 2024 and 2023, respectively.

v3.25.0.1
DEBT
12 Months Ended
Dec. 31, 2024
Debt Disclosure [Abstract]  
DEBT

Note 3 — DEBT

 

On September 11, 2023, the Company entered into a new revolving credit facility (the “Credit Facility”) with Comerica Bank (“Comerica”), replacing the prior facility with Silicon Valley Bank, that provided for maximum borrowings of $10 million. The Credit Facility may be terminated by the Company or Comerica at any time without penalty. At December 31, 2024, the available borrowings under this facility were $10 million. Any borrowings bear interest at the Secured Overnight Financing Rate plus 2.50% (or 6.99% at December 31, 2024) and would be due upon demand by Comerica. The Credit Facility is secured by all of the Company’s assets. In October 2024, the Credit Facility was amended to extend the term of the Credit Facility to November 1, 2026 and to increase the maximum borrowings to $15.0 million. The amended Credit Facility includes updated covenants requiring that the Company maintain (1) unencumbered liquid assets having a minimum value of $10.0 million in a Comerica account; (2) minimum profitability of $1 on a trailing 12-month basis; and (3) the contractual relationship with the manufacturer of the SRT-100 discussed in Note 6, Commitments and Contingencies – Manufacturing Agreement. There were no other significant changes to the terms of the Credit Facility.

 

The Company was in compliance with its financial covenants under the respective facilities as of December 31, 2024 and December 31, 2023. There were no borrowings outstanding under either facility at December 31, 2024 or December 31, 2023.

v3.25.0.1
Product Warranties
12 Months Ended
Dec. 31, 2024
Guarantees and Product Warranties [Abstract]  
Product Warranties

Note 4 — Product Warranties

 

Changes in product warranty liability were as follows for the years ended December 31, 2024 and 2023:

 

(in thousands)    
Balance, December 31, 2022  $403 
Warranties accrued during the period   603 
Payments on warranty claims   (468)
Balance, December 31, 2023  $538 
Warranties accrued during the period   255 
Payments on warranty claims   (464)
Balance, December 31, 2024  $329 

v3.25.0.1
Leases
12 Months Ended
Dec. 31, 2024
Leases  
Leases

Note 5 — Leases

 

Operating Lease Agreements

 

The Company leases its headquarters office from an unrelated third party under a lease expiring in September 2027. The amortization expense of the right of use lease asset was $0.2 million and $0.2 million for the years ended December 31, 2024 and 2023, respectively. In January 2025, the Company entered into a sublease agreement with an unrelated third party to lease a new office space which is adjacent to the current headquarters office. The sublease will be effective from January 2025 to September 2027.

 

The following table presents information about the amount, timing and uncertainty of cash flows arising from the Company’s operating leases as of December 31, 2024.

 

Maturity of Operating Lease Liability  Amount 
2025  $229 
2026   236 
2027   181 
Total undiscounted operating leases payments  $646 
Less: Imputed interest   (44)
Present Value of Operating Lease Liability  $602 
Operating lease liability, current portion  $204 
Operating lease liability, net of current portion  $398 
      
Other Information     
Weighted-average remaining lease term    2.75 years  
Weighted-average discount rate   5%

 

Cash paid for amounts included in the measurement of operating lease liabilities was $0.2 million and $0.2 million for the years ended December 31, 2024 and 2023, respectively, and is included in cash flows from operating activities in the accompanying consolidated statements of cash flows.

 

Operating lease cost recognized as expense was $0.2 million for the years ended December 31, 2024 and 2023. The financing component for operating lease obligations represents the effect of discounting the operating lease payments to their present value.

 

Lessor Accounting

 

Beginning in the quarter ended June 30, 2024, the Company, through its subsidiary, Sensus Healthcare Services, LLC, leases superficial radiotherapy equipment to dermatology clinics. These leases generally have an initial lease term of 60 months and automatically renew for a one-year period upon the expiration of the initial lease term. Payments due under the leases may be fixed or variable payments.

 

 

The components of lease income for the year ended December 31, 2024 are as follows:

 

     For the 
     Year Ended 
(in thousands)    December 31, 2024 
Lease income - operating leases - fixed payments    $192 
Lease income - operating leases - variable payments     55 
Total    $247 

 

The future minimum fixed lease payments to be received under the lease agreements as of December 31, 2024 are as follows:

 

(in thousands)   Amount 
2025   $256 
2026    256 
2027    256 
2028    256 
2029    256 
Thereafter    87 
Total    $1,367 

 

v3.25.0.1
Commitments and Contingencies
12 Months Ended
Dec. 31, 2024
Commitments and Contingencies Disclosure [Abstract]  
Commitments and Contingencies

Note 6 — Commitments and Contingencies

 

Manufacturing Agreement

 

The Company has a contract manufacturing agreement with an unrelated third party for the production and manufacture of the SRT-100 (and subsequently the SRT-100 Vision and the SRT-100+), in accordance with the Company’s product specifications. The agreement renews for successive one-year periods unless either party notifies the other party in writing, at least 60 days prior to the anniversary date of the agreement, that it will not renew the agreement. The Company or the manufacturer may terminate the agreement upon 90 days’ prior written notice.

 

The Company pays this manufacturer for finished goods in advance of the inventory being received. The Company paid this manufacturer $9.9 million and $10.3 million for finished goods for the years ended December 31, 2024 and 2023, respectively. Approximately $10.3 million and $12.7 million of finished goods was received from this manufacturer for the years ended December 31, 2024 and 2023, respectively. As of December 31, 2024 and December 31, 2023, a prepayment related to these finished goods of $3.3 million and $3.0 million, respectively, was presented in prepaid inventory in the accompanying consolidated balance sheets. 

 

Legal contingencies

 

The Company is party to certain legal proceedings in the ordinary course of business. The Company assesses, in conjunction with its legal counsel, the need to record a liability for litigation and related contingencies.

 

In 2015, the Company learned that the Department of Justice (the “Department”) had commenced an investigation of the billing to Medicare by a physician who had treated patients with the Company’s SRT-100. The Department subsequently advised the Company that it was considering expanding the investigation to determine whether the Company had any involvement in physician’s use of certain reimbursements codes. The Company has received two Civil Investigative Demands from the Department seeking documents and written responses in connection with its investigation. The Company has fully cooperated with the Department. The Company disputes that it has engaged in any wrongdoing with respect to such reimbursement claims; among other considerations, the Company does not submit claims for reimbursement or provide coding or billing advice to physicians. To the Company’s knowledge, the Department has made no determination as to whether the Company engaged in any wrongdoing, or whether to pursue any legal action against the Company. Should the Department decide to pursue legal action, the Company believes it has strong and meritorious defenses and will vigorously defend itself. As of December 31, 2024, the Company was unable to estimate the cost associated with this matter. 

v3.25.0.1
Employee Benefit Plans
12 Months Ended
Dec. 31, 2024
Retirement Benefits [Abstract]  
Employee Benefit Plans

Note 7 — Employee Benefit Plans

 

The Company sponsors a 401(k) defined contribution retirement plan that allows eligible employees to contribute a portion of their compensation, as defined by the plan and subject to Internal Revenue Code limitations. The Company makes contributions to the plan which include matching a percentage of the employees’ contributions up to certain limits. Expenses related to this plan totaled $0.1 million for each of the years ended December 31, 2024 and 2023.

v3.25.0.1
Stockholders’ Equity
12 Months Ended
Dec. 31, 2024
Equity [Abstract]  
Stockholders’ Equity

Note 8 — Stockholders’ Equity

 

Preferred Stock

 

The Company has authorized 5 million shares of preferred stock. No shares of preferred stock were issued or outstanding at December 31, 2024 or December 31, 2023.

 

Treasury Stock

 

Treasury stock includes shares surrendered by employees for tax withholding on the vesting of restricted stock awards and shares repurchased in open market transactions. 8,525 and 11,155 shares were surrendered by employees for tax withholding for the years ended December 31, 2024 and 2023, respectively. During the years ended December 31, 2024 and 2023, the Company repurchased 0 and 9,427 shares, respectively, in open market transactions.

v3.25.0.1
Equity-based Compensation
12 Months Ended
Dec. 31, 2024
Share-Based Payment Arrangement [Abstract]  
Equity-based Compensation

Note 9 — Equity-based Compensation

 

2016 and 2017 Equity Incentive Plans

 

The Company’s 2016 Equity Incentive Plan and the 2017 Incentive Plan, as amended in June 2023 (collectively, the “Plans”), provide for the issuance of up to 397,473 shares and 750,000 shares, respectively. In addition, unless the Compensation Committee specifically determines otherwise, the maximum number of shares available under the Plans and the awards granted under the Plans will be subject to appropriate adjustment in the case of any stock dividends, stock splits, recapitalizations, reorganizations, mergers, consolidations, exchanges or other changes in capitalization affecting the Company’s common stock. The awards may be made in the form of restricted stock awards or stock options, among other things. As of December 31, 2024 and 2023, 195,223 and 312,973 shares were available to be granted in the Plans, respectively.

 

On February 1, 2020, a total of 35,000 shares of restricted stock were issued to employees. The restricted shares vested 25% per year over a four-year period. The grant date fair value of $4.11 per share was recognized as expense on a straight-line basis over the vesting period. During the year ended December 31, 2024, 2,500 shares of common stock vested. During the year ended December 31, 2023, 5,000 shares of common stock vested, and 10,000 shares of unvested common stock were forfeited due to the termination of three employees. As of December 31, 2024, the shares issued on February 1, 2020 were fully vested.

 

On July 21, 2021, a total of 130,000 shares of restricted stock were issued to employees and board members. The restricted shares vested 25% at grant date and 25% per year over a three-year period. The grant date fair value of $3.84 per share was being recognized as expense on a straight-line basis over the vesting period. During each of the years ended December 31, 2024 and 2023, 32,500 shares of common stock vested. As of December 31, 2024, the shares issued on July 21, 2021 were fully vested.

 

 

On December 19, 2022, a total of 77,000 shares of restricted stock were issued to employees. The restricted shares vest 25% per year over a four-year period. The fair value of $6.40 per share, the stock price on grant date, is being recognized as expense on a straight-line basis over the vesting period. During the year ended December 31, 2024, 17,500 shares of common stock vested, and 2,250 shares of unvested common stock were forfeited due to the termination of three employees. During the year ended December 31, 2023, 18,250 shares of common stock vested, and 4,000 shares of unvested common stock were forfeited due to the termination of four employees.

 

On January 26, 2023, 10,000 shares of common stock were issued to an employee and were recorded at the fair value of $8.96 per share, the stock price on the grant date. The shares were fully vested on the grant date.

 

On January 11, 2024, 20,000 shares of common stock with a fair value of $2.65 per share, the stock price on the grant date, were issued to an employee. 10,000 of the shares vested and the expense related to these shares was recognized on the grant date. The remaining 10,000 shares vested in January 2025. The grant date fair value of $2.65 per share is being recognized as expense on a straight-line basis over the vesting period.

 

On December 17, 2024, 100,000 shares of common stock with a fair value of $7.78 per share, the stock price on the grant date, were issued to employees and directors. 10,000 of the shares issued to one individual vested and the expense related to these shares was recognized on the grant date. The remaining 30,000 shared issued to the same individual vest over a three-year period. The remaining 60,000 shares issued to other individuals vest 25% per year over a four-year period. The grant date fair value of $7.78 per share is being recognized as expense on a straight-line basis over the vesting period.

 

Restricted Stock

 

Restricted stock activity for the years ended December 31, 2024 and 2023 is summarized below:

 

Outstanding at  Restricted Stock   Weighted-Average Grant Date Fair Value 
December 31, 2022   159,500   $5.11 
Granted   10,000    8.96 
Vested   (65,750)   5.35 
Forfeited   (14,000)  $4.76 
December 31, 2023   89,750   $5.41 
Granted   120,000    6.93 
Vested   (72,500)   4.85 
Forfeited   (2,250)  $6.40 
December 31, 2024   135,000   $7.04 

  

The Company recognizes forfeitures as they occur. The reduction of stock compensation expense related to the forfeitures was $2 thousand and $31 thousand for the years ended December 31, 2024 and 2023, respectively.

 

Stock compensation expense related to restricted stock, excluding the recognition of forfeitures, was $0.3 million and $0.4 million for the years ended December 31, 2024 and 2023, respectively.

 

Unrecognized stock compensation expense was $0.9 million as of December 31, 2024, which will be recognized over a weighted-average period of 3.4 years.

 

 

Stock Options

 

Stock options expire 10 years after the grant date. Options that have been granted are exercisable and vest based on the terms of the related agreements.

 

The following table summarizes the Company’s stock options activity for the years ended December 31, 2024 and 2023:

 

    Number of Options   Weighted-Average Exercise Price   Weighted-Average Remaining Contractual Term  (In Years) 
Outstanding - December 31, 2022    97,884   $5.55    5.08 
Granted             
Exercised    (8,334)   5.55     
Expired             
Outstanding - December 31, 2023    89,550   $5.55    4.08 
Granted             
Exercised    (12,000)   5.55     
Expired             
Outstanding - December 31, 2024    77,550   $5.55    3.08 
Exercisable – December 31, 2023    89,550   $5.55    4.08 
Exercisable – December 31, 2024    77,550   $5.55    3.08 

  

As of December 31, 2024, the stock options have been fully vested. The stock options outstanding had an intrinsic value of $0.1 million and $0 as of December 31, 2024 and 2023, respectively.

v3.25.0.1
Income Taxes
12 Months Ended
Dec. 31, 2024
Income Tax Disclosure [Abstract]  
Income Taxes

Note 11 — Income Taxes

 

The provision for income taxes consisted of the following:

 

             
   For The Years Ended 
   December 31, 
(in thousands)  2024   2023 
Current - Federal  $1,576   $249 
Current - State   856    345 
Deferred - Federal   (71)   (369)
Deferred - State   14    (58)
Income tax provision  $2,375   $167 

  

 

For the years ended December 31, 2024 and 2023, the expected tax expense based on the statutory rate is reconciled with the actual tax expense as follows:

 

             
   For The Years Ended 
   December 31, 
   2024   2023 
U.S. federal statutory rate   21.0%   21.0%
State taxes, net of federal benefit   8.0%   9.7%
Permanent differences   (0.4%)   6.3%
Change in tax rates   (0.4%)   9.0%
Return-to-provision adjustments   (0.5%)   1.9%
Tax credits   (1.5%)   (22.3%)
Income tax provision   26.2%   25.6%

 

As of December 31, 2024 and December 31, 2023, the Company’s net deferred tax asset consisted of the effects of temporary differences attributable to the following:

 

             
   As of December 31, 
(in thousands)  2024   2023 
Deferred tax assets:   -      
Net operating losses  $647   $814 
Stock-based compensation   115    103 
Depreciation and amortization   942    762 
Accrued expenses and reserves   243    257 
Inventory capitalization   165       
Customer deposits   18    37 
Tax credits   267    367 
Lease accounting, net   6    2 
Gross deferred tax assets   2,403    2,342 
Valuation allowance   (185)   (185)
Total deferred tax assets   2,218    2,157 
Deferred tax liabilities   -      
Prepaid expenses   (21)   (17)
Total deferred tax liabilities   (21)   (17)
Net deferred tax assets  $2,197   $2,140 

 

The Company has state net operating loss carryforwards (each, an “NOL”) spread across various jurisdictions with a combined total of approximately $6.3 million as of December 31, 2024. A majority of the state NOL’s are attributed to the State of Illinois which begin to expire in 2037. Additionally, the Company also has federal and state tax credit carryforwards of approximately $0.3 million as of December 31, 2024. These credit carryforwards do not expire.

 

In assessing the realization of deferred tax assets, management considers whether it is more likely than not that some or all of the deferred tax assets will be realized. The ultimate realization of deferred tax assets is dependent upon the future generation of taxable income during the periods in which those temporary differences become deductible. Management considers the ability to carryback taxable income, future reversals of existing taxable temporary differences, tax-planning strategies, and future taxable income exclusive of reversing temporary differences and carryforwards in making this assessment. As of each reporting date, management considers new evidence, both positive and negative, that could affect its view of the future realization of deferred tax assets. As of December 31, 2024, management determined there continues to be sufficient positive evidence that it is more likely than not that the net deferred tax assets (other than foreign net operating losses) are realizable.

 

 

Management has evaluated and concluded that there were no material uncertain tax positions requiring recognition in the Company’s consolidated financial statements as of December 31, 2024 and 2023. The Company does not expect any significant changes in its unrecognized tax benefits within 12 months of the reporting date. The Company has U.S. federal and certain state tax returns subject to examination by tax authorities beginning with those filed for the year ended December 31, 2017.

v3.25.0.1
Segment Reporting
12 Months Ended
Dec. 31, 2024
Segment Reporting  
Segment Reporting

Note 12 — Segment Reporting

 

The Company has a single reportable segment focused around sale of similar products and related services. This reportable segment derives revenues from customers by selling medical devices which are used to treat oncological and non-oncological skin conditions with SRT technology and providing services related to operating, maintaining, and repairing these devices.

 

The Company’s chief operating decision-maker (the “CODM”), who is the chief executive officer, assesses performance for the reportable segment and decides how to allocate resources using net income as the primary measure of profitability. The CODM is not regularly provided with specific segment expenses, but focuses on revenue, gross profit, and net income. Expense information, including cost of sales can be easily computed from the provided information. These segment (and consolidated) measures of profitability are shown in the consolidated statements of income. The measure of segment assets is reported on the consolidated balance sheets as total assets.

v3.25.0.1
Subsequent Events
12 Months Ended
Dec. 31, 2024
Subsequent Events [Abstract]  
Subsequent Events

Note 13 — Subsequent Events

 

The Company has evaluated subsequent events and transactions that occurred after the balance sheet date up to the date that the financial statements were issued for potential recognition or disclosure. The Company did not identify any subsequent events that would have required adjustment or disclosure in the consolidated financial statements.

v3.25.0.1
Organization and Summary of Significant Accounting Policies (Policies)
12 Months Ended
Dec. 31, 2024
Accounting Policies [Abstract]  
Description of the Business

Description of the Business

 

Sensus Healthcare, Inc. (together, with its subsidiaries, unless the context otherwise indicates, “Sensus” or the “Company”) is a manufacturer of radiation therapy devices and sells the devices to healthcare providers globally through its distribution and marketing network. The Company operates from its corporate headquarters located in Boca Raton, Florida.

 

In 2024, the Company formed Sensus Healthcare Services, LLC, a wholly-owned subsidiary that provides operational healthcare services in the form of equipment, radiation oncology and physics oversight, including radiotherapy technologists for dermatology clinics.

Basis of Presentation and Principles of Consolidation

Basis of Presentation and Principles of Consolidation

 

These consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States (“GAAP”) and include the accounts of the Company and its subsidiaries. Accounts and transactions between consolidated entities have been eliminated.

Use of Estimates

Use of Estimates

 

The preparation of consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, including disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenue and expense during the reporting periods. Actual results could differ from those estimates.

Change in Accounting Estimate

Change in Accounting Estimate

 

In the fourth quarter of 2023, the Company changed its estimate that it was probable that it would make commission payments to certain of its employees as compensation expense. As it was no longer probable that the payments would be made, the Company reversed the accrued compensation expense, which was included in accounts payable and accrued expenses in the consolidated balance sheets, related to these payments. This change in estimate resulted in a decrease in selling and marketing expenses of $853,500, or $0.05 per share (basic and diluted) for the year ended December 31, 2023.

 

Revenue Recognition

Revenue Recognition

 

The Company’s revenue is derived from sales of the Company’s devices and services related to operating, maintaining and repairing the devices as part of a contract or on an ad-hoc basis without a service contract.

 

The Company provides warranties, generally for one year, in conjunction with the sale of its products. These warranties entitle the customer to repair, replacement, or modification of the defective product, subject to the terms of the relevant warranty. The Company has determined that these warranties do not represent separate performance obligations, as the customer does not have the option to purchase the warranty separately and the warranty does not provide the customer with a service in addition to the assurance that the product complies with agreed-upon specifications. The Company records an estimate of future warranty claims at the time it recognizes revenue from the sale of the device based upon management’s estimate of the future claims rate.

 

Revenue is recognized upon transfer of control of promised goods or services to customers when the product is shipped or the service is rendered, based on the amount the Company expects to receive in exchange for those goods or services. The Company enters into contracts that can include multiple services, which are accounted for separately if they are determined to be distinct.

 

 

To determine the transaction price for contracts in which a customer promises consideration in a form other than cash, the Company measures the estimated fair value of the noncash consideration at contract inception. If the Company cannot reasonably estimate the fair value of the noncash consideration, the Company measures the consideration indirectly by reference to the stand-alone selling price of the products promised to the customer or class of customer in exchange for the consideration.

 

Our service contracts include maintenance or repair service for device purchases and personnel service contracts to assist in the use and operation of leased-out equipment under lease agreements where the Company is the lessor.

 

The revenues from maintenance or repair service contracts are recognized over the service contract period on a straight-line basis. In the event that a customer does not sign a service contract, but requests maintenance or repair services after the warranty expires, the Company recognizes revenue when the service is rendered. There is no termination provision in the service contract or any penalties in practice for cancellation of the service contract.

 

The revenues from personnel service contracts are recognized in the period that the work is performed, as the Company has elected the practical expedient under Accounting Standards Codification ("ASC") 606, Revenue from Contracts with Customers, to recognize revenue in the amount to which the entity has a right to invoice. The service contracts can be terminated by mutual written agreement.

 

The Company has determined that in practice no significant discount is given on service contracts when offered with the device purchase or equipment lease as compared to when sold on a stand-alone basis. The service level provided is identical whether the service contract is purchased on a stand-alone basis or together with the device purchase or equipment lease. The Company may also incur preparation cost to ensure the customer’s space meets the requirements and specifications for the operation of the equipment. The preparation cost is expensed as incurred.

 

The components of disaggregated revenue for the years ended December 31, 2024 and 2023 were as follows: 

 

   For the Years Ended 
   December 31, 
(in thousands)  2024   2023 
Product Revenue - recognized at a point in time  $36,398   $20,347 
Product Revenue - recognized over time   247     
Service Revenue - recognized at a point in time   1,961    1,261 
Service Revenue - recognized over time   3,201    2,797 
Total Revenue  $41,807   $24,405 

 

The Company operates in a highly regulated environment, primarily in the U.S. dermatology market, in which state regulatory approval is sometimes required prior to the customer being able to use the product. In cases where such regulatory approval is pending, revenue is deferred until such time as regulatory approval is obtained.

 

Deferred revenue activity for 2024 and 2023 was as follows:

 

(in thousands)   Product   Service   Total 
December 31, 2022  $45   $787   $832 
Revenue recognized   (45)   (2,797)   (2,842)
Amounts invoiced   36    2,691    2,727 
December 31, 2023  $36   $681   $717 
Revenue recognized   (300)   (3,201)   (3,501)
Amounts invoiced   345    3,035    3,380 
December 31, 2024  $81   $515   $596 

 

Remaining performance obligations related to deposits for products have original expected durations of one year or less. Estimated service revenue to be recognized in the future related to the performance obligations that are unsatisfied (or partially unsatisfied) as of December 31, 2024 is as follows:

 

Year   Service Revenue 
2025    461 
2026    44 
2027    10 
Total   $515 

  

For the years ended December 31, 2024 and 2023, the Company paid commissions for certain equipment sales. Because the recovery of commissions is expected to occur from product revenue within one year, the Company charges commissions to expense as incurred.

 

In addition, the Company incurs commissions associated with equipment lease agreements, which are accounted for as initial direct costs and recorded in other noncurrent assets in the consolidated balance sheets. The commission is capitalized at the commencement of the lease and recognized as an expense in selling and marketing expenses over the lease term.

 

Shipping and handling costs are expensed as incurred and are included in cost of sales.

Concentration

Concentration

 

Financial instruments that potentially subject the Company to concentration of credit risk consist primarily of cash and cash equivalents and accounts receivable.

 

The Company maintains cash balances at financial institutions in excess of federally insured limits. The Company has not experienced any losses related to these balances. The Federal Deposit Insurance Corporation insures eligible accounts up to $250,000 per depositor at each financial institution. The Company holds cash at well-known banks and does not believe that it is exposed to any significant credit risks on its cash.

 

One customer in the U.S. accounted for 73% and 61% of revenue for the years ended December 31, 2024 and 2023, respectively, and 86% and 85% of accounts receivable as of December 31, 2024 and 2023, respectively.

Geographical Information

Geographical Information

 

The following table illustrates total revenue for the years ended December 31, 2024 and 2023 by geographic region.

 

   For the Years Ended 
   December 31, 
(in thousands)  2024   2023 
United States  $40,180    96%  $22,279    91%
China   1,445    3%   1,491    6%
Israel   172    1%   43    0%
Turkey       0%   265    1%
Guatemala       0%   190    1%
Ireland       0%   135    1%
Other   10    0%   2    0%
Total Revenue  $41,807    100%  $24,405    100%

Fair Value of Financial Instruments

Fair Value of Financial Instruments

 

Carrying amounts of cash equivalents, accounts receivable, accounts payable and the revolving credit facility approximate fair value due to their relative short maturities.

Fair Value Measurements

Fair Value Measurements

 

The Company uses a fair value hierarchy that prioritizes inputs to valuation approaches used to measure fair value. The fair value hierarchy gives the highest priority to quoted prices (unadjusted) in active markets for identical assets or liabilities and the lowest priority to unobservable inputs. Assets and liabilities measured and reported at fair value are classified and disclosed in one of the following categories:

 

Level 1 Inputs:

 

Quoted prices (unadjusted) in active markets for identical assets or liabilities at the reporting date.

 

  Level 1 assets may include listed mutual funds, ETFs and listed equities

 

Level 2 Inputs:

 

Quoted prices for similar assets or liabilities in active markets; quoted prices for identical or similar assets or liabilities that are not active; quotes from pricing services or brokers for which the Company can determine that orderly transactions took place at the quoted price or that the inputs used to arrive at the price are observable; and inputs other than quoted prices that are observable, such as models or other valuation methodologies. 

 

  Level 2 assets may include debt securities and foreign currency exchange contracts that have inputs to the valuations that generally can be corroborated by observable market data.

 

Level 3 Inputs:

 

Unobservable inputs for the valuation of the asset or liability, which may include nonbinding broker quotes.

 

  Level 3 assets include investments for which there is little, if any, market activity. These inputs require significant management judgment or estimation.

 

Significance of Inputs: The Company’s assessment of the significance of a particular input to the fair value measurement in its entirety requires judgment and considers factors specific to the financial instrument.

Foreign Currency

Foreign Currency

 

The Company’s foreign operation functional currency is the U.S. dollar. The Company considers its Israel subsidiary an extension of the parent company operations in the United States. The cash flow in the foreign operation depends primarily on the funding by the parent company.

Cash and Cash Equivalents

Cash and Cash Equivalents

 

Cash and cash equivalents primarily consists of cash, money market funds and short-term, highly liquid investments with original maturities of three months or less.

Accounts Receivable

Accounts Receivable

 

On January 1, 2023, the Company adopted Accounting Standards Update (ASU) 2016-13, Financial Instruments – Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments. The amendments in this ASU replace the incurred loss model for recognition of credit losses with a methodology that reflects expected credit losses over the life of the loan and requires consideration of a broader range of reasonable and supportable information to calculate credit loss estimates. This update did not have a significant impact on the Company’s consolidated financial statements.

 

The Company does business and extends credit based on an evaluation of each customer’s financial condition, generally without requiring collateral. Exposure to losses on receivables is expected to vary by customer due to the financial condition of each customer. The Company estimates future credit losses based on the age of customer receivable balances, collection history and forecasted economic trends. Future collections can be significantly different from historical collection trends or current estimates. The Company monitors exposure to credit losses and maintains allowances for anticipated losses considered necessary under the circumstances. The allowance for expected credit losses was $0.1 million and $0 as of December 31, 2024 and 2023, respectively. Credit loss expense for the years ended December 31, 2024 and 2023 was $0.1 million and $7 thousand, respectively.

Inventories

Inventories

 

Inventories consist of finished product and components and are stated at the lower of cost or net realizable value, determined using the first-in-first-out method.

Property and Equipment

Property and Equipment

 

Property and equipment are stated at cost less accumulated depreciation. Depreciation on property and equipment is calculated on the straight-line basis over the estimated useful life of each asset. Maintenance and repairs are expensed as incurred; expenditures that enhance the value of property or extend their useful lives are capitalized. When assets are sold or returned, the cost and related accumulated depreciation are removed from the accounts and the resulting gain or loss is included in other income in the consolidated statements of income.

 

Inventory units designated for customer demonstrations, as part of the sales process, are reclassified to property and equipment and the depreciation is recorded in selling and marketing expense. Property and equipment that were reclassified to or from inventory were $1.5 million and $0.2 million for the years ended December 31, 2024 and 2023, respectively. These property and equipment were for demonstrations and the leasing program where the Company is the lessor.

Research and Development

Research and Development

 

Research and development costs related to products under development by the Company and quality and regulatory costs and are expensed as incurred.

Earnings Per Share

Earnings Per Share

 

Basic net income per share is calculated by dividing the net income by the weighted-average number of common shares outstanding for the period using the treasury stock method for options, restricted stocks and warrants. Diluted net income per share is computed by giving effect to all potential dilutive common share equivalents outstanding for the period.

 

 

The factors used in the earnings per share computation are as follows:

 

   For the Years Ended 
   December 31, 
(in thousands)  2024   2023 
Basic        
Net income  $6,647   $485 
Weighted average number of shares used in computing net income per share – basic   16,312    16,259 
Net income per share - basic  $0.41   $0.03 
Diluted          
Net income  $6,647   $485 
Weighted average number of shares used in computing net income per share – basic   16,312    16,259 
Dilutive effects of:          
Stock options   7    5 
Restricted stock awards   41    2 
Weighted average number of shares used in computing net income per share – diluted   16,360    16,266 
Net income per share - diluted  $0.41   $0.03 
           
The full shares listed below were not included in the computation of diluted net income          
per share because to do so would have been antidilutive for the periods presented:          
Restricted stock awards       57,250 

  

Diluted net income per share for the year ended December 31, 2024 includes the dilutive effect of stock options and restricted stock awards that were issued in December 2022, January 2024, and December 2024 to directors, officers, and employees.

 

Diluted net income per share for the year ended December 31, 2023 includes the dilutive effect of stock options and restricted stock awards that were issued in July 2021. The stock options and 89,750 restricted stock awards were not in the money as the average price of common stock during the second to fourth quarter was less than the exercise prices. The assumed proceeds of stock options and the restricted stock awards for the treasury stock method is the amount the grantee pays on exercise plus the average amount of unrecognized compensation expense.

Equity-Based Compensation

Equity-Based Compensation

 

Pursuant to relevant accounting guidance related to accounting for equity-based compensation, the Company is required to recognize all share-based payments to non-employees and employees in the financial statements based on grant-date fair values. The Company has accounted for issuances of shares and options in accordance with the guidance, which requires the recognition of expense, based on grant-date fair values, over the service period, which is generally the period over which the shares and options vest.

Advertising Costs

Advertising Costs

 

Advertising and promotion costs are charged to expense as incurred. Advertising and promotion costs included in selling and marketing expense in the accompanying statements of income amounted to $1.2 million for both the years ended December 31, 2024 and 2023.

Leases

Leases

 

The Company evaluates arrangements at inception to determine if an arrangement is or contains a lease. Operating lease assets represent the Company’s right to control an underlying asset for the lease term, and operating lease liabilities represent the Company’s obligation to make lease payments arising from the lease. Control of an underlying asset is conveyed to the Company if the Company obtains the rights to direct the use of and to obtain substantially all of the economic benefits from using the underlying asset. Operating lease assets and liabilities are recognized at the commencement date of the lease based upon the present value of lease payments over the lease term. When determining the lease term, the Company includes options to extend or terminate the lease when it is reasonably certain that the Company will exercise that option. The Company uses an incremental borrowing rate that the Company would expect to incur for a fully collateralized loan over a similar term under similar economic conditions to determine the present value of the lease payments. The Company has lease agreements which include lease and non-lease components, which the Company has elected to account for as a single lease component for all classes of underlying assets.

The lease payments used to determine the Company’s operating lease assets may include lease incentives, and stated rent increases are recognized in the Company’s operating lease assets in the Company’s consolidated balance sheets. Operating lease assets are amortized to rent expense over the lease term and included in operating expenses in the consolidated statements of income.

 

For leases in which the Company is the lessor, the Company identifies the lease and non-lease components and allocates the contract consideration to the different components on a relative stand-alone selling price basis at lease inception. The Company uses a residual approach for the components when the stand-alone selling price is not directly observable or those for which the Company has not established a price.

 

The Company has elected the practical expedient to combine lease and non-lease components when the components qualify to be combined. Continuous supporting services are the primary non-lease components and are not predominant. As a result, the combined components are accounted for as a lease under ASC 842, Leases. The revenues from non-lease components that are not qualified to be combined are recognized when the services are rendered under ASC 606, Revenue from Contracts with Customers. The revenues from non-lease components were $0.3 million for the year ended December 31, 2024.

 

For operating leases where the Company is the lessor, the Company recognizes the underlying assets and depreciates them over the estimated useful life which is based upon an estimate of the residual value expected at the end of the lease term. Lease income is recognized on a straight-line basis over the lease term when the lease payment is determined. Lease income is not recognized when collection of all contractual rents over the term of the agreement is not probable. When collection is not probable, the Company limits the lease income to the lesser of the revenue recognized on a straight-line basis or cash basis. The lease income is included in revenues in the consolidated statements of income.

 

Variable lease payments associated with the leases are recognized when the event, activity, or circumstance in the lease agreement on which those payments are assessed occurs. Variable lease payments are presented within revenues in the consolidated statements of income.

Income Taxes

Income Taxes

 

The Company recognizes deferred tax assets and liabilities for the expected future tax consequences of events that have been recognized in the Company’s financial statements or tax returns. Under this method, deferred tax assets and liabilities are determined based on differences between the financial statement carrying amounts and the tax bases of the assets and liabilities using the enacted tax rates in effect in the years in which the differences are expected to reverse. A valuation allowance against deferred tax assets is recorded if, based on the weight of the available evidence, it is more likely than not that some or all of the deferred tax assets will not be realized.

 

Uncertain tax positions are recognized in the consolidated financial statements only if that position is more likely than not to be sustained upon examination by taxing authorities, based on the technical merits of the position. The Company’s practice is to recognize interest and/or penalties related to income tax matters in income tax expense.

Recent Accounting Pronouncements

Recent Accounting Pronouncements

 

In March 2020, the Financial Accounting Standard Board (“FASB”) issued ASU 2020-4, Reference Rate Reform (Topic 848): Facilitation of the Effects of Reference Rate Reform on Financial Reporting, to provide temporary optional expedients and exceptions to U.S. GAAP guidance on contract modifications to ease the financial reporting burdens of the expected market transition from the London Interbank Offered Rate, or LIBOR, to alternative reference rates, such as the Secured Overnight Financing Rate. Entities can elect not to apply certain modification accounting requirements to contracts affected by what the guidance calls reference rate reform if certain criteria are met. An entity that makes this election would not have to remeasure the contracts at the modification date or reassess a previous accounting determination. The guidance is effective prospectively as of March 12, 2020 through December 31, 2022 and interim periods within those fiscal years. In December 2022, the FASB issued ASU 2022-06, Deferral of the Sunset Date of Topic 848 which was issued to defer the sunset date of Topic 848 to December 31, 2024. These updates did not have a significant impact on the Company’s consolidated financial statements.

 

In November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures to enhance disclosures about significant segment expenses for public entities reporting segment information under ASC Topic 280. The amendments require public entities to disclose significant expense categories for each reportable segment, other segment items, the title and position of the chief operating decision-maker, and interim disclosures of certain segment-related information previously required only on an annual basis. The amendments clarify that entities reporting single segments must disclose both the new and existing segment disclosures under Topic 280, and a public entity is permitted to disclose multiple measures of segment profit or loss if certain criteria are met. The ASU is effective for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024. The adoption of ASU 2023-07 did not have a significant impact on the Company's consolidated financial statements. See Note 12, Segment Reporting, for the required disclosures.

 

In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures, to enhance transparency into income tax disclosures. The amendments require annual disclosure of certain information relating to the rate reconciliation, income taxes paid by jurisdiction, income (or loss) from continuing operations before income tax expense (or benefit) disaggregated between domestic and foreign, income tax expense (or benefit) from continuing operations disaggregated by federal (national), state, and foreign. The amendments also eliminate certain requirements relating to unrecognized tax benefits and certain deferred tax disclosure relating to subsidiaries and corporate joint ventures. The ASU is effective for fiscal years beginning after December 15, 2024, and interim periods within fiscal years beginning after December 15, 2025. Early adoption is permitted. The Company is currently evaluating the impact of this standard on its consolidated financial statements and related disclosures.

 

In March 2024, the FASB issued ASU 2024-01, Compensation - Stock Compensation (Topic 718): Scope Application of Profits Interest and Similar Awards, to clarify how an entity determines whether a profits interest or similar award is within the scope of Topic 718 or is not a share-based payment arrangement and therefore within the scope of other guidance. ASU 2024-01 provides an illustrative example with multiple fact patterns and also amends certain language in the “Scope” and “Scope Exceptions” sections of Topic 718 to improve its clarity and operability without changing the guidance. The ASU is effective for fiscal years beginning after December 15, 2024, and interim periods within those annual periods. Early adoption is permitted. These updates are not expected to have a significant impact on the Company’s consolidated financial statements. 

 

In November 2024, the FASB issued ASU 2024-03, Income Statement - Reporting Comprehensive Income - Expense Disaggregation Disclosures (“ASU 2024-03”) which requires entities to (i) disclose amounts of (a) purchase of inventory, (b) employee compensation, (c) depreciation, (d) intangible asset amortization, and, (e) depreciation, depletion, and amortization recognized as part of oil-and gas-producing activities, (ii) include certain amounts that are already required to be disclosed under current U.S. GAAP in the same disclosures as other disaggregation requirements, (iii) disclose a qualitative description of the amounts remaining in relevant expense captions that are not necessarily disaggregated quantitatively, and (iv) disclose the total amount of selling expenses, in annual reporting periods, an entity’s definition of selling expense. ASU 2024-03 is effective for annual reporting periods beginning after December 15, 2026 and interim reporting periods beginning after December 15, 2027.  Early adoption is permitted. The Company is currently evaluating ASU 2024-03 to determine the impact it may have on its consolidated financial statements.

v3.25.0.1
Organization and Summary of Significant Accounting Policies (Tables)
12 Months Ended
Dec. 31, 2024
Accounting Policies [Abstract]  
Schedule of Total Revenue

The components of disaggregated revenue for the years ended December 31, 2024 and 2023 were as follows: 

 

   For the Years Ended 
   December 31, 
(in thousands)  2024   2023 
Product Revenue - recognized at a point in time  $36,398   $20,347 
Product Revenue - recognized over time   247     
Service Revenue - recognized at a point in time   1,961    1,261 
Service Revenue - recognized over time   3,201    2,797 
Total Revenue  $41,807   $24,405 
Schedule of Deferred Revenue

Deferred revenue activity for 2024 and 2023 was as follows:

 

(in thousands)   Product   Service   Total 
December 31, 2022  $45   $787   $832 
Revenue recognized   (45)   (2,797)   (2,842)
Amounts invoiced   36    2,691    2,727 
December 31, 2023  $36   $681   $717 
Revenue recognized   (300)   (3,201)   (3,501)
Amounts invoiced   345    3,035    3,380 
December 31, 2024  $81   $515   $596 
Schedule of Remaining Performance Obligations

Remaining performance obligations related to deposits for products have original expected durations of one year or less. Estimated service revenue to be recognized in the future related to the performance obligations that are unsatisfied (or partially unsatisfied) as of December 31, 2024 is as follows:

 

Year   Service Revenue 
2025    461 
2026    44 
2027    10 
Total   $515 
Schedule of Total Revenue

The following table illustrates total revenue for the years ended December 31, 2024 and 2023 by geographic region.

 

   For the Years Ended 
   December 31, 
(in thousands)  2024   2023 
United States  $40,180    96%  $22,279    91%
China   1,445    3%   1,491    6%
Israel   172    1%   43    0%
Turkey       0%   265    1%
Guatemala       0%   190    1%
Ireland       0%   135    1%
Other   10    0%   2    0%
Total Revenue  $41,807    100%  $24,405    100%
Schedule of Earnings Per Share Computation

The factors used in the earnings per share computation are as follows:

 

   For the Years Ended 
   December 31, 
(in thousands)  2024   2023 
Basic        
Net income  $6,647   $485 
Weighted average number of shares used in computing net income per share – basic   16,312    16,259 
Net income per share - basic  $0.41   $0.03 
Diluted          
Net income  $6,647   $485 
Weighted average number of shares used in computing net income per share – basic   16,312    16,259 
Dilutive effects of:          
Stock options   7    5 
Restricted stock awards   41    2 
Weighted average number of shares used in computing net income per share – diluted   16,360    16,266 
Net income per share - diluted  $0.41   $0.03 
           
The full shares listed below were not included in the computation of diluted net income          
per share because to do so would have been antidilutive for the periods presented:          
Restricted stock awards       57,250 
v3.25.0.1
Property and Equipment (Tables)
12 Months Ended
Dec. 31, 2024
Property, Plant and Equipment [Abstract]  
Schedule of Property and Equipment

Property and equipment consists of the following:

 

(in thousands)  As of December 31, 2024   As of December 31, 2023   Estimated Useful Lives 
             
Operations equipment  $940   $1,018   3-10 years 
Equipment leased to customers   1,597       10 years 
Tradeshow and demo equipment   1,184    1,184   3 years 
Computer equipment   168    145   3 years 
Subtotal   3,889    2,347     
Construction in progress   228         
Less accumulated depreciation   (2,120)   (1,883)    
Property and Equipment, Net  $1,997   $464     
v3.25.0.1
Product Warranties (Tables)
12 Months Ended
Dec. 31, 2024
Guarantees and Product Warranties [Abstract]  
Schedule of Changes in Product Warranty Liability

Changes in product warranty liability were as follows for the years ended December 31, 2024 and 2023:

 

(in thousands)    
Balance, December 31, 2022  $403 
Warranties accrued during the period   603 
Payments on warranty claims   (468)
Balance, December 31, 2023  $538 
Warranties accrued during the period   255 
Payments on warranty claims   (464)
Balance, December 31, 2024  $329 
v3.25.0.1
Leases (Tables)
12 Months Ended
Dec. 31, 2024
Leases  
Schedule of Received Lease Agreements

The following table presents information about the amount, timing and uncertainty of cash flows arising from the Company’s operating leases as of December 31, 2024.

 

Maturity of Operating Lease Liability  Amount 
2025  $229 
2026   236 
2027   181 
Total undiscounted operating leases payments  $646 
Less: Imputed interest   (44)
Present Value of Operating Lease Liability  $602 
Operating lease liability, current portion  $204 
Operating lease liability, net of current portion  $398 
      
Other Information     
Weighted-average remaining lease term    2.75 years  
Weighted-average discount rate   5%
Schedule of Operating Lease Income

The components of lease income for the year ended December 31, 2024 are as follows:

 

     For the 
     Year Ended 
(in thousands)    December 31, 2024 
Lease income - operating leases - fixed payments    $192 
Lease income - operating leases - variable payments     55 
Total    $247 
Schedule of Received Lease Agreements

The future minimum fixed lease payments to be received under the lease agreements as of December 31, 2024 are as follows:

 

(in thousands)   Amount 
2025   $256 
2026    256 
2027    256 
2028    256 
2029    256 
Thereafter    87 
Total    $1,367 
v3.25.0.1
Equity-based Compensation (Tables)
12 Months Ended
Dec. 31, 2024
Share-Based Payment Arrangement [Abstract]  
Schedule of Restricted Stock Activity

Restricted stock activity for the years ended December 31, 2024 and 2023 is summarized below:

 

Outstanding at  Restricted Stock   Weighted-Average Grant Date Fair Value 
December 31, 2022   159,500   $5.11 
Granted   10,000    8.96 
Vested   (65,750)   5.35 
Forfeited   (14,000)  $4.76 
December 31, 2023   89,750   $5.41 
Granted   120,000    6.93 
Vested   (72,500)   4.85 
Forfeited   (2,250)  $6.40 
December 31, 2024   135,000   $7.04 
Schedule of Stock Option Activity

The following table summarizes the Company’s stock options activity for the years ended December 31, 2024 and 2023:

 

    Number of Options   Weighted-Average Exercise Price   Weighted-Average Remaining Contractual Term  (In Years) 
Outstanding - December 31, 2022    97,884   $5.55    5.08 
Granted             
Exercised    (8,334)   5.55     
Expired             
Outstanding - December 31, 2023    89,550   $5.55    4.08 
Granted             
Exercised    (12,000)   5.55     
Expired             
Outstanding - December 31, 2024    77,550   $5.55    3.08 
Exercisable – December 31, 2023    89,550   $5.55    4.08 
Exercisable – December 31, 2024    77,550   $5.55    3.08 
v3.25.0.1
Income Taxes (Tables)
12 Months Ended
Dec. 31, 2024
Income Tax Disclosure [Abstract]  
Schedule of Provision for Income Taxes

The provision for income taxes consisted of the following:

 

             
   For The Years Ended 
   December 31, 
(in thousands)  2024   2023 
Current - Federal  $1,576   $249 
Current - State   856    345 
Deferred - Federal   (71)   (369)
Deferred - State   14    (58)
Income tax provision  $2,375   $167 
Schedule of Tax Expense Based on the Statutory Rate is Reconciled with the Actual Tax Expense

For the years ended December 31, 2024 and 2023, the expected tax expense based on the statutory rate is reconciled with the actual tax expense as follows:

 

             
   For The Years Ended 
   December 31, 
   2024   2023 
U.S. federal statutory rate   21.0%   21.0%
State taxes, net of federal benefit   8.0%   9.7%
Permanent differences   (0.4%)   6.3%
Change in tax rates   (0.4%)   9.0%
Return-to-provision adjustments   (0.5%)   1.9%
Tax credits   (1.5%)   (22.3%)
Income tax provision   26.2%   25.6%
Schedule of Net Deferred Tax Asset

As of December 31, 2024 and December 31, 2023, the Company’s net deferred tax asset consisted of the effects of temporary differences attributable to the following:

 

             
   As of December 31, 
(in thousands)  2024   2023 
Deferred tax assets:   -      
Net operating losses  $647   $814 
Stock-based compensation   115    103 
Depreciation and amortization   942    762 
Accrued expenses and reserves   243    257 
Inventory capitalization   165       
Customer deposits   18    37 
Tax credits   267    367 
Lease accounting, net   6    2 
Gross deferred tax assets   2,403    2,342 
Valuation allowance   (185)   (185)
Total deferred tax assets   2,218    2,157 
Deferred tax liabilities   -      
Prepaid expenses   (21)   (17)
Total deferred tax liabilities   (21)   (17)
Net deferred tax assets  $2,197   $2,140 
v3.25.0.1
Schedule of Total Revenue (Details) - USD ($)
$ in Thousands
12 Months Ended
Dec. 31, 2024
Dec. 31, 2023
Product Information [Line Items]    
Revenues $ 41,807 $ 24,405
Total Revenue Percentage 100.00% 100.00%
UNITED STATES    
Product Information [Line Items]    
Revenues $ 40,180 $ 22,279
Total Revenue Percentage 96.00% 91.00%
CHINA    
Product Information [Line Items]    
Revenues $ 1,445 $ 1,491
Total Revenue Percentage 3.00% 6.00%
ISRAEL    
Product Information [Line Items]    
Revenues $ 172 $ 43
Total Revenue Percentage 1.00% 0.00%
TÜRKIYE    
Product Information [Line Items]    
Revenues $ 0 $ 265
Total Revenue Percentage 0.00% 1.00%
GUATEMALA    
Product Information [Line Items]    
Revenues $ 0 $ 190
Total Revenue Percentage 0.00% 1.00%
IRELAND    
Product Information [Line Items]    
Revenues $ 0 $ 135
Total Revenue Percentage 0.00% 1.00%
Other [Member]    
Product Information [Line Items]    
Revenues $ 10 $ 2
Total Revenue Percentage 0.00% 0.00%
Product [Member]    
Product Information [Line Items]    
Revenues $ 36,398 $ 20,347
Product Revenue [Member]    
Product Information [Line Items]    
Revenues 247
Service [Member]    
Product Information [Line Items]    
Revenues 1,961 1,261
Service Revenue [Member]    
Product Information [Line Items]    
Revenues $ 3,201 $ 2,797
v3.25.0.1
Schedule of Deferred Revenue (Details) - USD ($)
$ in Thousands
12 Months Ended
Dec. 31, 2024
Dec. 31, 2023
Dec. 31, 2022
Product Information [Line Items]      
Contract with Customer, Liability $ 596 $ 717 $ 832
Contract with Customer, Liability, Revenue Recognized (3,501) (2,842)  
Contract With Customer Liability Amounts Invoiced 3,380 2,727  
Product [Member]      
Product Information [Line Items]      
Contract with Customer, Liability 81 36 45
Contract with Customer, Liability, Revenue Recognized (300) (45)  
Contract With Customer Liability Amounts Invoiced 345 36  
Service [Member]      
Product Information [Line Items]      
Contract with Customer, Liability 515 681 $ 787
Contract with Customer, Liability, Revenue Recognized (3,201) (2,797)  
Contract With Customer Liability Amounts Invoiced $ 3,035 $ 2,691  
v3.25.0.1
Schedule of Remaining Performance Obligations (Details) - USD ($)
$ in Thousands
Dec. 31, 2024
Dec. 31, 2023
Dec. 31, 2022
Product Information [Line Items]      
Contract with Customer, Liability $ 596 $ 717 $ 832
Service Revenue [Member]      
Product Information [Line Items]      
Revenue Remaining Performance Obligation Next Twelve Months 461    
Revenue Remaining Performance Obligation Year Two 44    
Revenue Remaining Performance Obligation Year Three 10    
Contract with Customer, Liability $ 515    
v3.25.0.1
Schedule of Earnings Per Share Computation (Details) - USD ($)
$ / shares in Units, $ in Thousands
12 Months Ended
Dec. 31, 2024
Dec. 31, 2023
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]    
Net Income (Loss) Attributable to Parent $ 6,647 $ 485
Weighted Average Number of Shares Outstanding, Basic 16,312,351 16,259,254
Earnings Per Share, Basic $ 0.41 $ 0.03
Weighted Average Number of Shares Outstanding, Diluted 16,359,616 16,266,139
Earnings Per Share, Diluted $ 0.41 $ 0.03
Earnings Per Share [Member]    
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]    
Incremental Common Shares Attributable to Dilutive Effect of Call Options and Warrants 7,000 5,000
Earnings Per Share [Member]    
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]    
Net Income (Loss) Attributable to Parent $ 6,647 $ 485
Weighted Average Number of Shares Outstanding, Basic 16,312,000 16,259,000
Earnings Per Share, Basic $ 0.41 $ 0.03
Stock Issued During Period, Shares, Restricted Stock Award, Gross 41,000 2,000
Weighted Average Number of Shares Outstanding, Diluted 16,360,000 16,266,000
Earnings Per Share, Diluted $ 0.41 $ 0.03
Stock Issued During Period, Shares, Restricted Stock Award, Net of Forfeitures 57,250,000
v3.25.0.1
Organization and Summary of Significant Accounting Policies (Details Narrative) - USD ($)
12 Months Ended
Dec. 31, 2024
Dec. 31, 2023
Product Information [Line Items]    
Accounts Receivable, Allowance for Credit Loss, Period Increase (Decrease) $ 100,000 $ 0
Accounts Receivable, Allowance for Credit Loss, Current 100,000 7,000
Inventory, Gross $ 1,500,000 $ 200,000
Stock option 89,750  
Advertising Expense $ 1,200,000  
Customer [Member] | Customer Concentration Risk [Member] | Revenue Benchmark [Member]    
Product Information [Line Items]    
Concentration Risk, Percentage 73.00% 61.00%
Customer [Member] | Customer Concentration Risk [Member] | Accounts Receivable [Member]    
Product Information [Line Items]    
Concentration Risk, Percentage 86.00% 85.00%
v3.25.0.1
Schedule of Property and Equipment (Details) - USD ($)
$ in Thousands
Dec. 31, 2024
Dec. 31, 2023
Property, Plant and Equipment [Line Items]    
Property, Plant and Equipment, Gross $ 3,889 $ 2,347
Construction in Progress, Gross 228 0
Accumulated Depreciation, Depletion and Amortization, Property, Plant, and Equipment (2,120) (1,883)
Property, Plant and Equipment, Net 1,997 464
Equipment [Member]    
Property, Plant and Equipment [Line Items]    
Property, Plant and Equipment, Gross $ 940 1,018
Equipment [Member] | Minimum [Member]    
Property, Plant and Equipment [Line Items]    
Property, Plant and Equipment, Useful Life 3 years  
Equipment [Member] | Maximum [Member]    
Property, Plant and Equipment [Line Items]    
Property, Plant and Equipment, Useful Life 10 years  
F D A Program Equipment [Member]    
Property, Plant and Equipment [Line Items]    
Property, Plant and Equipment, Gross $ 1,597 0
Property, Plant and Equipment, Useful Life 10 years  
Tradeshow And Demo Equipment Member    
Property, Plant and Equipment [Line Items]    
Property, Plant and Equipment, Gross $ 1,184 1,184
Property, Plant and Equipment, Useful Life 3 years  
Computer Equipment [Member]    
Property, Plant and Equipment [Line Items]    
Property, Plant and Equipment, Gross $ 168 $ 145
Property, Plant and Equipment, Useful Life 3 years  
v3.25.0.1
Property and Equipment (Details Narrative) - USD ($)
$ in Millions
12 Months Ended
Dec. 31, 2024
Dec. 31, 2023
Property, Plant and Equipment [Abstract]    
Depreciation $ 0.2 $ 0.2
v3.25.0.1
DEBT (Details Narrative)
12 Months Ended
Dec. 31, 2024
USD ($)
Line of Credit Facility [Line Items]  
Line of Credit Facility, Current Borrowing Capacity $ 10,000,000
Line of Credit Facility, Interest Rate During Period 6.99%
Line of Credit Facility, Remaining Borrowing Capacity $ 15,000,000.0
Line of Credit [Member]  
Line of Credit Facility [Line Items]  
Unencumbered Liquid Assets 10,000,000.0
Minimum Profitability Granted $ 1
Secured Overnight Financing Rate (SOFR) Overnight Index Swap Rate [Member]  
Line of Credit Facility [Line Items]  
Line of Credit Facility, Interest Rate During Period 2.50%
Silicon Valley Bank [Member]  
Line of Credit Facility [Line Items]  
Line of Credit Facility, Maximum Borrowing Capacity $ 10,000,000
v3.25.0.1
Schedule of Changes in Product Warranty Liability (Details) - USD ($)
$ in Thousands
12 Months Ended
Dec. 31, 2024
Dec. 31, 2023
Guarantees and Product Warranties [Abstract]    
Product Warranty Accrual, Current $ 538 $ 403
Standard and Extended Product Warranty Accrual 255 603
Standard and Extended Product Warranty Accrual, Decrease for Payments (464) (468)
Product Warranty Accrual, Current $ 329 $ 538
v3.25.0.1
Schedule of Received Lease Agreements (Details) - USD ($)
Dec. 31, 2024
Dec. 31, 2023
Leases    
Lessee, Operating Lease, Liability, to be Paid, Year One $ 229,000  
Lessee, Operating Lease, Liability, to be Paid, Year Two 236,000  
Lessee, Operating Lease, Liability, to be Paid, Year Three 181,000  
Lessee, Operating Lease, Liability, to be Paid 646,000  
Lessee, Operating Lease, Liability, Undiscounted Excess Amount (44,000)  
Operating Lease, Liability 602,000  
Operating Lease, Liability, Current 204,000 $ 187,000
Operating Lease, Liability, Noncurrent $ 398,000 $ 596,000
Operating Lease, Weighted Average Remaining Lease Term 2 years 9 months  
Operating Lease, Weighted Average Discount Rate, Percent 5.00%  
Lessor, Operating Lease, Payment to be Received, Year One $ 256,000  
Lessor, Operating Lease, Payment to be Received, Year Two 256,000  
Lessor, Operating Lease, Payment to be Received, Year Three 256,000  
Lessor, Operating Lease, Payment to be Received, Year Four 256,000  
Lessor, Operating Lease, Payment to be Received, Year Five 256,000  
Lessor, Operating Lease, Payment to be Received, after Year Five 87,000  
Lessor, Operating Lease, Payment to be Received $ 1,367,000  
v3.25.0.1
Schedule of Operating Lease Income (Details)
$ in Thousands
12 Months Ended
Dec. 31, 2024
USD ($)
Leases  
Lease income - operating leases - fixed payments $ 192
Lease income - operating leases - variable payments 55
Lease Income $ 247
v3.25.0.1
Leases (Details Narrative) - USD ($)
$ in Thousands
12 Months Ended
Dec. 31, 2024
Dec. 31, 2023
Related Party Transaction [Line Items]    
Operating Lease, Right-of-Use Asset, Periodic Reduction $ 193 $ 186
Operating Lease, Payments, Use 200 200
Operating Lease, Cost 200 200
Unrelated third party [Member]    
Related Party Transaction [Line Items]    
Operating Lease, Right-of-Use Asset, Periodic Reduction $ 200 $ 200
v3.25.0.1
Commitments and Contingencies (Details Narrative) - USD ($)
$ in Thousands
12 Months Ended
Dec. 31, 2024
Dec. 31, 2023
Commitments and Contingencies Disclosure [Abstract]    
Paymentof Inventory Finished Goods $ 9,900 $ 10,300
Finished Goods Received 10,300 12,700
Prepaid inventory $ 3,347 $ 2,986
v3.25.0.1
Employee Benefit Plans (Details Narrative)
$ in Millions
12 Months Ended
Dec. 31, 2024
USD ($)
Retirement Benefits [Abstract]  
Defined Contribution Plan, Cost $ 0.1
v3.25.0.1
Stockholders’ Equity (Details Narrative) - shares
12 Months Ended
Dec. 31, 2024
Dec. 31, 2023
Equity [Abstract]    
Preferred Stock, Shares Authorized 5,000,000 5,000,000
Restricted Stock, Shares Issued Net of Shares for Tax Withholdings 8,525 11,155
Stock Repurchased During Period, Shares 0 9,427
v3.25.0.1
Schedule of Restricted Stock Activity (Details) - $ / shares
12 Months Ended
Dec. 31, 2024
Dec. 31, 2023
Dec. 31, 2022
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]      
Share-Based Compensation Arrangement by Share-Based Payment Award, Equity Instruments Other than Options, Nonvested, Number 89,750    
Restricted Stock [Member]      
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]      
Share-Based Compensation Arrangement by Share-Based Payment Award, Equity Instruments Other than Options, Nonvested, Number 135,000 89,750 159,500
Share-Based Compensation Arrangement by Share-Based Payment Award, Equity Instruments Other than Options, Nonvested, Weighted Average Grant Date Fair Value $ 7.04 $ 5.41 $ 5.11
Share-Based Compensation Arrangement by Share-Based Payment Award, Equity Instruments Other than Options, Grants in Period 120,000 10,000  
Share-Based Compensation Arrangement by Share-Based Payment Award, Equity Instruments Other than Options, Grants in Period, Weighted Average Grant Date Fair Value $ 6.93 $ 8.96  
Share-Based Compensation Arrangement by Share-Based Payment Award, Equity Instruments Other than Options, Vested in Period (72,500) (65,750)  
Share-Based Compensation Arrangement by Share-Based Payment Award, Equity Instruments Other than Options, Vested in Period, Weighted Average Grant Date Fair Value $ 4.85 $ 5.35  
Share-Based Compensation Arrangement by Share-Based Payment Award, Equity Instruments Other than Options, Forfeited in Period (2,250) (14,000)  
Share-Based Compensation Arrangement by Share-Based Payment Award, Equity Instruments Other than Options, Forfeitures, Weighted Average Grant Date Fair Value $ 6.40 $ 4.76  
v3.25.0.1
Schedule of Stock Option Activity (Details) - Equity Option [Member] - $ / shares
12 Months Ended
Dec. 31, 2023
Dec. 31, 2022
Dec. 31, 2024
Dec. 31, 2023
Dec. 31, 2022
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]          
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Outstanding, Number, Beginning Balance     89,550 97,884  
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Outstanding, Weighted Average Exercise Price, Beginning Balance     $ 5.55 $ 5.55  
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Outstanding, Weighted Average Remaining Contractual Term 4 years 29 days 5 years 29 days 3 years 29 days    
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Grants in Period, Net of Forfeitures      
Share-Based Compensation Arrangement by Share-Based Payment Award, Equity Instruments Other than Options, Grants in Period      
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Exercises in Period       (12,000) (8,334)
Share-Based Compensation Arrangements by Share-Based Payment Award, Options, Exercises in Period, Weighted Average Exercise Price       $ 5.55 $ 5.55
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Expirations in Period      
Share-Based Compensation Arrangements by Share-Based Payment Award, Options, Expirations in Period, Weighted Average Exercise Price      
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Outstanding, Number, Ending Balance 89,550 97,884 77,550 89,550 97,884
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Outstanding, Weighted Average Exercise Price, Ending Balance $ 5.55 $ 5.55 $ 5.55 $ 5.55 $ 5.55
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Exercisable, Number 89,550   77,550 89,550  
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Exercisable, Weighted Average Exercise Price $ 5.55   $ 5.55 $ 5.55  
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Exercisable, Weighted Average Remaining Contractual Term     3 years 29 days 4 years 29 days  
v3.25.0.1
Equity-based Compensation (Details Narrative) - USD ($)
12 Months Ended 36 Months Ended
Dec. 17, 2024
Jan. 11, 2024
Jan. 26, 2023
Dec. 19, 2022
Feb. 01, 2020
Dec. 31, 2024
Dec. 31, 2023
Jul. 21, 2024
Dec. 31, 2022
Jul. 21, 2021
Jul. 01, 2021
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]                      
Share-Based Compensation Arrangement by Share-Based Payment Award, Number of Shares Available for Grant           195,223 312,973        
Share-Based Compensation Arrangement by Share-Based Payment Award, Equity Instruments Other than Options, Nonvested, Number           89,750          
Restricted Vest Percentage 25.00%     25.00%       25.00%      
Restricted Grant Percentage               25.00%      
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Vested and Expected to Vest, Outstanding, Weighted Average Exercise Price     $ 8.96                
Share-Based Payment Arrangement, Expense           $ 2,000 $ 31,000        
Share-Based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Amount           $ 900,000          
Share-Based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Period for Recognition           3 years 4 months 24 days          
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Outstanding, Intrinsic Value           $ 100,000 $ 0        
Common Stock [Member]                      
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]                      
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Vested and Expected to Vest, Outstanding, Number           17,500 18,250     32,500  
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Nonvested, Number of Shares           2,250 4,000        
Stock Issued During Period, Shares, Employee Stock Purchase Plans     10,000                
Restricted Stock [Member]                      
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]                      
Share-Based Compensation Arrangement by Share-Based Payment Award, Equity Instruments Other than Options, Nonvested, Number           135,000 89,750   159,500    
Share-Based Compensation Arrangement by Share-Based Payment Award, Equity Instruments Other than Options, Nonvested, Weighted Average Grant Date Fair Value           $ 7.04 $ 5.41   $ 5.11    
Share-Based Compensation Arrangement by Share-Based Payment Award, Equity Instruments Other than Options, Vested in Period, Weighted Average Grant Date Fair Value           $ 4.85 $ 5.35        
Share-Based Payment Arrangement, Expense           $ 300,000 $ 400,000        
Equity Incentive Plans [Member]                      
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]                      
Excess Stock, Shares Authorized           397,473          
Equity Incentives Plan 1 [Member]                      
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]                      
Excess Stock, Shares Authorized           750,000          
Equity Incentive Plan [Member]                      
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]                      
Share-Based Compensation Arrangement by Share-Based Payment Award, Equity Instruments Other than Options, Vested in Period, Weighted Average Grant Date Fair Value $ 7.78 $ 2.65                  
Equity Incentive Plan [Member] | Equity Option [Member]                      
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]                      
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Outstanding, Weighted Average Remaining Contractual Term           10 years          
Equity Incentive Plan [Member] | Common Stock [Member]                      
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]                      
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Vested and Expected to Vest, Outstanding, Number             5,000        
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Nonvested, Number of Shares             10,000        
Equity Incentive Plan [Member] | Common Stock [Member]                      
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]                      
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Vested, Weighted Average Grant Date Fair Value $ 7.78                    
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Vested and Expected to Vest, Outstanding, Number 10,000         2,500          
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Nonvested, Number of Shares   10,000                  
Share-Based Compensation Arrangement by Share-Based Payment Award, Equity Instruments Other than Options, Vested in Period, Weighted Average Grant Date Fair Value   $ 2.65                  
Sharebased Arrangementby Reamaining Shares 30,000 10,000                  
Equity Incentive Plan [Member] | Equity Incentive Plan [Member]                      
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]                      
Share-Based Compensation Arrangement by Share-Based Payment Award, Shares Issued in Period 100,000 20,000                  
Equity Incentive Plan [Member] | Restricted Stock [Member]                      
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]                      
Share-Based Compensation Arrangement by Share-Based Payment Award, Equity Instruments Other than Options, Nonvested, Number       77,000 35,000            
Restricted Vest Percentage         25.00%            
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Vested, Weighted Average Grant Date Fair Value         $ 4.11            
Share-Based Compensation Arrangement by Share-Based Payment Award, Equity Instruments Other than Options, Nonvested, Weighted Average Grant Date Fair Value       $ 6.40           $ 3.84  
Equity Incentive Plan [Member] | Restricted Stock [Member] | Board of Directors Chairman [Member]                      
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]                      
Share-Based Compensation Arrangement by Share-Based Payment Award, Equity Instruments Other than Options, Nonvested, Number                     130,000
v3.25.0.1
Schedule of Provision for Income Taxes (Details) - USD ($)
$ in Thousands
12 Months Ended
Dec. 31, 2024
Dec. 31, 2023
Income Tax Disclosure [Abstract]    
Current - Federal $ 1,576 $ 249
Current - State 856 345
Deferred - Federal (71) (369)
Deferred - State 14 (58)
Income tax provision $ 2,375 $ 167
v3.25.0.1
Schedule of Tax Expense Based on the Statutory Rate is Reconciled with the Actual Tax Expense (Details)
12 Months Ended
Dec. 31, 2024
Dec. 31, 2023
Income Tax Disclosure [Abstract]    
U.S. federal statutory rate 21.00% 21.00%
State taxes, net of federal benefit 8.00% 9.70%
Permanent differences (0.40%) 6.30%
Change in tax rates (0.40%) 9.00%
Return-to-provision adjustments (0.50%) 1.90%
Tax credits (1.50%) (22.30%)
Income tax provision 26.20% 25.60%
v3.25.0.1
Schedule of Net Deferred Tax Asset (Details) - USD ($)
$ in Thousands
Dec. 31, 2024
Dec. 31, 2023
Deferred tax assets:    
Net operating losses $ 647 $ 814
Stock-based compensation 115 103
Depreciation and amortization 942 762
Accrued expenses and reserves 243 257
Inventory capitalization 165
Customer deposits 18 37
Tax credits 267 367
Lease accounting, net 6 2
Gross deferred tax assets 2,403 2,342
Valuation allowance (185) (185)
Total deferred tax assets 2,218 2,157
Deferred tax liabilities    
Prepaid expenses (21) (17)
Total deferred tax liabilities (21) (17)
Net deferred tax assets $ 2,197 $ 2,140
v3.25.0.1
Income Taxes (Details Narrative)
$ in Millions
1 Months Ended
Dec. 31, 2024
USD ($)
Income Tax Disclosure [Abstract]  
Income Tax Holiday, Aggregate Dollar Amount $ 6.3
Deferred Tax Assets, Tax Credit Carryforwards, Other $ 0.3

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