Form 8-K - Current report

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the

Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): August 28, 2023

NanoVibronix, Inc.

(Exact name of registrant as specified in its charter)

Delaware

001-36445

01-0801232

(State or other jurisdiction

of incorporation)

(Commission

File Number)

(IRS Employer

Identification No.)

525 Executive Blvd

Elmsford, New York

10523

(Address of principal executive offices)

(Zip Code)

Registrant’s telephone number, including area code: (914) 233-3004

(Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐	Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐	Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐	Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐	Pre-commencement communications pursuant to Rule 13e-4 (c) under the Exchange Act (17 CFR 240.13e-4(c))

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

Title of each class		Trading Symbol		Name of each exchange on which registered
Common Stock, par value $0.001 per share		NAOV		Nasdaq Capital Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

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. ☐

Item 7.01. Regulation FD Disclosure.

On August 28, 2023, NanoVibronix, Inc. (the “Company”), issued a press release announcing the Company’s application for inclusion of its UroShield products in the National Health Service’s Prescription Services’ Drug Tariff. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference. The Company undertakes no obligation to update, supplement or amend the materials attached hereto.

The information in this Current Report on Form 8-K (including Exhibit 99.1 attached hereto) is being furnished pursuant to Item 7.01 and shall not be deemed to be filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise be subject to the liabilities of that section, nor shall it be deemed to be incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date hereof and regardless of any general incorporation language in such filing.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

Exhibit Number		Description

99.1		Press Release dated August 28, 2023 (furnished pursuant to Item 7.01)
104		Cover Page Interactive Data File (formatted as Inline XBRL)

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

	NanoVibronix, Inc.

Date: August 28, 2023	By:	/s/ Stephen Brown
	Name:	Stephen Brown
	Title:	Chief Financial Officer

Exhibit 99.1

NanoVibronix Applies for Inclusion of UroShield Products in NHS Prescription Services’ Drug Tariff

Listing enables Reimbursement and Increased Distribution for NHS patients

ELMSFORD, N.Y., August 28, 2023 (Business Wire) — NanoVibronix, Inc., (NASDAQ: NAOV), a medical device company that produces the UroShield®, PainShield® and WoundShield® Surface Acoustic Wave (SAW) Portable Ultrasonic Therapeutic Devices, today provided an update on its efforts to expand distribution of its UroShield family of products.

In conjunction with the Company’s UK distribution partner, Peak Medical Ltd, the Company submitted an application to The National Health Service (“NHS”) Prescription Services for reimbursement of its UroShield family of products. NHS Prescription Services’ primary function is to determine the reimbursement and remuneration due when prescriptions are dispensed outside hospitals anywhere in England. All devices listed are nationally available on the NHS Drug Tariff. Listing of UroShield on the NHS Drug Tariff results in the NHS paying the cost of the device and not the patient.

Brian Murphy, Chief Executive Officer of NanoVibronix, Inc., commented, “We believe that inclusion in the NHS Drug Tariff enables UroShield technology to be reimbursed and gain broader distribution through pharmacies. Doctors and specialist nurses will be able to prescribe UroShield for patients who struggle with recurring catheter associated urinary tract infections (C-AUTI) and catheter blockages. This submission represents yet another channel that we are pursuing to get our products into the hands of the many patients who could benefit from them.”

Below is a sampling of testimonials that the Company has received from patients and clinicians:

“The wife of one patient swears that without the use of the UroShield, her husband would no longer be with us, as he suffered multiple infections and was resistant to many of the antibiotics. Since using the UroShield, he has not had any infections.”

“The use of Uroshield device has been transformational to N. and made his care much more straight forward. Given that UroShield contributes to a reduction in NHS resources, I strongly support the request for this to be provided by the NHS.”

Murphy continued, “We are hopeful of receiving approval of our application in the near-term as it could open many more channels for our UroShield products. Recent data from NHS indicates there were nearly 12,000 active community pharamacies and Dispensing Appliance Contractors responsible for dispensing medications, applicances and medical devices to NHS patients.¹ Expanding our addressable market and points of distribution are essential to growing and scaling our business. If approved, this application could make it financially feasible for an increasing number of patients to have access to UroShield.”

¹https://www.nhsbsa.nhs.uk/statistical-collections/general-pharmaceutical-services-england/general-pharmaceutical-services-england-201516-202021#:~:text=There%20were%2011%2C600%20active%20community,%2F21%2C%20while%20451%20closed

About NanoVibronix, Inc.

NanoVibronix, Inc. (NASDAQ: NAOV) is a medical device company headquartered in Elmsford, New York, with research and development in Nesher, Israel, focused on developing medical devices utilizing its patented low intensity surface acoustic wave (SAW) technology. The proprietary technology allows for the creation of low-frequency ultrasound waves that can be utilized for a variety of medical applications, including for disruption of biofilms and bacterial colonization, as well as for pain relief. The devices can be administered at home without the assistance of medical professionals. The Company’s primary products include PainShield® and UroShield®, which are portable devices suitable for administration at home without assistance of medical professionals. Additional information about NanoVibronix is available at: www.nanovibronix.com

Forward-looking Statements

This press release contains “forward-looking statements.” Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward-looking statements are not guarantees of future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified; consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with: (i) market acceptance of our existing and new products or lengthy product delays in key markets; (ii) negative or unreliable clinical trial results; (iii) inability to secure regulatory approvals for the sale of our products; (iv) intense competition in the medical device industry from much larger, multinational companies; (v) product liability claims; (vi) product malfunctions; (vii) our limited manufacturing capabilities and reliance on subcontractor assistance; (viii) insufficient or inadequate reimbursements by governmental and/or other third party payers for our products; (ix) our ability to successfully obtain and maintain intellectual property protection covering our products; (x) legislative or regulatory reform impacting the healthcare system in the U.S. or in foreign jurisdictions; (xi) our reliance on single suppliers for certain product components, (xii) the need to raise additional capital to meet our future business requirements and obligations, given the fact that such capital may not be available, or may be costly, dilutive or difficult to obtain; (xiii) our conducting business in foreign jurisdictions exposing us to additional challenges, such as foreign currency exchange rate fluctuations, logistical and communications challenges, the burden and cost of compliance with foreign laws, and political and/or economic instabilities in specific jurisdictions; and (xiv) market and other conditions. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’s web site at: http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events, or otherwise, except as required by law.

Investor Contacts:

Brett Maas, Managing Principal, Hayden IR, LLC

brett@haydenir.com

(646) 536-7331

SOURCE: NanoVibronix, Inc.

Cover	Aug. 28, 2023
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Aug. 28, 2023
Entity File Number	001-36445
Entity Registrant Name	NanoVibronix, Inc.
Entity Central Index Key	0001326706
Entity Tax Identification Number	01-0801232
Entity Incorporation, State or Country Code	DE
Entity Address, Address Line One	525 Executive Blvd
Entity Address, City or Town	Elmsford
Entity Address, State or Province	NY
Entity Address, Postal Zip Code	10523
City Area Code	(914)
Local Phone Number	233-3004
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Title of 12(b) Security	Common Stock, par value $0.001 per share
Trading Symbol	NAOV
Security Exchange Name	NASDAQ
Entity Emerging Growth Company	false