UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER
PURSUANT TO RULE 13a-16 OR 15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
For the month of January 2024
Commission file number: 001-40753
ICECURE
MEDICAL LTD.
(Translation of registrant’s name into
English)
7 Ha’Eshel St., PO Box 3163
Caesarea, 3079504 Israel
(Address of principal executive office)
Indicate by check mark whether the registrant
files or will file annual reports under cover of Form 20-F or Form 40-F:
☒ Form 20-F ☐
Form 40-F
CONTENTS
On January 10, 2024, IceCure
Medical Ltd. (the “Company”) issued a press release titled: “IceCure Medical CEO Issues Letter to Shareholders &
Reports Increase in Sales in Preliminary Unaudited 2023 Results,” a copy of which is furnished as Exhibit 99.1 with this Report
of Foreign Private Issuer on Form 6-K (the “Report”).
The press release is incorporated
by reference into the Company’s Registration Statements on Form F-3 (Registration Nos. 333-258660 and 333-267272) and Form S-8 (Registration
Nos. 333-270982, 333-264578, and 333-262620), filed with the Securities and Exchange Commission, to be a part thereof from the date on
which this Report is submitted, to the extent not superseded by documents or reports subsequently filed or furnished.
SIGNATURES
Pursuant to the requirements
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.
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IceCure Medical Ltd. |
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Date: January 10, 2024 |
By: |
/s/ Eyal Shamir |
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Name: |
Eyal Shamir |
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Title: |
Chief Executive Officer |
2
Exhibit 99.1
IceCure
Medical CEO Issues Letter to Shareholders & Reports
Increase
in Sales in Preliminary Unaudited 2023 Results
| ● | U.S.
sales continue to increase with 25% jump in ProSense® system and disposable probe sales
in 2023 over prior year |
| ● | ICE3
study is set for completion and final data read out |
CAESAREA,
Israel, January 10, 2024 – IceCure Medical Ltd. (Nasdaq: ICCM) (“IceCure” or the “Company”), developer
of the ProSense® System, a minimally-invasive cryoablation technology that destroys tumors by freezing as an alternative to surgical
tumor removal, today issued the following letter to its shareholders from its Chief Executive Officer, Eyal Shamir.
Dear
shareholders,
2023
was a year of strong growth for IceCure. Cryoablation became increasingly recognized as a highly favorable minimally invasive alternative
to open surgery and ProSense® achieved an expanded global rollout with regulatory clearances received in significantly large markets
such as Brazil, Canada, and China. Furthermore, the trend toward performing cryoablation procedures is increasing amongst breast surgeons
and breast radiologists. We believe that the growing abundance of peer-reviewed journals publishing ProSense® and cryoablation studies
will have a direct and favorable impact on IceCure as we continue to expand our global distribution footprint. We are very optimistic
about 2024 and believe it will be a pivotal year marked by the completion of our ICE3 breast cancer study and continued penetration in
the U.S. and global markets.
2023
Key Achievements
Increased
Revenues, System, and Probe Sales: Based on our expected preliminary unaudited 2023 results, ProSense® system and disposable
probe sales increased by 26% globally over 2022. Product sales in the U.S. were up 25% in 2023 over 2022 levels. On a preliminary unaudited
basis, total revenues increased for the financial year ended December 31, 2023 to $3.2 million, as compared to $3.1 million in 2022.
An increase in system and probe sales was partially offset by a decrease in revenue recognition from our distribution agreement with
Terumo Corporation. On a preliminary unaudited basis, as of December 31, 2023, we had cash and cash equivalents, including short-term
deposits, of $11 million. During the fourth quarter of 2023 we implemented an expense reduction plan to reduce our non-revenue generating
and clinical development costs, lowering monthly cash utilization, to help ensure that we meet our primary goals in 2024.
The
above information reflects preliminary unaudited estimates with respect to certain results of IceCure for the full year ended December
31, 2023, based on currently available information. Because the audit for 2023 is not yet complete, the Company’s final results
may vary from the preliminary estimates provided herein.
Growing
Adoption Among World’s Leading Physicians as Evidenced by 17 Ongoing Independent Studies Across Several Indications: Our expected
2023 revenue momentum and the growing number of independent, non-sponsored studies of ProSense® point to an increased adoption of
ProSense® around the world across several indications. Twelve non-sponsored studies that demonstrate ProSense®’s safety
and efficacy, in line with results reported in our own studies, have been published in peer reviewed journals and presented at scientific
conferences to date. Our two studies, ICE3 for breast cancer and ICESECRET for kidney cancer, and 17 independent, non-sponsored studies
are ongoing. Thirteen of the published and ongoing studies are for breast cancer with the remaining studies focused on fibroadenomas,
endometriosis, and malignant or benign tumors of the lung, kidney, and musculoskeletal system. The increased adoption by physicians of
ProSense® is attributable to a clear need in the market for a safe, effective, and more cost-efficient alternative to open surgery,
combined with IceCure’s well-executed awareness and marketing efforts at world leading medical conferences for breast care and
interventional radiology. 2023 marked a key year for cryoablation in the U.S. as the American Society of Breast Surgeons (ASBrS) 2023
Annual Meeting featured a first-of-its-kind continuing medical education (CME) course for cryotherapy that used the ProSense® system
in its demonstration. The ASBrS also presented its plan for a proposed ASBrS breast cancer cryoablation trial during the cryotherapy
CME course.
Completing
ICE3 Breast Cancer Study in the U.S.: Only 10 patients remain who need to undergo their five-year follow-up examinations in our ICE3
study, the largest of its kind in the U.S. We expect that the last patient will return for her final follow-up examination in the first
quarter of 2024.
ICESECRET
Kidney Cancer Study Continues: Interim results from our study of ProSense® in the treatment of kidney cancer had reported an
impressive 89.5% recurrence-free rate based on interim results at the end of 2022. We expect ICESECRET’s five-year patient follow-up
to be completed in 2026.
Regulatory
Approvals Received in Key Global Markets: Further expanding and supporting the global commercial rollout of ProSense®, our cryoablation
system, and disposable probes now have regulatory approval in 15 countries, including countries where approval was granted in 2023 such
as China, Canada, and Brazil.
Seeking
to Expand Approvals in the U.S. to Include Breast Cancer: ProSense® is currently approved by the U.S. Food and Drug Administration
(FDA) in general minimally invasive cryoablation procedures including kidney, liver, neurology, and fibroadenoma. We are focused on attaining
FDA clearance to market ProSense® to address a significant unmet need for a minimally invasive option to treat early-stage breast
cancer. In 2022, we had filed a De Novo Classification request with the FDA for regulatory approval of ProSense® for the indication
of early-stage low-risk breast cancer in patients who are at high risk for surgery, based on interim data from ICE3. We received a denial
from the FDA on our De Novo request in September 2023 and subsequently filed an appeal. The FDA’s decision has no bearing on patients
in the U.S. for indications already cleared by the FDA. Our appeal with the FDA focused on the FDA’s choice of comparator group
for our ICE3 interim study data. We believe that an appropriate comparator group agreement with the FDA and subsequent analysis of the
data may lead to marketing clearance for ProSense® in this indication. We anticipate a response to the appeal from the FDA by the
end of January 2024. Our continued commitment to the U.S. market, which represents more than 300,000 breast cancer patients diagnosed
annually, was further demonstrated this past year when we appointed Shad Good as our Vice President of Sales for North America. Mr. Good
brings nearly 20 years of medical device sales and leadership experience, including as a global leader in minimally invasive breast diagnostic
and therapeutic systems. He is focused on potential targeted users of ProSense® throughout the U.S. and Canada and continuing to
accelerate sales momentum.
Increased
Distributors and Global Installations: In 2023, we entered a non-exclusive distribution agreement with Medicinália Cormédica
– MC Medical, Lda., the largest distributor of third-party medical devices in Portugal, further expanding the distribution of ProSense®
in Europe where the system has the European Union’s CE mark of regulatory approval. In India, ProSense® was used to perform the country’s
first breast cryoablation procedure at a hospital where our system was installed earlier in the year. Having received regulatory approval
in Brazil, sales are expected through our $6.6 million, 5-year distribution agreement with Ktrfios Importação e
Exportação LTDA.
2024
Objectives
| ● | Driven
by growing awareness of ProSense®’s safety and efficacy in breast cancer and numerous
other indications, as demonstrated through the 17 independent and two IceCure studies, we
are focused on increasing sales of our systems and disposable probes with corresponding revenues
across the globe through current and new distribution partners. |
| ● | Broadening
ProSense®’s adoption as a breast cancer treatment, IceCure’s Japanese partner,
Terumo Corporation is expected to submit the request
for clearance under a breast cancer indication with the Pharmaceuticals and Medical Devices
Agency in Japan in the second half of 2024. |
| ● | The
ICE3 study is expected to be completed by the end of the first quarter of 2024. |
| ● | Top-line
results from ICE3 are expected in the second quarter of 2024. We believe these data, if favorable
and in line with the interim results that demonstrated an estimated 95.7% five-year recurrence
free rate, may lead to additional regulatory approvals and increased sales in territories
where ProSense® is already approved for breast cancer. |
| ● | We
anticipate a response from the FDA to our appeal by the end of January 2024 and are hopeful
for a positive response as we continue to work closely with the FDA towards an outcome that
would make ProSense® available to women in the U.S. who seek a non-surgical, minimally
invasive option for early-stage breast cancer. |
| ● | Our
next-generation single-probe cryoablation system is expected to be introduced in 2024. |
We
start 2024 with hope and wishes for a peaceful, healthy, and prosperous year for all.
Sincerely,
Eyal
Shamir, CEO
IceCure
Medical
About
ProSense®
The
ProSense® Cyroablation System provides a minimally invasive treatment option to destroy tumors by freezing them. The system
uniquely harnesses the power of liquid nitrogen to create large lethal zones for maximum efficacy in tumor destruction in benign and
cancerous lesions, including breast, kidney, lung, and liver.
ProSense®
enhances patient and provider value by accelerating recovery, reducing pain, surgical risks, and complications. With its easy, transportable
design and liquid nitrogen utilization, ProSense® opens that door to fast and convenient office-based procedure for breast
tumors.
About
IceCure Medical
IceCure
Medical (Nasdaq: ICCM) develops and markets ProSense®, an advanced liquid-nitrogen-based cryoablation therapy for the treatment of
tumors (benign and cancerous) by freezing, with the primary focus areas being breast, kidney, bone and lung cancer. Its minimally invasive
technology is a safe and effective alternative to hospital surgical tumor removal that is easily performed in a relatively short procedure.
The system is marketed and sold worldwide for the indications cleared and approved to date including in the U.S., Europe, and China.
Forward
Looking Statements
This
press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities
Litigation Reform Act of 1995 and other Federal securities laws. Words such as “expects,” “anticipates,” “intends,”
“plans,” “believes,” “seeks,” “estimates” and similar expressions or variations of such words
are intended to identify forward-looking statements. For example, IceCure is using forward looking statement in this press release when
it discusses its expected preliminary results for the financial year ended December 31, 2023, the Company’s strategy, the belief
that the growing number of published studies will have a direct and favorable impact on the Company, that 2024 will be a pivotal year
with the completion of the ICE3 study and continued penetration in the U.S. and global markets, that the implementation of its expense
reduction plan will help ensure the Company meets its primary goals in 2024, its belief that the increased adoption of ProSense®
by physicians is attributable to the cost-effective nature and its successful marketing efforts, its upcoming follow-up examinations
in the ICE3 study in the first quarter of 2024 that would mark the study’s completion and about which its top-line results are expected
in the second quarter of 2024, that the ICESECRET five-year patient follow-up is to be completed in 2026, its impending expansion of
the global commercial rollout of ProSense® and disposable probes, the impending result, expected by the end of January 2024, of the
Company’s appeal with regards to its ICE3 study, the Company’s focus on increasing sales of its systems across the globe
through current and new distribution partner, Terumo Corporation’s upcoming submission for clearance for ProSense® with the
Pharmaceuticals and Medical Devices Agency in Japan in the second half of 2024, and that the Company’s
next-generation single-probe cryoablation system is expected to be introduced in 2024. Important factors that could cause actual
results, developments and business decisions to differ materially from those anticipated in these forward-looking statements include,
among others: the Company’s planned level of revenues and capital expenditures; the Company’s available cash and its
ability to obtain additional funding; the Company’s ability to market and sell its products; legal and regulatory developments
in the United States and other countries; the Company’s ability to maintain its relationships with suppliers, distributors
and other partners; the Company’s ability to maintain or protect the validity of its patents and other intellectual property; the
Company’s ability to expose and educate medical professionals about its products; political, economic and military instability
in the Middle East, specifically in Israel; as well as those factors set forth in the Risk Factors section of the Company’s
Annual Report on Form 20-F for the year ended December 31, 2022 filed with the SEC on March 29, 2023, and other documents filed with
or furnished to the SEC which are available on the SEC’s website, www.sec.gov. The Company undertakes no obligation to update these statements
for revisions or changes after the date of this release, except as required by law.
IR
Contact:
Email:
investors@icecure-medical.com
Michael
Polyviou
Phone:
732-232-6914
Todd
Kehrli
Phone:
310-625-4462
4
IceCure Medical (NASDAQ:ICCM)
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