For the Month of: January 2026 (Report No. 3)
Indicate by check mark whether the registrant files or will file annual
reports under cover of Form 20-F or Form 40-F:
On January 12, 2026, IceCure
Medical Ltd. (the “Company”) issued a press release titled “IceCure CEO Issues Letter to Shareholders: Reports Record
Fourth Quarter and Full Year 2025 ProSense® Sales,” a copy of which is furnished as Exhibit 99.1 with this Report of Foreign
Private Issuer on Form 6-K.
This Report of Foreign Private
Issuer on Form 6-K is incorporated by reference into the Company’s Registration Statements on Form F-3 (File Nos. 333-258660,
333-267272 and 333-290046)
and Form S-8 (Registration Nos. 333-270982,
333-264578, 333-262620
and 333-281587), filed with
the Securities and Exchange Commission, to be a part thereof from the date on which this Report of Foreign Private Issuer on Form 6-K
is submitted, to the extent not superseded by documents or reports subsequently filed or furnished.
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.
Exhibit 99.1
IceCure CEO Issues Letter to Shareholders: Reports
Record Fourth Quarter and Full Year 2025 ProSense® Sales
Company experiencing strong demand in the U.S.
following FDA marketing authorization of ProSense® as the only on-label minimally invasive solution for the local treatment of low-risk
breast cancer, addressing a market opportunity of approximately 200,000 patients
Record European sales, driven by positive effects
of U.S. clearance and continued growing adoption of ProSense® cryoablation for breast cancer in key markets
Record number of peer-reviewed publications
and presentations at global conferences demonstrates growing clinical evidence for cryoablation of breast, musculoskeletal, and kidney
cancers with ProSense®
CAESAREA, Israel, January 12, 2026 –
IceCure Medical Ltd. (Nasdaq: ICCM) (“IceCure”, “IceCure Medical” or the “Company”), developer of
minimally-invasive cryoablation technology that destroys tumors by freezing as an option to surgical tumor removal, today issued the following
letter to shareholders from its Chief Executive Officer, Eyal Shamir.
Dear shareholders,
2025 was a pivotal year for IceCure – we
were granted the U.S. Food and Drug Administration’s (“FDA”) marketing authorization for ProSense® cryoablation
for the local treatment of low-risk breast cancer with endocrine therapy in women aged 70 and above, including those who are not candidates
for breast cancer surgery. This achievement has strengthened our belief that ProSense® can expand patient choice, enhance care, and
offer improved healthcare economics through a minimally invasive approach. This milestone marks a meaningful step toward establishing
cryoablation as a new standard of care for eligible women in the United States seeking effective care without surgical removal of breast
tissue.
Following the FDA marketing authorization in October
2025, we have experienced and continue to experience an overwhelmingly positive response and interest in ProSense® consoles and disposable
cryoprobes. This has contributed to record fourth quarter results in 2025 in North America. We are particularly enthused to see systems
being placed at highly regarded institutions in the United States, which we believe can further accelerate broader adoption of ProSense®.
Our sales team is engaged with leading hospitals, clinics, breast surgeons, and interventional radiologists currently evaluating ProSense®
in the U.S.
Based on preliminary, unaudited estimates, IceCure
delivered a record ProSense® sales of approximately $3.4 million for the year ended December 31, 2025, driven by growing demand in
the U.S. and record sales in Europe as we continue to execute our global commercial strategy. Our cash and cash equivalents balance as
of December 31, 2025 was approximately $8.9 million. This preliminary financial information has been prepared solely on the basis of information
that is currently available to, and that is the responsibility of, management. This preliminary financial information is based upon our
estimates and remains subject to, among other things, the completion of IceCure’s financial closing procedures and final adjustments,
which may impact the results and expectations set forth above.
We also saw continued advancement in the large
body of data supporting ProSense® for other indications. In 2025, independent investigators produced a record number of peer-reviewed
publications and presentations regarding the use of ProSense® for breast, musculoskeletal, and kidney cancers. We believe this expanding
body of evidence is critical to long-term adoption and to supporting expanded clinical use around the world.
2025 Key Achievements
FDA Marketing Authorization for Low-Risk Breast
Cancer in Women Aged 70 and Above: The FDA granted marketing authorization for ProSense® for the local treatment of low-risk breast
cancer in women aged 70 and above with endocrine therapy, establishing ProSense® as the first and only medical device to receive FDA
marketing authorization for the local treatment of breast cancer.
Significant Addressable U.S. Patient Population:
ProSense® addresses a U.S. patient population for breast cryoablation of approximately 200,000 women annually. This population includes
approximately 46,400 early-stage, low-risk breast cancer patients aged 70 and over, 88,500 patients who are not candidates for breast
cancer surgery, and 63,000 patients with fibroadenomas who opt for excision.
Commercial Expansion Across North America:
ProSense® systems were sold and installed at new locations across North America, including at one of the most highly regarded medical
institutions in the United States, reflecting strong clinical interest following the FDA marketing authorization.
Record Scientific Visibility and Independent
Validation: IceCure achieved a record number of peer-reviewed publications and conference presentations by 16 principal investigators
at 10 conferences across the globe including the U.S., Europe, and Asia, covering indications including breast, musculoskeletal and kidney
cancer. These independent third-party studies continue to demonstrate ProSense® efficacy and safety in breast cancer and its potential
for other indications.
Clinical Validation in Lung Cancer and Endometriosis:
While a large body of evidence in ProSense®’s treatment of breast cancer continues to accumulate, independent studies demonstrated
that IceCure’s cryoablation system, combined with radiation therapy, successfully treated non-small cell lung cancer (“NSCLC”),
demonstrating 92% disease-specific 5-year survival. Additional independent studies also demonstrated that ProSense® substantially
reduced abdominal wall endometriosis pain with high procedural efficacy.
Regulatory Achievements: ProSense®
received regulatory approval in Switzerland for indications including breast, lung, liver, and kidney cancer, while the next-generation
XSense™ received regulatory approval in Israel.
Intellectual Property Estate Continued to Grow:
IceCure was granted and allowed four new patents in the U.S. and China covering our latest innovations, including next-generation multi-probe
cryoablation system, cryogenic pump, and cryogenic flow control technology.
2026 Objectives
| ● | We
believe the commercial sales momentum in the U.S. and wider utilization in Europe is expected
to generate higher ProSense® system and cryoprobe sales in 2026. |
| ● | We
expect additional reimbursement coverage may potentially become available for ProSense®
procedures in 2026 and beyond based on factors including the FDA’s marketing authorization
in low-risk breast cancer, post-market activity, and recommendations from professional medical
associations. ProSense® currently has reimbursement under the CPT III code which increased
to $4,049 effective January 2026. |
| ● | Terumo,
our distributor in Japan, is expected to submit a request for breast cancer clearance to
Japan’s Pharmaceuticals and Medical Devices Agency in the first half of 2026. |
| ● | More
peer-reviewed publications are expected from ongoing independent studies of ProSense®
worldwide. |
| ● | We
expect continued progress toward regulatory approvals for ProSense® in additional global
markets. |
| ● | We
continue to explore opportunities for strategic cooperation and partnership, supported by
recent clinical, regulatory, and commercial progress. |
We wish you all a peaceful, healthy, and prosperous
2026.
Sincerely,
Eyal Shamir, CEO
About ProSense®
The ProSense® Cryoablation System is the first
and only medical device to receive FDA marketing authorization for the local treatment of low-risk breast cancer with adjuvant endocrine
therapy for women aged 70 and above, including patients who are not suitable for surgical alternatives for breast cancer treatment. A
full list of benefits and risks can be found on the Company’s website.
ProSense® is a minimally invasive cryosurgical
tool that provides the 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 in the 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 the door to fast and convenient office-based procedures for breast tumors.
About IceCure Medical
IceCure Medical (Nasdaq: ICCM) develops and markets
advanced liquid-nitrogen-based cryoablation therapy systems for the destruction 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 option to surgical
tumor removal that is easily performed in a relatively short procedure. The Company’s flagship ProSense® system is marketed
and sold worldwide for the indications cleared and approved to date including in the U.S., Europe, and Asia.
Forward Looking Statement
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 statements in this
press release when it discusses: its preliminary unaudited estimates for certain 2025 financial performance, which are subject to, among
other things, the completion of IceCure’s financial closing procedures and final adjustments, which may impact the results and expectations
set forth above; expectations that the FDA marketing authorization will accelerate broader adoption of ProSense® and support its establishment
as a new standard of care in the United States; beliefs that commercial sales in the U.S. and increased utilization in Europe are expected
to generate higher ProSense® system and cryoprobe sales in 2026; expectations that additional reimbursement coverage may potentially
become available in 2026 and beyond; anticipated regulatory submissions and approvals in additional global markets, including a planned
submission for breast cancer clearance in Japan; and expectations regarding future peer-reviewed publications, strategic collaborations,
and continued clinical, regulatory, and commercial progress. Historical results of scientific research and clinical and preclinical trials
do not guarantee that the conclusions of future research or trials will suggest identical or even similar conclusions. 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, 2024 filed with the SEC on March 27, 2025, 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
