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 2026 (Report No. 3)

 

Commission File Number: 001-40753

 

ICECURE MEDICAL LTD.

(Translation of registrant’s name intoEnglish)

 

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 annualreports under cover of Form 20-F or Form 40-F:

 

☒ Form 20-F            ☐ Form 40-F

 

 

 

 

 

CONTENTS

 

On January 12, 2026, IceCureMedical Ltd. (the “Company”) issued a press release titled “IceCure CEO Issues Letter to Shareholders: Reports RecordFourth Quarter and Full Year 2025 ProSense® Sales,” a copy of which is furnished as Exhibit 99.1 with this Report of ForeignPrivate Issuer on Form 6-K. 

 

This Report of Foreign PrivateIssuer 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, 333-262620and 333-281587), filed withthe Securities and Exchange Commission, to be a part thereof from the date on which this Report of Foreign Private Issuer on Form 6-Kis submitted, to the extent not superseded by documents or reports subsequently filed or furnished.

 

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EXHIBIT INDEX

 

Exhibit No.    
99.1   Press release dated January 12, 2026 titled “IceCure CEO Issues Letter to Shareholders: Reports Record Fourth Quarter and Full Year 2025 ProSense® Sales”.

 

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SIGNATURES

 

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

 

  ICECURE MEDICAL LTD.
     
Date: January 12, 2026 By: /s/ Eyal Shamir
    Name:  Eyal Shamir
    Title: Chief Executive Officer

 

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Exhibit 99.1

 

IceCure CEO Issues Letter to Shareholders: ReportsRecord 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-riskbreast cancer, addressing a market opportunity of approximately 200,000 patients

 

Record European sales, driven by positive effectsof U.S. clearance and continued growing adoption of ProSense® cryoablation for breast cancer in key markets

 

Record number of peer-reviewed publicationsand presentations at global conferences demonstrates growing clinical evidence for cryoablation of breast, musculoskeletal, and kidneycancers with ProSense®

 

CAESAREA, Israel, January 12, 2026 –IceCure Medical Ltd. (Nasdaq: ICCM) (“IceCure”, “IceCure Medical” or the “Company”), developer ofminimally-invasive cryoablation technology that destroys tumors by freezing as an option to surgical tumor removal, today issued the followingletter to shareholders from its Chief Executive Officer, Eyal Shamir.

 

Dear shareholders,

 

2025 was a pivotal year for IceCure – wewere granted the U.S. Food and Drug Administration’s (“FDA”) marketing authorization for ProSense® cryoablationfor the local treatment of low-risk breast cancer with endocrine therapy in women aged 70 and above, including those who are not candidatesfor breast cancer surgery. This achievement has strengthened our belief that ProSense® can expand patient choice, enhance care, andoffer improved healthcare economics through a minimally invasive approach. This milestone marks a meaningful step toward establishingcryoablation as a new standard of care for eligible women in the United States seeking effective care without surgical removal of breasttissue.

 

Following the FDA marketing authorization in October2025, we have experienced and continue to experience an overwhelmingly positive response and interest in ProSense® consoles and disposablecryoprobes. This has contributed to record fourth quarter results in 2025 in North America. We are particularly enthused to see systemsbeing 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, IceCuredelivered a record ProSense® sales of approximately $3.4 million for the year ended December 31, 2025, driven by growing demand inthe U.S. and record sales in Europe as we continue to execute our global commercial strategy. Our cash and cash equivalents balance asof December 31, 2025 was approximately $8.9 million. This preliminary financial information has been prepared solely on the basis of informationthat is currently available to, and that is the responsibility of, management. This preliminary financial information is based upon ourestimates 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 largebody of data supporting ProSense® for other indications. In 2025, independent investigators produced a record number of peer-reviewedpublications and presentations regarding the use of ProSense® for breast, musculoskeletal, and kidney cancers. We believe this expandingbody 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 BreastCancer in Women Aged 70 and Above: The FDA granted marketing authorization for ProSense® for the local treatment of low-risk breastcancer in women aged 70 and above with endocrine therapy, establishing ProSense® as the first and only medical device to receive FDAmarketing 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 includesapproximately 46,400 early-stage, low-risk breast cancer patients aged 70 and over, 88,500 patients who are not candidates for breastcancer 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 medicalinstitutions in the United States, reflecting strong clinical interest following the FDA marketing authorization.

 

Record Scientific Visibility and IndependentValidation: IceCure achieved a record number of peer-reviewed publications and conference presentations by 16 principal investigatorsat 10 conferences across the globe including the U.S., Europe, and Asia, covering indications including breast, musculoskeletal and kidneycancer. These independent third-party studies continue to demonstrate ProSense® efficacy and safety in breast cancer and its potentialfor 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 demonstratedthat 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® substantiallyreduced 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-generationXSense™ 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-probecryoablation 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 prosperous2026.

 

Sincerely,

Eyal Shamir, CEO

 

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About ProSense®

 

The ProSense® Cryoablation System is the firstand only medical device to receive FDA marketing authorization for the local treatment of low-risk breast cancer with adjuvant endocrinetherapy for women aged 70 and above, including patients who are not suitable for surgical alternatives for breast cancer treatment. Afull list of benefits and risks can be found on the Company’s website.

 

ProSense® is a minimally invasive cryosurgicaltool that provides the option to destroy tumors by freezing them. The system uniquely harnesses the power of liquid nitrogen to createlarge lethal zones for maximum efficacy in tumor destruction in benign and cancerous lesions, including in the breast, kidney, lung, andliver.

 

ProSense® enhances patient and provider valueby 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 marketsadvanced liquid-nitrogen-based cryoablation therapy systems for the destruction of tumors (benign and cancerous) by freezing, with theprimary focus areas being breast, kidney, bone and lung cancer. Its minimally invasive technology is a safe and effective option to surgicaltumor removal that is easily performed in a relatively short procedure. The Company’s flagship ProSense® system is marketedand sold worldwide for the indications cleared and approved to date including in the U.S., Europe, and Asia.

 

Forward Looking Statement

 

This press release containsforward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation ReformAct of 1995 and other Federal securities laws. Words such as “expects,” “anticipates,” “intends,”“plans,” “believes,” “seeks,” “estimates” and similar expressions or variations of suchwords are intended to identify forward-looking statements. For example, IceCure is using forward looking statements in thispress release when it discusses: its preliminary unaudited estimates for certain 2025 financial performance, which are subject to, amongother things, the completion of IceCure’s financial closing procedures and final adjustments, which may impact the results and expectationsset forth above; expectations that the FDA marketing authorization will accelerate broader adoption of ProSense® and support its establishmentas a new standard of care in the United States; beliefs that commercial sales in the U.S. and increased utilization in Europe are expectedto generate higher ProSense® system and cryoprobe sales in 2026; expectations that additional reimbursement coverage may potentiallybecome available in 2026 and beyond; anticipated regulatory submissions and approvals in additional global markets, including a plannedsubmission 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 trialsdo not guarantee that the conclusions of future research or trials will suggest identical or even similar conclusions. Important factorsthat could cause actual results, developments and business decisions to differ materially from those anticipated in these forward-lookingstatements include, among others: the Company’s planned level of revenues and capital expenditures; the Company’s availablecash and its ability to obtain additional funding; the Company’s ability to market and sell its products; legal and regulatory developmentsin the United States and other countries; the Company’s ability to maintain its relationships with suppliers, distributorsand other partners; the Company’s ability to maintain or protect the validity of its patents and other intellectual property; theCompany’s ability to expose and educate medical professionals about its products; political, economic and military instability inthe Middle East, specifically in Israel; as well as those factors set forth in the Risk Factors section of the Company’sAnnual Report on Form 20-F for the year ended December 31, 2024 filed with the SEC on March 27, 2025, and other documentsfiled with or furnished to the SEC which are available on the SEC’s website, www.sec.gov. The Company undertakes no obligationto 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

 

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