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: March 2026
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 March 2, 2026, the Company
issued a press release titled “IceCure Medical Reports Independent Study Published in PLOS One Demonstrating ProSense® Cryoablation
Safe and Effective in Treatment of Breast Fibroadenomas,” 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 (excluding the third paragraph of the press release included as Exhibit 99.1 hereto) is incorporated by reference into
the Company’s Registration Statements on Form F-3 (File Nos. 333-290046,
333-267272 and 333-258660)
and Form S-8 (File 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is submitted, to the extent not superseded by documents or reports subsequently filed or furnished.
EXHIBIT INDEX
| Exhibit No. |
|
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| 99.1 |
|
Press release dated March 2, 2026 titled “IceCure Medical Reports Independent Study Published in PLOS One Demonstrating ProSense® Cryoablation Safe and Effective in Treatment of Breast Fibroadenomas”. |
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.
| |
ICECURE MEDICAL LTD. |
| |
|
|
| Date: March
2, 2026 |
By: |
/s/
Eyal Shamir |
| |
|
Name: |
Eyal
Shamir |
| |
|
Title: |
Chief Executive
Officer |
Exhibit 99.1
IceCure Medical Reports Independent Study Published
in PLOS One Demonstrating ProSense® Cryoablation Safe and Effective in Treatment of Breast Fibroadenomas
Treatment with ProSense® resulted in 92.9%
volume reduction of fibroadenoma one-year post-cryoablation
Findings may impact treatment guidelines issued
by medical societies for large non-cancerous breast tumors; study is believed to be the first to evaluate larger lesions and use multiple
cryoprobe relocations
ProSense® Cryoablation has FDA-clearance
for fibroadenomas
CAESAREA, Israel, March 2, 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 announced the
publication of an independent, investigator-initiated study evaluating ProSense® for the treatment of non-cancerous breast tumors,
or fibroadenomas. The study, titled “Cryoablation for fibroadenoma with liquid nitrogen-based system: A retrospective analysis of
prospectively collected data,” was published in the peer-reviewed journal PLOS One.
Fibroadenoma is the most common benign breast
lesion identified through core needle biopsy. Up to 10% of women will have a fibroadenoma at some point in their lives, according to the
Cleveland Clinic. Surgical excision is currently the standard of care for many fibroadenomas, particularly for larger lesions or those
causing discomfort. IceCure estimates that cryoablation could address approximately 63,000 cases of fibroadenoma excision in the U.S.
annually.
“We believe this publication is very significant
because it reinforces the safety and effectiveness of ProSense® cryoablation for fibroadenomas and may contribute to updates in treatment
guidelines for non-cancerous breast tumors issued by medical societies in key markets where ProSense® is used, including the American
Society of Breast Surgeons,” said Eyal Shamir, IceCure’s Chief Executive Officer. “Previous studies supporting cryoablation
for fibroadenomas were often limited to lesions 4 centimeters or smaller, and many were published more than a decade ago. This study is
unique in that it includes a large patient cohort and evaluates larger lesions using multiple cryoprobe relocations. We are grateful to
the study’s investigators for their pursuit of improved outcomes for patients and their use of ProSense® for their study.”
The study was conducted at the Premier Med Healthcare,
Training, and Research Institute in Hungary and led by Dr. Teodora Filipov and Dr. Pál Ákos Deák. The investigators
concluded that cryoablation with a liquid nitrogen system, specifically ProSense®, proved safe and effective, demonstrating a median
volume reduction of 80.6% at approximately six months and 92.9% at one-year post-treatment. The study further found that sequential cryoprobe
relocations preserve safety and efficacy. ProSense® cryoprobes can be relocated up to three times per patient, per procedure enabling
physicians to fully treat large or multifocal lesions through complete ablation coverage.
IceCure believes these findings further support
the growing clinical adoption of minimally invasive cryoablation as an alternative to surgical excision for benign breast tumors, particularly
for women seeking minimal scarring and short procedure times.
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 United States, 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:
the potential number of cases of fibroadenoma excision that cryoablation could address in the U.S. annually; the potential impact of the
study’s findings on future treatment guidelines for non-cancerous breast tumors; the possibility that the results may contribute
to updates by medical societies such as the American Society of Breast Surgeons; and the expectation that these findings will further
support the growing clinical adoption of ProSense as an alternative to surgical excision for benign breast tumors. 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 U.S. Securities and
Exchange Commission (“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
