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: February 2026 (Report No. 2)
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 February 23, 2026, the
Company issued a press release titled “IceCure Medical Successfully Completes 5-Year Patient Follow Up in ICESECRET Kidney Cancer
Cryoablation Study: Final Analysis Expected in Second Quarter of 2026” 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date on which this Report of Foreign Private Issuer on Form 6-K is submitted, to the extent not superseded by documents or reports subsequently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. |
|
|
| 99.1 |
|
Press release dated February 23, 2026 titled “IceCure Medical Successfully Completes 5-Year Patient Follow Up in ICESECRET Kidney Cancer Cryoablation Study: Final Analysis Expected in Second Quarter of 2026”. |
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: February 23, 2026 |
By: |
/s/ Eyal Shamir |
| |
|
Name: |
Eyal Shamir |
| |
|
Title: |
Chief Executive Officer |
3
Exhibit
99.1
IceCure
Medical Successfully Completes 5-Year Patient Follow Up in ICESECRET Kidney Cancer Cryoablation Study: Final Analysis Expected in Second
Quarter of 2026
Previously
released interim data from 111 patients demonstrated ProSense® is safe and effective in destruction of kidney tumors with 88.7% recurrence-free
rate
Incidence
of kidney cancer is growing worldwide, with an estimated 400,000 new
cases globally; over 80,000 of which are in the U.S. alone highlighting
a growing unmet need
ProSense®
is approved for benign and malignant kidney tumors in the U.S., Europe, and numerous other countries
CAESAREA,
Israel, February 23, 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 completion of its last patients’ five-year follow up evaluation
in its ICESECRET clinical trial of ProSense® for the treatment of small renal masses (“SRMs”) in kidney cancer patients.
ICESECRET,
a prospective, multicenter, single-arm clinical trial, was performed at Bnai Zion Medical Center in Haifa, Israel and Shamir Medical
Center in Be’er Ya’akov, Israel and is led by Principal Investigator Prof. Halahmi Sarel. The trial included 114 patients
(138 lesions) with localized SRMs of ≤5 cm ablated with ProSense® cryoablation under CT guidance. Follow-up visits were performed
at six weeks, six months, one year and then annually up to five years after the procedure using ProSense®. During follow-up visits,
data related to local recurrence, based on CT imaging, was collected. Safety was determined by monitoring procedure-related adverse events
throughout the study.
“Interim
three-year data from ICESECRET, which was collected from 111 eligible patients at the time, was presented a year ago and demonstrated
the strong potential of ProSense® cryoablation as a safe and effective option for patients who are otherwise ineligible for kidney
preserving surgery, a growing unmet need,” stated Eyal Shamir, IceCure’s Chief Executive Officer. “Importantly, ProSense®
already has regulatory approval to treat kidney cancer in key markets including the U.S. and Europe. We are now working closely with
Prof. Sarel on data analysis and publication, with the intention of bringing this minimally invasive procedure to patients in Israel
with kidney cancer.”
SRMs
are increasingly detected due
to widespread imaging and represent a growing clinical challenge, particularly among elderly patients and those with comorbidities who
are not suitable candidates for surgery. Minimally invasive, nephron-sparing treatment options that preserve kidney function, while effectively
controlling tumors, are critically needed.
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: the expected timing of the final analysis of data from the ICESECRET study, including the expectation
that results will be available by the end of the first half of 2026; the clinical performance, safety, efficacy and recurrence-free rates
associated with ProSense® cryoablation treatment of kidney tumors; the potential of ProSense® as a safe and effective treatment
option for patients with SRMs and those ineligible for kidney-preserving surgery; and the anticipated clinical adoption, utilization
and expansion of ProSense® in the treatment of kidney cancer. 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:
Michael
Polyviou
Phone:
732-232-6914
Email: investors@icecure-medical.com
