6-K
IceCure Medical Ltd. (ICCM)
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: November 2025 (Report No. 2)
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 annual reports under cover of Form 20-F or Form 40-F:
☒ Form 20-F ☐ Form 40-F
CONTENTS
Changes in Management
On November 5, 2025, the Board of Directors of IceCure Medical Ltd. (the “Company”) approved the promotion of Mr. Shay Levav, who had been serving as the Company’s Vice President of Regulatory and Quality Assurance and Clinical Applications since September 2020, to the position of Chief Operating Officer.
Before joining the Company, Mr. Levav served as a member on the board of directors of Applied Spectral Imaging from December 2018 to August 2020 and as its quality and regulatory affairs manager since January 2015 to December 2018. He has also served as commercialization business manager of Carestream Health Inc. from 2012 to 2015, as its operations quality manager since 2001 to 2012, and service engineer since 2000 to 2001. Mr. Levav holds a B.A. from the Ruppin Academy Center, Israel.
Press Release
On November 10, 2025, the Company issued a press release titled “IceCure Promotes Shay Levav to Chief Operating Officer as Company Ramps up for Increased Commercial Traction,” a copy of which is furnished as Exhibit 99.1 with this Report of Foreign Private Issuer on Form 6-K.
The press release attached herewith as Exhibit 99.1 (excluding the second paragraph thereof) is incorporated by reference into the Company’s Registration Statements on Form F-3 (Registration 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a part thereof from the date on which this Report of Foreign Private Issuer on Form 6-K is submitted, to the extent not superseded by documents or reports subsequently filed or furnished.
EXHIBIT INDEX
| Exhibit No. | |
|---|---|
| 99.1 | Press release dated November 10, 2025 titled “IceCure Promotes Shay Levav to Chief Operating Officer as Company Ramps up for Increased Commercial Traction” |
1
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: November 10, 2025 | By: | /s/ Eyal Shamir | |
| Name: | Eyal Shamir | ||
| Title: | Chief Executive Officer |
2
Exhibit 99.1
IceCurePromotes Shay Levav to Chief Operating Officer as Company Ramps up for Increased Commercial Traction
Mr. Levav’s appointment ensures seamlessand focused organizational structure as Company expands commercial activities in the U.S. following FDA marketing clearance for ProSense®
CAESAREA, Israel, November 10 2025 – 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 promotion of Shay Levav to Chief Operating Officer, as the Company anticipates accelerating commercial momentum following ProSense®’s marketing authorization from the U.S. Food and Drug Administration (“FDA”) for low risk breast cancer in October 2025. Mr. Levav will continue to lead the Company’s Regulatory Affairs, Quality Assurance, and Clinical Affairs, under his new role, that he has overseen since 2020.
“Mr. Levav has been a valued contributor throughout the clinical and regulatory process for ProSense®, and his ability to seamlessly step into the role of Chief Operating Officer at this pivotal time will ensure greater commercial success as we expand our presence in the U.S. market,” stated Eyal Shamir, Chief Executive Officer of IceCure. “We are expecting to experience growing commercial traction for ProSense® in the U.S. and Shay’s leadership will be key in strengthening our operational foundation.”
About ProSense®
The ProSense® Cryoablation System is the first and only medical device to receive FDA marketing authorization for the local treatment of early-stage, 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 our 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.
ForwardLooking 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 anticipated impact of Mr. Levav’s promotion to Chief Operating Officer on operational effectiveness and anticipated commercial traction, operational growth, and market expansion following FDA clearance of the ProSense® system. 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