IceCure Promotes Shay Levav to Chief Operating Officer as Company Ramps up for Increased Commercial Traction

Rhea-AI Summary

IceCure (NASDAQ: ICCM) promoted Shay Levav to Chief Operating Officer on Nov 10, 2025 as the company prepares to scale U.S. commercial efforts following FDA marketing clearance for ProSense® for low‑risk breast cancer in Oct 2025.

Levav will continue to lead Regulatory Affairs, Quality Assurance, and Clinical Affairs, roles he has held since 2020, and management says his experience through the ProSense® clinical and regulatory process will support operational execution as U.S. market traction increases.

Positive

• FDA marketing clearance for ProSense® for low‑risk breast cancer (Oct 2025)
• Shay Levav promoted to COO to support U.S. commercial expansion (Nov 10, 2025)
• Levav continues to lead Regulatory, Quality, Clinical functions he has overseen since 2020

Negative

• None.

Mr. Levav's appointment ensures seamless and focused organizational structure as Company expands commercial activities in the U.S. following FDA marketing clearance for ProSense®

CAESAREA, Israel, Nov. 10, 2025 /PRNewswire/ -- 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.

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 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

Photo: https://mma.prnewswire.com/media/2818296/Shay_Levav.jpg
Logo: https://mma.prnewswire.com/media/2319310/IceCure_Medical_Logo.jpg

 

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SOURCE IceCure Medical

FAQ

What did IceCure announce about management on Nov 10, 2025 for ICCM?

IceCure announced the promotion of Shay Levav to Chief Operating Officer on Nov 10, 2025.

How does Shay Levav's role change affect IceCure's U.S. plans for ICCM?

As COO, Levav will lead operations while continuing Regulatory, Quality, and Clinical functions to support anticipated U.S. commercial traction.

What regulatory milestone preceded the COO promotion for ICCM?

IceCure received FDA marketing clearance for ProSense® for low‑risk breast cancer in Oct 2025.

Since when has Shay Levav overseen Regulatory, Quality Assurance, and Clinical Affairs at ICCM?

Mr. Levav has overseen those functions since 2020.

Will the promotion of Levav change IceCure's clinical leadership at ICCM?

No; Levav will continue to lead Clinical Affairs while serving as COO.

What commercial impact does IceCure expect for ProSense® in the U.S. for ICCM?

The company expects growing commercial traction in the U.S. following the Oct 2025 FDA clearance.