Full Press Release Details
IceCure Receives Regulatory Approval in Israel
for its Next-Generation
XSense Cryoablation System for Breast Cancer and Other Indications
Approved for a broad range of indications
including in gynecology, oncology and general surgery
CAESAREA, Israel, September 15, 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 it has received regulatory
approval from the Medical Device Division of Israel's Ministry of Health ("AMAR") for its next-generation single cryoprobe cryoablation
system, the XSense System and CryoProbes.
As of mid-2024, XSense and its cryoprobes have also received
regulatory clearance in the United States from the U.S. Food and Drug Administration ("FDA") for all of the indications for
which ProSense , the Company's flagship cryoablation system, has already received from the FDA.
"We believe that this latest regulatory approval for our next-generation
cryoablation system reaffirms IceCure's leadership position in liquid-nitrogen based cryoablation," stated IceCure's
Chief Executive Officer, Eyal Shamir. "The minimally invasive cryoablation option that we offer across a broad range of indications
can de-escalate cancer care, reduce treatment costs for payers, and accelerate recovery time for patients."
"We are particularly pleased with the breast cancer indication
approval in Israel, as we believe the growing body of evidence on cryoablation as a minimally invasive option for breast cancer supports
accelerated commercial adoption," Shamir added.
XSense is now approved in Israel for all indications for which
ProSense has already received approval in Israel, including general surgery, dermatology, neurology, including cryoanalgesia, thoracic
surgery, ENT (ear, nose, throat), gynecology, oncology (including benign and malignant breast tumors), proctology and urology.
About IceCure's Cryoablation Systems
IceCure's platform technology, including the ProSense Cryoablation
System and XSense Cryoablation System and CryoProbes, provides a minimally invasive treatment option to destroy tumors by freezing
them. The systems uniquely harness the power of liquid nitrogen to create large lethal zones for maximum efficacy in tumor destruction
in benign and cancerous lesions, including breast, kidney, lung, and liver.
IceCure's cryoablation systems enhance patient and provider value by
accelerating recovery, reducing pain, surgical risks and complications. With easy, transportable design and liquid nitrogen utilization,
ProSense and XSense open the door to fast and convenient office-based procedure 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 alternative
to hospital 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.
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 belief that the AMAR approval reaffirms IceCure's leadership position in liquid-nitrogen
based cryoablation; the potential advantage of XSense; and the belief that the growing body of evidence on cryoablation as a minimally
invasive option for breast cancer supports accelerated commercial adoption. 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.