IceCure Medical Ltd. announced it has filed a 510(k) submission with the United States Food and Drug Administration ("FDA") for clearance of its next-generation single probe cryoablation system, the XSense? System and cryoprobes. The filing contains a request for clearance for all of the indications for which ProSense® has already received the requisite FDA clearance, including general minimally invasive cryoablation applications for the kidney, liver, fibroadenomas and neurology.

This new application for IceCure's next-generation single probe XSense? with cryoprobes is based on the current clearance of the ProSense® System, and is being processed separately from the Company's De Novo application for the breast cancer indication. The ProSense® Cryoablation System provides a minimally invasive treatment 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 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 that door to fast and convenient office-based procedure for breast tumors.