IceCure Medical Seeks Israeli Regulatory Approval for Next-Gen XSense™ Cryoablation System

Application covering a wide range of indications is in line with trends in de-escalation of surgery and growth in minimally invasive cryoablation procedures, pointing

IceCure Medical Ltd. , developer of minimally-invasive cryoablation technology that destroys tumors by freezing as an alternative to surgical tumor removal, today announced it has filed for regulatory approval with the Medical Device Division ("AMAR") of Israel's Ministry of Health for its next-generation single cryoprobe cryoablation system, the XSense™ System and CryoProbes.

The filing contains a request for approval of 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. The Company has already received marketing authorization from the United States Food and Drug Administration (the "FDA") for the XSense™ System and its cryoprobes.

"As a leader in liquid-nitrogen based cryoablation technologies, we continue to innovate and bring to market healthcare advancements that support the global move toward de-escalation of surgery and the substantial increase in minimally invasive surgery procedures," stated IceCure's Chief Executive Officer, Eyal Shamir. "While de-escalation of surgery is a trend specific to the treatment of breast cancer, we see growing opportunities for our cryoablation systems to offer minimally invasive solutions in a wide range and expanding number of indications. We are optimistic about receiving regulatory clearance for XSense™ in Israel in the coming months."

The global minimally invasive surgery market is forecast to grow by a CAGR of 17% between 2022 and 2029 to reach $174 billion by 2029.