IceCure Submits Filing for Regulatory Approval of its Next-Generation XSense™ Cryoablation System in Israel

Core Viewpoint - IceCure Medical is advancing its minimally-invasive cryoablation technology with the filing for regulatory approval of its next-generation XSense™ System in Israel, aligning with the trend towards de-escalation of surgery and the growth of minimally invasive procedures [1][3]. Company Overview - IceCure Medical specializes in liquid-nitrogen-based cryoablation therapy systems aimed at destroying both benign and malignant tumors through freezing, focusing on breast, kidney, bone, and lung cancers [4]. - The ProSense® system is already marketed globally for various approved indications, including in the U.S., Europe, and China [4]. Regulatory Developments - The regulatory filing includes requests for approval across multiple indications already cleared for the ProSense® system in Israel, covering areas such as general surgery, dermatology, neurology, thoracic surgery, ENT, gynecology, oncology, proctology, and urology [2]. - The company has previously received marketing authorization from the FDA for the XSense™ System and its cryoprobes [2]. Market Trends - The global minimally invasive surgery market is projected to grow at a compound annual growth rate (CAGR) of 17% from 2022 to 2029, reaching $174 billion by 2029, indicating strong potential for increasing demand for IceCure's technologies [3].