
Core Insights - IceCure Medical Ltd. announced updated data on breast cancer cryoablation from an independent study involving over 600 women conducted from 2006 to 2023, highlighting the effectiveness of the ProSense® system [1][5] - The ProSense® system achieved a 0% local recurrence rate in a study led by Professor Hisanori Kawamoto, which won the Best of Breast Cancer Award [1][3] - IceCure's CEO, Eyal Shamir, emphasized the potential of ProSense® to improve breast cancer outcomes in Japan, anticipating strong commercial adoption following regulatory approval [2][4] Company Overview - IceCure Medical develops minimally invasive cryoablation technology that destroys tumors by freezing, offering an alternative to surgical tumor removal [1][8] - The ProSense® Cryoablation System utilizes liquid nitrogen to create large lethal zones for effective tumor destruction in various types of lesions, including breast cancer [6][8] - The system is designed to enhance patient and provider value by accelerating recovery, reducing pain, and minimizing surgical risks [7][8] Clinical Data - Professor Eisuke Fukuma presented data showing an overall ipsilateral breast tumor recurrence rate of 0.98% over up to 17 years, resulting in a 99.02% recurrence-free rate for patients treated with ProSense® [5] - For a subgroup with over 10 years of follow-up, the recurrence rate was 2.8%, leading to a 97.2% recurrence-free rate [5] - The independent study led by Professor Kawamoto reported zero local recurrence five years post-treatment with ProSense® [3][4] Regulatory and Market Potential - Terumo Corporation plans to submit an application to Japan's Pharmaceuticals and Medical Devices Agency for regulatory clearance of the ProSense® system for breast cancer by the end of 2025 [4] - The collaboration with Terumo, Japan's largest medical device company, is expected to facilitate strong market adoption upon regulatory approval [2][4]