
Core Viewpoint - IceCure Medical Ltd. is gaining significant interest in its ProSense® cryoablation technology for breast cancer treatment, particularly following positive FDA developments and its participation in the ASBrS 2025 Annual Meeting [2][5][9]. Company Participation and Technology - IceCure showcased its ProSense® cryoablation system at the ASBrS 2025 Annual Meeting, receiving a high level of interest from breast surgeons regarding participation in a planned post-market study [2][10]. - The ProSense® system utilizes liquid nitrogen to create large lethal zones for effective tumor destruction, offering a minimally invasive alternative to traditional surgical methods [6][11]. FDA Interaction and Study Plans - The company concluded a meeting with the FDA regarding its De Novo marketing authorization request for ProSense® in treating early-stage low-risk breast cancer, specifically for women aged 70 and over [5]. - The FDA has requested IceCure to conduct a post-market study involving at least 400 patients across 25 sites after marketing authorization is granted [5]. Industry Recognition - Cryoablation was positively highlighted during the ASBrS Presidential Address, emphasizing the need for breast surgeons to be skilled in various therapeutic procedures, including minimally invasive techniques like cryoablation [3][9]. - The ICE3 study, which supports the use of cryoablation, was recognized in the Best Papers of 2024 review, further validating the technology's relevance in the field [4][9].