Core Viewpoint - IceCure Medical is progressing towards obtaining FDA marketing authorization for its ProSense® system, aimed at treating early-stage low-risk breast cancer in women aged 70 and over, which represents approximately 46,000 patients annually in the U.S. [1][4] Group 1: FDA Interaction and Study Plans - IceCure Medical had a productive meeting with the FDA's CDRH regarding its De Novo marketing authorization request for ProSense® [1] - The FDA requested IceCure to conduct a post-market study after marketing authorization, which will include a minimum of 400 patients at 25 sites [2] - The company is preparing to submit its post-market study plan in the coming weeks and is actively recruiting clinical sites and doctors [3] Group 2: Product and Market Implications - ProSense® is a minimally invasive cryoablation system that uses liquid nitrogen to destroy tumors, offering a less invasive alternative to surgical tumor removal [5][8] - The system is designed to enhance patient recovery, reduce pain, and minimize surgical risks, making it suitable for office-based procedures [6] - The post-market study procedures will have access to reimbursement under the CPT III code, covering $3,800 of facility costs, with expectations for additional reimbursement coverage in the future [4] Group 3: Company Readiness and Market Strategy - IceCure's U.S. sales team is prepared for the commercialization of ProSense® following FDA approval [4][7] - The company aims to engage with leading breast surgeons and radiologists to finalize the post-market study, leveraging events like the ASBrS Annual Meeting for outreach [3][4] - ProSense® is positioned to become a first-in-class minimally invasive option for early-stage breast cancer treatment, representing a significant advancement in women's health [7]