IceCure Medical receives FDA marketing authorizationf or ProSense cryoablation

IceCure Medical (ICCM) announced that the U.S. Food and Drug Administration has granted marketing authorization to IceCure’s De Novo application for the ProSense cryoablation system for the local treatment of breast cancer in patients greater than or equal to70 years of age with biologically low-risk tumors less than or equal to1.5 cm in size and treated with adjuvant endocrine therapy, representing approximately 46,000 women annually in the U.S. The authorized indication includes patients that are not suitable for surgery for breast cancer treatment. In granting marketing authorization, the FDA requested that IceCure conduct a post-market surveillance study with the aim of producing additional data in this indication. The post-market study is expected to include approximately 400 patients at 30 sites, and the established reimbursement code may be used to support claims and reimbursement for the study procedures. These sites, while treating study participants, will also be active commercial sites where any appropriate patient seeking treatment with ProSense cryoablation may be treated. The FDA’s marketing authorization was based on data including IceCure’s ICE3 trial, the largest multi-center clinical trial ever completed for liquid-nitrogen based cryoablation for patients with low-risk, early-stage breast cancer without surgically removing the breast tumor.