IceCure Medical reports on FDA meeting for ProSense Cryoablation

IceCure Medical (ICCM) concluded a meeting with the leadership of the FDA Center for Devices and Radiological Health regarding the company’s De Novo marketing authorization request for ProSense in the treatment of early-stage low risk breast cancer when combined with adjuvant endocrine therapy for women aged 70 and over which represents approximately 46,000 patients annually in the U.S. During the meeting, the FDA requested that IceCure conduct a study after marketing authorization has been granted, with the aim of producing additional data in this indication. IceCure will present its post-market study plan to the FDA, and upon the CDRH’s approval of such plan, the FDA’s final marketing authorization decision is expected. IceCure plans to submit the post-market study in a few weeks. The company believes this post-market study will support accelerated market adoption of ProSense in early-stage breast cancer. Post-market study procedures will have access to reimbursement under the CPT III code, which covers $3,800 of facility costs. IceCure expects additional reimbursement coverage in the future pending the FDA’s marketing authorization and other factors.