On April 30, 2025, IceCure Medical Ltd. announced a productive meeting with the leadership of the U.S. Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH). The meeting focused on the company's De Novo marketing authorization request for ProSense® in the treatment of early-stage low-risk breast cancer for women aged 70 and over, a market segment representing approximately 46,000 patients annually in the U.S.
During the discussion, the FDA requested that IceCure conduct a post-market study after marketing authorization has been granted, with the aim of producing additional data for this indication. IceCure plans to submit its post-market study plan, which is expected to include a minimum of 400 patients across 25 sites, within a few weeks. The FDA's final marketing authorization decision is anticipated following the CDRH's approval of this plan.
IceCure's CEO, Eyal Shamir, described this as a very positive development, expressing pleasure at the clear path forward for women aged 70 and over to access a minimally invasive option for 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, supporting accelerated market adoption upon clearance. The company's U.S. sales team is preparing for commercialization.
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