Following the FDA’s marketing authorization in October 2025, IceCure Medical aims to enroll up to 400 patients across 30 domestic locations. The study evaluates the effectiveness of cryoablation combined with endocrine therapy, offering a minimally invasive alternative to traditional surgical tumor removal. Dr. Richard Gilmore, a breast surgical oncologist at the Margaret West Comprehensive Breast Center, will lead the clinical efforts at the Tennessee facility.

Eyal Shamir, CEO of IceCure Medical, noted that the inclusion of the West Cancer Center serves to build momentum for the broader adoption of ProSense. Under the study framework, participating centers will function as both research sites and active commercial hubs. This dual-purpose model allows physicians to offer the cryoablation procedure to eligible patients who do not meet specific study participation criteria, thereby increasing overall access to the technology. The company expects the resulting data to bolster its position in the market as it continues to expand its footprint in breast, kidney, bone, and lung cancer treatments.