FDA Clears 30-Site, 400-Patient Post-Marketing Study for IceCure ProSense
U.S. FDA approved IceCure's post-market ChoICE Trial design evaluating ProSense cryoablation for low-risk breast cancer, planning to enroll 80 patients in year one and 400 patients across 30 U.S. sites within 36 months. Participating centers can use CPT Category III code CAESAREA, providing about $4,000 facility fee per procedure.
1. FDA Approval and Study Design
In March 2026, the U.S. FDA approved IceCure’s post-market ChoICE Trial design to evaluate its ProSense cryoablation system as a minimally invasive local treatment for low-risk breast cancer in patients receiving adjuvant endocrine therapy.
2. Enrollment and Timeline
Patient enrollment is set to start in the second half of 2026, targeting at least 80 participants in the first year and approximately 400 patients across 30 U.S. clinical sites over a 36-month period.
3. Reimbursement and Commercial Strategy
The study will utilize cryoprobes sold exclusively by IceCure, and participating facilities can bill under CPT Category III code CAESAREA, which provides roughly $4,000 in facility fees per procedure, supporting broader commercial adoption.
4. Leadership and Site Engagement
IceCure has secured interest from leading medical institutions nationwide and named Dr. Robert Ward and Dr. Nathalie Johnson as Co-Principal Investigators, leveraging their expertise and American Society of Breast Surgeons guidelines to drive enrollment and advocacy.