IceCure Medical Receives FDA Approval for ChoICE Trial Design

IceCure Medical announced that the FDA has approved the study design for the "ChoICE Trial Post-Market Study," the Company's post-marketing study for ProSense in the treatment of low-risk breast cancer. Patient enrollment is expected to commence in the second half of 2026, with at least 80 patients expected to be enrolled in the first year of the Study. The FDA previously granted marketing authorization in October 2025 for ProSense for the treatment of patients aged 70 years and older with biologically low-risk tumors less than or equal to1.5 cm in size who are treated with adjuvant endocrine therapy. In connection with its grant of marketing authorization, the FDA requested that IceCure conduct a post-market surveillance study to generate additional real-world data regarding the use of ProSense in this indication. The Study is expected to enroll and treat approximately 400 patients across 30 clinical sites in the U.S. within 36 months. IceCure has already received interest and engagement from leading medical institutions across the country seeking to participate in the Study. Under the approved study design, participating sites will treat enrolled patients while also serving as active commercial sites, providing cryoablation to patients outside of the study, thereby supporting the Company's commercial expansion. The Study will be conducted using cryoprobes sold exclusively by IceCure and facilities will be able to use an established CPT Category III reimbursement code. Study procedures are eligible for reimbursement under the established Centers for Medicaid and Medicare Services CPT Category III code, which provides approximately $4,000 for the facility fee alone.