Postmarketing Study Approved for IceCure’s ProSense Cryoablation in Low-Risk Breast Cancer Treatment

March 11, 2026—IceCure Medical Ltd. announced that the FDA has approved the study design for the ChoICE trial, the company’s postmarketing study of its ProSense cryoablation in the treatment of low-risk breast cancer.

The company advised patient enrollment is expected to commence in the second half of 2026 with at least 80 patients enrolled in the first year. A total of approximately 400 patients will be enrolled across 30 clinical sites in the United States within 36 months.

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. 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, stated IceCure.

Robert C. Ward, MD, and Nathalie McDowell Johnson, MD, will serve as Coprincipal Investigators of the CHoICE postmarket study.

In October 2025, the company announced that FDA granted marketing authorization for ProSense for the treatment of patients aged ≥ 70 years with biologically low-risk tumors ≤ 1.5 cm in size who are treated with adjuvant endocrine therapy.

In connection with this authorization, the FDA requested that IceCure conduct a postmarket surveillance study to generate additional real-world data regarding the use of ProSense in this indication, noted the company.

The company advised that 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.

IceCure further stated that it believes the existing reimbursement framework may support reimbursement claims for study procedures, and that additional reimbursement pathways may develop over time, particularly in light of the recent FDA marketing authorization and inclusion of cryoablation for breast cancer in the updated American Society of Breast Surgeons resource guide.