IceCure said the FDA approved the design of its post-marketing ChoICE study evaluating ProSense cryoablation for local treatment of low-risk breast cancer. The study is expected to start enrolling patients in the second half of 2026, with at least 80 patients planned for the first year. IceCure expects to enroll about 400 patients across 30 U.S. clinical sites within 36 months. The company said the FDA’s October 2025 marketing authorization covered patients aged 70 and older with tumors up to 1.5 cm who receive adjuvant endocrine therapy. No study results were reported, and the company did not specify when results will be presented.

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