On October 3, 2025, IceCure Medical Ltd. announced that the U.S. Food and Drug Administration (FDA) has granted marketing authorization for its ProSense® cryoablation system. This landmark approval is for the local treatment of early-stage low-risk breast cancer in women aged 70 and over, when combined with adjuvant endocrine therapy. This indication targets an estimated 46,000 women annually in the U.S., representing a significant new market opportunity.
ProSense® is now the first and only medical device to receive FDA marketing authorization for the local treatment of breast cancer. The authorized indication specifies patients aged ≥70 years with biologically low-risk tumors ≤1.5 cm in size, who are ER+, PR+, HER2-, Ki-67<15% and/or have genomic testing indicative of low-risk breast cancer, infiltrating ductal carcinoma, and clinically negative lymph nodes. It also includes patients not suitable for surgery.
In granting authorization, the FDA requested IceCure conduct a post-market surveillance study, expected to include approximately 400 patients at 30 sites, to gather additional data. The existing CPT III code covers $3,800 of facility costs for these study procedures. IceCure's CEO, Eyal Shamir, stated that this approval offers women a minimally invasive, outpatient procedure that minimizes recovery time and cosmetic changes, potentially setting a new standard of care.
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