IceCure Medical (Nasdaq:ICCM) announced today that the FDA granted marketing authorization for its ProSense cryoablation system for breast cancer.
The company picked up de novo approval for the local treatment of breast cancer in patients ≥70 years of age with biologically low-risk tumors ≤1.5 cm in size and treated with adjuvant endocrine therapy. It says this represents approximately 46,000 women annually in the U.S. Clearance includes patients not suitable for surgery for breast cancer treatment.
IceCure designed ProSense as a minimally invasive cryosurgical tool that provides the option to destroy tumors by freezing them. It harnesses the power of liquid nitrogen to create large lethal zones for maximum efficacy in tumor destruction. The system can help accelerate recovery, reduce pain, surgical risks and complications.
ProSense system already holds FDA clearance with indications including minimally invasive cryoablation in general surgery, dermatology and neurology, including cryoanalgesia. It also covers thoracic surgery, ENT, gynecology, oncology, proctology and urology. Now,
IceCure has long sought clearance for ProSense in the treatment of breast cancer. However, the FDA in 2022 denied IceCure’s de novo classification request for ProSense to treat patients with early-stage, low-risk breast cancer. In January 2024, the FDA agreed to reopen the de novo file. An affirmative response from the FDA provided IceCure with a potential pathway to clearance.
“ProSense offers the first new innovation in the treatment of women aged 70 and above with low-risk early-stage breast cancer in decades. We are proud to deliver a significant advancement and enhancement to women’s cancer care and quality of life. We expect that the FDA’s marketing authorization, the very enthusiastic response from physicians who have had clinical experience with ProSense, and the existing reimbursement code, will all combine to drive strong demand for our cryoablation procedure in breast cancer,” said IceCure CEO Eyal Shamir.
