FDA Grants Marketing Authorization To IceCure's De Novo Application For ProSense Cryoablation System For Local Treatment Of Breast Cancer

Author: Benzinga Newsdesk | October 03, 2025 11:22am

• ProSense® is the first and only medical device to be granted FDA marketing authorization for the local treatment of breast cancer
• Major advancement and new paradigm in breast cancer care as a simple, minimally invasive out-patient procedure
• Initial reimbursement under the CPT III code which covers $3,800 of facility costs, with additional reimbursement coverage expected
• U.S. sales and distribution team ready to drive sales of ProSense® systems and disposable probes—supporting medical community and patients looking for a new minimally invasive option to lumpectomy 
• Enthusiastic response from top U.S. breast surgeons and radiologists
• Conference call to be held Monday, October 6 at 8:30AM Eastern Time

CAESAREA, Israel, Oct. 3, 2025 /PRNewswire/ -- IceCure Medical Ltd. (NASDAQ:ICCM) ("IceCure", "IceCure Medical" or the "Company"), developer of minimally-invasive cryoablation technology that destroys tumors by freezing as an option to surgical tumor removal, today announced that the U.S. Food and Drug Administration ("FDA") has granted marketing authorization to IceCure's De Novo application for the ProSense® cryoablation system 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, representing approximately 46,000 women annually in the U.S. The authorized indication includes patients that are not suitable for surgery for breast cancer treatment.  

Posted In: ICCM