IceCure Medical Soars on FDA Nod for Breast Cancer Device

Shares of IceCure Medical (NASDAQ: ICCM) surged over 14% after the company announced it had received marketing authorization from the U.S. Food and Drug Administration (FDA) for its breast cancer treatment device. The approval marks a significant commercial milestone, making the ProSense® system the first and only minimally invasive cryoablation technology authorized for treating early-stage, low-risk breast cancer.

The for use in women aged 70 and above with specific tumor characteristics who are also undergoing adjuvant endocrine therapy. This provides a much-needed alternative to traditional surgical lumpectomy for a patient population that may not be ideal candidates for surgery, addressing an estimated 46,000 women annually in the United States.

The system uses a small, ultrasound-guided probe to deliver liquid nitrogen into a tumor, creating an ice ball that destroys the cancerous tissue, which is then reabsorbed by the body. The approval was based on compelling data from the company's ICE3 clinical trial, the largest study of its kind for liquid-nitrogen-based cryoablation.

The , with a local recurrence rate of just 3.1% over five years, comparable to standard surgical outcomes but with positive cosmetic results and high patient satisfaction. The news was met with enthusiasm on Wall Street, with from bearish to extremely bullish following the announcement.

As a condition of the authorization, IceCure will conduct a post-market surveillance study across approximately 30 sites, which are also expected to become commercial treatment centers. The ProSense® procedure currently has access to reimbursement under a CPT III code, which covers facility costs and provides a clear pathway for commercial adoption. This regulatory green light positions IceCure to establish a new paradigm in breast cancer care, offering a less invasive option for a growing demographic.