FDA Approves Groundbreaking Cryoablation Treatment for Early-Stage Breast Cancer

The U.S. Food and Drug Administration (FDA) has granted approval to IceCure Medical's ProSense, a novel cryoablation system for the treatment of early-stage breast cancer. This landmark decision marks the first time a medical device of this kind has been authorized for local treatment of breast cancer in the United States.

Revolutionary Tumor-Freezing Technology

ProSense, developed by Israeli medical technology company IceCure Medical, offers a minimally invasive approach to treating early-stage, low-risk breast cancer. The outpatient procedure destroys tumors by freezing them, eliminating the need for surgical removal of breast tissue. This innovative method promises excellent cosmetic results with minimal scarring, potentially transforming the landscape of breast cancer treatment.

The FDA approval specifically allows ProSense to be used in combination with adjuvant endocrine therapy for local treatment of early-stage, low-risk breast cancer in women aged 70 and older. IceCure estimates this patient population to be approximately 46,000 women annually in the U.S.

Market Impact and Company Performance

Following the FDA announcement on October 3, 2025, IceCure Medical's stock experienced a significant boost, jumping more than 17% in after-hours trading. While the shares retreated slightly by the following Monday morning, they still maintained an 8% increase from the previous Friday's close.

Eyal Shamir, CEO of IceCure, expressed enthusiasm about the approval, stating, "We are excited to add a minimally invasive choice around breast cancer treatments and to offer patients an effective, outpatient procedure." He emphasized the treatment's potential to allow women to "freeze their cancer, not their lives," highlighting the minimal recovery time and cosmetic changes associated with the procedure.

Regulatory Requirements and Market Landscape

As part of the FDA's approval, IceCure is required to conduct a postmarket surveillance study to generate additional data for this indication. This ongoing research will likely provide further insights into the long-term efficacy and safety of the ProSense system.

While ProSense is the first cryoablation treatment approved specifically for breast cancer, it enters a market where similar technologies exist for other indications. Competitors in the cryoablation space include Varian Medical Systems with their ISOLIS Cryoprobe system and V-Probe, as well as Boston Scientific's ICEfx system. The unique positioning of ProSense in the breast cancer treatment market may give IceCure a significant advantage in this growing field of medical technology.