FDA Approves IceCure Medical's ProSense for Breast Cancer Treatment

IceCure Medical, an Israeli medical technology company, has received FDA approval for its tumor-freezing treatment ProSense, marking a significant milestone in breast cancer therapy. The approval makes ProSense the first medical device of its kind to be endorsed for the local treatment of breast cancer, offering a minimally invasive alternative to traditional surgical interventions.

Breakthrough in Cryoablation Technology

ProSense utilizes cryoablation technology to destroy tumors by freezing them without the need for surgical removal of breast tissue. This outpatient procedure aims to provide excellent cosmetic results with minimal scarring, addressing both medical and aesthetic concerns for patients.

The FDA license specifically allows the use of ProSense for local treatment of early-stage, low-risk breast cancer in combination with adjuvant endocrine therapy for women 70 years and older. IceCure estimates this approval could benefit approximately 46,000 women annually in the United States.

Market Impact and Future Studies

Following the announcement of FDA approval on October 3, 2025, IceCure Medical's shares experienced a significant boost, jumping more than 17% in afterhours trading. While the stock price moderated by the following Monday, it still maintained an 8% increase from the previous Friday's close.

As part of the approval process, the FDA has mandated a postmarket surveillance study to generate additional data on the treatment's efficacy in the approved indication. This requirement underscores the ongoing commitment to patient safety and treatment effectiveness in the rapidly evolving field of cancer therapy.

Competitive Landscape and Industry Perspective

While ProSense is the first of its kind for this specific breast cancer indication, the cryoablation market includes several other players. Competing systems include the ISOLIS Cryoprobe system from Varian Medical Systems (used in conjunction with Siemens Healthineers' myNeedle laser navigation system), Varian's V-Probe, and Boston Scientific's ICEfx system.

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." Shamir emphasized the treatment's potential to allow women with low-risk, early-stage breast cancer to "freeze their cancer, not their lives," highlighting the procedure's effectiveness and minimal impact on patients' daily activities.

This FDA approval represents a significant advancement in breast cancer treatment options, potentially reshaping approaches to early-stage cancer management and improving quality of life for eligible patients.