IceCure Reports 70% Growth in Active U.S. Commercial Install Base for Breast Cancer Cryoablation Following FDA Clearance

IceCure Medical Ltd. has reported a 70% increase in its active commercial install base of ProSense® for breast cancer cryoablation in the United States. This growth follows the U.S. Food and Drug Administration (FDA) marketing authorization received in October 2025, suggesting accelerating commercial adoption and a rise in physician demand for the technology.

The ProSense® system offers a minimally invasive alternative for treating low-risk breast cancer, utilizing cryoablation to destroy tumors by freezing. This option is particularly relevant for women aged 70 and above, as well as for patients not suitable for surgical intervention.

ProSense® procedures have gained traction in major metropolitan areas across the U.S., including Los Angeles, New York, Atlanta, Dallas, Detroit, Philadelphia, and Phoenix. IceCure has noted a significant increase in sales leads generated during key breast health conferences this year, such as the Society of Breast Imaging Annual Symposium and the American Society of Breast Surgeons Annual Meeting, compared to 2025, reflecting heightened interest from healthcare providers.

Eyal Shamir, CEO of IceCure, emphasized the importance of physician interest and clinical acceptance as indicators of a substantial commercial opportunity in cryoablation. He highlighted the company's commitment to expanding its installed base, providing training and education for physicians, and facilitating access to ProSense® for eligible patients.

In addition to FDA approval, IceCure credits growing clinical acceptance, evidenced by recent updates to professional guidelines recommending cryoablation, and increasing patient awareness bolstered by media coverage, including features on CBS and CW-affiliated stations across the country. This visibility is believed to enhance understanding of treatment options among both patients and physicians.