FDA Panel Backs IceCure's ProSense for Early-Stage Breast Cancer
Key Insights
An FDA advisory panel has favorably recommended IceCure Medical's ProSense (search) cryoablation system for treating early-stage, low-risk breast cancer (search).
The panel voted 9-5 that the benefits of ProSense (search) outweigh the risks when used with adjuvant endocrine therapy, offering a potential alternative to lumpectomy.
The FDA's final decision on marketing authorization for ProSense (search) is expected in the first quarter of 2025.
An FDA Medical Device Advisory Committee has given a favorable recommendation to IceCure Medical's ProSense (search) cryoablation system for the treatment of early-stage, low-risk invasive breast cancer (search). The panel voted 9-5 in favor of the benefit-risk profile of ProSense when used with cryoablation and adjuvant endocrine therapy, marking a significant step toward potential FDA marketing authorization. The FDA's final decision is anticipated in the first quarter of 2025.
The positive vote was based on a comprehensive review of data, including results from IceCure's ICE3 study, which compared ProSense (search) to the current standard of care, lumpectomy. The panel also considered testimonies from patients, advocacy groups, doctors, nurses, and researchers.
Eyal Shamir, CEO of IceCure, stated, "This is a significant milestone on the path towards the marketing authorization of ProSense (search) cryoablation in the U.S. for early-stage low risk breast cancer (search) and I believe a critically important development for women seeking an alternative to lumpectomy." Shamir also noted that the company's U.S. sales and distribution team is prepared to support doctors and patients if marketing authorization is granted.
How ProSense Works
The ProSense (search) Cryoablation System offers a minimally invasive approach to tumor destruction by freezing. Utilizing liquid nitrogen, the system creates large lethal zones, maximizing its effectiveness in treating both benign and cancerous lesions in the breast, kidney, lung, and liver.
ProSense (search) aims to improve patient and provider experiences by accelerating recovery and reducing pain, surgical risks, and complications. Its design allows for convenient office-based procedures for breast tumors (search).
About IceCure Medical
IceCure Medical (Nasdaq: ICCM) develops and markets cryoablation therapy systems that use liquid nitrogen to freeze and destroy tumors (search). The company focuses primarily on breast, kidney, bone, and lung cancer treatments. ProSense (search), IceCure's flagship system, is currently marketed and sold worldwide for approved indications, including in the U.S., Europe, India, Brazil, and China.