IceCure Medical Ltd. (Nasdaq: ICCM) announced that the FDA's Medical Device Advisory Committee Panel is scheduled to meet on November 7, 2024, to review the De Novo Classification Request for ProSense cryoablation. The panel will provide independent expert advice on the scientific, technical, and policy considerations for marketing authorization of ProSense in treating early-stage, low-risk invasive breast cancer with cryoablation followed by adjuvant endocrine therapy.
The advisory panel will include breast surgeons, interventional radiologists, and regulatory community representatives. They will review extensive data on ProSense, including results from the ICE3 study, the largest controlled multicenter clinical trial for liquid nitrogen-based cryoablation of early-stage malignant breast tumors.
Clinical Evidence from ICE3 Study
The ICE3 study demonstrated promising results, with a 5-year follow-up evaluation showing that 96.3% of patients treated with ProSense cryoablation and adjuvant endocrine therapy were estimated to be free from local recurrence. Additionally, the study reported 100% patient and physician satisfaction.
ProSense Cryoablation System
ProSense is a minimally invasive treatment option that destroys tumors by freezing them using liquid nitrogen. It is designed to create large lethal zones for effective tumor destruction in both benign and cancerous lesions, including those in the breast, kidney, lung, and liver.
Potential Benefits
According to IceCure, ProSense offers enhanced patient and provider value by accelerating recovery and reducing pain, surgical risks, and complications. Its design and liquid nitrogen utilization facilitate fast and convenient office-based procedures for breast tumors.
Market Opportunity
If authorized, ProSense could provide an alternative to lumpectomy for an estimated 70,000 women diagnosed annually in the U.S. with early-stage, low-risk breast cancer.
Regulatory Timeline
Following the Advisory Panel meeting, the FDA is expected to make a decision regarding marketing clearance of ProSense by early 2025. The FDA typically makes Advisory Panel meeting materials and the live webcast link available to the public no later than two business days before the meeting.
