IceCure Announces FDA Advisory Panel Meeting Date For Marketing Authorization Of ProSense In Early-Stage Low Risk Breast Cancer Scheduled For November 7, 2024

Author: Benzinga Newsdesk | September 12, 2024 08:09am

• Public forum to evaluate ProSense® cryoablation as a minimally invasive alternative to lumpectomy for an estimated 70,000 women diagnosed in U.S. annually with early-stage low risk breast cancer
• FDA decision regarding marketing authorization of ProSense® expected by early 2025

CAESAREA, Israel, Sept. 12, 2024 /PRNewswire/ -- IceCure Medical Ltd. (NASDAQ:ICCM) ("IceCure", "IceCure Medical" or the "Company"), developer of minimally-invasive cryoablation technology that destroys tumors by freezing as an alternative to surgical tumor removal, today announced the U.S. Food and Drug Administration's ("FDA") Medical Device Advisory Committee Panel (the "Advisory Panel") is scheduled to take place on Thursday, November 7, 2024. The purpose of the Advisory Panel is for the FDA to obtain independent expert advice on scientific, technical and policy matters related to the De Novo Classification Request for marketing authorization of ProSense® for the indication of treating patients with early-stage low risk invasive breast cancer with cryoablation and adjuvant endocrine therapy.

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