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State: 17.08.2024 | 11PM
Tue, 29.10.2024       IceCure Medical
IL0011224156

Comments from key stakeholders, including doctors, nurses, researchers, and breast cancer patients, are available on FDA websiteFDA Advisory Panel providing recommendations and vote on information concerning the benefit-risk profile for a De Novo marketing submission of the IceCure ProSense® Cryoablation System in early-stage low risk breast cancer scheduled for November 7, 2024

CAESAREA, Israel, Oct. 29, 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 that a large number of public comments have been posted from key stakeholders ahead of the U.S. Food and Drug Administration (the 'FDA') Medical Device Advisory Committee Panel (the 'Advisory Panel') for marketing authorization of ProSense® cryoablation in early-stage low risk breast cancer, which 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 potential granting of marketing authorization of ProSense® for treating patients with early-stage low risk invasive breast cancer with cryoablation and adjuvant endocrine therapy. The Advisory Panel will include breast surgeons, interventional radiologists, industry representatives from the regulatory community, and other experts.

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