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State: 17.08.2024 | 11PM
Fri, 08.11.2024       IceCure Medical
IL0011224156

FDA decision on marketing authorization expected in the first quarter of 2025

CAESAREA, Israel, Nov. 8, 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, announced the U.S. Food and Drug Administration's ("FDA") Medical Device Advisory Committee Panel's (the "Advisory Panel") favorable recommendation with 9 panelists voting in favor and 5 voting against the benefit-risk profile of IceCure's ProSense®. The majority of panelists voted that the benefits of IceCure's ProSense® System outweigh the risks when used according to the proposed indications for the treatment of patients with early-stage low risk invasive breast cancer with cryoablation and adjuvant endocrine therapy. Among those that voted "no", there were three who stated that if the FDA applied adequate special controls, this would have swayed their opinion in favor.

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