IceCure Medical Ltd. announced the U.S. Food and Drug Administration ("FDA") will convene a Medical Device Advisory Committee for a panel meeting (the "Advisory Panel") to obtain independent expert advice on scientific, technical, and policy matters related to ProSense® to help the FDA make a sound decision. The Advisory Panel is expected to convene in the fourth quarter of 2024, with an FDA decision on whether to approve ProSense® expected by early 2025. The FDA is expected to provide the exact date for the Advisory Panel in the coming weeks, which the Company will also make known to its shareholders.

The FDA generally makes Advisory Panel meeting materials and the live webcast link available to the public no later than two business days before any meeting. The Advisory Panel will review the vast body of data available on ProSense® as a treatment for early-stage breast cancer, including results from the ICE3 study, the largest controlled multicenter clinical trial ever performed for liquid nitrogen-based cryoablation of early-stage malignant breast tumors. Per the analysis, at the 5-year follow-up evaluation, 96.3% of the subgroup of patients treated with ProSense® cryoablation, followed by hormone therapy, were estimated to be free from local recurrence.

100% patient and physician satisfaction was reported. As part of its De Novo Classification Request for Marketing Authorization, IceCure submitted data, including its final ICE3 study results, to the FDA, as part of its request for clearance for ProSense® for the indication of treating patients with early stage T1 invasive breast cancer with cryoablation and adjuvant hormone therapy.