IceCure Medical Ltd. announced it has filed a request for supervisory review under 21 CFR 10.75 with the U.S. Food and Drug Administration regarding the agency's denial of the Company's De Novo Classification Request for treating patients with early-stage, low risk breast cancer. IceCure filed the De Novo request with the FDA in October 2022 based on interim data from its ICE3 breast cancer study for the Breakthrough Indication of early-stage (Luminal A T1 invasive) low-risk breast cancer patients. The interim ICE3 results, which estimate a five-year 95.7% recurrence free rate, and 100% doctor and patient satisfaction with cosmetic results, were submitted in the De Novo request in an effort to make the breakthrough minimally-invasive cryoablation procedure available to women in the U.S. sooner.

On September 20, 2023, IceCure announced that the FDA denied its De Novo request. The Company believes the FDA's response is largely due to the agency's choice of comparator group against which the ICE3 interim results were evaluated. During the appeal process, the Company is committed to working with the FDA to identify a comparator group that is more appropriate and representative of the patient population it is seeking to treat with its ProSense® system.

Per the FDA's guidelines, IceCure expects a response to its appeal by the end of January 2024. The ICE3 study is expected to be completed in the first quarter of 2024 following the last patient's five-year follow-up exam. Furthermore, the FDA's decision regarding the De Novo Classification request for breast cancer has no effect on ProSense®s FDA cleared authorization for other indications in the U.S., and patients continue to have access to and benefit from ProSense® for those indications.

Outside of the U.S., ProSense® is approved for early-stage breast cancer in numerous countries, including in the European Union, Brazil, and China. ProSense® cryoablation is a minimally invasive, non-surgical, outpatient 40-minute procedure that only requires a local 1% lidocaine injection (similar to its use by dentists when performing certain dental procedures) enabling the patient to remain alert during the procedure and then walk out of the doctor's office to resume their day.