IceCure Medical Ltd. announced that the U.S. Food and Drug Administration ("FDA") has at this time denied the Company's De Novo Classification request for breast cancer which was submitted based on interim analysis from its ICE3 study. The FDA's position on 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 in the U.S. continue to have access to ProSense for those treatments. The Company is pursuing all avenues to address the FDA's response as global adoption of ProSense outside of the United States continues to build.

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 who are at high risk to surgery (not suitable for surgical alternatives). IceCure continues its ICE3 clinical study, the largest clinical trial of its kind, which is expected to complete during the first quarter of 2024. The Company, along with regulatory consultants, believe the FDA's response to the De Novo Classification request is largely due to the FDA's need for additional scientific literature as a comparator rate of recurrence in patients treated with lumpectomy.

The company are committed to working with the FDA to address its comments by using the broadly available published scientific literature on recurrence outcomes in patients treated with lum expectomy. ProSense remains available in the U.S. under prior FDA clearances and will continue to execute plan and progress towards achieving primary objective of completing the 5-year follow ups with last patients in the ICE3 study by the first quarter of 2024, while simultaneously evaluate all strategies to efficiently and effectively address the FDA's comments. The Company's ProSense system was given a Breakthrough Device Designation by the FDA in March 2021, and previously received clearance in the U.S. for general minimally invasive cryoablation applications, including kidney, liver and benign breast tumors.

ICE3 is the largest controlled multi-location clinical trial ever performed for liquid nitrogen (LN2)-based cryoablation of small, low-risk, early-stage malignant breast tumors without subsequently removing them. For example, IceCure is using forward looking statement when it discusses: the expected plan and progress towards completion of the ICE3 clinical study.