IceCure Medical Ltd. announced that it has been granted designation as a breakthrough device from the U.S. Food and Drug Administration (FDA) for its lead asset, ProSense®, and proposed indication for use, including for use in the treatment of patients with T1 invasive breast cancer and/or patients not suitable for surgical alternatives for the treatment of breast cancer. ProSense® is a liquid-nitrogen-based cryoablation system that enables minimally-invasive, treatment of cancer tumors. The FDA breakthrough device program is intended to help patients receive more timely access to medical devices that have the potential to provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases or conditions. Under the program, the FDA will provide a priority review and feedback through development to commercialization. The company looks forward to this accelerated collaborative dialogue with the FDA to expedite the commercialization of ProSense® for the treatment of benign and malignant tumors. As part of the breakthrough device program, the Medicare Coverage of Innovative Technology (MCIT) program, which is pending approval by the Biden Administration, could provide national Medicare coverage for breakthrough-designated devices, such as the ProSense®, for a four-year duration starting on the day of the FDA marketing authorization. The company will still be required to apply for CPT1 codes under regular approval procedures in order to receive reimbursement after the four-year provisional coverage period.