The U.S. FDA has granted cryoablation technology developer IceCure Medical Ltd. Designation as a Breakthrough Device for its lead product, 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. IceCure looks forward to this accelerated collaborative dialogue with the FDA to expedite the commercialization of ProSense for the treatment of benign and malignant tumors, company officials say.

IceCure CEO Eyal Shamir says, “We are thrilled to receive the Breakthrough Device Designation from the FDA for our lead asset, ProSens, based on promising clinical outcomes in multiple clinical studies to date. ProSense has successfully demonstrated the potential to be an exceptionally safe and effective minimally invasive cryoablation approach to tumor destruction. We believe receipt of this designation is a testimony to the potential of ProSense to become the new gold standard for cryoablation tumor therapy.”

“As we continue to evaluate ProSense for the treatment of breast cancer tumors in our ICE3 clinical trial, we are grateful to the FDA’s Breakthrough Device Program. The FDA’s rapid approval process combined with its extensive feedback, leaves IceCure well-positioned for an expedited path toward breast cancer commercialization in the U.S. We are looking forward to continuing to work closely with the FDA to make ProSense available to the breast cancer patients that can benefit from our minimally-invasive cryoablation solution,” concludes Shamir.

As part of the Breakthrough Device Program, the Medicare Coverage of Innovative Technology 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.