IceCure Medical Ltd. (Nasdaq: ICCM) (“IceCure”, “IceCure Medical” or the “Company”), developer of minimally-invasive cryoablation technology that destroys tumors by freezing as an alternative to surgical tumor removal, announced the U.S. Food and Drug Administration’s (“FDA”) Medical Device Advisory Committee Panel’s (the “Advisory Panel”) favorable recommendation with 9 panelists voting in favor and 5 voting against the benefit-risk profile of IceCure’s ProSense. The majority of panelists voted that the benefits of IceCure’s ProSense System outweigh the risks when used according to the proposed indications for the treatment of patients with early-stage low risk invasive breast cancer with cryoablation and adjuvant endocrine therapy. Among those that voted “no”, there were three who stated that if the FDA applied adequate special controls, this would have swayed their opinion in favor.
“This is a significant milestone on the path towards the marketing authorization of ProSense cryoablation in the U.S. for early-stage low risk breast cancer and I believe a critically important development for women seeking an alternative to lumpectomy,” stated IceCure’s Chief Executive Officer, Eyal Shamir. “We expect the FDA’s decision, based on the Advisory Panel’s recommendation, in the first quarter of 2025. Our U.S. sales and distribution team is ready to support doctors and patients in the event of a successful marketing authorization for ProSense in breast cancer.”
The Advisory Panel’s favorable vote was based on the comprehensive body of data available on ProSense as a treatment for early-stage low risk breast cancer, including results from the Company’s ICE3 study compared with data from the current standard of care, lumpectomy, as well as testimonies and input from a broad range of key stakeholders, including women with breast cancer and their family members, patient advocacy groups, doctors, nurses and researchers.
The purpose of the Advisory Panel was for the FDA to obtain independent non-binding expert advice on scientific, technical and policy matters related to the potential granting of marketing authorization of ProSense for treating patients with early-stage low risk invasive breast cancer with cryoablation and adjuvant endocrine therapy. The Advisory Panel included breast surgeons, interventional radiologists, breast oncologists, and representatives from the patient, consumer, and regulatory communities.
