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Icecure Medical Submits an Appeal to the U.s. Fda, Seeking a Review of the De Novo Classification for Prosense® in Early-stage Breast Cancer

Thursday, November 16, 2023

IceCure Medical has disclosed that it filed an appeal under 21 CFR 10.75 with the U.S. Food and Drug Administration (FDA) following the agency's rejection of the company's De Novo Classification Request. This request pertains to the use of its ProSense® System, a minimally-invasive cryoablation technology designed to freeze and destroy tumors, as an alternative to surgical tumor removal. The FDA denied the De Novo request for treating patients with early-stage, low-risk breast cancer, a submission made by IceCure in October 2022 based on interim data from its ICE3 breast cancer study.

The interim results from ICE3, indicating a five-year 95.7% recurrence-free rate and 100% satisfaction with cosmetic results among doctors and patients, were submitted in the De Novo request to expedite the availability of the breakthrough cryoablation procedure for women in the U.S. The FDA's denial, according to IceCure, is largely attributed to the agency's selection of a comparator group for evaluating the ICE3 interim results.

During the appeal process, IceCure is committed to collaborating with the FDA to identify a comparator group that is more suitable and representative of the patient population targeted for treatment with the ProSense® system. Importantly, IceCure clarified that the FDA's decision regarding the De Novo Classification request for breast cancer does not impact the FDA-cleared authorization for ProSense® in the U.S. for other indications. Patients can still access and benefit from the ProSense® system for these approved indications. This development underscores the challenges in navigating the regulatory landscape for innovative medical technologies, and IceCure remains dedicated to working with the FDA to address concerns and bring its cryoablation procedure to women in the U.S.