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IceCure Medical Files Appeal with U.S. FDA Requesting a Review of its De Novo Classification for ProSense® in Early-Stage Breast Cancer
Objective is to reopen file to address comments and find appropriate comparator group that is more representative of the patient population the Company is
About this update from Icecure Medical Ltd.
[{"type":"text","content":"Objective is to reopen file to address comments and find appropriate comparator group that is more representative of the patient population the Company is seeking to treat with its ProSense® systemCompany seeks to complete the review process, establish special controls, and finalize classification of ProSense®CAESAREA, Israel, Nov. 15, 2023 /PRNewswire/ -- IceCure Medical Ltd. (Nasdaq: ICCM), developer of the ProSense® System, a minimally-invasive cryoablation technology that destroys tumors by freezing as an alternative to surgical tumor removal, today announced it has filed a request for supervisory review (\"appeal\") under 21 CFR 10.75 with the U.S. Food and Drug Administration (\"FDA\") regarding the agency's denial of the Company's De Novo Classification Request for treating patients with early-stage, low risk breast cancer.\n\nIceCure 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. The interim ICE3 results, which estimate a five-year 95.7% recurrence free rate, and 100% doctor and patient satisfaction with cosmetic results, were submitted in the De Novo request in an effort to make the breakthrough minimally-invasive cryoablation procedure available to women in the U.S. sooner.\nOn September 20, 2023, IceCure announced that the FDA denied its De Novo request. The Company believes the FDA's response is largely due to the agency's choice of comparator group against which the ICE3 interim results were evaluated. During the appeal process, the Company is committed to working with the FDA to identify a comparator group that is more appropriate and representative of the patient population it is seeking to treat with its ProSense® system. Per the FDA's guidelines, IceCure expects a response to its appeal by the end of January 2024.\nThe ICE3 study is expected to be completed in the first quarter of 2024 following the last patient's five-year follow-up exam. Furthermore, the FDA's decision regarding 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 continue to have access to and benefit from ProSense® for those indications. Outside of the U.S., ProSense® is appr...