IceCure Medical Receives FDA Response to De Novo Classification Request for Breast Cancer

About this update from Icecure Medical Ltd.

[{"type":"text","content":"CAESAREA, Israel, Sept. 20, 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 that the U.S. Food and Drug Administration (\"FDA\") has at this time denied the Company's De Novo Classification request for breast cancer which was submitted based on interim analysis from its ICE3 study. The FDA's position on 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 in the U.S. continue to have access to ProSense for those treatments. The Company is pursuing all avenues to address the FDA's response as global adoption of ProSense outside of the United States continues to build. IceCure 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 who are at high risk to surgery (not suitable for surgical alternatives). IceCure continues its ICE3 clinical study, the largest clinical trial of its kind, which is expected to complete during the first quarter of 2024.\n\n\"The positive expected five-year results based on the interim analysis of the ICE3 trial, which demonstrated a survival-based estimate for the 5-year ipsilateral breast tumor recurrence (IBTR) of 4.3%*, allowed us a rare and unique opportunity to submit a De Novo Classification request and make our minimally-invasive ProSense cryoablation procedure available to women sooner for this important and underserved indication,\" commented Eyal Shamir, Chief Executive Officer. \"We, along with our regulatory consultants, believe the FDA's response to the De Novo Classification request is largely due to the FDA's need for additional scientific literature as a comparator rate of recurrence in patients treated with lumpectomy. We are committed to working with the FDA to address its comments by using the broadly available published scientific literature on recurrence outcomes in patients treated with lumpectomy. ProSense remains available in the U.S. under prior FDA clearances and we will continue to execute our plan and progress towards achieving our primary ...

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