The decision will not impact the device’s FDA clearance for other indications.
FDA denied a De Novo classification request by IceCure Medical for its ProSense System to be used with breast cancer. According to a press release from IceCure Medical, this decision does not impact the device’s previous FDA authorizations for other indications.
IceCure Medical’s CEO Eyal Shamir said that he believes the decision is based on FDA’s need for additional scientific literature.
The ProSense System is a minimally-invasive cryoablation technology that freezes and then destroys tumors.
In a press release, IceCure Medical’s CEO Eyal Shamir said, “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.”
Shamir continued, “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 objective of completing the 5-year follow ups with our last patients in the ICE3 study by the first quarter of 2024, while we simultaneously evaluate all strategies to efficiently and effectively address the FDA's comments."