IceCure Medical Requests Marketing Authorization to Treat Early-Stage Breast Cancer from FDA

April 15, 2024

DENVER, Colo., Apr 15, 2024 (247marketnews.com)- IceCure Medical Ltd. (NASDAQ:ICCM) stated that it submitted final data to the U.S. Food and Drug Administration (“FDA”) requesting marketing authorization for ProSense, which received the FDA’s Breakthrough Designation and is already cleared for use in the U.S. for several other indications, for the indication of treating patients with early stage T1 invasive breast cancer with cryoablation and adjuvant hormone therapy.

Eyal Shamir, IceCure CEO, stated, “We believe ICE3 is a ground-breaking study and are excited to report that the efficacy data of our minimally invasive ProSense® cryoablation procedure show similar outcomes in recurrence compared to more invasive breast surgery, the current standard of care for early-stage breast cancer.

“I, along with our marketing and clinical team, were at the ASBrS Annual Meeting where we witnessed an overwhelmingly positive response from breast surgeons who voted on Dr. Fine’s presentation to win the Scientific Impact Award, demonstrating how impactful our cryoablation technology is expected to be for women with early-stage breast cancer. Further demonstrating its potential, ASBrS’s President-Elect Dr. Berry deemed cryoablation is ready for prime time.

“Initial reimbursement codes are already in place and our U.S. marketing and commercial team is ready, as we await the FDA’s response. Driven by favorable healthcare economics combined with patient satisfaction and demand, we expect rapid adoption pending FDA granting the DeNovo Classification Request for Marketing Approval.”

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