IceCure Medical Reports Final ICE3 Breast Cancer Cryoablation Trial Results of 100% Patient and Physician Satisfaction and 96.3% Recurrence Free Rate: Data Submitted to FDA Requesting Marketing Authorization to Treat Early-Stage Breast Cancer
CAESAREA, Israel, April 15, 2024 /PRNewswire/ — IceCure Medical Ltd. (Nasdaq: ICCM) (“IceCure” or the “Company”), developer of the ProSense® System, a minimally-invasive cryoablation technology that destroys tumors by freezing as an alternative to surgical tumor removal, announced today that it has submitted final data to the U.S. Food and Drug Administration (“FDA”) requesting marketing authorization for ProSense® for the indication of treating patients with early stage T1 invasive breast cancer with cryoablation and adjuvant hormone therapy. ProSense®, which received the FDA’s Breakthrough Designation, is already cleared for use in the U.S. for several other indications, including treating benign tumors of the breast, and tumors in the kidney and liver.