IceCure Announces Positive FDA Development: Understanding on Path Forward for Marketing Authorization of ProSense® Cryoablation in Women 70+ with Early-Stage Breast Cancer

Provided By PR Newswire

Last update: Apr 30, 2025

CAESAREA, Israel, April 30, 2025 /PRNewswire/ -- IceCure Medical Ltd. (NASDAQ: ICCM) ("IceCure", "IceCure Medical" or the "Company"), developer of minimally-invasive cryoablation technology that destroys tumors by freezing as an alternative to surgical tumor removal, today announced it concluded a productive meeting with the leadership of the U.S. Food and Drug Administration's ("FDA") Center for Devices and Radiological Health ("CDRH") regarding the Company's De Novo marketing authorization request for ProSense^® in the treatment of early-stage low risk breast cancer when combined with adjuvant endocrine therapy for women aged 70 and over which represents approximately 46,000 patients annually in the U.S.