IceCure Reports Updated Timeline and Progress with FDA Regarding Marketing Authorization for ProSense® Cryoablation in Early-Stage Breast Cancer

IceCure working in close collaboration with FDA towards De Novo decision

CAESAREA, Israel, March 20, 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 is in continued discussions with the U.S. Food and Drug Administration ("FDA") regarding its De Novo marketing authorization request for ProSense® in early-stage low risk breast cancer with endocrine therapy. The Company now expects the FDA's marketing authorization decision to be reached after the first quarter of 2025.

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