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IceCure Reports Updated Timeline and Progress with FDA Regarding Marketing Authorization for ProSense® Cryoablation in Early-Stage Breast Cancer
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 authoriza
About this update from Icecure Medical Ltd.
[{"type":"text","content":"IceCure working in close collaboration with FDA towards De Novo decision","length":72,"tagName":"p","attribs":{}},{"type":"text","content":"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.","length":653,"tagName":"p"},{"type":"image","alt":"IceCure Medical Logo","displaySize":"","headline":null,"caption":"IceCure Medical Logo","className":"","disableSlideshowImg":false,"size":{"original":{"width":400,"height":200,"url":"https://media.zenfs.com/en/prnewswire.com/b7eb1c2182e71b18810d670876604029"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/sbF1Y_Xm.7puZp47u3Oh6g--/YXBwaWQ9aGlnaGxhbmRlcjt3PTcwNTtoPTM1MztjZj13ZWJw/https://media.zenfs.com/en/prnewswire.com/b7eb1c2182e71b18810d670876604029","width":400,"height":200}}},{"type":"text","content":""Given the novelty of our product and the importance of breast cancer in public health, the FDA has included many stakeholders in the discussion of the De Novo marketing clearance for ProSense® for the treatment of early-stage, low-risk breast cancer with endocrine therapy" stated IceCure's Chief Executive Officer, Eyal Shamir.","length":343,"tagName":"p"},{"type":"text","content":""We appreciate the attention of many at the FDA despite the evolving situation at the agency as we work productively together towards a decision on marketing authorization," Shamir added.","length":197,"tagName":"p"},{"type":"text","content":"Due to the public health importance of breast cancer, the FDA convened a Medical Device Advisory Committee Panel ("Advisory Panel") in November 2024 to obtain independent non-binding expert advice on scientific, technical and policy matters related to the potential granting of marketing authorization of ProSense® for treating patients with earl...