FDA's marketing authorization decision for ProSense in early-stage low risk breast cancer with endocrine therapy, to be reached after the first quarter of 2025 - IceCure Medical

IceCure Medical Ltd., developer of minimally-invasive cryoablation technology that destroys tumors by freezing as an alternative to surgical tumor removal,  announced it is in continued discussions with the  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.

"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. "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.

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 early-stage low risk breast cancer with endocrine therapy. The Advisory Panel, which included breast surgeons, interventional radiologists, breast oncologists, and representatives from the patient, consumer, and regulatory communities, voted in favor of ProSense's benefit-risk profile in early-stage low risk breast cancer.

ProSense has approvals in 15 countries including FDA clearance in the U.S. for general minimally invasive cryoablation applications for kidney, liver, neurology, and fibroadenoma. It is approved to treat breast cancer tumors in the European Union, Brazil, Thailand, Singapore, Israel, India, South Africa, as well as China (for IceSense3). ProSense has been granted Breakthrough Devices Designation for proposed indications including for use in kidney and liver cancer as well as addressing pain for bone cancer.