IceCure Medical announces FDA’s favorable recommendation for ProSense

IceCure Medical (ICCM) announced the FDA’s Medical Device Advisory Committee Panel’s favorable recommendation with 9 panelists voting in favor and 5 voting against the benefit-risk profile of IceCure’s ProSense. The majority of panelists voted that the benefits of IceCure’s ProSense System outweigh the risks when used according to the proposed indications for the treatment of patients with early-stage low risk invasive breast cancer with cryoablation and adjuvant endocrine therapy. Among those that voted “no”, there were three who stated that if the FDA applied adequate special controls, this would have swayed their opinion in favor. The Advisory Panel’s favorable vote was based on the comprehensive body of data available on ProSense as a treatment for early-stage low risk breast cancer, including results from the Company’s ICE3 study compared with data from the current standard of care, lumpectomy, as well as testimonies and input from a broad range of key stakeholders, including women with breast cancer and their family members, patient advocacy groups, doctors, nurses and researchers. The purpose of the Advisory Panel was for the FDA 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 invasive breast cancer with cryoablation and adjuvant endocrine therapy.