IceCure Medical submitts data to FDA for marketing authorization of ProSense

IceCure Medical announced that it has submitted final data to the FDA requesting marketing authorization for ProSense for the indication of treating patients with early stage T1 invasive breast cancer with cryoablation and adjuvant hormone therapy. ProSense, which received the FDA’s Breakthrough Designation, is already cleared for use in the U.S. for several other indications, including treating benign tumors of the breast, and tumors in the kidney and liver. The Company provided the following requested data to the FDA: ICE3 5-year follow up full data-set; sub-analysis of the ICE3 results compared with data from the “LUMINA” study; analysis of the ICE3 data compared to an updated PRISMA meta-analysis; and real-world data from the use of ProSense globally, including post-market commercial use as well as data from independent third-party studies. The ICE3 study was the largest controlled multicenter clinical trial ever performed for liquid nitrogen based cryoablation of low-risk, early-stage malignant breast tumors.