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IceCure Files De Novo Classification Request with the FDA for Marketing Authorization of ProSense® with Breakthrough Indication: Early-Stage Low-Risk Breast Cancer Patients at High Risk to Surgery
43,000 cases estimated annually in the U.S. alone for indication in initial filing representing an estimated $80 million annual addressable market 65,000
About this update from Icecure Medical Ltd.
[{"type":"text","content":"43,000 cases estimated annually in the U.S. alone for indication in initial filing representing an estimated $80 million annual addressable market 65,000 cases estimated annually in the U.S. for broader indication Company intends to file based on FDA's guidance, reflecting the full ICE3 study population after ICE3 5-year follow-ups are completed for all patients in 2024 To date, the Ipsilateral Breast Tumor Recurrence (IBTR) rate for the entire study population is 3.09%Submission data include IBTR as the primary endpointCAESAREA, Israel, Oct. 19, 2022 /PRNewswire/ -- IceCure Medical Ltd. (Nasdaq: ICCM) (TASE: ICCM) (\"IceCure\" or the \"Company\"), developer of minimally-invasive cryoablation technology, the ProSense® System that destroys tumors by freezing, today announced it submitted a regulatory filing (De Novo Classification Request) with the U.S. Food and Drug Administration (\"FDA\") for marketing authorization based on ICE3 clinical trial (\"ICE3\") interim analysis of ProSense for the indication of early-stage (Luminal A T1 invasive) low-risk breast cancer in patients who are at high risk to surgery (not suitable for surgical alternatives), representing approximately 43,000 women in the U.S. annually. The specific indication filed is based on interim data and is in accordance with discussions IceCure has had with the FDA, which granted ProSense Breakthrough Device Designation, enabling closer communications regarding its regulatory filing.\nICE3 is the largest controlled, multicenter clinical trial ever performed in the U.S. for liquid nitrogen-based cryoablation of small, low-risk, early-stage malignant breast tumors. To date, there have been six cases of ipsilateral breast tumor recurrence (\"IBTR\") out of 194 patients, or 3.09%. The survival-based estimate for the 5-year IBTR is 4.3% with a one-sided 95% confidence level, upper bound of 8.4% for the entire study population. Final ICE3 5-year follow-up data are expected in the first half of 2024, at which time IceCure plans to file with the FDA for a broader indication reflecting the entire study population—early-stage (Luminal A T1 invasive) low-risk breast cancer for patients age 60 and over, representing approximately 65,000 women in the U.S. annually.\nThe total group of Luminal A breast cancer for women in all ages, is estimated at 144,000 cases annually in the ...