IceCure Eyes Proceeding with System for Early Low-Risk Breast Cancer with 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 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 endpoint

https://finance.yahoo.com/news/icecure-files-novo-classification-request-120000332.html