IceCure Medical’s appeal for ProSense in breast cancer accepted by FDA

IceCure Medical announced the FDA has responded affirmatively to the company’s request for supervisory review regarding the FDA’s prior denial of IceCure’s De Novo Classification Request for treating patients with early-stage, low risk breast cancer. The FDA determined there is sufficient basis to reopen the De Novo file and requested IceCure to submit the full 5-year dataset from the company’s ICE3 trial. The final ICE3 study patient is expected to complete her 5-year follow up examination by the end of February 2024. IceCure plans to expedite data monitoring and analysis to submit the final 5-year dataset to the FDA by April 2024, which is several months ahead of the company’s prior submission timeline. Additionally, the FDA requested that IceCure submit an analysis of the ICE3 results compared with data from the LUMINA study. IceCure was invited by the FDA to submit real-world data from the use of ProSense globally, including post-market commercial use in territories where ProSense is approved for breast cancer, as well as data from independent third-party studies.