IceCure Medical’ reports positive topline results for breast tumor cryoablation

IceCure Medical announced positive topline results from the company’s ICE3 study, the largest controlled multicenter clinical trial ever performed for liquid nitrogen based cryoablation of low-risk, early-stage malignant breast tumors, following the 5-year follow-up evaluation of the ICE3 study’s last patient. In the ICE3 study, 96.39% of 194 patients were local recurrence-free with no significant device-related adverse events or complications reported. Based on the strength of the topline results, ProSense has the potential to be a safe and effective alternative to lumpectomy for early-stage breast cancer. The company plans to complete the analysis and evaluation of the full data set and expects to submit the results to the FDA in April, as previously requested by the FDA with respect to IceCure’s De Novo Classification Request for Marketing Authorization of ProSense for the treatment of early-stage low-risk breast cancer.