March 20, 2024 — IceCure Medical Ltd., developer of the ProSense System, a minimally-invasive cryoablation technology that destroys tumors by freezing as an alternative to surgical tumor removal, today announced positive topline results from the Company's ICE3 study, the largest controlled multicenter clinical trial ever performed for liquid nitrogen (LN2) 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 patients (187 out 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 U.S. Food and Drug Administration (the "FDA") in April 2024, 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.
"We are very pleased with this topline outcome and believe these results demonstrate a highly favorable safety and efficacy profile that positions ProSense as a desirable alternative to lumpectomy for early-stage breast cancer. Having completed the study on schedule, we are now compiling the full data set which we plan to submit to the FDA next month for marketing clearance," stated Eyal Shamir, Chief Executive Officer of IceCure. "While the FDA evaluates the data, we are optimistic their upcoming decision will give women in the U.S. the same access as those who are already benefitting from ProSense in other countries."
"On behalf of the entire IceCure team, I thank the patients, their families, the sites and the clinicians for taking part in this landmark study. This has been a rigorous and thoroughly performed, ten-year long trial with positive data at each interval that is validated by recent independent studies performed globally by leading physicians ."
April 18, 2024 
