IceCure Medical Ltd. 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. The ProSense® Cryoablation System provides a minimally invasive treatment option to destroy tumors by freezing them. The system uniquely harnesses the power of liquid nitrogen to create large lethal zones for maximum efficacy in tumor destruction in benign and cancerous lesions, including breast, kidney, lung, and liver.

ProSense® enhances patient and provider value by accelerating recovery, reducing pain, surgical risks, and complications. With its easy, transportable design and liquid nitrogen utilization, ProSense® opens that door to fast and convenient office-based procedure for breast tumors.