IceCure Medical Ltd. announced that it has submitted final data to the U.S. Food and Drug Administration (FDA) requesting marketing authorization for ProSense®? for the indication of treating patients with early stage T1 invasive breast cancer with cryoablation and adjuvant hormone therapy. ProSense®?, which received the FDA's Breakthrough Designation, is already cleared for use in the U.S. for several other indications, including treating benign tumors of the breast, and tumors in the kidney and liver.

The Company provided the following requested data to the FDA: ICE3 5-year follow up full data-set; sub-analysis of the ICE3 results compared with data from the "LUMINA" study (a study sponsored by Canada'sOntario Clinical Oncology Group, which evaluated the risk of recurrence in patients with low-risk Luminal A breast cancer who were treated with lumpectomy surgery and who had received adjuvant hormone therapy); analysis of the ICE3 data compared to an updated PRISMA meta-analysis; and real-world data from the use of ProSense® globally, including post-market commercial use as well as data from independent third-party studies. The ICE3 study was the largest controlled multicenter clinical trial ever performed for liquid nitrogen (LN2) based cryoablation of low-risk, early-stage malignant breast tumors. The 5-year recurrence-free rates from this groundbreaking study, which evaluated IceCure's minimally invasive 20-to-40-minute outpatient cryoablation procedure, were in line with expectations and show similar outcomes to lumpectomy, the current standard of care for early-stage breast cancer patients.

Per the analysis, at the 5-year follow-up evaluation, 96.3% of the subgroup of patients treated with ProSense® cryoablation, followed by hormone therapy, were estimated to be free from local recurrence. A comparison of this result, from the ICE3 study, shows similar outcomes in 5-year recurrence rates compared to patients who were treated with lumpectomy followed by hormone therapy in the LUMINA study, which reported a 97.7% recurrence free rate at 5-year follow up and the PRISMA meta-study, which included Lumina, reporting a 97.19% recurrence free rate at 5-year follow up. ICE3 results are also in line with data from real-world use of ProSense® by third parties in territories where IceCure's cryoablation system is used to treat early-stage breast cancer.

In the final ICE3 analysis, no significant device related adverse events or complications were reported, and all patients and physicians reported satisfaction with the ProSense® procedure.