IceCure Medical Ltd. (ICCM), the developer of the ProSense System, announced Tuesday positive topline results from ICE3 Cryoablation Breast Cancer study.
In pre-market activity on Nasdaq, IceCure shares were gaining around 2.5 percent.
ProSense System is a minimally-invasive cryoablation technology that destroys tumors by freezing as an alternative to surgical tumor removal. The company said that in the ICE3 study, 96.39% of patients were local recurrence-free with no significant device-related adverse events or complications reported.
The company noted that the trial was the largest controlled multicenter clinical trial ever performed for liquid nitrogen or LN2 based cryoablation of low-risk, early-stage malignant breast tumors. The results were announced following the 5-year follow-up evaluation of the ICE3 study's last patient.
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 in April 2024 for marketing authorization of ProSense for minimally invasive treatment of early-stage breast cancer.
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