IceCure Medical Ltd, the creator of the ProSense System, disclosed positive preliminary findings from its ICE3 Cryoablation Breast Cancer trial this past Tuesday. Prior to activity starting at Nasdaq, IceCure shares were up by around 2.5 percent.
The ProSense System employs a less invasive cryoablation technology that eradicates tumors by freezing them, presenting an alternate option to surgical removal. In the ICE3 trial, 96.39% of the patients showed no signs of local recurrence, and there were no significant adverse effects or complications related to the device.
IceCure mentioned that this trial constitutes the biggest ever controlled multicenter clinical trial conducted on liquid nitrogen (LN2) based cryoablation of low-risk, early-stage malignant breast tumors. The findings were made public following a 5-year review of the last patient under the ICE3 study.
The top-line results suggest that the ProSense System has the potential to be a safer and more effective alternative to lumpectomy in treating early-stage breast cancer.
The company intends to complete the analysis of the full data set and is anticipating submitting the results to the U.S. Food and Drug Administration in April 2024 for marketing authorization of the ProSense as a minimally invasive treatment for early-stage breast cancer.
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