© IceCure Medical PR
CAESAREA, Israel – IceCure Medical Ltd. (NASDAQ:ICCM), an Israeli medical device company, announced today that its ICE3 clinical trial has shown promising results for the treatment of early-stage breast cancer. The study, which is the largest of its kind in the United States to examine the efficacy of liquid nitrogen-based cryoablation, observed a 96.39% recurrence-free rate among participants.
The ICE3 trial, which spanned over a decade, followed the treatment outcomes of patients with low-risk, early-stage malignant breast tumors using IceCure’s ProSense® system. This minimally invasive technology offers an alternative to traditional surgery by freezing and destroying tumors. The final evaluation, which took place after a 5-year follow-up of the last patient, reported no significant device-related adverse events or complications.
With these topline results, IceCure plans to submit the full dataset to the U.S. Food and Drug Administration (FDA) in April 2024 for marketing authorization of ProSense®. Eyal Shamir, CEO of IceCure, expressed optimism about the potential for ProSense® to become a viable alternative to lumpectomy, citing the system’s safety and effectiveness.
ProSense® is designed to enhance the value for both patients and providers by reducing recovery time, pain, and surgical risks. The system’s portability and the use of liquid nitrogen allow for procedures to be performed conveniently in office settings. Currently, ProSense® is marketed globally for approved indications, including in the U.S., Europe, and China.
The announcement comes with the caveat that historical scientific research and clinical trial results do not guarantee future outcomes.
This news is based on a press release statement from IceCure Medical.
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