IceCure Presents Interim Data From ICE3 Breast Cancer Trial of ProSense Cryoablation System

April 27, 2022—IceCure Medical Ltd., an Israel-based developer of minimally-invasive cryoablation technology, announced that interim data from the ICE3 trial on cryoablation of small, low-risk breast cancers with the company’s ProSense system were presented by ICE3 Coprincipal Investigator Kenneth R. Tomkovich, MD, at ECIO 2022, the European Conference on Interventional Oncology, held April 24-27 in Vienna, Austria.

IceCure stated that the ProSense system is a liquid nitrogen (LN2) cryoablation solution that creates large, lethal zones for optimal tumor destruction with a rapid cooling rate and stable ultracold temperatures (-160° ± 10° C).

According to the company, the minimally invasive technology is a safe and effective alternative to hospital surgical tumor removal that is easily performed in a relatively short procedure. The system has FDA clearance in the United States and CE Mark approval in Europe and is marketed worldwide.

As summarized in the press release, the interim results showed that approximately 98% of patients who received ProSense system cryoablation treatment are free of recurrence, with one-third of patients reaching 5 years posttreatment. No significant device-related adverse events were reported with no scarring or change in shape and size of the breasts, and 98% of doctors and 95% of patients reported satisfaction with the cosmetic results. These data were originally published in April 2021, noted the company.

The ICE3 trial was designed to evaluate the safety and efficacy of breast cryoablation with the ProSense system, enabling women aged > 60 years with low-risk early-stage breast cancers to benefit from a nonsurgical treatment and avoid the associated surgical risks.

The study enrolled 194 eligible patients. It is the largest controlled multicenter clinical trial ever performed in the United States for LN2 based cryoablation of small, low-risk, early-stage malignant breast tumors as an alternative to surgery, according to the company.

Dr. Tomkovich commented in IceCure Medical’s press release, “The inclusion of the ICE3 clinical trial interim results as part of the scientific program at ECIO 2022 represents a major milestone in women’s health and more specifically breast cancer care. It presents an opportunity for interventional oncologists, in Europe and around the world, to use their expertise in image-guided tumor ablation to consider breast cancer cryoablation as a treatment now that the procedure is gaining wider acceptance as a viable nonsurgical option for certain patients.”

The company further reported that Professor Franco Orsi, MD, of the European Institute of Oncology in Milan, Italy, moderated the IceCure Industry Symposium, “Liquid Nitrogen-Based Cryoablation for Optimal Tumor Destruction,” at ECIO 2022. Prof. Orsi provided an overview and rationale for performing cryoablation procedures followed by two case studies. In one case study, Yair Halpern, MD, of Bnei Zion Medical Center, Haifa, Israel, performed a renal cancer cryoablation. In the second case, cryoablation of adrenal gland and vertebral metastasis was performed by Ghizlane Touimi Benjelloun, MD, of CHU de Nîmes, the University Hospital in Nîmes, France.

IceCure also participated in ECIO’s three hands-on cryoablation sessions with the IceCure team and physicians well experienced with the ProSense system guiding participants during the sessions.