IceCure’s ProSense for Cryoablation Treatment of Breast Tumors Evaluated in Six Studies

October 7, 2024—IceCure Medical Ltd. announced new data from the ICE3 trial and five additional studies of the company’s ProSense cryoablation system for the treatment of breast cancer and fibroadenoma. The ProSense system is approved in Europe for both of these indications.

The findings were presented at the 2024 European Society of Breast Imaging (EUSOBI) scientific meeting and annual conference held October 3-5 in Lisbon, Portugal.

IceCure’s press release summarized the six abstracts presented at EUSOBI 2024 as outlined below.

• Kenneth Tomkovich, MD, presented “Image-guided cryoablation as a primary treatment for low-risk breast cancers: Results and imaging findings of the ICE3 trial,” which was the winner of the EUSOBI 2024 Abstract Award. The company’s press release reported that the study concluded, “The overall 5-year recurrence rate of 4.3% in the ICE3 trial is similar to reported recurrence rates for the current gold standard, surgical lumpectomy. Substantial benefits as compared to surgery include performance in an outpatient setting using local anesthesia, only minor reported adverse events, and 100% satisfaction with cosmetic outcomes. Results of the ICE3 trial suggest that cryoablation for small low-risk breast cancers is a safe and effective primary treatment option alternative to surgical lumpectomy. Additional trials are encouraged.” Dr. Tomkovich commented in the press release, “The significance of a United States study gaining such high recognition by a European medical society is a testament to the excellent results—a 96.3% recurrence-free rate for those treated with ProSense and endocrine therapy—that demonstrate cryoablation for small, low-risk breast cancer to be a safe and effective primary treatment option to surgical lumpectomy.”
• Sophie Wooldrik, MD, presented “The treatment of breast cancer with percutaneous thermal ablation: Results of the THERMAC trial,” which was the winner of the EUSOBI Young Physician Scientist competition. THERMAC trial compared the efficacy of treatment in terms of complete ablation with radiofrequency, microwave, and cryoablation. According to IceCure, the trial showed that cryoablation demonstrated the highest complete rate of ablation at 94% with no adverse events, making it the safest and most effective among the methods used in the trial. In comparison, for patients in the same study who underwent radiofrequency there was a complete ablation rate of 33%, and 50% experienced mild to moderate adverse events. For patients in the same study treated with microwave, there was a complete ablation rate of 73%, and 40% experienced mild to moderate adverse events, reported the company. The conclusion stated, “In this study, cryoablation demonstrated the highest completed ablation rate (94%) with no adverse events, making it the most effective and safest method compared to radiofrequency and microwave.”
• Dr. Wooldrik also presented “The treatment of breast cancer with percutaneous thermal ablation—cosmetic outcome and patient satisfaction.” The study concluded, “Patients reported cosmetic outcomes to be more favorable following thermal ablation as compared to surgery. Patients appeared to experience the least pain with cryoablation.”
• S.E. Balidi Giorgi, MD, et al presented “Assessment of pain level and quality of life (QoL) in breast cancer patients treated with ultrasound-guided cryoablation.” The study concluded, “Ultrasound-guided cryoablation is a noninvasive and effective treatment in breast cancer patients ineligible for surgical excision. It is associated with improvement of pain and QoL. No significant differences in QoL were found between patients treated with cryoablation and hormone therapy compared to patients treated only with cryoablation, confirming that cryoablation maintains good QoL levels in all breast cancer patients.”
• Georgiana Camen, MD, presented “Single-center experience with percutaneous cryoablation for benign and malignant breast lesions in Romania: Tumor reduction and safety” that concluded, “Cryoablation with a LN2-based system was safe and effective for tumors 26 mm and smaller. Data collection continues with high expectations for long-term outcomes.”
• Teodora Filipov, MD, presented “Single-center experience with percutaneous cryoablation of fibroadenomas in Hungary: Volume reduction and safety” that concluded, “Liquid nitrogen-based cryoablation demonstrated both safety and efficacy for the treatment of fibroadenomas resulting in a 92.9% reduction in volume 1-year postprocedure.”

The ProSense system, which is IceCure’s flagship product, is available for the indications cleared and approved in the respective markets of the United States, Europe, and China, advised the company.