IceCure’s ProSense Cryoablation System Evaluated for Breast Cancer Treatment in THERMAC Trial

September 17, 2025—IceCure Medical announced two publications reporting positive results for the company’s ProSense cryoablation system in breast cancer.

The company noted that the findings stem from the THERMAC trial, an independent study being conducted in the Netherlands that is comparing different methods of thermal ablation used for early-stage breast cancer. ProSense has regulatory approval for breast cancer in the European Union.

According to IceCure, THERMAC was a phase II study that compared radiofrequency ablation (RFA), microwave ablation (MWA), and cryoablation with ProSense for early-stage breast cancer.

The study was composed of 41 patients. Based on the phase II results, the study’s investigators concluded that cryoablation is the preferred technique for comparison with surgery in a future phase III trial, stated the company.

The first article, which was published by Sophie M. Wooldrik, MD, et al in European Journal of Surgical Oncology, assessed patient-reported cosmetic outcome and satisfaction following percutaneous thermal ablation with ProSense and breast-conserving surgery.

As outlined in IceCure’s press release, the findings included the following:

• Overall median cosmetic outcome was good after thermal ablation, and intermediate after surgery (1.6 vs 1.8; P = .07).
• Most domains of the BREAST-Q patient-reported outcome instrument were scored higher after thermal ablation as compared to breast conserving surgery.
• 95% of patients were very satisfied or satisfied with thermal ablation.
• 91% of patients would prefer thermal ablation over surgery.
• On the BCCT—Breast Cancer Conservation Treatment—core, 94% of cases were rated as good or excellent after thermal ablation, compared to 80% after surgery.

The company stated that the second article, which was published by Dr. Wooldrik et al in Radiology, reported the following:

• Cryoablation with ProSense achieved the highest complete ablation rate with no complications, supporting its selection for a phase 3 trial.
• Cryoablation with ProSense was associated with zero cases requiring oncoplastic surgery, compared to two (40%) in the RFA group, and two (11%) in the MWA group.
• RFA was halted early because of protocol-defined issues.
• MWA delivered moderate efficacy.

Additionally, IceCure also announced it has received regulatory approval from the Medical Device Division of Israel’s Ministry of Health for the XSense system as well as CryoProbes, the company’s next-generation single cryoprobe cryoablation system.

IceCure advised that XSense is now approved in Israel for all indications for which the company’s flagship ProSense cryoablation system has received approval, including general surgery; dermatology; neurology, including cryoanalgesia; thoracic surgery; otorhinolaryngology; gynecology, oncology, including benign and malignant breast tumors; proctology; and urology.