IceCure Medical has announced positive results from two peer-reviewed publications stemming from the independent THERMAC trial, demonstrating superior performance of its ProSense cryoablation system in treating early-stage breast cancer. The publications, appearing in the European Journal of Surgical Oncology and Radiology, provide compelling evidence for cryoablation as a minimally invasive alternative to surgical tumor removal.
THERMAC Trial Design and Results
The THERMAC trial was a phase II study conducted in the Netherlands that compared three thermal ablation techniques for early-stage breast cancer: radiofrequency ablation (RFA), microwave ablation (MWA), and cryoablation using IceCure's ProSense system. The study included 41 patients and was led by Dr. Sophie Wooldrik from the Department of Surgery at Franciscus Gasthuis & Vlietland in Rotterdam.
Based on the phase II results, study investigators concluded that cryoablation is the preferred technique for comparison with surgery in a future phase III trial. The ProSense system achieved the highest complete ablation rate with no complications, supporting its selection for the next phase of clinical evaluation.
Superior Patient Satisfaction and Cosmetic Outcomes
The European Journal of Surgical Oncology publication focused on cosmetic outcomes and patient satisfaction, revealing remarkable patient acceptance of the thermal ablation approach. The study found that 95% of patients were very satisfied or satisfied with thermal ablation, while 91% would prefer thermal ablation over surgery.
Cosmetic outcomes also favored thermal ablation over traditional surgery. The overall median cosmetic outcome was good after thermal ablation and intermediate after surgery (1.6 vs 1.8; P = 0.07). Using the BCCT core evaluation method, 94% of cases were rated as good or excellent after thermal ablation, compared to 80% after surgery.
Most domains of the BREAST-Q instrument, a widely used patient-reported outcome measure for health-related quality-of-life and patient satisfaction in breast surgery, were scored higher after thermal ablation compared to breast-conserving surgery.
Clinical Efficacy and Safety Profile
The Radiology publication demonstrated the clinical superiority of cryoablation over alternative thermal ablation techniques. ProSense cryoablation was associated with zero cases requiring oncoplastic surgery, compared to 2 cases (40%) in the RFA group and 2 cases (11%) in the MWA group.
The study revealed significant differences in technique performance. RFA was halted early due to protocol-defined issues, while MWA delivered only moderate efficacy. In contrast, cryoablation with ProSense achieved the highest complete ablation rate with no adverse events.
Technology and Clinical Impact
The ProSense Cryoablation System utilizes liquid nitrogen to create large lethal zones for maximum efficacy in tumor destruction. The system is designed as a minimally invasive treatment option that destroys tumors by freezing them, offering benefits including accelerated recovery, reduced pain, and fewer surgical risks and complications.
"These peer-reviewed publications further advance ProSense's clinical validation," stated Eyal Shamir, IceCure's Chief Executive Officer. "In the THERMAC Trial, ProSense cryoablation outperformed alternative thermal ablation techniques and delivered cosmetic outcomes superior to surgery, showcasing its safety and efficacy in early-stage breast cancer."
Regulatory Status and Future Development
ProSense has regulatory approval for breast cancer treatment in the European Union. The positive phase II results position the technology for advancement to phase III trials, where it will be directly compared to surgical approaches. Some data from these publications were previously presented at major medical conferences, including the European Conference on Interventional Oncology 2025, the Society of Interventional Oncology Annual Meeting, and the European Society of Breast Imaging, where the study won the Young Physician Scientist Competition.
The system's transportable design and liquid nitrogen utilization enable fast and convenient office-based procedures for breast tumors, potentially transforming the treatment paradigm for early-stage breast cancer patients seeking minimally invasive alternatives to surgery.
