On September 8, 2025, IceCure Medical Ltd. announced two new publications reporting positive results for its ProSense® cryoablation system from the independent THERMAC Trial in the Netherlands. This Phase II study compared radiofrequency ablation (RFA), microwave ablation (MWA), and cryoablation with ProSense® for early-stage breast cancer. ProSense® has regulatory approval for breast cancer in the European Union.
An article published in Radiology demonstrated that cryoablation with ProSense® achieved the highest complete ablation rate compared to alternative thermal ablation techniques, with no adverse events. The study's investigators concluded that cryoablation is the preferred technique for comparison with surgery in a future Phase III trial. This highlights ProSense®'s superior efficacy and safety profile.
A related article in the European Journal of Surgical Oncology (EJSO) focused on cosmetic outcomes and patient satisfaction, reporting that 95% of patients were very satisfied or satisfied with thermal ablation. IceCure's CEO, Eyal Shamir, stated that ProSense® cryoablation outperformed alternatives and delivered cosmetic outcomes superior to surgery, further advancing its clinical validation and supporting its role in minimally invasive breast cancer care.
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