The study, authored by prominent Japanese specialists including Professor Eisuke Fukuma, evaluates the efficacy of ProSense cryoablation against traditional breast-conserving surgery and radiofrequency ablation (RFA). Researchers highlighted that cryoablation offers distinct procedural advantages, most notably the ability to perform the treatment under local anesthesia and the clear visibility of the ice ball margin during the procedure. In contrast, RFA remains difficult to monitor due to tissue resistance and faint visualization of micro-bubbles.

Clinical data underscores the findings, with recurrence-free rates for cryoablation reaching 99.02% in long-term follow-ups. As IceCure heads to the 34th Annual Meeting of the Japanese Breast Cancer Society in Kyoto, the company is coordinating with its distributor, Terumo Corporation, to submit ProSense for regulatory approval to Japan’s Pharmaceuticals and Medical Devices Agency. This move follows the system's FDA marketing authorization, which has already helped solidify its role as a minimally invasive option for patients seeking to avoid more extensive surgical interventions.