EDAP TMS SA recently shared encouraging outcomes from the Focal Ablation versus Radical Prostatectomy (FARP) Randomized Controlled Trial at the American Urological Association (AUA) Annual Meeting. The study, presented on April 27, 2025, revealed that the Focal Ablation (FA) group’s treatment failure rate was comparable to the Radical Prostatectomy (RP) group after 36 months. This trial marked the first of its kind, comparing ultrasound energy-based focal ablation to robotic prostatectomy.
The trial’s Principal Investigator, Eduard Baco, MD, PhD, highlighted the significance of generating Level 1 evidence for focal therapy in localized prostate cancer treatment. The study’s 3-year results demonstrated non-inferiority between FA and RP, with a notably lower treatment failure rate in the FA arm. These findings offer substantial support for utilizing focal ablation with ultrasound energy, particularly High-Intensity Focused Ultrasound (HIFU), in managing organ-localized prostate cancer.
With 213 patients enrolled, evenly split between FA and RP groups, the trial showcased the equivalence of both arms in various parameters like age, PSA levels, and tumor characteristics. Notably, 25% of RP patients transitioned to FA due to surgery refusal. The intention-to-treat analysis indicated a 5.6% treatment failure rate in the FA group versus 7.9% in the RP group, favoring Focal Ablation by 2.3%.
Ryan Rhodes, CEO of EDAP TMS, emphasized the trial’s positive implications for robotic focal ablation with ultrasound energy in prostate cancer management. The study predominantly utilized Focal One Robotic HIFU, underscoring its leadership in prostate cancer focal therapy. These favorable FARP trial results, alongside the HIFI Study’s recent publication showcasing Focal One’s efficacy in cancer control and preserving urinary and erectile functions, are poised to drive the adoption of Focal One Robotic HIFU.
EDAP TMS SA, a frontrunner in robotic energy-based therapies, focuses on developing and distributing minimally invasive medical devices worldwide, leveraging ultrasound technology. The introduction of Focal One® has positioned the company as a key player in prostate focal therapy, with potential applications beyond prostate cancer treatment.
Looking ahead, while acknowledging historical data, it’s crucial to note the forward-looking statements in this press release. These statements reflect management’s expectations but are subject to risks and uncertainties, including market acceptance of HIFU devices, economic conditions, geopolitical factors, and public health crises like the ongoing COVID-19 pandemic.
For further details on EDAP TMS SA and its innovative solutions in the medical field, visit their official website. Investors and inquiries can reach out to the company’s representatives for additional information.
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