EDAP Announces Positive Results from the FARP Randomized Controlled Trial Presented at the American Urological Association (AUA) Annual Meeting

Core Insights - EDAP TMS SA announced positive final results from the Focal Ablation Versus Radical Prostatectomy (FARP) Study, demonstrating non-inferiority of focal ablation compared to robotic prostatectomy in treating localized prostate cancer [1][6] Study Results - The FARP study achieved its primary endpoint, showing a treatment failure rate of 5.6% in the Focal Ablation (FA) group versus 7.9% in the Radical Prostatectomy (RP) group, indicating a statistical difference of 2.3% in favor of Focal Ablation [7] - A total of 213 patients were enrolled, with 107 randomized to FA and 106 to RP, and 25% of RP patients crossed over to FA [7] Clinical Implications - The study provides significant evidence supporting the use of ultrasound energy-based focal ablation for organ-localized prostate cancer, particularly High-Intensity Focused Ultrasound (HIFU) [2][4] - The positive results from the FARP trial, along with the HIFI Study, are expected to accelerate the adoption of Focal One Robotic HIFU in clinical practice [4] Company Overview - EDAP TMS SA is a leader in robotic energy-based therapies, developing minimally invasive medical devices utilizing ultrasound technology for various conditions [5] - The Focal One® system is positioned as a leading prostate focal therapy, with potential applications beyond prostate cancer [5]