Core Insights - The HIFI Study is the largest prospective, comparative, multi-center clinical study ever conducted comparing prostate cancer treatments, involving 3,328 patients [1][2] - Positive results from the study are expected to drive further adoption of Focal One as a first-line treatment option for localized prostate cancer [1][2] - The study demonstrated that Focal One Robotic HIFU is non-inferior to surgery, meeting the primary endpoint of noninferiority for Salvage Treatment-free Survival (STFS) at 30 months [1][3] Clinical Data Highlights - At 30 months, the adjusted STFS was higher in the HIFU arm (90%) compared to the RP arm (86%) [3] - The risk of salvage treatment was lower in the HIFU arm compared to RP, with a hazard ratio of 0.71 [95% CI, 0.52-0.97], p=0.008 [3] - The International Continence Society score showed significantly less deterioration for HIFU (29%) versus RP (44%) [3] - The International Index of Erectile Function-5 indicated a significantly smaller decrease in erectile function after HIFU compared to RP [3] Publication and Impact - The results of the HIFI study were published in the prestigious journal European Urology, which has the highest impact factor among urology-focused scientific journals [1][4] - The publication is expected to increase awareness of robotic HIFU technology and its benefits among the global urology and patient community [2] - The study's findings underscore HIFU's excellent oncologic control and significantly better functional outcomes compared to radical prostatectomy [2] Company Overview - EDAP TMS SA is a recognized leader in robotic energy-based therapies, developing and distributing minimally invasive medical devices using ultrasound technology [5] - The company introduced Focal One as a leading prostate focal therapy, with potential applications beyond prostate cancer [5]
Landmark HIFI Study Publication Demonstrates Positive Outcomes with Focal One® Robotic HIFU Versus Surgery in the Management of Prostate Cancer