EDAP Announces Positive Final Results from the HIFI Study Comparing Outcomes of Focal One HIFU Versus Radical Prostatectomy During Plenary Session at the 119th American Urological Association (AUA) Annual Meeting

        

Final results demonstrate a significantly higher salvage treatment free survival rate (STFS) at 30 months of 89.6% in the HIFU-treated arm versus 86.2% in patients who underwent radical prostatectomy (RP)

Functional evaluation criteria show better results with respect to urinary continence and erectile function in patients receiving HIFU therapy versus patients receiving RP

Final study results were presented during a plenary session of the AUA focused on paradigm-shifting and practice-changing clinical trials in urology

HIFI Study is the largest clinical study ever conducted evaluating treatment outcomes with Focal One robotic HIFU, enrolling a total of 3,328 prospective patients, including 1,967 consecutive HIFU patients and 1,361 RP patients across 46 centers

LYON, France, May 6, 2024 - EDAP TMS SA (Nasdaq: EDAP), the global leader in robotic energy-based therapies, announced a recent presentation highlighting the positive, final results from a large, prospective, multicenter, non-inferiority study, the HIFI Study, comparing Focal One high intensity focused ultrasound (HIFU) versus radical prostatectomy (RP) at the 119^th American Urological Association Annual Meeting (AUA 2024), which took place from May 3-6, 2024, in San Antonio, Texas, USA. Professor Pascal Rischmann of Rangueil University Hospital in Toulouse, France, and lead investigator of the HIFI Study, highlighted the final results from the study during an oral presentation at the AUA plenary session, “Paradigm-shifting, Practice-changing Clinical Trials in Urology”.

HIFI is the first prospective, multi-center, investigator-sponsored study comparing robotic HIFU to RP in the management of prostate cancer. The study, which ran from April 2015 through March 2022, compared Focal One HIFU versus RP as a first line treatment for patients with localized prostate cancer (grade groups <3). A total of 3,328 patients from 46 treatment centers were included: 1,967 consecutive patients were treated with EDAP’s robotic HIFU technologies, where Focal One was used for 90% of the patients. 1,361 patients underwent radical prostatectomy surgery. All patients were followed for 30 months.