Landmark HIFI Study Publication Validates Focal One Robotic HIFU for Prostate Cancer

EDAP
October 08, 2025

EDAP TMS announced the publication of the full results from the HIFI study in European Urology, a peer-reviewed journal with the highest impact factor in urology. The study evaluated HIFU versus radical prostatectomy (RP) as a first-line treatment for localized prostate cancer.

The HIFI study, a prospective, multi-center, non-inferiority trial, demonstrated comparable cancer control with 90% salvage treatment-free survival for HIFU patients compared to 86% for radical prostatectomy patients. Focal One was utilized for 90% of the HIFU treatments in the study.

Crucially, the study also highlighted superior functional outcomes for HIFU, including significantly better urinary continence and less impaired erectile function when compared to radical prostatectomy. This data is expected to increase awareness and drive adoption of Focal One, while advancing treatment decision guidelines.

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