In context
By late 2024, robotic energy-based therapies were gaining ground in oncology, with a growing emphasis on minimally invasive, tissue-sparing options. The publication of the HIFI study in a top-tier urology journal marked a milestone in validating robotic high-intensity focused ultrasound (HIFU) as a first-line treatment for localized prostate cancer.
What was reported
EDAP TMS, a provider of robotic energy-based therapies, announced the publication of full results from the HIFI study in European Urology, a leading peer-reviewed journal. The study compared HIFU using EDAP's Focal One robotic system against radical prostatectomy (RP) for localized prostate cancer.
The prospective, multi-center, non-inferiority trial ran from April 2015 to March 2022, enrolling 3,328 patients across 46 centers. Of these, 1,967 were treated with robotic HIFU (90% using Focal One), and 1,361 underwent RP. All patients were followed for 30 months.
Results indicated that HIFU provided excellent oncologic control and significantly better functional outcomes—particularly preserving sexual function and urinary continence—compared to RP. The study is the largest and most rigorous comparison of robotic HIFU versus surgery to date.
Why it mattered
The findings strengthened the case for robotic HIFU as a viable first-line treatment, potentially shifting clinical guidelines and accelerating adoption of Focal One. For industrial automation, it underscored how robotic precision can expand into medical applications, offering less invasive alternatives that improve patient quality of life.
“The data from the HIFI Study not only underscores HIFU’s excellent oncologic control, but also highlights its significantly better functional outcomes when compared to radical prostatectomy.”
Source: Robotics & Automation News (roboticsandautomationnews.com) · Published 2024-12-09 · “EDAP TMS publishes results of cancer treatment through robotic system”