EDAP TMS released the results of the HIFI‑2 study, a large prospective nationwide trial that evaluated salvage high‑intensity focused ultrasound (HIFU) using its Focal One robotic system for patients with localized prostate cancer recurrence after radiotherapy. The study was published in European Urology Oncology on April 28 2026 and was announced by the company on April 30 2026.
The trial enrolled 531 patients across 32 centers in France between 2015 and 2019. Its primary endpoint was androgen‑deprivation‑therapy‑free survival (ADT‑FS). At 30 months, 71 % of all patients remained free of ADT, rising to 84 % in favorable subgroups. Safety data showed 19 of 531 patients (3.6 %) experienced high‑grade complications per the Dindo‑Clavien classification, and the incidence of severe incontinence increased from 7 % to 12 % after salvage HIFU.
Quality‑of‑life outcomes were encouraging: the EORTC QLQ‑C30 median score showed no deterioration at 12 months, indicating that the procedure preserves patient well‑being while delivering oncologic control.
Predictive factors for success identified in the study included pre‑HIFU prostate‑specific antigen levels and Gleason score, providing clinicians with tools to better select patients who are most likely to benefit from the therapy.
The publication reinforces payer coverage decisions and accelerates clinical adoption. NCCN guidelines already recommend HIFU for prostate recurrence, and Medicare and commercial payors provide coverage, positioning EDAP TMS to capture a growing market segment that seeks organ‑sparing, function‑preserving options.
Dr. Guillaume Ploussard, the study’s first author, noted that the large prospective multicenter data “demonstrate that salvage HIFU can achieve clinically meaningful oncologic control while maintaining an acceptable safety profile in patients with localized recurrence after radiotherapy.” CEO Ryan Rhodes added that the results “provide compelling evidence supporting Focal One as a non‑invasive, organ‑sparing, function‑preserving option for patients facing recurrence after radiotherapy.”
The HIFI‑2 study strengthens EDAP TMS’s evidence base and supports the company’s strategic focus on expanding the indications for its robotic HIFU platform, potentially driving future revenue growth as adoption increases.
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