EDAP TMS Reports 71% ADT-Free Survival in 531-Patient HIFI-2 Trial
EDAP TMS published results from its HIFI-2 trial involving 531 patients across over 30 centers, showing 71% androgen deprivation therapy-free survival at 30 months. Subgroups with PSA ≤4.5 ng/mL and Gleason 7 or lower achieved up to 84% ADT-free survival with low severe complication rates.
1. HIFI-2 Study Design
The HIFI-2 study was a large prospective multicenter trial evaluating salvage high-intensity focused ultrasound using the Focal One Robotic HIFU system for localized prostate cancer recurrence after radiotherapy. It enrolled 531 patients across more than 30 centers, focusing on androgen deprivation therapy-free survival and safety outcomes.
2. Clinical Efficacy and Safety
At the 30-month follow-up, the trial reported a 71% androgen deprivation therapy-free survival rate, which increased to 84% in patients with pre-HIFU PSA ≤4.5 ng/mL and Gleason score 7 or lower. Severe complication rates remained low, and patient-reported quality of life showed no significant deterioration at 12 months.
3. Guideline Endorsement and Reimbursement
Following the HIFI-2 results, high-intensity focused ultrasound has been recommended in NCCN guidelines as a treatment option for localized recurrence after radiotherapy. Medicare and major commercial payors have established coverage policies for the Focal One procedure, facilitating broader patient access.
4. Strategic Market Implications
These clinical findings reinforce EDAP TMS’s leadership in focal prostate cancer therapy and strengthen its market position. The company plans to leverage this robust evidence to drive global adoption of its energy-based therapy portfolio and support future growth.