EDAP TMS HIFI-2 Study Validates Focal One HIFU for Radiorecurrent Prostate Cancer

Event summary

  • HIFI-2 study published in European Urology Oncology with 531 patients across 30 centers.
  • 71% androgen deprivation therapy-free survival at 30 months, up to 84% in favorable subgroups.
  • Low severe complication rates and preserved quality of life post-treatment.
  • NCCN guidelines already recommend HIFU for prostate recurrence; Medicare covers procedure.

The big picture

EDAP TMS's HIFI-2 study provides robust clinical validation for Focal One HIFU in a niche but growing segment of radiorecurrent prostate cancer patients. The data reinforces the shift toward minimally invasive, organ-preserving treatments and positions EDAP to capture market share from more invasive alternatives. With existing NCCN endorsement and Medicare coverage, the company is well-positioned to expand access globally.

What we're watching

Market Adoption
How the HIFI-2 data will accelerate payer coverage and physician adoption of Focal One HIFU.
Competitive Positioning
Whether EDAP TMS can sustain leadership in focal therapy amid growing competition.
Regulatory Expansion
The pace at which global health authorities will incorporate HIFU into treatment guidelines for prostate cancer recurrence.