Edap TMS SA, a global leader in robotic energy-based therapies, announced on September 8, 2025, that the French Ministry of Health has granted reimbursement for the High Intensity Focused Ultrasound (HIFU) procedure for prostate cancer treatment in France. This approval covers the use of the Focal One Robotic HIFU procedure under France's national universal health system, "Sécurité Sociale," for eligible patients as a primary treatment for localized prostate cancer and as a salvage treatment following radiotherapy. This reimbursement milestone, effective from September 1, 2025, enhances patient access to non-invasive prostate cancer management in France. The decision follows the positive findings of the HIFI Study, sponsored by the French Urology Association, and is expected to facilitate similar approvals across Europe.