EDAP Receives HIFU Reimbursement for Prostate Cancer in France

Core Viewpoint - EDAP TMS SA has secured reimbursement for its Focal One Robotic HIFU procedure for prostate cancer treatment in France, marking a significant commercial milestone that enhances patient access to non-invasive treatment options [1][2][6] Company Developments - The French Ministry of Health's decision to reimburse the Focal One procedure allows eligible patients to receive it as a primary treatment for localized prostate cancer and as a salvage option post-radiotherapy [1][2] - The reimbursement coverage became effective on September 1, 2025, following a favorable opinion from the French National Authority for Health in December 2023 [2] Market Implications - The reimbursement in France is expected to accelerate similar reimbursements in other European countries, potentially increasing the adoption of the Focal One platform among urologists [2] - The positive outcomes from the HIFI Study and Level 1 evidence from the FARP Study are anticipated to further drive demand for the Focal One Robotic HIFU procedure [2] Technology and Product Information - EDAP TMS specializes in robotic energy-based therapies and has developed the Focal One as a leading prostate focal therapy device, which utilizes advanced imaging, robotics, and non-invasive energy delivery technologies [4]