EDAP TMS Strengthens Market Position with Landmark HIFI-2 Data Supporting Focal One® Robotic HIFU in Radiorecurrent Prostate Cancer

AUSTIN, Texas, April 30, 2026 - EDAP TMS SA (NASDAQ:EDAP), the global leader in robotic energy-based therapies, today announced the publication of the HIFI-2 study, a large, prospective, nationwide trial evaluating salvage high-intensity focused ultrasound (HIFU) using Focal One Robotic HIFU for the treatment of localized prostate cancer recurrence following radiotherapy.

Published in European Urology Oncology, the study titled "Salvage High-intensity Focused Ultrasound for Prostate Cancer Recurrence after Radiotherapy (HIFI-2 Study)" represents the largest prospective dataset to date in this clinical setting, including 531 patients treated across more than 30 centers.