EDAP News & Events

EDAP TMS announced the appointment of David Horn to its Board of Directors, effective February 11, 2026. The addition of Horn strengthens the Board with experience both advising and leading companies through periods of strategic growth and transformation. Horn will serve as a member of the Company's Audit Committee and Nominations Committee.

"Our preliminary results reflect a strong finish to 2025 and accelerating demand for Focal One across global markets," said Ryan Rhodes, Chief Executive Officer. "System placements reached a quarterly record, and procedure growth in the U.S. continues to scale, which we believe reinforces the strength and durability of our recurring revenue model. For the first time in the Company's history, the expected growth in HIFU revenue represents more than half of our expected annual revenue, validating our execution strategy."

FY26 combined non-core business revenue is expected to be in the range of $22.0M-$26.0M

EDAP TMS announced that the U.S. Food and Drug Administration has granted 510(k) clearance for new ultrasound imaging and workflow enhancements to the Focal One High Intensity Focused Ultrasound system, further strengthening the company's market leadership in robotic focal therapy for prostate cancer. "We are proud to receive this new FDA clearance, which further enhances the capabilities of the new Focal One i and represents another important technical milestone in Focal One's product roadmap," said Ryan Rhodes, Chief Executive Officer of EDAP TMS. "This achievement demonstrates our team's continued commitment to innovation and reinforces Focal One's global leadership in focal therapy."