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EDAP Reports Record Fourth Quarter and Full-Year 2025 HIFU Revenue

EDAP Reports Record Fourth Quarter and Full-Year 2025 HIFU Revenue 39% Full-Year YoY HIFU Revenue Growth, Record Performance Driven by Increased Focal One® System Sales and Growth in the Number of U.S. Focal One Procedures 69% Full-Year YoY Growth in Focal One System Placements 28% Q4 YoY Growth in U.S. Procedures, Marking the Second Consecutive Quarter of Double-Digit Procedure Growth Demand for Focal One Systems Remains Strong with System Placements in Academic Cancer Centers, Community Hospitals, and Large Integrated Healthcare Networks Company Reiterates its Previously Issued 2026 Revenue Guidance; HIFU Revenue Expected to Grow Between 34% and 45% YoY AUSTIN, Texas, March 25, 2026 - EDAP TMS SA (Nasdaq: EDAP), the global leader in robotic energy-based therapies, reported today financial results for the fourth quarter and full-year 2025. “We experienced strong global demand for Focal One Robotic HIFU as demonstrated by our 2025 results,” said Ryan Rhodes, Chief Executive Officer.

EDAP Announces Appointment of David Horn to Board of Directors

EDAP Announces Appointment of David Horn to Board of Directors AUSTIN, Texas, February 12, 2026 – EDAP TMS S.A. (Nasdaq: EDAP) (“the Company” or “EDAP”), a global leader in therapeutic ultrasound technology, today announced the appointment of David Horn to its Board of Directors, effective February 11, 2026.

EDAP Announces Preliminary Record Fourth Quarter and Full Year 2025 HIFU Revenue; Issues 2026 Revenue Guidance

EDAP Announces Preliminary Record Fourth Quarter and Full Year 2025 HIFU Revenue; Issues 2026 Revenue Guidance 36% to 38% Annual YoY HIFU Revenue Growth, Record Performance  Driven by Increased Focal One ® System Sales and Growth in Number of U.S. Focal One Procedures 69% Annual YoY Growth in Focal One System Placements 28% Q4 YoY Growth in U.S. Procedures Highlights Accelerating Quarterly Procedure Growth AUSTIN, Texas, January 12, 2026 -- EDAP TMS SA (Nasdaq: EDAP) (“the Company” or “EDAP”), the global leader in robotic energy-based therapies, today announced select preliminary unaudited financial and operational results highlighting record fourth quarter and full-year 2025 HIFU revenue, driven by strong system placements and accelerating procedure growth. The Company also issued initial worldwide revenue guidance for 2026.

EDAP Receives FDA 510(k) Clearance for Latest Evolution of Focal One Robotic HIFU

EDAP Receives FDA 510(k) Clearance for Latest Evolution of Focal One Robotic HIFU  AUSTIN, Texas, November 20, 2025 - EDAP TMS SA (Nasdaq: EDAP), the global leader in robotic energy-based therapies, today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for new ultrasound imaging and workflow enhancements to the Focal One High Intensity Focused Ultrasound (HIFU) system, further strengthening the company's market leadership in robotic focal therapy for prostate cancer. The 510(k) clearance introduces advanced ultrasound imaging, streamlined treatment planning, and an optimized user-interface to the Focal One i launched earlier this year.