Achieved a Record Number of Focal One® Robotic HIFU System Placements for a First Quarter Period Received CE Mark Designation for Focal One for the Treatment of Deep Infiltrating Endometriosis Positive Final Results of FARP Randomized Controlled Trial Presented at American Urology Association Annual Meeting (AUA 2025) Launched the New Focal One i Robotic HIFU System Performed World's First Remote Transcontinental Focal One Robotic HIFU Procedure Successfully AUSTIN, Texas, May 15, 2025 - EDAP TMS SA (Nasdaq: EDAP), the global leader in robotic energy-based therapies, reported today unaudited consolidated financial results for the first quarter of 2025. “Demand for Focal One remains on a solid growth trajectory, as demonstrated by our strong first quarter system placements.

Company to host conference call and webcast on Thursday, May 15 th at 8:30am EDT LYON, France, May 1, 2025 -- EDAP TMS SA (Nasdaq: EDAP) (“the Company”), the global leader in robotic energy-based therapies, today announced that it will release its financial results for the first quarter ended March 31, 2025, before the markets open on Thursday, May 15th, 2025. An accompanying conference call and webcast will be conducted by Ryan Rhodes, Chief Executive Officer, Ken Mobeck, Chief Financial Officer, and François Dietsch, Chief Accounting Officer.

AUSTIN, Texas, April 29, 2025 - EDAP TMS SA (Nasdaq: EDAP), the global leader in robotic energy-based therapies, announced the positive final results of the Focal Ablation Versus Radical Prostatectomy (FARP) Study, the first randomized controlled trial completed comparing ultrasound energy-based focal ablation versus Robotic Prostatectomy. The study achieved its primary endpoint and demonstrated that the rate of treatment failure in the Focal Ablation (FA) group is non-inferior to that in the Radical Prostatectomy (RP) group at the final 36-month follow-up.

Focal One i expands HIFUsion® patient-specific imaging compatibility to include PSMA PET, ExactVu™ Micro-Ultrasound, along with AI-driven and intelligent algorithms including Unfold AI™ and OnQ™ Prostate Focal One i extends HIFUsion capabilities to integrate Koelis® 3D biopsy maps and DynaCAD Urology datasets Focal One i system will enable future capabilities including treatment streaming and recording, remote collaborative procedures and expanded clinical indications AUSTIN, Texas, April 24, 2025 - EDAP TMS SA (Nasdaq: EDAP), the global leader in robotic energy-based therapies, announced the launch of the new Focal One i system at the upcoming 120th American Urological Association (AUA) Annual Meeting being held in Las Vegas, Nevada from April 26-29, 2025. The Focal One i system incorporates important new features and enhanced capabilities including: Expanded HIFUsion compatibility including Prostate-Specific Membrane Antigen (PSMA) PET scans, ExactVu Micro-Ultrasound, Unfold AI® and OnQ Prostate®, as well as extended capabilities for Koelis 3D biopsy maps and DynaCAD Urology datasets Streamlined HIFUsion and treatment workflows with guided, step-by-step procedures designed to improve efficiency Onboard Video Libraries to facilitate sharing standard techniques and clinical best practices Integrated ability to stream and record Focal One i treatments as well as enabling remote proctoring and remote collaborative procedures “The new features and design of the Focal One i system are based directly on the feedback from our customers, as well as anticipating the future needs of surgeons performing focal therapy.

Activities to include expert-led demonstrations, semi-live Focal One procedures and hands-on simulations Final results of randomized clinical trial (FARP Study) comparing ultrasound-based focal ablation versus radical prostatectomy as a first-line treatment for prostate cancer Presentation on the first ever remote transatlantic Focal One Robotic HIFU procedure will be given by Ruben Olivares, MD, Urologic Surgeon at the Cleveland Clinic, at the AUA session of the Engineering & Urology Society Notable increase in the number of scientific presentations on focal therapy and ablation in the management of prostate cancer Focal One Robotic HIFU Masterclass will be held at the Keck School of Medicine of the University of Southern California on April 24-25th, prior to AUA Annual Meeting AUSTIN, Texas, April 22, 2025 - EDAP TMS SA (Nasdaq: EDAP), the global leader in robotic energy-based therapies, today announced that Focal One will have its largest presence ever at the upcoming 120th American Urological Association (AUA) Annual Meeting. “This year's AUA meeting promises to be the most significant scientific meeting to date highlighting the growing acceptance and utilization of the Focal One Robotic HIFU platform by the global urology community,” said Ryan Rhodes, Chief Executive Officer of EDAP TMS.

Record full-year 2024 HIFU revenue of USD 25.7 million, an increase of 15.3% over full-year 2023 Record Q4 2024 HIFU revenue of USD 9.3 million, an increase of 15.0% over Q4 2023 U.S. Focal One HIFU procedures grew 51% on a year-over-year basis in 2024 Focal One receives CE Mark for the treatment of deep infiltrating endometriosis Recent landmark HIFI study publication demonstrates positive outcomes with Focal One® Robotic HIFU versus surgery in the management of prostate cancer First patients treated in Phase I/II study evaluating Focal One Robotic HIFU for the treatment of Benign Prostatic Hyperplasia (BPH) Company to host conference call and webcast today, March 27th, at 8:30 a.m. EDT AUSTIN, Texas, March 27, 2025 - EDAP TMS SA (Nasdaq: EDAP), the global leader in robotic energy-based therapies, reported today unaudited consolidated financial results for the fourth quarter and full-year 2024.

Company to host conference call and webcast on Thursday, March 27 th at 8:30am EDT AUSTIN, Texas, March 6, 2025 -- EDAP TMS SA (Nasdaq: EDAP) (“the Company”), the global leader in robotic energy-based therapies, today announced that it will release its financial results for the fourth quarter and full year ended December 31, 2024, before the markets open on Thursday, March 27th, 2025. An accompanying conference call and webcast will be conducted by Ryan Rhodes, Chief Executive Officer, Ken Mobeck, Chief Financial Officer, and François Dietsch, Chief Accounting Officer.