EDAP TMS SA (EDAP) Company Overview

San Diego, CA and Austin, Texas, February 6, 2025 - Cortechs.ai, an emerging leader in novel imaging solutions for prostate cancer care, and EDAP TMS SA (Nasdaq: EDAP), the global leader in robotic energy-based therapies, today announced the successful completion of the world's first OnQ Prostate-assisted Focal One® Robotic HIFU procedure at the University of California, San Francisco (UCSF) Prostate Center. This milestone marks the first clinical application of OnQ Prostate's patented RSI technology to guide focal therapy, demonstrating how advanced MR-imaging can improve lesion localization and targeting for urologists performing focal therapy.

Company Reports Preliminary Worldwide Record Fourth Quarter Sales of 11 Focal One Systems  Record U.S. Fourth Quarter Focal One System Sales Record Number of U.S. Focal One Procedures, with Year-Over-Year Growth of 30% PDF Version AUSTIN, Texas, January 13, 2025 -- EDAP TMS SA (Nasdaq: EDAP) (“the Company” or “EDAP”), the global leader in robotic energy-based therapies, today announced preliminary record Focal One System sales for the fourth quarter of calendar year 2024. The Company experienced robust demand for its Focal One Robotic HIFU technology, reporting preliminary record fourth quarter of 11 Focal One Systems.

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AUSTIN, Texas, January 8, 2025 - EDAP TMS SA (Nasdaq: EDAP), the global leader in robotic energy-based therapies, today announced that the first patient has been treated in a phase I/II PULS Trial sponsored by the Centre Léon Bérard, Lyon, France, evaluating proprietary High Intensity Focused Ultrasound (HIFU) technology for the treatment of pancreatic tumors.

HIFI Study is the largest (N = 3,328) prospective, comparative, multi-center clinical study ever conducted comparing prostate cancer treatments Positive study results are expected to drive further adoption of Focal One as a first line treatment option for the management of localized prostate cancer Study shows Focal One Robotic HIFU is non-inferior to surgery, meeting primary endpoint of non-inferiority for Salvage Treatment-free Survival (STFS) after High Intensity Focused Ultrasounds (HIFU) compared to Radical Prostatectomy (RP) at 30 months Study shows that patients receiving HIFU had better outcomes with respect to urinary continence and erectile function compared to patients receiving RP LYON, France, December 4, 2024 - EDAP TMS SA (Nasdaq: EDAP), the global leader in robotic energy-based therapies, today announced the publication of the full results from the HIFI study in the prestigious, peer-reviewed journal, European Urology, which has the highest impact factor amongst scientific journals focused in urology. The study evaluated HIFU versus radical prostatectomy (RP) as a first line treatment of localized prostate cancer.

Treatment with robotic HIFU showed reduction in moderate and severe post-operative complications and reduced hospital stay compared to surgery LYON, France, November 19, 2024 - EDAP TMS SA (Nasdaq: EDAP), the global leader in robotic energy-based therapies, today announced a moderated scientific presentation of clinical data comparing Focal One HIFU versus surgery for the treatment of deep infiltrating endometriosis at the 2024 AAGL Global Congress, which took place from November 16-19, 2024, in New Orleans, LA. The presentation was entitled, "Evaluation of rectal endometriosis treatment with high-intensity focused ultrasound versus surgery: a retrospective multicenter study", and was delivered by Professor Gil Dubernard, Head of Gynecology Department at Croix-Rousse University Hospital, Lyon, France, and Principal Investigator.

EDAP TMS S.A. (NASDAQ:EDAP ) Q3 2024 Earnings Conference Call November 7, 2024 8:30 AM ET Company Participants John Fraunces - LifeSci Advisors Ryan Rhodes - Chief Executive Officer Ken Mobeck - Chief Financial Officer Conference Call Participants Michael Sarcone - Jefferies Sean Lee - H.C.

When combined with EDAP's Focal One platform, Avenda's Unfold AI enables more accurate and patient-specific treatment options.

First Unfold AI ® -Assisted Focal One procedures successfully performed at the UCLA School of Medicine FDA-cleared Unfold AI enables urologists to provide tailored, patient-specific Robotic HIFU ablation for prostate cancer patients EDAP and Avenda Health to present Unfold AI-Assisted Focal One simulated procedures at the 2024 Joint Meeting of the Focal Therapy Society & Society of Urologic Robotic Surgeons in Washington, DC September 19-21, 2024 LYON, France, September 19, 2024 - EDAP TMS SA (Nasdaq: EDAP), the global leader in robotic energy-based therapies, and Avenda Health (“Avenda”), a leading AI healthcare company, today announced a collaboration agreement for the purpose of offering personalized prostate cancer care, utilizing Avenda's groundbreaking AI technology, Unfold AI, to launch the world's first AI-assisted Focal One robotic high-intensity focused ultrasound (HIFU) procedures. Avenda Health's Unfold AI is a multimodal AI decision support platform cleared by the U.S. Food and Drug Administration (FDA) that brings “superhuman” abilities to cancer surgeons and oncologists to power the future of cancer care.