Semi-Live Focal One Procedure to be Conducted on August 15th at 5:00 pm (KST) LYON, France, August 6, 2024 - EDAP TMS SA (NASDAQ:EDAP), the global leader in robotic energy-based therapies, today announced that the Company's leading robotic HIFU technology platform, Focal One, will be featured at the 41st World Congress of Endourology and Uro-Technology (WCET 2024) meeting, taking place in Seoul, South Korea, from August 12-16, 2024. "Our leading Focal One platform continues to generate strong interest from ...

LYON, France, July 19, 2024 - EDAP TMS SA (Nasdaq: EDAP), the global leader in robotic energy-based therapies, today announced interim results from its Phase 3 study evaluating robotic High-Intensity Focused Ultrasound (HIFU) therapy for the treatment of deep infiltrating endometriosis. The Phase 3 study is a 60- patient comparative, randomized, double blind trial, with the primary objective of evaluating acute pelvic pain levels. All patients were initially followed for three months after either the HIFU t ...

Robotic HIFU therapy continues to maintain an excellent safety profile, confirming positive safety data from prior Phase 1 and 2 studies in patients with deep infiltrating endometriosis At three months post procedure, the study's primary endpoint of reduced acute pelvic pain in the HIFU treatment arm compared to the Sham treatment arm was not met Significant improvements were observed across primary and secondary outcome measures (endometriosis and digestive symptoms) across the entire study population at t ...

New appointments bring significant commercial experience with a focus on growing key strategic markets Expands executive leadership in growing disruptive, robotics-based capital equipment in both Urology and Gynecology therapeutic applications LYON, France, June 3, 2024 - EDAP TMS SA (Nasdaq: EDAP), the global leader in robotic energy-based therapies, today announced the appointments of Damien Desmedt and Alexander Fromm to further strengthen the Company's European and Middle Eastern commercial leadership. ...

EDAP TMS (NASDAQ:EDAP) Q1 2024 Earnings Call Transcript May 16, 2024 8:30 AM ET John Fraunces - LifeSci Advisors Ryan Rhodes - Chief Executive Officer Ken Mobeck - Chief Financial Officer Michael Sarcone - Jefferies Frank Takkinen - Lake Street Capital Jason Bednar - Piper Sandler Swayampakula Ramakanth - HC Wainwright Greetings and welcome to the EDAP TMS First Quarter 2024 Earnings Conference Call. At this time. all participants are in a listen-only mode. A brief question-and-answer session will follow th ...

LYON, France, April 23, 2024 - EDAP TMS SA (NASDAQ:EDAP), the global leader in robotic energy-based therapies, announced that final results from the HIFI Study, the largest clinical trial ever conducted comparing EDAP's Focal One robotic high intensity focused ultrasound (HIFU) versus radical prostatectomy (RP) for the treatment of prostate cancer, will be presented during a plenary session at the 119th American Urological Association Annual Meeting (AUA 2024), which is taking place from May 3-6, 2024, in S ...

Table of Contents As filed with the Securities and Exchange Commission on March 28, 2024 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 20-F ☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(B) OR (G) OF THE SECURITIES EXCHANGE ACT OF 1934, OR ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Fiscal Year Ended December 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☐ SHELL COMP ...

EDAP TMS S.A. (NASDAQ:EDAP) Q4 2023 Earnings Conference Call March 27, 2024 8:30 AM ET Company Participants Ryan Rhodes - Chief Executive Officer Ken Mobeck - Chief Financial Officer John Fraunces - LifeSci Advisors Conference Call Participants Michael Sarcone - Jefferies Frank Takkinen - Lake Street Capital Swayampakula Ramakanth - HC Wainwright Operator Greetings and welcome to the EDAP TMS fourth quarter 2023 earnings call. At this time, all participants are in a listen-only mode. A question and answer ...

Focal One HIFU has potential to address large market impacting thousands of women each year LYON, France, March 4, 2024 - EDAP TMS SA (NASDAQ:EDAP), the global leader in robotic energy-based therapies, announced today that its Focal One platform has been granted Breakthrough Device designation by the US Food and Drug Administration (FDA) for the treatment of deep infiltrating endometriosis (DIE). In June 2018, the FDA cleared Focal One Robotic Focal HIFU for the ablation of prostatic tissue. "Receiving Bre ...

Record full-year 2023 preliminary unaudited revenue of EUR 60.4 million ($65.4 million USD), an increase of 9.6% over full-year 2022, driven by 31.7% HIFU growth Record Q4 2023 preliminary unaudited revenue of EUR 19.6 million ($21.3 million USD), an increase of 24.8% over for Q4 2022, driven by 38.8% HIFU growthStrong Q4 2023 U.S. Focal One® HIFU procedure growth of 136% year-over-year LYON, France, February 29, 2024 - EDAP TMS SA (NASDAQ:EDAP), a global leader in robotic energy-based therapies, today ann ...