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 ...

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 COMPANY REPORT PURSUAN ...

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 ...

60 Patients Completed Enrollment in Under 9 Months Study Results Expected in the Second Half of 2024 LYON, France, February 1, 2024 - EDAP TMS SA (NASDAQ:EDAP), the global leader in robotic energy-based therapies, announced today that it has completed enrollment in its Phase 3 study (Endo-HIFU-R2) evaluating Focal One High-Intensity Focused Ultrasound (HIFU) therapy for the treatment of deep infiltrating rectal endometriosis. The ongoing Phase 3 study (NCT05755958) is a comparative, randomized, double blin ...

EDAP TMS S.A. (NASDAQ:EDAP) Q3 2023 Earnings Conference Call November 9, 2023 8:30 AM ET Company Participants John Fraunces - LifeSci Advisors Ryan Rhodes - CEO Ken Mobeck - CFO, US Subsidiary Conference Call Participants Michael Sarcone - Jefferies Frank Takkinen - Lake Street Capital Markets John Fraunces Factors that may cause such a difference include, but are not limited to, those described in the company's filings with the Securities and Exchange Commission. Thank you, John, and good morning, everyone ...

Company Participants In closing, we remain optimistic about the remainder of 2023. And I would like to thank the entire EDAP team for their dedication and hard work that is driving increased awareness amongst clinicians and patients of Focal One HIFU as an important and growing treatment option for prostate cancer management. We look forward to sharing our progress with you again in the fall. And I will now turn it back over to the operator for questions. Operator? Question-and-Answer Session Operator [Oper ...

Start Time: 08:30 January 1, 0000 9:10 AM ET EDAP TMS S.A. (NASDAQ:EDAP) Q1 2023 Earnings Conference Call May 17, 2023, 08:30 AM ET Company Participants Ryan Rhodes - CEO Ken Mobeck - CFO, U.S. Subsidiary Francois Dietsch - CFO John Fraunces - Managing Director of Life Advisors Conference Call Participants Joseph Downing - Piper Sandler Michael Sarcone - Jefferies Sean Lee - H.C. Wainwright Frank Takkinen - Lake Street Capital Markets Operator Greetings, and welcome to the EDAP TMS First Quarter 2023 Earnin ...

As filed with the Securities and Exchange Commission on April 7, 2023 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, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☐ SHELL COMPANY REPORT PURSUANT ...