Core Insights - The HIFI Study is the largest prospective, comparative, multi-center clinical study ever conducted comparing prostate cancer treatments, involving 3,328 patients [1][2] - Positive results from the study are expected to drive further adoption of Focal One as a first-line treatment option for localized prostate cancer [1][2] - The study demonstrated that Focal One Robotic HIFU is non-inferior to surgery, meeting the primary endpoint of noninferiority for Salvage Treatment-free Survival (STFS) at 30 months [1][3] Clinical Data Highlights - At 30 months, the adjusted STFS was higher in the HIFU arm (90%) compared to the RP arm (86%) [3] - The risk of salvage treatment was lower in the HIFU arm compared to RP, with a hazard ratio of 0.71 [95% CI, 0.52-0.97], p=0.008 [3] - The International Continence Society score showed significantly less deterioration for HIFU (29%) versus RP (44%) [3] - The International Index of Erectile Function-5 indicated a significantly smaller decrease in erectile function after HIFU compared to RP [3] Publication and Impact - The results of the HIFI study were published in the prestigious journal European Urology, which has the highest impact factor among urology-focused scientific journals [1][4] - The publication is expected to increase awareness of robotic HIFU technology and its benefits among the global urology and patient community [2] - The study's findings underscore HIFU's excellent oncologic control and significantly better functional outcomes compared to radical prostatectomy [2] Company Overview - EDAP TMS SA is a recognized leader in robotic energy-based therapies, developing and distributing minimally invasive medical devices using ultrasound technology [5] - The company introduced Focal One as a leading prostate focal therapy, with potential applications beyond prostate cancer [5]

           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 ...

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. Wainwright & Co. Operator Good day, everyone, and welcome to today's EDAP TMS Third Quarter 2024 Earnings Conference Call. At this time all participants are in a listen-only mode. Later you will have an opportunity to ask ...

Company to host conference call and webcast on Thursday, November 7th at 8:30am EDT LYON, France, October 24, 2024 -- 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 third quarter ended September 30, 2024, before the markets open on Thursday, November 7th, 2024. An accompanying conference call and webcast will be conducted by Ryan Rhodes, Chief Executive Officer, Ken Mobeck, Chief Financial O ...

EDAP TMS (EDAP) has taken a significant step toward expanding its AI-assisted prostate cancer care through a strategic collaboration with AI healthcare company Avenda Health. This partnership is centered around integrating Avenda's FDA-cleared Unfold AI technology into EDAP's Focal One robotic high-intensity focused ultrasound (HIFU) platform. This is expected to create the world's first AI-assisted Focal One HIFU procedures. EDAP Stock Movement Since the announcement on Sept. 19, EDAP shares have remained ...

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), ...

LYON, France, August 29, 2024 - EDAP TMS SA (Nasdaq: EDAP), the global leader in robotic energy-based therapies, announced that Ryan Rhodes, Chief Executive Officer, is scheduled to participate in a fireside chat and host 1x1 investor meetings at the H.C. Wainwright 26th Annual Global Investment Conference, which is being held September 9-11, 2024, in New York City. | --- | --- | |-------|---------------------------------------| | | | | | Date: Tuesday, September 10th | | | Time: 3:00-3:30 PM ET | | | Locat ...

EDAP TMS S.A. (NASDAQ:EDAP) Q2 2024 Results Conference Call August 28, 2024 8:30 AM ET Company Participants John Fraunces - LifeSci Advisors Ryan Rhodes - Chief Executive Officer Ken Mobeck - Chief Financial Officer Francois Dietsch - Chief Accounting Officer Conference Call Participants Michael Sarcone - Jefferies Joseph Downing - Piper Sandler RK Ramakanth - H.C. Wainwright Operator Good day, and welcome to the EDAP TMS Second Quarter 2024 Earnings Conference Call. All participants will be in a listen-onl ...

Record Q2 2024 total worldwide revenue of EUR 15.8 million (USD 17.0 million) increased 10.6% over Q2 2023 Record first half 2024 total worldwide revenue of EUR 30.7 million (USD 33.1 million) increased 5.6% over first half 2023 Strong Q2 2024 U.S. Focal One® HIFU procedure growth of +63% year-over-year Company to host conference call and webcast today, August 28th, at 8:30 a.m. EDT LYON, France, August 28, 2024 - EDAP TMS SA (Nasdaq: EDAP), the global leader in robotic energy-based therapies, reported toda ...

Company to host conference call and webcast on Wednesday, August 28th at 8:30am EDT LYON, France, August 7, 2024 -- 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 second quarter ended June 30, 2024, before the markets open on Wednesday, August 28th, 2024. An accompanying conference call and webcast will be conducted by Ryan Rhodes, Chief Executive Officer, Ken Mobeck, Chief Financial Officer, ...