Core Insights - EDAP TMS SA reported preliminary record sales of 11 Focal One Systems in the fourth quarter of 2024, indicating strong demand for its robotic HIFU technology [2] - The number of Focal One procedures in the U.S. grew by 30% year-over-year, reflecting the increasing adoption of this treatment for prostate cancer [2] - The company anticipates that the recent publication of the HIFI study in European Urology will further enhance awareness and adoption of the Focal One technology [2] Company Overview - EDAP TMS SA is recognized as a leader in robotic energy-based therapies, focusing on minimally invasive medical devices utilizing ultrasound technology [3] - The Focal One system is positioned as a leading prostate focal therapy, with potential applications extending beyond prostate cancer [3]

Company Overview - EDAP TMS SA is a global leader in robotic energy-based therapies, focusing on minimally invasive medical devices utilizing ultrasound technology [3] - The company has introduced the Focal One platform, which is recognized as the leading prostate focal therapy controlled by urologists, with potential applications beyond prostate cancer [3] Leadership Appointment - Joshua H. Levine has been appointed to the Board of Directors of EDAP TMS, bringing extensive executive experience in the medical technology sector [1] - Levine's previous roles include President and CEO of Accuray Incorporated, where he led a turnaround that restored consistent growth and profitability [1][2] - He has also served as President and CEO of Immucor, Inc., overseeing its transition to a private entity in a $2 billion acquisition [1][2] Strategic Vision - Levine's appointment is expected to enhance EDAP's strategic vision and execution as the company expands its leadership in advanced HIFU technology applications [1] - The Focal One platform is noted for transforming treatment paradigms in prostate cancer and has potential applications in other therapeutic areas such as endometriosis and BPH [1] Market Position - EDAP TMS has made significant progress in establishing the Focal One platform as the dominant technology for robotic HIFU over the past two years [1] - The company aims to leverage Levine's expertise in portfolio transformation and strategic business development to drive shareholder value [1][2]

Core Insights - EDAP TMS SA has initiated a phase I/II PULS Trial to evaluate High Intensity Focused Ultrasound (HIFU) technology for treating pancreatic tumors, marking a significant milestone in addressing this challenging disease [1][2] - The trial aims to assess the tolerance and preliminary efficacy of HIFU in patients with locally advanced and unresectable pancreatic tumors, highlighting the urgent need for new treatment options in this area [2][3] Company Overview - EDAP TMS SA is recognized as a leader in robotic energy-based therapies, developing and distributing minimally invasive medical devices utilizing ultrasound technology [4] - The company has introduced the Focal One system, which is a leading prostate focal therapy device, and is exploring its potential for multiple indications beyond prostate cancer [4] Industry Context - Pancreatic cancer has a five-year survival rate of only 11.5%, with an estimated 62,210 new cases and 49,830 deaths projected in the U.S. for 2022, making it one of the most difficult cancers to treat [3] - Despite a 5.5% improvement in the relative five-year survival rate over the past decade, pancreatic cancer remains the third leading cause of cancer deaths, underscoring the critical need for innovative treatment solutions [3]

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]

Core Insights - Robotic High-Intensity Focused Ultrasound (HIFU) therapy shows significant advantages over traditional surgery for treating deep infiltrating endometriosis, including reduced post-operative complications and shorter hospital stays [1][2][3] Company Overview - EDAP TMS SA is a leader in the global therapeutic ultrasound market, developing and distributing minimally invasive medical devices for various pathologies using ultrasound technology [5] - The company introduced the Focal One® device in Europe and the U.S. for prostate tissue ablation and offers a complete solution from diagnostics to treatment of prostate cancer [5] Study Details - A retrospective multicenter study compared outcomes of 120 patients, with 60 receiving HIFU treatment and 60 undergoing surgical excision for endometriosis [2][3] - The study aimed to evaluate treatment-related improvements in symptoms and morbidity between the two approaches [2] Key Findings - HIFU therapy resulted in fewer moderate and severe post-operative complications compared to surgery, indicating its potential as a viable alternative for select patients [3] - Patients treated with HIFU experienced shorter operating times and reduced lengths of hospital stay [3] Future Developments - The ongoing Phase 3 trial for Focal One HIFU continues, with over 85% of patients from the Sham treatment arm opting for HIFU therapy as their symptoms returned [4] - The company plans to communicate with the FDA regarding the trial data and next steps for the HIFU program [4]

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 ...