EDAP Edap Tms S.A. ADS

EDAP TMS SA : HIFU Pioneer Houston Methodist Hospital Acquires EDAP's Next Generation Focal One HIFU System

EDAP TMS SA : HIFU Pioneer Houston Methodist Hospital Acquires EDAP's Next Generation Focal One HIFU System

  

Houston Methodist's Upgrade from Ablatherm to Focal One Reinforces EDAP's Position as a Leading HIFU Innovator

LYON, France, March 4, 2019 -- EDAP TMS SA (Nasdaq: EDAP) -- Houston Methodist Hospital, one of the first hospitals in the U.S. to offer Ablatherm® Robotic High Intensity Focused Ultrasound (HIFU) for patients with localized prostate cancer, has acquired Focal One®, the most advanced HIFU technology available today. 

Houston Methodist Hospital initially invested in EDAP's first generation HIFU system, Ablatherm, in early 2016, and within two years of positive experience made the decision to invest in the next generation Focal One device. This confirms the benefits of EDAP's innovative HIFU technology not only for patients, but also in terms of hospital financials.  Based on a solid business case built upon Ablatherm's usage, the Hospital showed a rapid return on investment, resulting in the acquisition of Focal One.

"Each proposal for cutting edge medical technology must demonstrate how a new procedure will benefit patients, how it differs from competing technologies and how it contributes to the hospital's overall growth," said Michael Garcia, Senior Vice President, Operations at Houston Methodist Hospital.  "In deciding whether to invest in Focal One, we applied these same due diligence principles that we used in the previous technology evaluations. Following the successful business case that we experienced with Ablatherm, we believe Focal One's capabilities will meet and exceed our expectations." 

"Focal One realizes the promise of focal therapy for prostate cancer that has long been anticipated," said Brian Miles, MD, Professor of Urology at Houston Methodist's Weill Cornell Medical College who championed the effort to acquire Focal One. "Just like the lumpectomy has become a standard option for treating breast cancer, we can now use Focal One to ablate only the diseased portion of the prostate when appropriate, rather than removing the prostate altogether."

"Houston Methodist Hospital's acquisition of Focal One is a clear validation of Focal One's superior technology," commented Marc Oczachowski, Chief Executive Officer of EDAP TMS. "By upgrading from Ablatherm, Houston Methodist is confirming the strong clinical interest and technological benefits of Focal One, the latest generation HIFU device, compared to first generation devices currently available in the U.S. We believe Focal One is well positioned to become the standard of care for the focal treatment of localized prostate cancer worldwide."

About EDAP TMS SA

A recognized leader in the global therapeutic ultrasound market for almost 40 years, EDAP TMS develops, manufactures, promotes and distributes worldwide minimally invasive medical devices for urology using ultrasound technology. By combining the latest technologies in imaging and treatment modalities in its complete range of Robotic HIFU devices, EDAP TMS introduced the Focal One® in 2013 in Europe and in 2018 in the US as the answer to all requirements for ideal prostate tissue ablation as a complement to the existing FDA-cleared Ablatherm® Robotic HIFU and Ablatherm® Fusion. As a pioneer and key player in the field of extracorporeal shock wave lithotripsy (ESWL), EDAP TMS exclusively utilizes the latest generation of shock wave source in its Sonolith® range of ESWL systems. For more information on the Company, please visit , and .

About Houston Methodist Hospital

Houston Methodist Hospital is a not-for-profit, faith-based, 907-bed hospital located in the Texas Medical Center. For nearly 100 years, Houston Methodist has been providing highly specialized health care services to the community and the world through its hospital and our six . Medical services include advanced cancer care, heart care, neurology and neurosurgery, orthopedics and sports medicine and much more. Houston Methodist is proud to offer the highest quality patient-focused, family centered care in a spiritual environment. In close affiliation with the Texas Conference of the United Methodist Church, Houston Methodist continues its longstanding commitment to improving the community's health and well-being. 

Forward-Looking Statements

In addition to historical information, this press release may contain forward-looking statements. Such statements are based on management's current expectations and are subject to a number of risks and uncertainties, including matters not yet known to not currently considered material or us by us, and there can be no assurance that anticipated events will occur or that the objectives set out will actually be achieved. Important factors that could cause actual results to differ materially from the results anticipated in the forward-looking statements include, among others, the clinical status and market acceptance of our HIFU devices and the continued market potential for our lithotripsy device. Factors that may cause such a difference also may include, but are not limited to, those described in the Company's filings with the Securities and Exchange Commission and in particular, in the sections "Cautionary Statement on Forward-Looking Information" and "Risk Factors" in the Company's Annual Report on Form 20-F.

Company Contact

Blandine Confort

Investor Relations / Legal Affairs

EDAP TMS SA

50

Investor Contact

Jeremy Feffer

LifeSci Advisors, LLC

212-915-2568

         

  

EN
04/03/2019

Underlying

To request access to management, click here to engage with our
partner Phoenix-IR's CorporateAccessNetwork.com

Reports on Edap Tms S.A. ADS

 PRESS RELEASE

EDAP Announces Appointment of David Horn to Board of Directors

EDAP Announces Appointment of David Horn to Board of Directors          EDAP Announces Appointment of David Horn to Board of Directors AUSTIN, Texas, February 12, 2026 – EDAP TMS S.A. (Nasdaq: EDAP) (“the Company” or “EDAP”), a global leader in therapeutic ultrasound technology, today announced the appointment of David Horn to its Board of Directors, effective February 11, 2026. The addition of Mr. Horn strengthens the Board with extensive experience both advising and leading companies through periods of strategic growth and transformation. Mr. Horn will serve as a member of the Company’...

 PRESS RELEASE

EDAP Announces Preliminary Record Fourth Quarter and Full Year 2025 HI...

EDAP Announces Preliminary Record Fourth Quarter and Full Year 2025 HIFU Revenue; Issues 2026 Revenue Guidance EDAP Announces Preliminary Record Fourth Quarter and Full Year 2025 HIFU Revenue; Issues 2026 Revenue Guidance 36% to 38% Annual YoY HIFU Revenue Growth, Record Performance Driven by Increased Focal One® System Sales and Growth in Number of U.S. Focal One Procedures 69% Annual YoY Growth in Focal One System Placements 28% Q4 YoY Growth in U.S. Procedures Highlights Accelerating Quarterly Procedure Growth AUSTIN, Texas, January 12, 2026 -- EDAP TMS SA (Nasdaq: EDAP) (“the Compan...

 PRESS RELEASE

EDAP Receives FDA 510(k) Clearance for Latest Evolution of Focal One R...

EDAP Receives FDA 510(k) Clearance for Latest Evolution of Focal One Robotic HIFU  EDAP Receives FDA 510(k) Clearance for Latest Evolution of Focal One Robotic HIFU  AUSTIN, Texas, November 20, 2025 - EDAP TMS SA (Nasdaq: EDAP), the global leader in robotic energy-based therapies, today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for new ultrasound imaging and workflow enhancements to the Focal One High Intensity Focused Ultrasound (HIFU) system, further strengthening the company’s market leadership in robotic focal therapy for prostate cancer. ...

 PRESS RELEASE

EDAP to Present at Piper Sandler 37th Annual Healthcare Conference

EDAP to Present at Piper Sandler 37th Annual Healthcare Conference EDAP to Present at Piper Sandler 37th Annual Healthcare Conference Company to Present and Host 1x1 Investor Meetings on Tuesday, December 2nd, 2025 AUSTIN, Texas, November 18, 2025 -- EDAP TMS SA (Nasdaq: EDAP) (“the Company”), the global leader in robotic energy-based therapies, today announced that Chief Executive Officer Ryan Rhodes is scheduled to present and, together with Chief Financial Officer Ken Mobeck, will host 1x1 investor meetings at the upcoming Piper Sandler 37th Annual Healthcare Conference in New York Cit...

 PRESS RELEASE

EDAP Reports Third Quarter 2025 Financial Results

EDAP Reports Third Quarter 2025 Financial Results EDAP Reports Third Quarter 2025 Financial Results 49% YoY HIFU Revenue Growth, Driven by Increased Focal One® Sales and U.S. Procedure Volumes167% YoY Growth in Focal One System Placements15% YoY Growth in U.S. Focal One HIFU ProceduresCompany to Host Conference Call and Webcast on November 6 at 8:30 a.m. ET AUSTIN, Texas, November 6, 2025 - EDAP TMS SA (Nasdaq: EDAP), the global leader in robotic energy-based therapies, reported today unaudited consolidated financial results for the third quarter of 2025. “Our record-breaking third-quart...

ResearchPool Subscriptions

Get the most out of your insights

Get in touch