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Focal One® HIFU Receives Prestigious Innovation Award

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EDAP TMS SA (Nasdaq: EDAP), a leader in robotic energy-based therapies, has received the prestigious 2025 Industry Award for Innovations in Endourological Instrumentation from the Endourological Society for its Focal One High-Intensity Focused Ultrasound (HIFU) platform.

The award, presented at the 42nd World Congress of Endourology and Uro-Technology, recognizes Focal One as the first Focal Therapy technology to receive this distinction. The platform was honored for its pioneering development in robotic HIFU for prostate cancer treatment.

EDAP TMS SA (Nasdaq: EDAP), líder en terapias robóticas basadas en energía, ha recibido el prestigioso Industry Award 2025 for Innovations in Endourological Instrumentation de la Endourological Society por su plataforma Focal One High-Intensity Focused Ultrasound (HIFU).

El premio, otorgado en el 42.º Congreso Mundial de Endourología y Uro-Technología, reconoce a Focal One como la primera tecnología de Focal Therapy en recibir esta distinción. La plataforma fue galardonada por su desarrollo pionero en HIFU robótico para el tratamiento del cáncer de próstata.

EDAP TMS SA (Nasdaq: EDAP), líder en terapias basadas en energía con robots, ha recibido el prestigioso Premio de la Industria 2025 a Innovaciones en Instrumentación Endourológica de la Endourological Society por su plataforma Focal One High-Intensity Focused Ultrasound (HIFU).

El premio, presentado en el 42º Congreso Mundial de Endourología y Uro-Tecnología, reconoce a Focal One como la primera tecnología de Focal Therapy en recibir esta distinción. La plataforma fue honrada por su desarrollo pionero en HIFU robótico para el tratamiento del cáncer de próstata.

EDAP TMS SA (나스닥: EDAP), 로봇 기반 에너지 치료의 선두 주자, Endourological Society로부터 2025 Industry Award for Innovations in Endourological Instrumentation 상을 Focal One High-Intensity Focused Ultrasound (HIFU) 플랫폼으로 수상했습니다.

이 상은 제42회 세계 Endourology 및 Uro-Technology 학술대회에서 수여되었으며, Focal One이 이 표상을 받은 최초의 Focal Therapy 기술임을 인정받았습니다. 이 플랫폼은 전립선암 치료를 위한 로봇 HIFU의 선구적 개발로 인정받았습니다.

EDAP TMS SA (Nasdaq: EDAP), leader des thérapies robotiques basées sur l’énergie, a reçu le prestigieux Prix Industry 2025 pour les Innovations dans l’Instrumentation Endourologique de la Endourological Society pour sa plateforme Focal One High-Intensity Focused Ultrasound (HIFU).

Le prix, remis au 42e Congrès mondial de l’endourologie et de l’urotechnologie, reconnaît Focal One comme la première technologie de Focal Therapy à recevoir cette distinction. La plateforme a été honorée pour son développement pionnier du HIFU robotiques dans le traitement du cancer de la prostate.

EDAP TMS SA (Nasdaq: EDAP), ein führendes Unternehmen für roboterunterstützte energiebasierte Therapien, hat den renommierten Industry Award 2025 für Innovationen in der endourologischen Instrumentierung von der Endourological Society für seine Plattform Focal One High-Intensity Focused Ultrasound (HIFU) erhalten.

Der Preis wurde auf dem 42. Weltskongress für Endourologie und Uro-Technologie verliehen und erkennt Focal One als erste Focal-Therapy-Technologie an, die diese Auszeichnung erhält. Die Plattform wurde für ihre wegweisende Entwicklung des roboterbasierten HIFU zur Behandlung von Prostatakrebs geehrt.

EDAP TMS SA (ناسداك: EDAP)، رائدة في العلاجات المعتمدة على الطاقة الروبوتية، حصلت على جائزة الصناعة 2025 لابتكارات في أدوات Endourology من جمعية Endourological بفضل منصتها Focal One High-Intensity Focused Ultrasound (HIFU).

تم تقديم الجائزة في المؤتمر العالمي الأربعين الثاني لEndourology والتقنية البولية، وتُعرّف فوكال ون كأول تقنية علاج مركّز محلي تحصل على هذا التمييز. تم تكريم المنصة لتطويرها الرائد في HIFU الروبوتي لعلاج سرطان البروستاتا.

EDAP TMS SA(纳斯达克:EDAP),在机器人能量治疗领域的领军者,获得由泌尿道学会授予的<2025行业创新奖(Endourological Instrumentation Innovations),表彰其 Focal One 高强度聚焦超声(HIFU)平台

该奖项在第42届泌尿外科与泌尿科技世界大会上颁发,认定 Focal One 为首个获得此荣誉的焦点治疗技术。该平台因在机器人HIFU用于前列腺癌治疗方面的开创性发展而获奖。

Positive
  • First Focal Therapy technology to receive the prestigious Endourological Society Industry Award
  • Recognition validates company's leadership in HIFU and focal therapy innovation
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  • None.

         

Focal One® HIFU Receives Prestigious Innovation Award

AUSTIN, Texas, September 16, 2025 - EDAP TMS SA (Nasdaq: EDAP), the global leader in robotic energy-based therapies, announced today that the company has been honored with the 2025 Industry Award for Innovations in Endourological Instrumentation by the Endourological Society in recognition of its groundbreaking work with the Focal One High-Intensity Focused Ultrasound (HIFU) platform.

Focal One is the first Focal Therapy technology to receive this distinguished award. The Endourological Society Industry Award is presented annually to an individual or an organization that has made outstanding contributions in the field of urology. Focal One was recognized for its pioneering development and expansion of robotic HIFU for prostate cancer.

“We are deeply honored that the Endourological Society has recognized our leadership in advancing HIFU and focal therapy,” said Ryan Rhodes, CEO. “This award celebrates the continued innovation behind Focal One and our commitment to providing urologists with best-in-class technology that expands treatment options for patients with localized prostate cancer.”

The award was presented during the 42nd World Congress of Endourology and Uro-Technology (WCET).


About EDAP TMS SA

A recognized leader in robotic energy-based therapies, EDAP TMS develops, manufactures, promotes and distributes worldwide minimally invasive medical devices for various conditions using ultrasound technology. By combining the latest technologies in imaging, robotics and precise non-invasive energy delivery, EDAP introduced the Focal One® in Europe and in the U.S. as the leading prostate focal therapy controlled by urologists with the potential to expand to multiple indications beyond prostate cancer. For more information on the Company, please visit https://focalone.com/

Forward-Looking Statements

In addition to historical information, this press release contains forward-looking statements within the meaning of applicable federal securities laws, including Section 27A of the U.S. Securities Act of 1933 (the “Securities Act”) or Section 21E of the U.S. Securities Exchange Act of 1934, which may be identified by words such as “believe,” “can,” “contemplate,” “could,” “plan,” “intend,” “is designed to,” “may,” “might,” “potential,” “objective,” “target,” “project,” “predict,” “forecast,” “ambition,” “guideline,” “should,” “will,” “estimate,” “expect” and “anticipate,” or the negative of these and similar expressions, which reflect our views about future events and financial performance. Such statements include our expectations to enter into a credit facility with EIB, the size thereof, the timing thereof and the use of proceeds from such credit facility. 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 us or not currently considered material 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 and distribution divisions, as well as risks associated with the current worldwide inflationary environment, the uncertain worldwide economic, political and financial environment, geopolitical instability, climate change and pandemics like the COVID 19 pandemic, or other public health crises, and their related impact on our business operations, including their impacts across our businesses or demand for our devices and services. Other factors that may cause such a difference may also 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.

Forward-looking statements speak only as of the date they are made. Other than required by law, we do not undertake any obligation to update them in light of new information or future developments. These forward-looking statements are based upon information, assumptions and estimates available to us as of the date of this press release, and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete.

Company Contact
Blandine Confort
Investor Relations / Legal Affairs
EDAP TMS SA
+33 4 72 15 31 50
bconfort@edap-tms.com

Investor Contact
John Fraunces
LifeSci Advisors, LLC
(917) 355-2395
jfraunces@lifesciadvisors.com


FAQ

What award did EDAP receive for its Focal One HIFU technology in 2025?

EDAP received the 2025 Industry Award for Innovations in Endourological Instrumentation from the Endourological Society for its Focal One HIFU platform.

Why was EDAP's Focal One HIFU platform recognized by the Endourological Society?

Focal One was recognized for its pioneering development and expansion of robotic HIFU technology for prostate cancer treatment.

Who presents the Endourological Society Industry Award?

The Endourological Society presents this award annually to individuals or organizations making outstanding contributions in urology.

Where was EDAP's Focal One HIFU award presented?

The award was presented during the 42nd World Congress of Endourology and Uro-Technology (WCET).
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