Focal One® HIFU Receives Prestigious Innovation Award

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 42^nd 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