LYON, France, November 30, 2023 - EDAP TMS SA (Nasdaq: EDAP), (“EDAP”), the global leader in robotic energy-based therapies, today announced that is has received the Industry Category Award from the French National Institute for Intellectual Property (INPI) based on the Company’s innovative therapeutic ultrasound technology. On November 23, 2023, the jury for the 2023 edition of the INPI Trophies honored five companies at an awards ceremony in Paris, which spanned five different categories: Export, Industry, Start-up, Responsible Innovation, and Partnership Research.

“We are very pleased to receive this prestigious award from the INPI for the Industry category, which recognizes EDAP’s strategic priority of securing critical IP protections to help us commercialize therapeutic ultrasound technology globally,” said Ryan Rhodes, Chief Executive Officer of EDAP. “As the value of therapeutic ultrasound technology continues to grow, EDAP remains well positioned with a strong and growing foundation of intellectual property to support the delivery of these innovations to physicians and their patients.”

The Industry Category Award from INPI recognizes EDAP as a developer of medical solutions based on the use of therapeutic ultrasound. Ultrasound therapy reduces the need for certain major surgical and radiation-based procedures, thereby greatly improving patients' quality of life. Based in Lyon, France, with U.S. corporate offices in Los Altos, California, EDAP’s robotic ultrasound platform, Focal One^®, is a non-invasive, incision-free treatment for localized prostate cancer. With sub-millimeter precision, Focal One concentrates high-intensity focused ultrasound (HIFU) on a defined area inside the prostate. This concentration of ultrasound raises the temperature at the focal point until the gland cells are destroyed without damaging surrounding tissue. EDAP is actively pursuing developments of its HIFU proprietary technology in cooperation with Inserm Labtau to address additional targeted pathologies. Other possible uses for Focal One are currently being explored, notably to treat patients suffering from deep rectal endometriosis, a gynecological disease that affects two out of ten French women of childbearing age and 1.3 million of women in the U.S. A clinical research protocol is currently being evaluated with Professor Gil Dubernard, Head of Gynecology Department at Croix-Rousse Academic Hospital, Lyon, France.

About EDAP TMS SA

A recognized leader in the global therapeutic ultrasound market, EDAP TMS develops, manufactures, promotes and distributes worldwide minimally invasive medical devices for various pathologies 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 Europe and in the U.S. as an answer to all requirements for ideal prostate tissue ablation. With the addition of the ExactVu™ Micro-Ultrasound device, EDAP TMS is now the only company offering a complete solution from diagnostics to focal treatment of Prostate Cancer. EDAP TMS also produces and distributes other medical equipment including the Sonolith^® i-move lithotripter and lasers for the treatment of urinary tract stones using extra-corporeal shockwave lithotripsy (ESWL). For more information on the Company, please visit http://www.edap-tms.com, us.hifu-prostate.com and www.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 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
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Investor Contact
John Fraunces
LifeSci Advisors, LLC
(917) 355-2395
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