Focal One^® Prostate Cancer Awareness Month Campaign Shines Spotlight on Robotic HIFU Treatment Option

• Focal One Robotic HIFU Patient Story Featured on Health Uncensored with Dr. Drew on Lifetime Network
   

AUSTIN, Texas – September 30, 2025 – EDAP TMS SA (Nasdaq: EDAP), a global leader in robotic energy-based therapies, announced that its non-invasive, nonsurgical treatment option, Focal One Robotic HIFU, was featured on national television on Friday, September 26, reaching millions of viewers nationwide. The segment, which included an interview with a patient treated with Focal One, aired during an episode of Health Uncensored with Dr. Drew on the Lifetime Network, as part of the company’s Prostate Cancer Awareness Month campaign. This broadcast reached viewers across the United States, providing unprecedented national exposure, allowing millions of people across the country to learn about Focal One. In addition, the Company drove multiple patient education events and partnered with hospitals and practices to further educate their local communities through a variety of outreach activities.

During the interview conducted by Dr. Drew Pinsky, prostate cancer patient, Peter D., from Austin, TX, shared his journey from evaluating different treatment options to selecting Focal One Robotic HIFU. Peter explained how he achieved his cancer treatment goals with minimal disruption to his daily life, rapidly returning to normal activities. He was joined on the show by his urologist, Eric Giesler, MD, from Urology Austin, who highlighted how Focal One fits in the spectrum of treatment options in the management of prostate cancer.

Following the show, Dr. Eric Giesler commented, “More patients like Peter are seeking an effective treatment for their prostate cancer without impacting their quality of life. We have entered a new era in the management of prostate cancer where eligible patients now have a non-invasive treatment option with Focal One Robotic HIFU that precisely targets the cancer in the prostate while avoiding the morbidity and the complications of radical treatments such as surgery and radiotherapy. Through advancements in technology, we are now able to diagnose a patient with prostate cancer more accurately which enables us to offer a non-invasive treatment to certain patients, maximizing cancer control and minimizing side effects, which can significantly impact a patient’s quality of life on a daily basis.”

Ryan Rhodes, CEO commented, “We would like to thank Peter for sharing his inspiring story, so other men can benefit from his prostate cancer journey. This national exposure along with all the regional activities are a significant step forward in Focal One’s efforts to raise awareness among patients, caregivers, physicians, and the broader public. More patients, like Peter, are seeking treatments like Focal One to target their cancer, while avoiding the debilitating side effects of radical treatments.”

The full interview is available at https://focalone.com/prostatetreatment/.

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