UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER
PURSUANT TO RULE 13a-16 OR 15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
September 8, 2025
Commission File Number: 0-29374
EDAP TMS S.A.
Parc Activite La Poudrette Lamartine
4/6 Rue du Dauphine
69120 Vaulx-en-Velin - France
Indicate by check mark whether the registrant files or will file annual reports under cover
of Form 20-F or Form 40-F.
Form 20-F [ x] Form 40-F [ ]
SIGNATURES
Pursuant to the requirements of the Securities Act of 1934, the registrant has duly caused this
report to be signed on its behalf by the undersigned, thereunto duly authorized.
Date: September 8, 2025
EDAP TMS S.A.
/s/ KEN MOBECK
KEN MOBECK
CHIEF FINANCIAL OFFICER
EDAP Receives HIFU Reimbursement for Prostate
Cancer in France
| · | Focal One Robotic HIFU procedure now covered under France’s national universal health system |
| · | Reimbursement milestone allows increased patient access to Focal One Robotic HIFU |
AUSTIN, Texas, September 8, 2025 - EDAP TMS SA
(Nasdaq: EDAP), the global leader in robotic energy-based therapies, announced today that the French Ministry of Health has awarded reimbursement
for High Intensity Focused Ultrasound (HIFU) procedure for the treatment of prostate cancer in France. Reimbursement in France will specifically
cover use of the Focal One Robotic HIFU procedure for eligible patients as a primary treatment of localized prostate cancer as well
as a salvage treatment option following radiotherapy.
“Securing reimbursement for Focal One
in France represents an important commercial milestone for our company, allowing a significant number of prostate cancer patients access
to an effective, non-invasive, treatment for managing their prostate cancer. Importantly, the positive results from the groundbreaking
HIFI Study provided the critical scientific evidence to help secure reimbursement for Focal One,” said Ryan Rhodes, Chief Executive
Officer. “As one of the largest healthcare markets in Europe, we also believe that securing reimbursement in France is likely to
accelerate reimbursement for Focal One Robotic HIFU in additional European countries. Over time, we anticipate additional emerging
clinical evidence supporting the use of focal therapy in the management of prostate cancer will drive further adoption of Focal One.
In addition to the HIFI study, we believe the Level 1 evidence from the FARP Study, which was recently presented at this year’s
American Urological Association Annual Meeting, will also help accelerate demand for our leading Focal One platform, as a growing
number of urologists realize the benefits of HIFU over radical treatment options such as surgery or radiation.”
This final step in the reimbursement pathway follows the positive favorable
opinion issued in December 2023 by the French National Authority for Health (HAS) to include HIFU as a procedure covered under the national
universal health system, Social Security ("Sécurité Sociale") following the completion and analysis of the HIFI
Study sponsored by the French Urology Association. Coverage became effective on September 1, 2025, and reimbursement details will become
available in the near future.
For more information about the results from HIFI Study, please
visit hifistudy.com.
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
