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
July
1, 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: July 1, 2025
EDAP TMS S.A.
/s/
KEN MOBECK
KEN MOBECK
CHIEF FINANCIAL OFFICER
EDAP
Announces Transition from Foreign Private Issuer to U.S. Domestic Filer Status
Transition
to U.S. reporting status to take effect on January 1, 2026
AUSTIN,
Texas, July 1, 2025 - EDAP TMS SA (Nasdaq: EDAP) (“the Company” or “EDAP”), the global leader in robotic energy-based
therapies, announced a change in its U.S. reporting status. EDAP TMS S.A. (the “Company”) currently qualifies as a foreign
private issuer under applicable U.S. Securities and Exchange Commission (“SEC”) rules and regulations. Effective January
1, 2026, the Company will no longer qualify for foreign private issuer status and will begin complying with and reporting under SEC reporting
and other rules and Nasdaq listing requirements applicable to U.S. domestic filers, including, but not limited to, requirements with
respect to the composition of the Company’s board of directors and committees, certain corporate governance matters and shareholder
approval of certain actions.
“This
transition marks a significant milestone in our evolution as a public company,” said Ryan Rhodes, Chief Executive Officer of EDAP.
“It underscores our long-term commitment to transparency, regulatory best practices and expanding our presence within the U.S.
Investor community. We believe this move will further strengthen our relationship with shareholders and attract new institutional
investors.”
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
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
