6-K

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

Transitionto 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-basedtherapies, announced a change in its U.S. reporting status. EDAP TMS S.A. (the “Company”) currently qualifies as a foreignprivate issuer under applicable U.S. Securities and Exchange Commission (“SEC”) rules and regulations. Effective January1, 2026, the Company will no longer qualify for foreign private issuer status and will begin complying with and reporting under SEC reportingand other rules and Nasdaq listing requirements applicable to U.S. domestic filers, including, but not limited to, requirements withrespect to the composition of the Company’s board of directors and committees, certain corporate governance matters and shareholderapproval of certain actions.“Thistransition 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 institutionalinvestors.”About EDAPTMS SAArecognized leader in robotic energy-based therapies, EDAP TMS develops, manufactures, promotes and distributes worldwide minimallyinvasive medical devices for various conditions using ultrasound technology. By combining the latest technologies in imaging, roboticsand precise non-invasive energy delivery, EDAP introduced the Focal One^®^ in Europe and in the U.S. asthe 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-LookingStatementsInaddition to historical information, this press release contains forward-looking statements within the meaning of applicable federal securitieslaws, including Section 27A of the U.S. Securities Act of 1933 (the “Securities Act”) or Section 21E of the U.S. SecuritiesExchange 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 statementsare based on management's current expectations and are subject to a number of risks and uncertainties, including matters not yet knownto us or not currently considered material by us, and there can be no assurance that anticipated events will occur or that the objectivesset out will actually be achieved. Important factors that could cause actual results to differ materially from the results anticipatedin the forward-looking statements include, among others, the clinical status and market acceptance of our HIFU devices and the continuedmarket potential for our lithotripsy and distribution divisions, as well as risks associated with the current worldwide inflationaryenvironment, the uncertain worldwide economic, political and financial environment, geopolitical instability, climate change and pandemicslike the COVID 19 pandemic, or other public health crises, and their related impact on our business operations, including their impactsacross our businesses or demand for our devices and services.Otherfactors that may cause such a difference may also include, but are not limited to, those described in the Company's filings with theSecurities and Exchange Commission and in particular, in the sections "Cautionary Statement on Forward-Looking Information" and "RiskFactors" in the Company's Annual Report on Form 20-F. Forward-lookingstatements speak only as of the date they are made. Other than required by law, we do not undertake any obligation to update them inlight of new information or future developments. These forward-looking statements are based upon information, assumptions and estimatesavailable 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.CompanyContactBlandineConfortInvestorRelations / Legal AffairsEDAPTMS SA+334 72 15 31 50bconfort@edap-tms.comInvestorContactJohnFrauncesLifeSciAdvisors, LLC(917)355-2395jfraunces@lifesciadvisors.com