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EDAP Announces Transition from Foreign Private Issuer to U.S. Domestic Filer Status

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EDAP TMS (NASDAQ:EDAP), the global leader in robotic energy-based therapies, announced its transition from foreign private issuer status to U.S. domestic filer status, effective January 1, 2026.

The transition will require EDAP to comply with SEC reporting rules and Nasdaq listing requirements applicable to U.S. domestic filers, including new requirements regarding board composition, corporate governance matters, and shareholder approval processes. CEO Ryan Rhodes emphasized this change as a significant milestone that demonstrates the company's commitment to transparency and regulatory best practices.

EDAP TMS (NASDAQ:EDAP), leader mondiale nelle terapie robotiche basate sull'energia, ha annunciato il passaggio dallo status di emittente privata estera a quello di società quotata domestica negli Stati Uniti, a partire dal 1° gennaio 2026.

Questa transizione richiederà a EDAP di conformarsi alle norme di rendicontazione della SEC e ai requisiti di quotazione Nasdaq applicabili alle società domestiche statunitensi, inclusi nuovi obblighi riguardanti la composizione del consiglio di amministrazione, le questioni di governance aziendale e i processi di approvazione degli azionisti. Il CEO Ryan Rhodes ha sottolineato che questo cambiamento rappresenta una tappa importante che dimostra l'impegno dell'azienda verso la trasparenza e le migliori pratiche regolamentari.

EDAP TMS (NASDAQ:EDAP), líder mundial en terapias robóticas basadas en energía, anunció su transición de emisor privado extranjero a presentador doméstico en EE.UU., efectiva a partir del 1 de enero de 2026.

Esta transición obligará a EDAP a cumplir con las normas de reporte de la SEC y los requisitos de cotización de Nasdaq aplicables a presentadores domésticos estadounidenses, incluyendo nuevos requisitos sobre la composición del consejo, asuntos de gobernanza corporativa y procesos de aprobación de accionistas. El CEO Ryan Rhodes destacó este cambio como un hito significativo que demuestra el compromiso de la empresa con la transparencia y las mejores prácticas regulatorias.

EDAP TMS (NASDAQ:EDAP)는 로봇 에너지 기반 치료 분야의 글로벌 선두주자로서, 2026년 1월 1일부로 외국 사설 발행자에서 미국 내 국내 제출자 신분으로 전환한다고 발표했습니다.

이번 전환으로 EDAP는 미국 국내 제출자에게 적용되는 SEC 보고 규칙과 나스닥 상장 요건을 준수해야 하며, 이에는 이사회 구성, 기업 지배구조 문제, 주주 승인 절차에 관한 새로운 요구사항이 포함됩니다. CEO 라이언 로즈는 이번 변화를 회사의 투명성과 규제 최선 관행에 대한 의지를 보여주는 중요한 이정표로 강조했습니다.

EDAP TMS (NASDAQ:EDAP), leader mondial des thérapies robotisées basées sur l'énergie, a annoncé sa transition du statut d'émetteur privé étranger à celui de déposant domestique américain, effective à partir du 1er janvier 2026.

Cette transition obligera EDAP à se conformer aux règles de reporting de la SEC et aux exigences de cotation du Nasdaq applicables aux déposants domestiques américains, incluant de nouvelles exigences concernant la composition du conseil d'administration, les questions de gouvernance d'entreprise et les processus d'approbation des actionnaires. Le CEO Ryan Rhodes a souligné que ce changement constitue une étape importante démontrant l'engagement de la société envers la transparence et les meilleures pratiques réglementaires.

EDAP TMS (NASDAQ:EDAP), der weltweit führende Anbieter robotergestützter, energie-basierter Therapien, gab bekannt, dass das Unternehmen ab dem 1. Januar 2026 vom Status eines ausländischen Privatunternehmens zum Status eines inländischen US-Meldenden übergeht.

Dieser Übergang verpflichtet EDAP zur Einhaltung der SEC-Berichtspflichten und der Nasdaq-Listing-Anforderungen, die für inländische US-Meldende gelten, einschließlich neuer Anforderungen hinsichtlich der Zusammensetzung des Vorstands, der Unternehmensführung und der Prozesse zur Aktionärszustimmung. CEO Ryan Rhodes betonte, dass dieser Schritt einen bedeutenden Meilenstein darstellt, der das Engagement des Unternehmens für Transparenz und regulatorische Best Practices unterstreicht.

Positive
  • Transition demonstrates commitment to transparency and regulatory best practices
  • Potential to attract new institutional investors
  • Enhanced relationship with shareholders through increased reporting transparency
Negative
  • Additional regulatory compliance requirements and reporting obligations
  • Potential increased compliance costs associated with 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


FAQ

When will EDAP (NASDAQ:EDAP) transition to U.S. domestic filer status?

EDAP will transition to U.S. domestic filer status effective January 1, 2026.

What changes will EDAP need to make as a U.S. domestic filer?

EDAP will need to comply with SEC reporting rules and Nasdaq requirements for U.S. domestic filers, including new requirements for board composition, corporate governance, and shareholder approval processes.

How will EDAP's transition to U.S. domestic filer status benefit investors?

The transition is expected to strengthen shareholder relationships through increased transparency and potentially attract new institutional investors.

What is EDAP's current filing status with the SEC?

EDAP currently qualifies as a foreign private issuer under SEC rules and regulations.
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