EDAP TMS SA

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

SCHEDULE 14A

Proxy Statement Pursuant to Section 14(a) of

the Securities Exchange Act of 1934 (Amendment No.)

Dear Fellow Shareholders,

2025 marked a pivotal year for EDAP, defined by strong execution, accelerating growth, and meaningful progress toward our long-term vision of establishing Focal One®Robotic High-Intensity Focused Ultrasound (HIFU) as a global standard of care. Throughout the year, we remained focused on scaling our core and leading Focal One platform, expanding adoption, and strengthening our position as a market leader in non-invasive therapeutic ultrasound. We also marked an important milestone with the introduction of Focal One i, our most advanced HIFU platform built with increased clinical capabilities and designed to integrate seamlessly with next-generation imaging technologies. The results we achieved reflect both the growing demand for organ-sparing, function preserving treatments and the disciplined execution of our strategic priorities.

Our financial performance in 2025 underscores this momentum. We delivered robust year-over-year growth in our HIFU business, with revenue reaching record levels and becoming the primary driver of overall company performance. This growth was supported by increased system placements, rising procedure volumes, and expanded utilization across key markets, particularly in the United States.

A central highlight of the year was the continued adoption of our Focal One Robotic HIFU platform, alongside early enthusiasm for Focal One i. This next-generation system enables physicians to leverage a wide range of advanced imaging modalities, including PSMA PET, to improve lesion targeting and treatment precision. We expanded our installed base across multiple leading academic institutions, community hospitals, and integrated healthcare systems. These placements reflect not only physician confidence in our technology but also a broader shift toward image-guided focal therapy. As more clinicians gain experience and clinical evidence continues to build, we believe Focal One is moving beyond early adoption toward broader standardization in prostate cancer care.

Equally important has been the growth in patient demand for minimally invasive treatment options. Patients are becoming more informed and are actively seeking therapies that effectively treat disease while preserving quality of life. HIFU addresses this need directly, offering a non-invasive solution with reduced side effects compared to surgery or radiation. The ability to combine precise imaging, enabled by platforms such as Focal One I, with targeted therapy represents a significant advancement in personalized care. This shift in patient preference is reinforcing physician adoption and creating a powerful tailwind for our business, which we expect to continue driving long-term growth globally.

In parallel with our commercial progress, we made important advancements in innovation, regulatory milestones, and clinical development. We continued to invest in expanding the capabilities of our HIFU platform while exploring new indications beyond prostate cancer, including benign prostatic hyperplasia (BPH) and endometriosis. In March 2025, we achieved a significant milestone with the receipt of CE Mark for the treatment of posterior deep infiltrating endometriosis, particularly involving the rectum and surrounding pelvic structures. This approval enables the use of our Focal One Robotic HIFU system as a non-invasive, organ-preserving alternative to conventional surgery, which often involves complex and highly invasive procedures such as surgical bowel resection.

Our strategic focus in 2025 also included refining our business model to prioritize high-growth, high-margin opportunities. We took deliberate steps to reduce emphasis on legacy and non-core activities, allowing us to concentrate resources on scaling our core HIFU business. While this transition impacted certain aspects of our overall revenue mix in the near term, it positions us for more sustainable growth and improved operating leverage in the future. We are confident that this focus will enhance long-term shareholder value.

Looking ahead, we enter 2026 with strong momentum and a clear roadmap for continued growth. Our priorities remain centered on expanding global adoption of Focal One, increasing procedure volumes, advancing new clinical indications, developing increased technology capabilities and strengthening our commercial infrastructure. We are particularly encouraged by the trajectory of our U.S. and EU business units, where increasing utilization and growing reimbursement support are creating a foundation for sustained expansion. We believe that recent regulatory achievements, including our progress in endometriosis, alongside continued innovation in imaging integration, position us to further extend our leadership in non-invasive, precision therapies.

In closing, 2025 was a year of meaningful progress and important milestones for EDAP. We are proud of the achievements of our team and the impact our technology is having on patients and physicians worldwide. While there is still significant opportunity ahead, we believe we are well positioned to lead the ongoing transformation in the treatment of prostate cancer and beyond. On behalf of the entire organization, I thank you for your continued support and confidence in our mission and strategy.

Sincerely,

Ryan Rhodes

Chief Executive Officer

Notice of 2026 Annual General Meeting of Shareholders

To Our Shareholders:

Notice is hereby given that the Annual General Meeting of the Company will be held in person on June 26, 2026 at 3:00 pm, local time at the Company’s registered office located at Parc d’Activites la Poudrette-Lamartine, 4/6, rue du Dauphiné, 69120 Vaulx-en-Velin, France. We intend that this notice of the Annual General Meeting and accompanying proxy materials will be first made available to you, as a holder of record of the Company’s Ordinary Shares, on or about May 14, 2026. The Bank of New York Mellon, as the depositary (the “Depositary”), or a broker, bank or other nominee will provide the proxy materials to holders of American Depositary Shares (“ADSs”), each of which represents one Ordinary Share of the Company.

If you are a holder of Ordinary Shares at 2:55 pm, Paris time, on June 26, 2026 (the “ORD Record Date”), you will be eligible to vote on the items to be presented at the Annual General Meeting. You may (i) vote in person at the Annual General Meeting, (ii) vote by submitting your proxy card by mail, (iii) grant your voting proxy directly to the chairperson of the Annual General Meeting, or (iv) grant your voting proxy to another shareholder, your spouse or your partner with whom you have entered into a civil union. You can change your vote by submitting another properly completed proxy card with a later date (i) by the Annual General Meeting if you choose to (x) grant a proxy to the chairperson of the Annual General Meeting or (y) grant a proxy to another shareholder, your spouse or a partner with whom you are in a civil union, (ii) at any time prior to June 23, 2026 if you choose to vote in advance by mail, or (iii) by attending the Annual General Meeting and voting in person.

If you hold ADSs, you may instruct the Depositary, either directly or through your broker, bank or other nominee, how to vote the Ordinary Shares underlying your ADSs. Please note that only holders of Ordinary Shares, and not ADS holders, are entitled to vote directly at the Annual General Meeting. The Depositary has fixed a record date for the determination of holders of ADSs who shall be entitled to give such voting instructions. We have been informed by the Depositary that it has set the ADS record date for the Annual General Meeting as of April 29, 2026 (the “ADS Record Date”). If you wish to have your votes cast at the meeting, you must obtain, complete and timely return a voting instruction form from the Depositary, if you are a registered holder of ADSs, or from your broker, bank or other nominee in accordance with any instructions provided therefrom.

**Your vote is important.**Please read the proxy statement and the accompanying materials. Whether or not you plan to attend the Annual General Meeting, and no matter how many Ordinary Shares or ADSs you own, please submit your proxy card or voting instruction form, as applicable, in accordance with the procedures described above.

By order of the Board of Directors

Dr. Lance Willsey

Chairman of the Board of Directors