EDAP / EDAP TMS S.A. - Depositary Receipt (Common Stock) - SEC-Einreichungen, Jahresbericht, Proxy Statement

EDAP TMS S.A. - Depositary Receipt (Common Stock)
US ˙ NasdaqGM ˙ US2683111072
DIESES SYMBOL IST NICHT MEHR AKTIV

Basisstatistiken
LEI 9695007G9BC43P81WC36
CIK 1041934
SEC Filings
All companies that sell securities in the United States must register with the Securities and Exchange Commission (SEC) and file reports on a regular basis. These reports include company annual reports (10K, 10Q), news updates (8K), investor presentations (found in 8Ks), insider trades (form 4), ownership reports (13D, and 13G), and reports related to the specific securities sold, such as registration statements and prospectus. This page shows recent SEC filings related to EDAP TMS S.A. - Depositary Receipt (Common Stock)
SEC Filings (Chronological Order)
Auf dieser Seite finden Sie eine vollständige, chronologische Liste der SEC-Einreichungen, mit Ausnahme der Eigentumseinreichungen, die wir an anderer Stelle bereitstellen.
June 1, 2026 8-K

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): June 1, 2026 EDAP TMS SA (Exact n

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): June 1, 2026 EDAP TMS SA (Exact name of Registrant as specified in its charter) France 000-29374 98-1644844 (State or other jurisdiction of incorporation) (Commission File No.) (I.R.S

June 1, 2026 EX-99.1

2026 Investor Day Nasdaq (FOCL) June 1, 2026 1 FORWARD - LOOKING STATEMENTS & DISCLAIMER This presentation is being furnished for informational purposes only and may be given in conjunction with an oral presentation. It should not be taken out of con

Exhibit 99.1 2026 Investor Day Nasdaq (FOCL) June 1, 2026 1 FORWARD - LOOKING STATEMENTS & DISCLAIMER This presentation is being furnished for informational purposes only and may be given in conjunction with an oral presentation. It should not be taken out of context. Unless the context requires otherwise, references to "FocalTherics," "the Company," "we," "us," and "our" refer to EDAP TMS S.A., o

May 29, 2026 8-K

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): May 29, 2026 EDAP TMS SA (Exact n

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): May 29, 2026 EDAP TMS SA (Exact name of Registrant as specified in its charter) France 000-29374 98-1644844 (State or other jurisdiction of incorporation) (Commission File No.) (I.R.S

May 29, 2026 EX-99.1

EDAP Announces Corporate Name Change to FocalTherics

Exhibit 99.1 EDAP Announces Corporate Name Change to FocalTherics™ to Reflect Exclusive Focus on High-Growth Robotic Focal Therapy · Company will Begin Trading Under New Ticker Symbol “FOCL” at Market Open on June 1, 2026 · Company Intends to Report and Classify its Legacy Non-Core ESWL and Distribution Operating Segments as Discontinued Operations Beginning with Second Quarter 2026 Financial Resu

May 14, 2026 DEF 14A

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.)

Table of Contents 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.) Filed by the Registrant ☒ Filed by a Party other than the Registrant ☐ Check the appropriate box: ☐ Preliminary Proxy Statement ☐ Confidential, for Use of the Commission Only (as permitted by Rule 14a

May 14, 2026 ARS

ARS

EDAP TMS S.A. 2025 Annual Report UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File

May 14, 2026 DEFA14A

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.)

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.) Filed by the Registrant ☒ Filed by a Party other than the Registrant ☐ Check the appropriate box: ☐ Preliminary Proxy Statement ☐ Confidential, for Use of the Commission Only (as permitted by Rule 14a-6(e)(2)) ☐ Defini

May 14, 2026 DEFA14A

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.)

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.) Filed by the Registrant ☒ Filed by a Party other than the Registrant ☐ Check the appropriate box: ☐ Preliminary Proxy Statement ☐ Confidential, for Use of the Commission Only (as permitted by Rule 14a-6(e)(2)) ☐ Defini

May 7, 2026 8-K

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): May 7, 2026 EDAP TMS SA (Exact na

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): May 7, 2026 EDAP TMS SA (Exact name of registrant as specified in its charter) France 000-29374 98-1644844 (State or Other Jurisdiction of Incorporation) (Commission File Number) (I.R

May 7, 2026 EX-10.1

EDAP TMS S.A. EXECUTIVE SEVERANCE PLAN (Effective as of March 24, 2026)

Exhibit 10.1 EDAP TMS S.A. EXECUTIVE SEVERANCE PLAN (Effective as of March 24, 2026) 1.Purpose and Scope. The purpose of this EDAP TMS S.A. Executive Severance Plan (this “Plan”) is to set forth the compensation and benefits, if any, that are due to designated executive officers and other senior management employees of the Subsidiaries of EDAP TMS S.A., a French société anonyme (the “Company”), in

May 7, 2026 EX-99.1

EDAP Reports Strong Financial Results with Record First Quarter HIFU Revenue Seventh Consecutive Quarter of Year-Over-Year HIFU Revenue Growth

Exhibit 99.1 EDAP Reports Strong Financial Results with Record First Quarter HIFU Revenue Seventh Consecutive Quarter of Year-Over-Year HIFU Revenue Growth · 78% Growth in First Quarter HIFU Revenue Year-Over-Year · 53% Growth in First Quarter U.S. HIFU Procedures Year-Over-Year · 83% Growth in First Quarter Focal One Shipments Year-Over-Year Demonstrating Strong Momentum · Landmark HIFI-2 Study R

May 7, 2026 10-Q

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Quarterly Period Ended March 31, 2026 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 for the transition period from to Commission File Number: 0

May 1, 2026 PRE 14A

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.)

Table of Contents 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.) Filed by the Registrant ☒ Filed by a Party other than the Registrant ☐ Check the appropriate box: ☒ Preliminary Proxy Statement ☐ Confidential, for Use of the Commission Only (as permitted by Rule 14a

April 2, 2026 8-K

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): April 1, 2026 EDAP TMS SA (Exact

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): April 1, 2026 EDAP TMS SA (Exact name of registrant as specified in its charter) France 000-29374 98-1644844 (State or Other Jurisdiction of Incorporation) (Commission File Number) (I

March 31, 2026 424B3

EDAP TMS S.A. Warrants to Purchase up to 4,574,421 Ordinary Shares 4,574,421 Ordinary Shares, which may be represented by American Depositary Shares

Pursuant to Rule 424(b)(3)  Registration No. 333-294597 PROSPECTUS EDAP TMS S.A. Warrants to Purchase up to 4,574,421 Ordinary Shares 4,574,421 Ordinary Shares, which may be represented by American Depositary Shares This prospectus relates to the offer and resale from time to time by the selling securityholder named herein of (i) warrants (bons de souscription d’actions) to purchase up to 4,574,42

March 27, 2026 CORRESP

March 27, 2026

March 27, 2026 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, DC 20549-6010 Re: Edap TMS S.A. Request for Acceleration of Effective Date of Registration Statement on Form S-3 (File No. 333-294597) Ladies and Gentlemen: In accordance with Rules 460 and 461 under the Securities Act of 1933, as amended, Edap TMS S.A. (the “Registrant”)

March 27, 2026 S-3/A

As filed with the Securities and Exchange Commission on March 27, 2026

As filed with the Securities and Exchange Commission on March 27, 2026 Registration No.

March 26, 2026 LETTER

LETTER

March 26, 2026 Ryan Rhodes Chief Executive Officer EDAP TMS S.A. Parc d Activit s la Poudrette-Lamartine 4/6, rue du Dauphin 69120 Vaulx-en-Velin, France Re: EDAP TMS S.A. Registration Statement on Form S-3 Filed March 25, 2026 File No. 333-294597 Dear Ryan Rhodes: This is to advise you that we have not reviewed and will not review your registration statement. Please refer to Rules 460 and 461 reg

March 25, 2026 EX-4.3

DESCRIPTION OF SECURITIES REGISTERED UNDER SECTION 12 OF THE EXCHANGE ACT

EXHIBIT 4.3 DESCRIPTION OF SECURITIES REGISTERED UNDER SECTION 12 OF THE EXCHANGE ACT As of December 31, 2025, EDAP TMS S.A. (the “Company,” “we,” “us,” and “our”) had the following series of securities registered pursuant to Section 12(b) of the Exchange Act: Title of Each Class Trading Symbol Name of each exchange on which registered American Depositary Shares, each representing 1 share, nominal

March 25, 2026 EX-10.14

EDAP TECHNOMED INC. AMENDED AND RESTATED EMPLOYMENT AGREEMENT

EXHIBIT 10.14 EDAP TECHNOMED INC. AMENDED AND RESTATED EMPLOYMENT AGREEMENT This Amended and Restated Employment Agreement (this “Agreement”) is entered into as of May 1, 2023 (the “Effective Date”) by and between Ryan Rhodes (“Executive”) and EDAP Technomed Inc. (the “Company”) (together referred to herein as the “Parties”). Certain capitalized terms used in this Agreement are defined in Section

March 25, 2026 EX-10.15

EDAP TECHNOMED INC. EMPLOYMENT AGREEMENT

EXHIBIT 10.15 EDAP TECHNOMED INC. EMPLOYMENT AGREEMENT This Employment Agreement (the “Agreement”) is made and entered into by and between Ken Mobeck (“Executive”) and EDAP Technomed Inc. (the “Company”) (together referred to herein as the “Parties”), dated as of October 31, 2022 and effective as of the Effective Date (as defined below). R E C I T A L S A. The Company desires to assure itself of t

March 25, 2026 EX-3.1

EDAP TMS A stock company (société anonyme) with a capital of Euros 4,907,697.47 Head office: Parc d’activité- La Poudrette Lamartine 4 rue du Dauphiné 69120 Vaulx en Velin - France MEMORANDUM AND ARTICLES OF ASSOCIATION - BYLAWS - Including modificat

EXHIBIT 3.1 EDAP TMS A stock company (société anonyme) with a capital of Euros 4,907,697.47 Head office: Parc d’activité- La Poudrette Lamartine 4 rue du Dauphiné 69120 Vaulx en Velin - France MEMORANDUM AND ARTICLES OF ASSOCIATION - BYLAWS - Including modifications approved by the Board of Directors held on December 18, 2025 Articles of Association – December 18, 2025 - English translation for in

March 25, 2026 EX-10.16

January 1, 2024

EXHIBIT 10.16 January 1, 2024 PERSONAL AND CONFIDENTIAL Kenneth Mobeck 2349 Walden Square San Jose, CA 95124 (408) 391-2513 Re: Promotion | Employment Agreement October 31, 2022 Dear Ken, We are delighted to promote you within EDAP Technomed, Inc. This letter confirms the terms of your promotion. All terms of your employment agreement dated October 31, 2022, remain in effect except for new job tit

March 25, 2026 EX-21.1

EDAP TMS S.A. SUBSIDIARIES

EXHIBIT 21.1 EDAP TMS S.A. SUBSIDIARIES Name of Subsidiary Jurisdiction of Incorporation EDAP TMS France S.A.S. France EDAP Technomed, Inc. United States EDAP Technomed Co. Ltd. Japan EDAP Technomed Sdn Bhd Malaysia EDAP TMS GmbH Germany EDAP TMS Switzerland Switzerland

March 25, 2026 8-K

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): March 25, 2026 EDAP TMS SA (Exact

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): March 25, 2026 EDAP TMS SA (Exact name of registrant as specified in its charter) France 000-29374 98-1644844 (State or Other Jurisdiction of Incorporation) (Commission File Number) (

March 25, 2026 10-K

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2025 OR ☐TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number 000-29374

March 25, 2026 EX-FILING FEES

Security Type

Exhibit 107 Calculation of Filing Fee Tables S-3 EDAP TMS SA Table 1: Newly Registered and Carry Forward Securities ☐Not Applicable Security Type Security Class Title Fee Calculation or Carry Forward Rule Amount Registered Proposed Maximum Offering Price Per Unit Maximum Aggregate Offering Price Fee Rate Amount of Registration Fee Carry Forward Form Type Carry Forward File Number Carry Forward Initial Effective Date Filing Fee Previously Paid in Connection with Unsold Securities to be Carried Forward Newly Registered Securities Equity Ordinary Shares, EUR 0.

March 25, 2026 S-3

As filed with the Securities and Exchange Commission on March 25, 2026

As filed with the Securities and Exchange Commission on March 25, 2026 Registration No.

March 25, 2026 EX-19.1

EDAP TMS S.A. Insider Trading Policy Adopted and Effective January 1, 2026

EXHIBIT 19.1 EDAP TMS S.A. Insider Trading Policy Adopted and Effective January 1, 2026 1.Purpose This Insider Trading Policy (the “Policy”) provides guidelines with respect to transactions in the securities of EDAP TMS S.A. and its subsidiaries (the “Company”) and the handling of Material Nonpublic Information (as defined by Section 4) about the Company and the companies with which the Company ha

March 25, 2026 EX-99.1

EDAP Reports Record Fourth Quarter and Full-Year 2025 HIFU Revenue

Exhibit 99.1 EDAP Reports Record Fourth Quarter and Full-Year 2025 HIFU Revenue • 39% Full-Year YoY HIFU Revenue Growth, Record Performance Driven by Increased Focal One® System Sales and Growth in the Number of U.S. Focal One Procedures • 69% Full-Year YoY Growth in Focal One System Placements • 28% Q4 YoY Growth in U.S. Procedures, Marking the Second Consecutive Quarter of Double-Digit Procedure

March 18, 2026 8-K

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): March 18, 2026 EDAP TMS SA (Exact

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): March 18, 2026 EDAP TMS SA (Exact name of registrant as specified in its charter) France 000-29374 98-1644844 (State or Other Jurisdiction of Incorporation) (Commission File Number) (

March 18, 2026 EX-99.1

The Global Leader in Therapeutic Ultrasound 1 Statements & Disclaimer F O R W A R D - L O O K I N G 2 Strategic Company Focus 3 Global Leader in Therapeutic Ultrasound for the Treatment of Cancer and Benign Disease Large and Growing Market Opportunit

Exhibit 99.1 The Global Leader in Therapeutic Ultrasound 1 Statements & Disclaimer F O R W A R D - L O O K I N G 2 Strategic Company Focus 3 Global Leader in Therapeutic Ultrasound for the Treatment of Cancer and Benign Disease Large and Growing Market Opportunity In Urology and Prostate Cancer 4 Prostate Cancer Market Opportunity Number of New Prostate Cancer Cases Region Europe Asia North Americ

February 12, 2026 EX-99.1

EDAP Announces Appointment of David Horn to Board of Directors

Exhibit 99.1 EDAP Announces Appointment of David Horn to Board of Directors AUSTIN, Texas, February 12, 2026 – EDAP TMS S.A. (Nasdaq: EDAP) (“the Company” or “EDAP”), a global leader in therapeutic ultrasound technology, today announced the appointment of David Horn to its Board of Directors, effective February 11, 2026. The addition of Mr. Horn strengthens the Board with extensive experience both

February 12, 2026 8-K

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): February 10, 2026 EDAP TMS SA (Ex

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): February 10, 2026 EDAP TMS SA (Exact name of registrant as specified in its charter) France 000-29374 98-1644844 (State or Other Jurisdiction of Incorporation) (Commission File Number

January 12, 2026 EX-99.2

1 The Global Leader in Therapeutic Ultrasound 2 Statements & Disclaimer FORWARD - LOOKING 3 Company Overview 4 Strategic Company Focus Global Leader in Therapeutic Ultrasound for the Treatment of Cancer and Benign Disease 5 5 Investment Thesis: Stron

Exhibit 99.2 1 The Global Leader in Therapeutic Ultrasound 2 Statements & Disclaimer FORWARD - LOOKING 3 Company Overview 4 Strategic Company Focus Global Leader in Therapeutic Ultrasound for the Treatment of Cancer and Benign Disease 5 5 Investment Thesis: Strong Growth Opportunity x Large and Growing Market Opportunity: Urology and Prostate Cancer x Solves an Important Unmet Clinical Need in Can

January 12, 2026 EX-99.1

EDAP Announces Preliminary Record Fourth Quarter and Full Year 2025 HIFU Revenue; Issues 2026 Revenue Guidance

Exhibit 99.1 EDAP Announces Preliminary Record Fourth Quarter and Full Year 2025 HIFU Revenue; Issues 2026 Revenue Guidance 36% to 38% Annual YoY HIFU Revenue Growth, Record Performance Driven by Increased Focal One® System Sales and Growth in Number of U.S. Focal One Procedures 69% Annual YoY Growth in Focal One System Placements 28% Q4 YoY Growth in U.S. Procedures Highlights Accelerating Quarte

January 12, 2026 8-K

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): January 12, 2026 EDAP TMS SA (Exa

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): January 12, 2026 EDAP TMS SA (Exact name of registrant as specified in its charter) France 000-29374 98-1644844 (State or Other Jurisdiction of Incorporation) (Commission File Number)

November 20, 2025 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 November 20, 2025 Commission File Number: 0-29374 EDAP TMS S

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 November 20, 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

November 18, 2025 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 November 18, 2025 Commission File Number: 0-29374 EDAP TMS S

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 November 18, 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

November 6, 2025 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 November 6, 2025 Commission File Number: 0-29374 EDAP TMS S.

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 November 6, 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

October 20, 2025 EX-99.2

DATED                         October 17, 2025 EDAP TMS as the Company The European Investment Bank as the Original Warrantholder Warrant Agreement

Exhibit 99.2 FI N° 99053 Serapis N° 2025-0092 DATED                         October 17, 2025 EDAP TMS as the Company AND The European Investment Bank as the Original Warrantholder Warrant Agreement 1. Definitions and interpretation 1 2. The Warrants 9 3. Issuance of the Warrants 10 4. Anti-dilution Protection 12 5. Events 12 6. Warrant Settlement and Transfer 13 7. Issuance of Warrant Shares 19 8.

October 20, 2025 EX-99.3

EDAP Secures €36 Million Credit Facility from European Investment Bank to Accelerate Growth of Focal One

Exhibit 99.3 EDAP Secures €36 Million Credit Facility from European Investment Bank to Accelerate Growth of Focal One® Robotic HIFU Lyon, France – October 20, 2025 – EDAP TMS SA (Nasdaq: EDAP) (“EDAP” or the “Company”), a global leader in robotic, energy-based therapeutic technologies, today announced that it has entered into a €36 million multi-tranche credit facility (the “Credit Facility”) with

October 20, 2025 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 October 20, 2025 Commission File Number: 0-29374 EDAP TMS S.

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 October 20, 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

October 20, 2025 EX-99.1

ROBOTIC HIFU (IEU LS) (InvestEU) Finance Contract between the European Investment Bank EDAP TMS SA 17 October 2025

Exhibit 99.1 Contract number (FI No): 99053 Serapis No: 2025-0092 ROBOTIC HIFU (IEU LS) (InvestEU) Finance Contract between the European Investment Bank and EDAP TMS SA 17 October 2025 WHEREAS: 6 ARTICLE 1 7 1.1 INTERPRETATION 7 ARTICLE 2 17 2.1 AMOUNT OF CREDIT 17 2.2 DISBURSEMENT PROCEDURE 17 2.2.1 TRANCHES 17 2.2.2 DISBURSEMENT OFFER 17 2.2.3 DISBURSEMENT ACCEPTANCE 18 2.3 DISBURSEMENT ACCOUNT

September 30, 2025 EX-4.2

EDAP TMS S.A. 2025-2 RESTRICTED STOCK UNIT (FREE SHARE) PLAN Adopted by the Board of Directors on September 30, 2025 TABLE OF CONTENTS

Exhibit 4.2 EDAP TMS S.A. 2025-2 RESTRICTED STOCK UNIT (FREE SHARE) PLAN Adopted by the Board of Directors on September 30, 2025 TABLE OF CONTENTS 1. Implementation of the Restricted Stock Unit (Free Share) Plan 3 2. Definitions 3 3. Purpose 5 4. Beneficiaries: Eligible Employees 5 5. Notice of the Allocation of the RSUs 5 6. Vesting Period 6 7. Holding Period 8 8. Characteristics of the RSUs 8 9.

September 30, 2025 EX-4.3

This is a free translation from the French language and is supplied solely for information purposes. Only the original version in French language has legal force. EDAP TMS A French société anonyme Capital of [4,889,299.48] Euros Headquarters: Parc d’

Exhibit 4.3 Share Subscription Option Plan– September 2025 This is a free translation from the French language and is supplied solely for information purposes. Only the original version in French language has legal force. EDAP TMS A French société anonyme Capital of [4,889,299.48] Euros Headquarters: Parc d’Activité de La Poudrette Lamartine, 4, rue du Dauphiné, 69120 Vaulx-en-Velin France 316 488

September 30, 2025 S-8

As filed with the Securities and Exchange Commission on September 30, 2025

As filed with the Securities and Exchange Commission on September 30, 2025 Registration No.

September 30, 2025 EX-FILING FEES

Table 1: Newly Registered Securities

Calculation of Filing Fee Tables S-8 EDAP TMS SA Table 1: Newly Registered Securities Security Type Security Class Title Fee Calculation Rule Amount Registered Proposed Maximum Offering Price Per Unit Maximum Aggregate Offering Price Fee Rate Amount of Registration Fee 1 Equity Ordinary Shares, EUR0.

September 9, 2025 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 September 9, 2025 Commission File Number: 0-29374 EDAP TMS S

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 9, 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

September 8, 2025 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 September 8, 2025 Commission File Number: 0-29374 EDAP TMS S

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

August 28, 2025 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 August 28, 2025 Commission File Number: 0-29374 EDAP TMS S.A

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 August 28, 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 f

August 26, 2025 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 August 26, 2025 Commission File Number: 0-29374 EDAP TMS S.A

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 August 26, 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 f

July 1, 2025 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. P

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

June 2, 2025 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 June 2, 2025 Commission File Number: 0-29374 EDAP TMS S.A. P

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 June 2, 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

May 15, 2025 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 May 15, 2025 Commission File Number: 0-29374 EDAP TMS S.A. P

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 May 15, 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

May 14, 2025 EX-FILING FEES

Calculation of Filing Fee Tables Form S-8 (Form Type) EDAP TMS S.A. (Exact Name of Registrant as Specified in its Charter) Table 1: Newly Registered Securities

Exhibit 107 Calculation of Filing Fee Tables Form S-8 (Form Type) EDAP TMS S.A. (Exact Name of Registrant as Specified in its Charter) Table 1: Newly Registered Securities Security Type Security Class Title(1) Fee Calculation Rule Amount Registered(2) Proposed Maximum Offering Price Per Unit(3) Maximum Aggregate Offering Price(3) Fee Rate Amount of Registration Fee Equity Ordinary Shares, €0.13 no

May 14, 2025 S-8

As filed with the Securities and Exchange Commission on May 14, 2025

As filed with the Securities and Exchange Commission on May 14, 2025 Registration No.

May 14, 2025 EX-4.2

EDAP TMS S.A. 2025 RESTRICTED STOCK UNIT (FREE SHARE) PLAN Adopted by the Board of Directors on May 14, 2025 TABLE OF CONTENTS

Exhibit 4.2 EDAP TMS S.A. 2025 RESTRICTED STOCK UNIT (FREE SHARE) PLAN Adopted by the Board of Directors on May 14, 2025 TABLE OF CONTENTS 1. Implementation of the Restricted Stock Unit (Free Share) Plan 4 2. Definitions 4 3. Purpose 6 4. Beneficiaries: Eligible Employees 6 5. Notice of the Allocation of the RSUs 6 6. Vesting Period 7 7. Holding PerioD 9 8. Characteristics of the RSUs 10 9. Delive

March 27, 2025 EX-1.1

EDAP TMS A stock company (société anonyme) with a capital of Euros 4,896,010.47 Head office: Parc d’activité- La Poudrette Lamartine 4 rue du Dauphiné 69120 Vaulx en Velin - France MEMORANDUM AND ARTICLES OF ASSOCIATION - BYLAWS - Including modificat

Exhibit 1.1 EDAP TMS A stock company (société anonyme) with a capital of Euros 4,896,010.47 Head office: Parc d’activité- La Poudrette Lamartine 4 rue du Dauphiné 69120 Vaulx en Velin - France MEMORANDUM AND ARTICLES OF ASSOCIATION - BYLAWS - Including modifications approved by the Board of Directors held on December 19th, 2024 Articles of Association – December 19, 2024 - English translation for

March 27, 2025 EX-11.1

INSIDER TRADING POLICY

Exhibit 11.1 INSIDER TRADING POLICY ARTICLE 1 – Objectives EDAP TMS Group, including its subsidiaries (hereinafter “EDAP TMS”), as well as its Directors, Officers, Employees, consultants and contractors, as well as (i) members of each such person’s immediate family and household, and (ii) entities controlled by individuals subject to this Insider Trading Policy (“Covered Persons”), are subject to

March 27, 2025 20-F

As filed with the Securities and Exchange Commission on March 27, 2025 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 20-F

Table of Contents As filed with the Securities and Exchange Commission on March 27, 2025 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.

March 27, 2025 EX-2.3

DESCRIPTION OF SECURITIES REGISTERED UNDER SECTION 12 OF THE EXCHANGE ACT

Exhibit 2.3 DESCRIPTION OF SECURITIES REGISTERED UNDER SECTION 12 OF THE EXCHANGE ACT As of December 31, 2024, EDAP TMS S.A. (the “Company,” “we,” “us,” and “our”) had the following series of securities registered pursuant to Section 12(b) of the Exchange Act: Title of Each Class Trading Symbol Name of each exchange on which registered American Depositary Shares, each representing 1 share, nominal

March 27, 2025 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 March 27, 2025 Commission File Number: 0-29374 EDAP TMS S.A.

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 March 27, 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 fi

March 27, 2025 EX-4.1

Deed of renewal of the commercial lease dated May 22, 2015 which became effective July 1, 2015 Maison Antoine Baud EDAP TMS France Premises located at: 4, Rue du Bâtiment B 69120- VAULX-EN-VELIN Lots n°B1 to B7

Exhibit 4.1 iD3 LAWYERS Deed of renewal of the commercial lease dated May 22, 2015 which became effective July 1, 2015 Between: Maison Antoine Baud & EDAP TMS France Premises located at: 4, Rue du Dauphiné Bâtiment B 69120- VAULX-EN-VELIN Lots n°B1 to B7 Contents 1. DESIGNATION 5 2. TERM - 9-YEAR LEASE 5 3. DESTINATION OF THE LEASED PREMISES 5 4. CHARGES AND CONDITIONS 6 4.1. STATE OF THE ART 6 4.

March 27, 2025 EX-12.1

Certification by the Principal Executive Officer pursuant to Securities Exchange Rules 13a-14(a) and 15d-14(a), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002

EXHIBIT 12.1 Certification by the Principal Executive Officer pursuant to Securities Exchange Rules 13a-14(a) and 15d-14(a), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 I, Ryan Rhodes, certify that: 1. I have reviewed this annual report on Form 20-F of EDAP TMS S.A.; 2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to s

March 27, 2025 EX-12.2

Certification by the Principal Financial Officer pursuant to Securities Exchange Rules 13a-14(a) and 15d-14(a), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002

EXHIBIT 12.2 Certification by the Principal Financial Officer pursuant to Securities Exchange Rules 13a-14(a) and 15d-14(a), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 I, Ken Mobeck, certify that: 1. I have reviewed this annual report on Form 20-F of EDAP TMS S.A.; 2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to st

March 27, 2025 EX-15.1

Consent of Independent Registered Public Accounting Firm

EXHIBIT 15.1 Consent of Independent Registered Public Accounting Firm The Board of Directors, We consent to the incorporation by reference in the registration statements No. 333-281720, No. 333-268265, No. 333-261182, No. 333-259857, No. 333-257142 and No. 333-217160 on Form S-8 and No. 333-278526 on Form F-3 of our reports dated March 27, 2025, with respect to the consolidated financial statement

March 27, 2025 EX-13.1

Certification by the Principal Executive Officer and Principal Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to pursuant to Section 906 of the Sarbanes-Oxley Act of 2002

EXHIBIT 13.1 Certification by the Principal Executive Officer and Principal Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 (subsections (a) and (b) of Section 1350, Chapter 63 of Title 18, United States Code), each of the undersigned officers of EDAP TMS

March 3, 2025 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 March 3, 2025 Commission File Number: 0-29374 EDAP TMS S.A.

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 March 3, 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 fil

January 13, 2025 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 January 13, 2025 Commission File Number: 0-29374 EDAP TMS S.

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 January 13, 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

January 10, 2025 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 January 10, 2025 Commission File Number: 0-29374 EDAP TMS S.

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 January 10, 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

December 4, 2024 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 December 4, 2024 Commission File Number: 0-29374 EDAP TMS S.

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 December 4, 2024 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

November 14, 2024 SC 13G/A

EDAP / EDAP TMS S.A. - Depositary Receipt (Common Stock) / Soleus Private Equity Fund II, L.P. - AMENDMENT NO. 5 TO SCHEDULE 13G Passive Investment

SC 13G/A 1 ea0221047-13ga5soleus2edap.htm AMENDMENT NO. 5 TO SCHEDULE 13G UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G Under the Securities Exchange Act of 1934 (Amendment No. 5)* EDAP TMS S.A. (Name of Issuer) Ordinary Shares, nominal value £0.13 per share, in the form of American Depositary Shares (Title of Class of Securities) 268311107 (CUSIP Number) Sep

November 7, 2024 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 November 7, 2024 Commission File Number: 0-29374 EDAP TMS S.

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 November 7, 2024 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

August 28, 2024 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 August 28, 2024 Commission File Number: 0-29374 EDAP TMS S.A

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 August 28, 2024 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 f

August 22, 2024 S-8

As filed with the Securities and Exchange Commission on August 22, 2024

As filed with the Securities and Exchange Commission on August 22, 2024 Registration No.

August 22, 2024 EX-FILING FEES

Calculation of Filing Fee Tables Form S-8 (Form Type) EDAP TMS S.A. (Exact Name of Registrant as Specified in its Charter) Table 1: Newly Registered Securities

Exhibit 107 Calculation of Filing Fee Tables Form S-8 (Form Type) EDAP TMS S.A. (Exact Name of Registrant as Specified in its Charter) Table 1: Newly Registered Securities Security Type Security Class Title(1) Fee Calculation Rule Amount Registered(2) Proposed Maximum Offering Price Per Unit(3) Maximum Aggregate Offering Price(3) Fee Rate Amount of Registration Fee Equity Ordinary Shares, €0.13 no

August 22, 2024 EX-4.2

This is a free translation from the French language and is supplied solely for information purposes. Only the original version in French language has legal force. EDAP TMS A French société anonyme Capital of 4,889,299.48 Euros Headquarters: Parc d’Ac

Exhibit 4.2 Share Subscription Option Plan– August 2024 This is a free translation from the French language and is supplied solely for information purposes. Only the original version in French language has legal force. EDAP TMS A French société anonyme Capital of 4,889,299.48 Euros Headquarters: Parc d’Activité de La Poudrette Lamartine, 4, rue du Dauphiné, 69120 Vaulx-en-Velin France 316 488 204

August 22, 2024 EX-4.1

EDAP TMS A stock company (société anonyme) with a capital of Euros 4,858,530.56 Head office: Parc d’activité- La Poudrette Lamartine 4 rue du Dauphiné 69120 Vaulx en Velin - France MEMORANDUM AND ARTICLES OF ASSOCIATION - BYLAWS - Including modificat

Exhibit 4.1 EDAP TMS A stock company (société anonyme) with a capital of Euros 4,858,530.56 Head office: Parc d’activité- La Poudrette Lamartine 4 rue du Dauphiné 69120 Vaulx en Velin - France MEMORANDUM AND ARTICLES OF ASSOCIATION - BYLAWS - Including modifications approved by the Ordinary and Extraordinary Meeting of Shareholders held on June 28th, 2024 Articles of Association – June 28th, 2024

July 19, 2024 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 19, 2024 Commission File Number: 0-29374 EDAP TMS S.A.

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 19, 2024 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 fil

July 8, 2024 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 8, 2024 Commission File Number: 0-29374 EDAP TMS S.A. P

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 8, 2024 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

June 7, 2024 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 June 7, 2024 Commission File Number: 0-29374 EDAP TMS S.A. P

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 June 7, 2024 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

May 16, 2024 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 May 16, 2024 Commission File Number: 0-29374 EDAP TMS S.A. P

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 May 16, 2024 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

April 12, 2024 LETTER

LETTER

United States securities and exchange commission logo April 12, 2024 Ryan Rhodes Chief Executive Officer EDAP TMS S.

April 12, 2024 CORRESP

April 12, 2024

April 12, 2024 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, DC 20549-6010 Re: Edap TMS S.A. Request for Acceleration of Effective Date of Registration Statement on Form F-3 (File No. 333- 278526) Ladies and Gentlemen: In accordance with Rules 460 and 461 under the Securities Act of 1933, as amended, Edap TMS S.A. (the “Registrant”

April 5, 2024 F-3

As filed with the Securities and Exchange Commission on April 5, 2024

TABLE OF CONTENTS As filed with the Securities and Exchange Commission on April 5, 2024 Registration No.

April 5, 2024 EX-4.5

DESCRIPTION OF SECURITIES REGISTERED UNDER SECTION 12 OF THE EXCHANGE ACT

Exhibit 4.5 DESCRIPTION OF SECURITIES REGISTERED UNDER SECTION 12 OF THE EXCHANGE ACT As of December 31, 2023, EDAP TMS S.A. (the “Company,” “we,” “us,” and “our”) had the following series of securities registered pursuant to Section 12(b) of the Exchange Act: Title of Each Class Trading Symbol Name of each exchange on which registered American Depositary Shares, each representing 1 share, nominal

April 5, 2024 EX-FILING FEES

Calculation of Filing Fee Tables F-3 (Form Type) EDAP TMS S.A. (Exact Name of Registrant as Specified in its Charter) Table 1: Newly Registered and Carry Forward Securities

Exhibit 107 Calculation of Filing Fee Tables F-3 (Form Type) EDAP TMS S.A. (Exact Name of Registrant as Specified in its Charter) Table 1: Newly Registered and Carry Forward Securities Security Type Security Class Title Fee Calculation or Carry Forward Rule Amount Registered(1) Proposed Maximum Offering Price Per Unit(2) Maximum Aggregate Offering Price(3)(4) Fee Rate Amount of Registration Fee Ca

March 28, 2024 EX-97.1

EDAP TMS S.A. Clawback Policy Effective November 8, 2023

Exhibit 97.1 EDAP TMS S.A. Clawback Policy Effective November 8, 2023 Purpose As required pursuant to Rule 5608 of the listing standards of the Nasdaq Stock Market LLC (the “Stock Exchange”), Section 10D of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and Rule 10D-1 under the Exchange Act, the Board of Directors (the “Board”) of EDAP TMS S.A. (the “Company”), upon the reco

March 28, 2024 EX-12.2

Annual Certification Pursuant to Section 302 of Sarbanes-Oxley Act of 2002

EXHIBIT 12.2 Annual Certification Pursuant to Section 302 of Sarbanes-Oxley Act of 2002 I, Ken Mobeck, certify that: 1. I have reviewed this annual report on Form 20-F of EDAP TMS S.A.; 2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such

March 28, 2024 EX-12.1

Annual Certification Pursuant to Section 302 of Sarbanes-Oxley Act of 2002 Certification by the Principal Executive Officer pursuant to Securities Exchange Rules 13a-14(a) and 15d-14(a), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of

EXHIBIT 12.1 Annual Certification Pursuant to Section 302 of Sarbanes-Oxley Act of 2002 Certification by the Principal Executive Officer pursuant to Securities Exchange Rules 13a-14(a) and 15d-14(a), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 I, Ryan Rhodes, certify that: 1. I have reviewed this annual report on Form 20-F of EDAP TMS S.A.; 2. Based on my knowledge, this r

March 28, 2024 20-F

As filed with the Securities and Exchange Commission on March 28, 2024 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 20-F

Table of Contents As filed with the Securities and Exchange Commission on March 28, 2024 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.

March 28, 2024 EX-1.1

EDAP TMS A stock company (société anonyme) with a capital of Euros 4,858,530.56 Head office: Parc d’activité- La Poudrette Lamartine 4 rue du Dauphiné 69120 Vaulx en Velin - France MEMORANDUM AND ARTICLES OF ASSOCIATION - BYLAWS - Including modificat

Exhibit 1.1 EDAP TMS A stock company (société anonyme) with a capital of Euros 4,858,530.56 Head office: Parc d’activité- La Poudrette Lamartine 4 rue du Dauphiné 69120 Vaulx en Velin - France MEMORANDUM AND ARTICLES OF ASSOCIATION - BYLAWS - Including modifications approved by Board of Directors on December 6th, 2023 Articles of Association – December 6th, 2023 - English translation for informati

March 28, 2024 EX-13.1

Annual Certification Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002

EXHIBIT 13.1 Annual Certification Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 (subsections (a) and (b) of Section 1350, Chapter 63 of Title 18, United States Code), each of the undersigned officers of EDAP TMS S.A. (the “Company”), does hereby certify, to such officer's knowledge, that: The Annual Report on Form 20-F for the y

March 28, 2024 EX-15.1

Consent of Independent Registered Public Accounting Firm

EXHIBIT 15.1 Consent of Independent Registered Public Accounting Firm We consent to the incorporation by reference in the registration statements No. 333-268265, No. 333-261182, No. 333-259857, No. 333-257142 and No. 333-217160 on Form S-8 and No. 333-255101 on Form F-3 of our reports dated March 28, 2024, with respect to the consolidated financial statements of EDAP TMS S.A. and subsidiaries, and

March 28, 2024 EX-2.3

DESCRIPTION OF SECURITIES REGISTERED UNDER SECTION 12 OF THE EXCHANGE ACT

Exhibit 2.3 DESCRIPTION OF SECURITIES REGISTERED UNDER SECTION 12 OF THE EXCHANGE ACT As of December 31, 2023, EDAP TMS S.A. (the “Company,” “we,” “us,” and “our”) had the following series of securities registered pursuant to Section 12(b) of the Exchange Act: Title of Each Class Trading Symbol Name of each exchange on which registered American Depositary Shares, each representing 1 share, nominal

March 27, 2024 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 March 27, 2024 Commission File Number: 0-29374 EDAP TMS S.A.

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 March 27, 2024 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 fi

March 4, 2024 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 March 4, 2024 Commission File Number: 0-29374 EDAP TMS S.A.

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 March 4, 2024 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 fil

February 2, 2024 SC 13G/A

EDAP / EDAP TMS S.A. - Depositary Receipt (Common Stock) / Soleus Capital Master Fund, L.P. - AMENDMENT NO. 4 TO SCHEDULE 13G Passive Investment

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G Under the Securities Exchange Act of 1934 (Amendment No. 4)* EDAP TMS S.A. (Name of Issuer) Ordinary Shares, nominal value €0.13 per share, in the form of American Depositary Shares (Title of Class of Securities) 268311107 (CUSIP Number) December 31, 2023 (Date of Event Which Requires Filing of this Statement) Che

January 2, 2024 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 January 2, 2024 Commission File Number: 0-29374 EDAP TMS S.A

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 January 2, 2024 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 f

December 7, 2023 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 December 7, 2023 Commission File Number: 0-29374 EDAP TMS S.

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 December 7, 2023 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

November 9, 2023 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 November 9, 2023 Commission File Number: 0-29374 EDAP TMS S.

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 November 9, 2023 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

August 24, 2023 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 August 24, 2023 Commission File Number: 0-29374 EDAP TMS S.A

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 August 24, 2023 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 f

June 6, 2023 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 June 6, 2023 Commission File Number: 0-29374 EDAP TMS S.A. P

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 June 6, 2023 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

May 17, 2023 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 May 17, 2023 Commission File Number: 0-29374 EDAP TMS S.A. P

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 May 17, 2023 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

April 7, 2023 20-F

As filed with the Securities and Exchange Commission on April 7, 2023 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 20-F

Table of Contents As filed with the Securities and Exchange Commission on April 7, 2023 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.

April 7, 2023 EX-12.1

Certification of Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

EXHIBIT 12.1 Annual Certification Pursuant to Section 302 of Sarbanes-Oxley Act of 2002 I, Marc Oczachowski, certify that: 1. I have reviewed this annual report on Form 20-F of EDAP TMS S.A.; 2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which

April 7, 2023 EX-2.3

Description of securities registered under Section 12 of the Exchange Act

Exhibit 2.3 DESCRIPTION OF SECURITIES REGISTERED UNDER SECTION 12 OF THE EXCHANGE ACT As of December 31, 2022, EDAP TMS S.A. (the “Company,” “we,” “us,” and “our”) had the following series of securities registered pursuant to Section 12(b) of the Exchange Act: Title of Each Class Trading Symbol Name of each exchange on which registered American Depositary Shares, each representing 1 share, nominal

April 7, 2023 EX-13.1

Certification of Chief Executive Officer and Chief Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

EXHIBIT 13.1 Annual Certification Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 (subsections (a) and (b) of Section 1350, Chapter 63 of Title 18, United States Code), each of the undersigned officers of EDAP TMS S.A. (the “Company”), does hereby certify, to such officer's knowledge, that: The Annual Report on Form 20-F for the y

April 7, 2023 EX-15.1

Consent of KPMG.

EXHIBIT 15.1 Consent of Independent Registered Public Accounting Firm We consent to the incorporation by reference in the registration statements No. 333-268265, No. 333-261182, No. 333-259857, No. 333-257142 and No. 333-217160 on Form S-8 and No. 333-255101 on Form F-3 of our reports dated April 7, 2023, with respect to the consolidated financial statements of EDAP TMS S.A. and subsidiaries, and

April 7, 2023 EX-1.1

By-laws (statuts) of EDAP TMS S.A. as amended as of January 24, 2023

Exhibit 1.1 EDAP TMS A stock company (société anonyme) with a capital of Euros 4,835,705.03 Head office: Parc d’activité- La Poudrette Lamartine 4 rue du Dauphiné 69120 Vaulx en Velin - France MEMORANDUM AND ARTICLES OF ASSOCIATION - BYLAWS - Including modifications approved by Board of Directors on January 24th, 2023 Articles of Association – January 24th, 2023 - English translation for informati

April 7, 2023 EX-12.2

Certification of Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

EXHIBIT 12.2 Annual Certification Pursuant to Section 302 of Sarbanes-Oxley Act of 2002 I, François Dietsch, certify that: 1. I have reviewed this annual report on Form 20-F of EDAP TMS S.A.; 2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which

March 30, 2023 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 March 30, 2023 Commission File Number: 0-29374 EDAP TMS S.A.

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 March 30, 2023 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 fi

February 14, 2023 SC 13G/A

EDAP / EDAP TMS S.A. / Soleus Capital Master Fund, L.P. - SC 13G/A Passive Investment

SC 13G/A UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G Under the Securities Exchange Act of 1934 (Amendment No. 3)* EDAP TMS S.A. (Name of Issuer) Ordinary Shares, nominal value €0.13 per share, in the form of American Depositary Shares (Title of Class of Securities) 268311107 (CUSIP Number) December 31, 2022 (Date of Event Which Requires Filing of this State

February 9, 2023 SC 13G/A

EDAP / EDAP TMS S.A. / MORGAN STANLEY - MS AMENDMENT Passive Investment

SC 13G/A 1 EdapEDAP.txt MS AMENDMENT UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G Under the Securities Exchange Act of 1934 (Amendment No.1)* EDAP TMS SA - (Name of Issuer) Ordinary Shares / American Depositary Shares - (Title of Class of Securities) 268311107 - (CUSIP Number) December 30, 2022 - (Date Of Event which Requires Filing of this Statement) Check

November 16, 2022 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 November 16, 2022 Commission File Number: 0-29374 EDAP TMS S

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 November 16, 2022 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

November 9, 2022 S-8

As filed with the Securities and Exchange Commission on November 9, 2022

As filed with the Securities and Exchange Commission on November 9, 2022 Registration No.

November 9, 2022 EX-4.2

EDAP TMS S.A. Form of 2022 Free Share Plan

Exhibit 4.2 EDAP TMS S.A. 2022 FREE SHARE PLAN restricted stock units Adopted by the Board of Directors on November 8, 2022 TABLE OF CONTENTS 1. Implementation of the free share plan 3 2. Definitions 3 3. Purpose 5 4. Beneficiaries: Eligible Employees 5 5. Notice of the Allocation of the Free Shares 5 6. Vesting Period 5 7. Holding Period 8 8. Characteristics of the Free Shares 9 9. Delivery and h

November 9, 2022 EX-FILING FEES

Filing Fee Table

EX-FILING FEES 5 exh107.htm CALCULATION OF FILING FEE TABLES Exhibit 107 Calculation of Filing Fee Tables Form S-8 (Form Type) EDAP TMS S.A. (Exact Name of Registrant as Specified in its Charter) Table 1: Newly Registered Securities Security Type Security Class Title Fee Calculation Rule Amount Registered Proposed Maximum Offering Price Per Unit Maximum Aggregate Offering Price Fee Rate Amount of

September 28, 2022 SC 13G/A

EDAP / EDAP TMS S.A. / Soleus Capital Master Fund, L.P. - SC 13G/A Passive Investment

SC 13G/A 1 d382632dsc13ga.htm SC 13G/A UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G Under the Securities Exchange Act of 1934 (Amendment No. 2)* EDAP TMS S.A. (Name of Issuer) Ordinary Shares, nominal value €0.13 per share, in the form of American Depositary Shares (Title of Class of Securities) 268311107 (CUSIP Number) September 27, 2022 (Date of Event Whic

September 28, 2022 EX-99.A

JOINT FILING AGREEMENT

EXHIBIT A JOINT FILING AGREEMENT Soleus Capital Master Fund, L.P., a Cayman Islands exempted limited partnership, Soleus Capital, LLC, a Delaware limited liability company, Soleus Capital Group, LLC, a Delaware limited liability company, Soleus Private Equity Fund III, L.P., a Delaware limited partnership, Soleus Private Equity GP III, LLC, a Delaware limited liability company, Soleus PE GP III, L

September 26, 2022 EX-1.1

Underwriting Agreement, dated as of September 22, 2022, between the Company and Jefferies LLC, as representative of the several underwriters

Exhibit 1.1 EDAP TMS S.A. 2,666,667 American Depositary Shares Representing 2,666,667 Ordinary Shares (Nominal Value ?0.13 per share) UNDERWRITING AGREEMENT September 22, 2022 JEFFERIES LLC As Representative of the several Underwriters named in Schedule I hereto c/o Jefferies LLC 520 Madison Avenue New York, New York 10022 Ladies and Gentlemen: EDAP TMS S.A., a soci?t? anonyme organized under the

September 26, 2022 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 September 26, 2022 Commission File Number: 0-29374 EDAP TMS

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 26, 2022 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 wil

September 23, 2022 424B5

Per ADS

TABLE OF CONTENTS ?FILED PURSUANT TO RULE 424(B)(5) ?REGISTRATION STATEMENT NO. 333-255101? PROSPECTUS SUPPLEMENT (TO PROSPECTUS DATED APRIL 16, 2021) American Depositary Shares (Representing 2,666,667 Ordinary Shares) $7.50 per share ? We are offering 2,666,667 of EDAP TMS?s American depositary shares, or ADSs pursuant to this prospectus supplement and the accompanying prospectus. Each ADS will r

September 23, 2022 EX-FILING FEES

EX-FILING FEES

Exhibit 107.1 The prospectus supplement to which this exhibit is attached is a final prospectus for the related offering. The maximum aggregate offering price of that offering is $23,000,003.

September 23, 2022 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 September 23, 2022 Commission File Number: 0-29374 EDAP TMS

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 23, 2022 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 wil

September 22, 2022 424B5

Per ADS

TABLE OF CONTENTS The information in this preliminary prospectus supplement and the accompanying prospectus is not complete and may be changed.

August 24, 2022 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 August 24, 2022 Commission File Number: 0-29374 EDAP TMS S.A

6-K 1 f6k082422.htm FORM 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 August 24, 2022 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 t

June 9, 2022 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 June 9, 2022 Commission File Number: 0-29374 EDAP TMS S.A. P

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 June 9, 2022 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

May 17, 2022 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 May 17, 2022 Commission File Number: 0-29374 EDAP TMS S.A. P

6-K 1 f6k051722.htm FORM 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 May 17, 2022 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

April 8, 2022 EX-13.1

Certification of Chief Executive Officer and Chief Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

EXHIBIT 13.1 Annual Certification Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 (subsections (a) and (b) of Section 1350, Chapter 63 of Title 18, United States Code), each of the undersigned officers of EDAP TMS S.A. (the “Company”), does hereby certify, to such officer's knowledge, that: The Annual Report on Form 20-F for the y

April 8, 2022 EX-2.3

Description of securities registered under Section 12 of the Exchange Act

? Exhibit 2.3 DESCRIPTION OF SECURITIES REGISTERED UNDER SECTION 12 OF THE EXCHANGE ACT As of December 31, 2021, EDAP TMS S.A. (the ?Company,? ?we,? ?us,? and ?our?) had the following series of securities registered pursuant to Section 12(b) of the Exchange Act: Title of Each Class ? Trading Symbol ? Name of each exchange on which registered ? American Depositary Shares, each representing 1 share,

April 8, 2022 20-F

As filed with the Securities and Exchange Commission on April 8, 2022 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 20-F

Table of Contents As filed with the Securities and Exchange Commission on April 8, 2022 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.

April 8, 2022 EX-12.1

Certification of Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

EXHIBIT 12.1 Annual Certification Pursuant to Section 302 of Sarbanes-Oxley Act of 2002 I, Marc Oczachowski, certify that: 1. I have reviewed this annual report on Form 20-F of EDAP TMS S.A.; 2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which

April 8, 2022 EX-15.1

Consent of KPMG.

EXHIBIT 15.1 ? ? ? ? Consent of Independent Registered Public Accounting Firm ? We consent to the incorporation by reference in the registration statements No. 333-261182, No. 333-259857, No. 333-257142, No. 333-188112 and No. 333-217160 on Form S-8 and No. 333-255101 on Form F-3 of our reports dated April 8, 2022, with respect to the consolidated financial statements of EDAP TMS S.A. and subsidia

April 8, 2022 EX-1.1

By-laws (statuts) of EDAP TMS S.A. as amended as of January 24, 2022

Exhibit 1.1 By-laws (statuts) of EDAP TMS S.A. as amended as of January 24, 2022 EDAP TMS A stock company (société anonyme) with a capital of Euros 4,388,613.32 Head office: Parc d’activité- La Poudrette Lamartine 4 rue du Dauphiné 69120 Vaulx en Velin - France MEMORANDUM AND ARTICLES OF ASSOCIATION - BYLAWS - Including modifications approved by Board of Directors on 24th January, 2022 Articles of

April 8, 2022 EX-12.2

Certification of Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

EXHIBIT 12.2 Annual Certification Pursuant to Section 302 of Sarbanes-Oxley Act of 2002 I, François Dietsch, certify that: 1. I have reviewed this annual report on Form 20-F of EDAP TMS S.A.; 2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which

March 30, 2022 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 March 30, 2022 Commission File Number: 0-29374 EDAP TMS S.A.

6-K 1 f6k032922.htm FORM 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 March 30, 2022 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 th

February 10, 2022 EX-99.A

JOINT FILING AGREEMENT

Exhibit 99A EXHIBIT A JOINT FILING AGREEMENT Soleus Capital Master Fund, L.P., a Cayman Islands exempted limited partnership, Soleus Capital, LLC, a Delaware limited liability company, Soleus Capital Group, LLC, a Delaware limited liability company, and Guy Levy, an individual, hereby agree to file jointly the statement on Schedule 13G/A (Amendment No. 1) to which this Joint Filing Agreement is at

February 10, 2022 SC 13G

EDAP / EDAP TMS S.A. / MORGAN STANLEY - MS INITIAL Passive Investment

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G Under the Securities Exchange Act of 1934 (Amendment No.)* EDAP TMS SA - (Name of Issuer) Ordinary Shares / American Depositary Shares - (Title of Class of Securities) 268311107 - (CUSIP Number) December 31, 2021 - (Date Of Event which Requires Filing of this Statement) Check the appropriate box to designate the r

February 10, 2022 SC 13G/A

EDAP / EDAP TMS S.A. / Soleus Capital Master Fund, L.P. - SC 13G/A Passive Investment

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G Under the Securities Exchange Act of 1934 (Amendment No. 1)* EDAP TMS S.A. (Name of Issuer) Ordinary Shares, nominal value ?0.13 per share, in the form of American Depositary Shares (Title of Class of Securities) 268311107 (CUSIP Number) December 31, 2021 (Date of Event Which Requires Filing of this Statement) Che

November 18, 2021 S-8

2021 Share Subscription Option Plan on Form S-8 dated November 18, 2021, File Number 333-261182

As filed with the Securities and Exchange Commission on November 18, 2021 Registration No.

November 18, 2021 EX-4.2

EDAP TMS S.A. 2021 Form of Share Subscription Option Plan

Exhibit 4.2 This is a free translation from the French language and is supplied solely for information purposes. Only the original version in French language has legal force. EDAP TMS (the ?Company?) Capital of 4,373,013.32 Euros Headquarters : Parc d?Activit? de La Poudrette Lamartine, 4, rue du Dauphin?, 69120 VAULX-EN-VELIN 316488204 RCS LYON 2021 SHARE SUBSCRIPTION OPTION PLAN Ordinary and Ext

November 17, 2021 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 November 17, 2021 Commission File Number: 0-29374 EDAP TMS S

6-K 1 f6k111721.htm FORM 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 November 17, 2021 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

September 28, 2021 S-8

2021 Free Share Plan on Form S-8 dated September 28, 2021, File Number 333-259857

S-8 1 fs8092821.htm FORM S-8 As filed with the Securities and Exchange Commission on September 28, 2021 Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-8 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 EDAP TMS S.A. (Exact name of registrant as specified in its charter) France Not applicable (State or other jurisdiction of incorporation

September 28, 2021 EX-4.2

EDAP TMS S.A. Form of 2021 Free Share Plan

Exhibit 4.2 EDAP TMS S.A. 2021 FREE SHARE PLAN restricted stock units Adopted by the Board of Directors on September 28, 2021 1 TABLE OF CONTENTS 1. Implementation of the free share plan 4 2. Definitions 4 3. Purpose 6 4. Beneficiaries: Eligible Employees 6 5. Notice of the Allocation of the Free Shares 6 6. Vesting Period 6 7. Holding Period 9 8. Characteristics of the Free Shares 10 9. Delivery

August 25, 2021 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 August 25, 2021 Commission File Number: 0-29374 EDAP TMS S.A

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 August 25, 2021 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 f

June 16, 2021 EX-4.2

EDAP TMS S.A. 2019 Form of Stock-Option Subscription Plan

Exhibit 4.2 This is a free translation from the French language and is supplied solely for information purposes. Only the original version in French language has legal force. EDAP TMS (the ?Company?) Capital of 4,373,013.32 Euros Headquarters : Parc d?Activit? de La Poudrette Lamartine, 4, rue du Dauphin?, 69120 VAULX-EN-VELIN 316488204 RCS LYON SHARE SUBSCRIPTION OPTION PLAN Ordinary and Extraord

June 16, 2021 S-8

2019 Stock-Option Subscription Plan on Form S-8 dated June 16, 2021, File Number 333-257142

As filed with the Securities and Exchange Commission on June 16, 2021 Registration No.

June 16, 2021 EX-4.3

EDAP TMS S.A. 2019 Form of Stock-Option Purchase Plan

Exhibit 4.3 This is a free translation from the French language and is supplied solely for information purposes. Only the original version in French language has legal force. EDAP TMS (the ?Company?) Capital of 4,373,013.32 Euros Headquarters : Parc d?Activit? de La Poudrette Lamartine, 4, rue du Dauphin?, 69120 VAULX-EN-VELIN 316488204 RCS LYON SHARE PURCHASE OPTION PLAN Ordinary and Extraordinar

June 11, 2021 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 June 11, 2021 Commission File Number: 0-29374 EDAP TMS S.A.

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 June 11, 2021 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 fil

May 11, 2021 6-K

Form 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 May 11, 2021 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

May 11, 2021 EX-99.1

EDAP TMS S.A. UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Amounts in thousands of Euros and U.S. Dollars, except per share data)

Exhibit 99.1 EDAP Reports First Quarter 2021 Results and Provides Operational Update - Generated record first quarter revenue of EUR 10.3 million (USD 12.4 million), an increase of 35.4% year-over-year - Increased gross margin year-over-year to 42.4%, contributing to a profitable quarter - Raised gross proceeds of approximately $28 million through an underwritten offering of American Depository Sh

April 28, 2021 SC 13G

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G Under the Securities Exchange Act of 1934 (Amendment No. )* EDAP TMS S.A. (Name of Issuer) Ordinary Shares, nominal value €0.13 per share, in the form of American De

SC 13G UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G Under the Securities Exchange Act of 1934 (Amendment No. )* EDAP TMS S.A. (Name of Issuer) Ordinary Shares, nominal value €0.13 per share, in the form of American Depositary Shares (Title of Class of Securities) 268311107 (CUSIP Number) April 23, 2021 (Date of Event Which Requires Filing of this Statement)

April 28, 2021 EX-99.A

JOINT FILING AGREEMENT

EXHIBIT A JOINT FILING AGREEMENT Soleus Capital Master Fund, L.P., a Cayman Islands exempted limited partnership, Soleus Capital, LLC, a Delaware limited liability company, Soleus Capital Group, LLC, a Delaware limited liability company, and Guy Levy, an individual, hereby agree to file jointly the statement on Schedule 13G to which this Joint Filing Agreement is attached, and any amendments there

April 26, 2021 EX-1.1

Purchase Agreement, dated as of April 22, 2021, between the Company and Piper Sandler & Co., as representative of the several underwriters

EX-1.1 2 tm2111528d9ex1-1.htm EXHIBIT 1.1 Exhibit 1.1 Execution version EDAP TMS S.A. 4,150,000 American Depositary Shares Representing 4,150,000 Ordinary Shares (Nominal Value €0.13 per share) PURCHASE AGREEMENT April 22, 2021 PIPER SANDLER & CO. As Representative of the several Underwriters named in Schedule I hereto c/o Piper Sandler & Co. U.S. Bancorp Center 800 Nicollet Mall Minneapolis, Minn

April 26, 2021 6-K

Current Report of Foreign Issuer - FORM 6-K

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 EDAP TMS S.A. April 26, 2021 Commission File Number 000-29374 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 f

April 23, 2021 6-K

Current Report of Foreign Issuer - FORM 6-K

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 EDAP TMS S.A. April 23, 2021 Commission File Number 000-29374 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 f

April 23, 2021 424B5

Per ADS

TABLE OF CONTENTS ?FILED PURSUANT TO RULE 424(B)(5)? ?REGISTRATION STATEMENT NO. 333-255101? PROSPECTUS SUPPLEMENT (TO PROSPECTUS DATED APRIL 16, 2021) American Depositary Shares (Representing 4,150,000 Ordinary Shares) ? EDAP TMS S.A.? ? ? ? $6.75 per share ? We are offering 4,150,000 American depositary shares, or ADSs, of EDAP TMS S.A. pursuant to this prospectus supplement and the accompanying

April 22, 2021 6-K

Current Report of Foreign Issuer - FORM 6-K

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 EDAP TMS S.A. April 22, 2021 Commission File Number 000-29374 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 f

April 22, 2021 FWP

EDAP Announces Launch of Follow-On Offering

Filed Pursuant to Rule 433 Registration No. 333-255101 Relating to the Prospectus dated April 16, 2021 and the Preliminary Prospectus Supplement dated April 22, 2021 EDAP Announces Launch of Follow-On Offering LYON, France, April 22, 2021 - EDAP TMS S.A. (NASDAQ: EDAP) (the “Company”), a global leader in robotic energy-based therapies, announced today the launch of a follow-on public offering of i

April 22, 2021 424B5

Subject to completion, dated April 22, 2021

TABLE OF CONTENTS The information in this preliminary prospectus supplement and the accompanying prospectus is not complete and may be changed.

April 14, 2021 LETTER

LETTER

United States securities and exchange commission logo April 13, 2021 Marc Oczachowski Chief Executive Officer and Chairman EDAP TMS S.

April 14, 2021 TEXT-EXTRACT

TEXT-EXTRACT

United States securities and exchange commission logo April 13, 2021 Marc Oczachowski Chief Executive Officer and Chairman EDAP TMS S.

April 14, 2021 CORRESP

April 14, 2021

April 14, 2021 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, DC 20549-6010 Re: Edap TMS S.A. Request for Acceleration of Effective Date of Registration Statement on Form F-3 (File No. 333-255101) Ladies and Gentlemen: Pursuant to Rule 461(a) of Regulation C under the Securities Act of 1933, as amended (the ?Securities Act?), EDAP T

April 7, 2021 20-F

- 20-F

Table of Contents ? As filed with the Securities and Exchange Commission on April 7, 2021 ? ? UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.

April 7, 2021 EX-2.3

Description of securities registered under Section 12 of the Exchange Act

? Exhibit 2.3 DESCRIPTION OF SECURITIES REGISTERED UNDER SECTION 12 OF THE EXCHANGE ACT As of December 31, 2020, EDAP TMS S.A. (the ?Company,? ?we,? ?us,? and ?our?) had the following series of securities registered pursuant to Section 12(b) of the Exchange Act: ? ? ? ? ? ? Title of Each Class Trading Symbol ? Name of each exchange on which registered ? American Depositary Shares, each representin

April 7, 2021 EX-13.1

Certification of Chief Executive Officer and Chief Financial Officer pursuant to Section 906 of the Sarbanes- Oxley Act of 2002.

EXHIBIT 13.1 Annual Certification Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 (subsections (a) and (b) of Section 1350, Chapter 63 of Title 18, United States Code), each of the undersigned officers of EDAP TMS S.A. (the “Company”), does hereby certify, to such officer's knowledge, that: The Annual Report on Form 20-F for the y

April 7, 2021 EX-12.1

Certification of Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

EXHIBIT 12.1 ? Annual Certification Pursuant to Section 302 of Sarbanes-Oxley Act of 2002 ? I, Marc Oczachowski, certify that: ? 1. I have reviewed this annual report on Form 20-F of EDAP TMS S.A.; ? 2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances und

April 7, 2021 EX-15.1

Consent of KPMG.

EX-15.1 8 edap-20201231xex15d1.htm EXHIBIT- 15.1 EXHIBIT 15.1 Consent of Independent Registered Public Accounting Firm The Board of Directors EDAP TMS S.A.: We consent to the incorporation by reference in the registration statements (No. 333-188112 and No. 333-217160) on Form S-8 of EDAP TMS S.A. of our reports dated April 7, 2021, with respect to the consolidated balance sheets of EDAP TMS S.A. a

April 7, 2021 F-3

- F-3

TABLE OF CONTENTS As filed with the Securities and Exchange Commission on April 7, 2021 Registration No.

April 7, 2021 EX-12.2

Certification of Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

EXHIBIT 12.2 Annual Certification Pursuant to Section 302 of Sarbanes-Oxley Act of 2002 I, François Dietsch, certify that: 1. I have reviewed this annual report on Form 20-F of EDAP TMS S.A.; 2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which

April 7, 2021 EX-1.1

Memorandum and Articles of Association of the Registrant (incorporated herein by reference to Exhibit 1.1 to the Registrant’s Annual Report on Form 20-F (Commission No. 000-29374) filed with the Commission on April 7, 2021)

Exhibit 1.1 ? EDAP TMS ? A stock company (soci?t? anonyme) with a capital of Euros 3,833,513.32 Head office: Parc d?activit?- La Poudrette Lamartine 4 rue du Dauphin? 69120 Vaulx en Velin - France ? MEMORANDUM AND ARTICLES OF ASSOCIATION - BYLAWS - ? Including modifications approved by Board of Directors on 30th March, 2021 ? ? ? Articles of Association ? March 30, 2021 English translation for inf

March 30, 2021 EX-99.1

EDAP TMS S.A. UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Amounts in thousands of Euros and U.S. Dollars, except per share data)

Exhibit 99.1 EDAP Reports Fourth Quarter 2020 Results and Provides Operational Update - Generated record fourth quarter revenue of EUR 15.4 million (USD 18.3 million), an increase of 28% year-over-year; HIFU revenue up 51% year-over-year - Generated €41.7 million revenue and profitable operating result for the full year 2020. - Completed sales to renowned healthcare institutions, such as Universit

March 30, 2021 6-K

Current Report of Foreign Issuer - FORM 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 March 30, 2021 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 fi

February 12, 2021 SC 13G/A

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G/A Under the Securities Exchange Act of 1934 (Amendment No. 2) EDAP TMS S.A. (Name of Issuer) American Depositary Shares and Ordinary Shares, nominal value €0.13 per

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G/A Under the Securities Exchange Act of 1934 (Amendment No. 2) EDAP TMS S.A. (Name of Issuer) American Depositary Shares and Ordinary Shares, nominal value €0.13 per share (Title of Class of Securities) 268311107** (CUSIP Number) December 31, 2020 (Date of Event Which Requires Filing of this Statement) Check the ap

November 18, 2020 EX-99.1

EDAP TMS S.A. UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Amounts in thousands of Euros and U.S. Dollars, except per share data)

Exhibit 99.1 EDAP Reports Third Quarter 2020 Results and Provides Operational Update - Generated strongest total revenue quarter of 2020 - Reported growth in HIFU procedure revenues year-over-year notwithstanding ongoing COVID-19 pandemic - Completed sales to renowned healthcare institutions Mount Sinai Health System in New York and Keck Medical Center at the University of Southern California - An

November 18, 2020 6-K

Current Report of Foreign Issuer - FORM 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 November 18, 2020 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

August 26, 2020 EX-99.1

EDAP TMS S.A. UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Amounts in thousands of Euros and U.S. Dollars, except per share data)

Exhibit 99.1 EDAP Reports Second Quarter 2020 Results and Provides Operational Update - Completed multiple Focal One sales to renowned U.S. and international health care institutions, including multiple Focal One™-ExactVu™ bundled sales - Announced first two U.S. publications in Journal of Urology detailing positive outcomes from U.S. studies of HIFU for the successful partial-gland ablation of pr

August 26, 2020 6-K

Current Report of Foreign Issuer - FORM 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 August 26, 2020 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 f

June 11, 2020 6-K

Current Report of Foreign Issuer - FORM 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 June 11, 2020 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 fil

May 13, 2020 EX-99.1

EDAP TMS S.A. UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Amounts in thousands of Euros and U.S. Dollars, except per share data)

Exhibit 99.1 EDAP Reports First Quarter 2020 Results and Provides Operational Update - Maintains strong balance sheet with EUR 18.5 million (USD 20.3 million) in cash as of March 31, 2020 - Signs exclusive worldwide distribution agreement with Exact Imaging to combine their innovative micro-ultrasound technology with Focal One to offer an end-to-end focal therapy solution for the diagnosis and man

May 13, 2020 6-K

Current Report of Foreign Issuer - FORM 6-K

6-K 1 f6k051320.htm FORM 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 May 13, 2020 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

April 16, 2020 EX-15.1

Consent of KPMG.

EX-15.1 7 exh151.htm EXHIBIT 15.1 EXHIBIT 15.1 Consent of Independent Registered Public Accounting Firm The Board of Directors EDAP TMS S.A.: We consent to the incorporation by reference in the registration statements (No. 333-188112 and No. 333-217160) on Form S-8 of EDAP TMS S.A. of our reports dated April 16, 2020, with respect to the consolidated balance sheets of EDAP TMS S.A. and subsidiarie

April 16, 2020 EX-12.1

Certification of Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

EXHIBIT 12.1 Annual Certification Pursuant to Section 302 of Sarbanes-Oxley Act of 2002 I, Marc Oczachowski, certify that: 1. I have reviewed this annual report on Form 20-F of EDAP TMS S.A.; 2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which

April 16, 2020 EX-13.1

Certification of Chief Executive Officer and Chief Financial Officer pursuant to Section 906 of the Sarbanes- Oxley Act of 2002.

EXHIBIT 13.1 Annual Certification Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 (subsections (a) and (b) of Section 1350, Chapter 63 of Title 18, United States Code), each of the undersigned officers of EDAP TMS S.A. (the “Company”), does hereby certify, to such officer's knowledge, that: The Annual Report on Form 20-F for the y

April 16, 2020 EX-12.2

Certification of Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

EXHIBIT 12.2 Annual Certification Pursuant to Section 302 of Sarbanes-Oxley Act of 2002 I, François Dietsch, certify that: 1. I have reviewed this annual report on Form 20-F of EDAP TMS S.A.; 2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which

April 16, 2020 EX-1.1

By-laws (statuts) of EDAP TMS S.A. as amended as of January 24, 2020

EX-1.1 2 exh11.htm EXHIBIT 1.1 EXHIBIT 1.1 By-laws (statuts) of EDAP TMS S.A. as amended as of January 24, 2020 EDAP TMS A stock company (société anonyme) with a capital of Euros 3,826,419.22 Head office: Parc d’activité- La Poudrette Lamartine 4 rue du Dauphiné 69120 Vaulx en Velin - France MEMORANDUM AND ARTICLES OF ASSOCIATION - BYLAWS - Including modifications approved on January 24, 2020 Arti

April 16, 2020 EX-15.2

Consent of independent registered public accounting firm

EX-15.2 8 exh152.htm EXHIBIT 15.2 EXHIBIT 15.2 Consent of independent registered public accounting firm We hereby consent to the incorporation by reference in the Registration Statements on Form S-8 No. 333-188112 and on Form S-8 No. 333-217160 of EDAP TMS S.A. of our report dated April 30, 2018 relating to the financial statements, which appears in this Form 20-F. Lyon, France, April 16, 2020 /s/

April 16, 2020 20-F

EDAP / EDAP TMS S.A. 20-F - - FORM 20-F

20-F 1 f20f041620p.htm FORM 20-F As filed with the Securities and Exchange Commission on April 16, 2020 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 20-F ☐ Registration Statement Pursuant to Section 12(b) or (g) of the Securities Exchange Act of 1934, Or ☒ Annual Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the Fiscal Year Ended

March 30, 2020 EX-99.1

EDAP TMS S.A. UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Amounts in thousands of Euros and U.S. Dollars, except per share data)

EDAP Reports Record Full Year 2019 Results and Provides Operational Update - Record full year 2019 revenues of €44.

March 30, 2020 6-K

EDAP / EDAP TMS S.A. 6-K - Current Report of Foreign Issuer - FORM 6-K

6-K 1 f6k033020.htm FORM 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 March 30, 2020 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 th

February 14, 2020 SC 13G/A

EDAP / EDAP TMS S.A. / Opaleye Management Inc. Passive Investment

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G/A Under the Securities Exchange Act of 1934 (Amendment No. 1) EDAP TMS S.A. (Name of Issuer) American Depositary Shares and Ordinary Shares, nominal value €0.13 per share (Title of Class of Securities) 268311107** (CUSIP Number) December 31, 2019 (Date of Event Which Requires Filing of this Statement) Check the ap

November 13, 2019 EX-99.1

EDAP TMS S.A. UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Amounts in thousands of Euros and U.S. Dollars, except per share data)

EDAP Reports 2019 Third Quarter and Nine Months Results - 67.8% growth in HIFU revenue through the nine month period ended September 30 over the comparable period in 2018 - 48.2% Gross margin for the nine month period ended September 30 compared to 42.3% for the comparable period in 2018 - Fourth consecutive quarter of profitability - Continued to drive US sales strategy towards reference centers

November 13, 2019 6-K

EDAP / EDAP TMS S.A. 6-K - Current Report of Foreign Issuer - FORM 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 November 13, 2019 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

November 7, 2019 SC 13G

EDAP / EDAP TMS S.A. / Opaleye Management Inc. Passive Investment

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G Under the Securities Exchange Act of 1934 EDAP TMS S.A. (Name of Issuer) American Depositary Shares and Ordinary Shares, nominal value €0.13 per share (Title of Class of Securities) 268311107** (CUSIP Number) October 28, 2019 (Date of Event Which Requires Filing of this Statement) Check the appropriate box to desi

August 28, 2019 EX-99.1

EDAP TMS S.A. UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Amounts in thousands of Euros and U.S. Dollars, except per share data)

Exhibit 99.1 EDAP Reports 2019 Second Quarter Results - Third consecutive profitable quarter - Positive reimbursement decision by the American Medical Association announced in June - Significant improvement in gross profit margin from 41.3% in Q2 2018 to 50.7% in Q2 2019 - Q2 HIFU sales growth of 98% year-over-year - Total Q2 revenues of EUR 12.5 million; +45% year-over-year, strongest Q2 to date

August 28, 2019 6-K

EDAP / EDAP TMS S.A. 6-K - Current Report of Foreign Issuer - FORM 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 August 28, 2019 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 f

July 25, 2019 6-K

EDAP / EDAP TMS S.A. 6-K - Current Report of Foreign Issuer - FORM 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 25, 2019 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 fil

July 25, 2019 EX-99.1

EDAP TMS Pre-Announces Strong 98% Growth in HIFU sales in the Second Quarter 2019

Exhibit 99.1 EDAP TMS Pre-Announces Strong 98% Growth in HIFU sales in the Second Quarter 2019 - 45% growth in total Q2 2019 revenue year-over-year - 78% growth in HIFU sales year-to-date through June 30, 2019 - Company to Report Second Quarter 2019 Financial Results on Wednesday, August 28, 2019 and to host conference call and webcast on Thursday August 29, at 8:30 am EDT LYON, France, July 25, 2

June 12, 2019 6-K

EDAP / EDAP TMS S.A. 6-K - Current Report of Foreign Issuer - FORM 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 June 12, 2019 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 fil

May 15, 2019 6-K

EDAP / EDAP TMS S.A. 6-K Current Report of Foreign Issuer FORM 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 May 15, 2019 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

May 15, 2019 EX-99.1

EDAP TMS S.A. UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Amounts in thousands of Euros and U.S. Dollars, except per share data)

Exhibit 99.1 EDAP Reports 2019 First Quarter Results - HIFU revenue growth of 58.6% year-over-year - Profitable for second consecutive quarter - Total Q1 revenues of EUR 10.1 million; strongest Q1 to date - Improved Q1 gross profit margin by 4.2 percentage points vs prior year LYON, France, May 15, 2019 - EDAP TMS SA (Nasdaq: EDAP) (“the Company”), the global leader in therapeutic ultrasound, anno

April 12, 2019 EX-15.1

Consent of KPMG.

EXHIBIT 15.1 Consent of Independent Registered Public Accounting Firm The Board of Directors, We consent to the incorporation by reference in the registration statements (No. 333-188112 and No. 333-217160) on Form S-8 of EDAP TMS S.A. of our reports dated April 10, 2019, with respect to the consolidated balance sheet of EDAP TMS S.A. and subsidiaries as of December 31, 2018, the related consolidat

April 12, 2019 EX-15.3

Letter to the SEC from PriceWaterhouseCoopers Audit re: disclosure in Item 16F

EXHIBIT 15.3 LETTER TO THE SEC FROM PRICEWATERHOUSECOOPERS AUDIT RE. DISCLOSURE IN ITEM 16F Securities and Exchange Commission 100 F Street, N.E. Washington, DC 20549 Commissioners: We have read the statements made by EDAP TMS S.A. (copy attached), which we understand will be filed with the Securities and Exchange Commission, pursuant to Item 16F of 20F of EDAP TMS S.A. dated April 12, 2019. We ag

April 12, 2019 EX-12.1

Certification of Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

EXHIBIT 12.1 Annual Certification Pursuant to Section 302 of Sarbanes-Oxley Act of 2002 I, Marc Oczachowski, certify that: 1. I have reviewed this annual report on Form 20-F of EDAP TMS S.A.; 2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which

April 12, 2019 EX-13.1

Certification of Chief Executive Officer and Chief Financial Officer pursuant to Section 906 of the Sarbanes- Oxley Act of 2002.

EXHIBIT 13.1 Annual Certification Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 (subsections (a) and (b) of Section 1350, Chapter 63 of Title 18, United States Code), each of the undersigned officers of EDAP TMS S.A. (the “Company”), does hereby certify, to such officer's knowledge, that: The Annual Report on Form 20-F for the y

April 12, 2019 EX-15.2

Consent of PricewaterhouseCoopers Audit for years ended 2017 and 2016

EXHIBIT 15.2 CONSENT OF PRICEWATERHOUSECOOPERS AUDIT FOR YEARS ENDED 2017 AND 2016 We hereby consent to the incorporation by reference in the Registration Statements on Form S-8 No. 333-188112 and on Form S-8 No. 333-217160 of EDAP TMS S.A. of our report dated April 30, 2018 relating to the financial statements, which appears in this Form 20-F. Lyon, France, April 12, 2019 /s/ PricewaterhouseCoope

April 12, 2019 20-F

EDAP / EDAP TMS S.A. FORM 20-F

20-F 1 f20f041219p.htm FORM 20-F As filed with the Securities and Exchange Commission on April 12, 2019 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 20-F ☐ Registration Statement Pursuant to Section 12(b) or (g) of the Securities Exchange Act of 1934, Or ý Annual Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the Fiscal Year Ended

April 12, 2019 EX-12.2

Certification of Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

EXHIBIT 12.2 Annual Certification Pursuant to Section 302 of Sarbanes-Oxley Act of 2002 I, François Dietsch, certify that: 1. I have reviewed this annual report on Form 20-F of EDAP TMS S.A.; 2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which

April 1, 2019 EX-99.1

EDAP Reports Q4 and Full Year 2018 Results Reports record revenues for the fifth consecutive year

Exhibit 99.1 EDAP Reports Q4 and Full Year 2018 Results Reports record revenues for the fifth consecutive year · Record fiscal year 2018 revenues of €39.2 million · Q4 2018 HIFU net sales increased 79% year-over-year · Profitable and cash flow positive during the fourth quarter of 2018 · Completed first U.S. sale of Focal One at the end of 2018 · Ended the year with a strong cash position of $22.3

April 1, 2019 6-K

EDAP / EDAP TMS S.A. FORM 6-K (Current Report of Foreign Issuer)

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 April 1, 2019 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 fil

November 14, 2018 EX-99.1

EDAP TMS S.A. UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Amounts in thousands of Euros and U.S. Dollars, except per share data)

EDAP Reports 2018 Third Quarter Results · Generated revenue growth of more than 14% as compared to the third quarter of 2017 · Continued geographic expansion of Focal One with installations in Brazil and South Korea · Since receiving FDA clearance for Focal One in June 2018, progressed through the lengthy capital equipment sales cycle with U.

November 14, 2018 6-K

EDAP / EDAP TMS S.A. FORM 6-K (Current Report of Foreign Issuer)

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 November 14, 2018 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

September 26, 2018 6-K

EDAP / EDAP TMS S.A. FORM 6-K (Current Report of Foreign Issuer)

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 EDAP TMS S.A. Files on September 26, 2018 EDAP TMS S.A. Parc d’activités la Poudrette - Lamartine 4/6 Rue du Dauphine 69120 Vaulx-en-Velin - France Commission File Number: 0-29374 Indicate by check mark whether the registran

August 29, 2018 EX-99.1

EDAP TMS S.A. UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Amounts in thousands of Euros and U.S. Dollars, except per share data)

Exhibit 99.1 EDAP Reports 2018 Second Quarter Results · Receives FDA clearance for novel Focal One device for prostate tissue ablation LYON, France, August 29, 2018 - EDAP TMS SA (Nasdaq: EDAP) (“the Company”), the global leader in therapeutic ultrasound, announced today financial results for the second quarter of 2018 and provided a strategic and operational update. Management will host a confere

August 29, 2018 6-K

EDAP / EDAP TMS S.A. FORM 6-K (Current Report of Foreign Issuer)

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 August 29, 2018 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 f

June 7, 2018 6-K

EDAP / EDAP TMS S.A. FORM 6-K (Current Report of Foreign Issuer)

18UNITED 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 June 7, 2018 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 fi

June 7, 2018 EX-99.1

EDAP Announces FDA Clearance for Focal One®

Exhibit 99.1 EDAP Announces FDA Clearance for Focal One® AUSTIN, TX, LYON, FRANCE - JUNE 7, 2018 - EDAP TMS SA (Nasdaq: EDAP) (“the Company”), the global leader in therapeutic ultrasound, today announced that it has received 510(k) clearance from the US Food and Drug Administration (FDA) for its Focal One device for the ablation of prostate tissue. The Focal One high intensity focused ultrasound (

June 5, 2018 6-K

EDAP / EDAP TMS S.A. FORM 6-K (Current Report of Foreign Issuer)

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 June 5, 2018 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

May 14, 2018 EX-99.1

EDAP TMS S.A. UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Amounts in thousands of Euros and U.S. Dollars, except per share data)

Exhibit 99.1 EDAP Reports 2018 First Quarter Results · 2018 Q1 total revenue records a 6% increase year-over-year · Focal One Final Additional Information submitted to FDA early May · EDAP to attend American Urological Association congress in San Francisco, May 18-21, 2018 LYON, France, May 14, 2018 - EDAP TMS SA (Nasdaq: EDAP) (“the Company”), the global leader in therapeutic ultrasound, announce

May 14, 2018 6-K

EDAP / EDAP TMS S.A. FORM 6-K (Current Report of Foreign Issuer)

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 May 14, 2018 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

April 30, 2018 EX-12.2

Certification of Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

EXHIBIT 12.2 Annual Certification Pursuant to Section 302 of Sarbanes-Oxley Act of 2002 I, François Dietsch, certify that: 1. I have reviewed this annual report on Form 20-F of EDAP TMS S.A.; 2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which

April 30, 2018 EX-13.1

Certification of Chief Executive Officer and Chief Financial Officer pursuant to Section 906 of the Sarbanes- Oxley Act of 2002.

EXHIBIT 13.1 Annual Certification Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 (subsections (a) and (b) of Section 1350, Chapter 63 of Title 18, United States Code), each of the undersigned officers of EDAP TMS S.A. (the “Company”), does hereby certify, to such officer's knowledge, that: The Annual Report on Form 20-F for the y

April 30, 2018 EX-12.1

Certification of Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

EXHIBIT 12.1 Annual Certification Pursuant to Section 302 of Sarbanes-Oxley Act of 2002 I, Marc Oczachowski, certify that: 1. I have reviewed this annual report on Form 20-F of EDAP TMS S.A.; 2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which

April 30, 2018 EX-15.1

Consent of PricewaterhouseCoopers Audit.

EX-15.1 7 exh151.htm EXHIBIT 15.1 EXHIBIT 15.1 CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM We hereby consent to the incorporation by reference in the Registration Statement on Form S-8 No. 333-188112 and Form S-8 No. 333-217160 of EDAP TMS S.A. of our report dated April 30, 2018, relating to the financial statements and the effectiveness of internal control over financial reporting, w

April 30, 2018 EX-1.1

By-laws (statuts) of EDAP TMS S.A. as amended as of January 19, 2018

EX-1.1 2 exh11.htm EXHIBIT 1.1 EXHIBIT 1.1 EDAP TMS A stock company (société anonyme) with a capital of Euros 3,817,891.22 Head office: Parc d’activité- La Poudrette Lamartine 4 rue du Dauphiné 69120 Vaulx en Velin - France MEMORANDUM AND ARTICLES OF ASSOCIATION - BYLAWS - Including modifications approved on January 19, 2018 Articles of Association – January 19, 2018 English translation for inform

April 30, 2018 20-F

EDAP / EDAP TMS S.A. FORM 20-F

As filed with the Securities and Exchange Commission on April 30, 2018 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.

March 27, 2018 6-K

EDAP / EDAP TMS S.A. FORM 6-K (Current Report of Foreign Issuer)

6-K 1 f6k032718.htm FORM 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 March 27, 2018 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 th

March 27, 2018 EX-99.1

EDAP TMS S.A. UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Amounts in thousands of Euros and U.S. Dollars, except per share data)

Exhibit 99.1 EDAP Reports 2017 Annual Results 2017 Highlights · 2017 revenue on par with 2016; lower HIFU capital equipment sales offset by double-digit HIFU treatment revenue growth · CMS issued C-Code allocation for reimbursement of HIFU for prostate tissue ablation in July · CIGNA to reimburse HIFU as salvage therapy for prostate cancer patients, at the start of 2018 · Meeting scheduled for Apr

November 15, 2017 EX-99.1

EDAP TMS Reports Third Quarter 2017 Results

Exhibit 99.1 EDAP TMS Reports Third Quarter 2017 Results ? EDAP's HIFU patient treatment revenues grew 29% compared to third quarter 2016. ? EDAP received FDA clearance for its Ablatherm Fusion? late in the quarter. ? EDAP's cash position remains strong at US $21.3 million on September 30, 2017 LYON, France, November 15, 2017 - EDAP TMS SA (Nasdaq: EDAP), the global leader in therapeutic ultrasoun

November 15, 2017 6-K

EDAP / EDAP TMS S.A. FORM 6-K (Current Report of Foreign Issuer)

6-K 1 f6k111517.htm FORM 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 November 15, 2017 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

October 4, 2017 EX-99.1

EDAP Announces FDA Clearance of its Ablatherm-Fusion® device

Exhibit 99.1 EDAP Announces FDA Clearance of its Ablatherm-Fusion? device LYON, France, October 4, 2017 - EDAP TMS SA (Nasdaq:EDAP), the global leader in therapeutic ultrasound, today announced FDA approval of its Ablatherm-Fusion device enabling a more precise method for targeting of diagnosed areas within the prostate. Marc Oczachowski, Chief Executive Officer of EDAP TMS, commented: "We are ver

October 4, 2017 6-K

EDAP TMS FORM 6-K (Current Report of Foreign Issuer)

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 October 4, 2017 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 f

September 21, 2017 6-K

Current Report of Foreign Issuer - FORM 6-K

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 EDAP TMS S.A. Files on September 21, 2017 EDAP TMS S.A. Parc d’activités la Poudrette - Lamartine 4/6 Rue du Dauphine 69120 Vaulx-en-Velin - France Commission File Number: 0-29374 Indicate by check mark whether the registran

September 11, 2017 EX-99.1

EDAP Announces Filing of New 510(k) Application for Focal One® Device

Exhibit 99.1 EDAP Announces Filing of New 510(k) Application for Focal One? Device 510(k) Includes New Clinical Data to Support EDAP?s File LYON, France, September 11, 2017 - EDAP TMS SA (Nasdaq:EDAP), the global leader in therapeutic ultrasound, today announced that the Company submitted a new 510(k) application for its Focal One device, including an updated clinical section for FDA review. As re

September 11, 2017 6-K

EDAP TMS FORM 6-K (Current Report of Foreign Issuer)

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 11, 2017 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 wil

August 23, 2017 EX-99.1

EDAP-TMS Reports Record Second Quarter and First Half 2017 Results

Exhibit 99.1 EDAP-TMS Reports Record Second Quarter and First Half 2017 Results ? Revenue increased 13.7% to a record ?9.3 million for the second quarter of 2017 compared to ?8.2 million in 2016 ? HIFU revenue grew 25% when compared to first quarter of 2017 ? Ablatherm Fusion 510(k) submission completed ? C-Code reimbursement for HIFU treatments active as of July 1st, 2017 LYON, France, August 23,

August 23, 2017 6-K

EDAP TMS FORM 6-K (Current Report of Foreign Issuer)

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 August 23, 2017 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 f

July 31, 2017 EX-99.1

EDAP Announces filing of 510(k) Application for Ablatherm-Fusion® device

EdgarFiling EXHIBIT 99.1 EDAP Announces filing of 510(k) Application for Ablatherm-Fusion? device LYON, France, July 31, 2017 - EDAP TMS SA (Nasdaq:EDAP), the global leader in therapeutic ultrasound, today announced that the Company submitted a 510(k) application for its Ablatherm Fusion device, enabling a more precise method for targeting of diagnosed areas within the prostate. Marc Oczachowski,

July 31, 2017 6-K

EDAP TMS FORM 6-K (Current Report of Foreign Issuer)

6-K 1 f6k073117.htm FORM 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 31, 2017 Commission File Number: 000-29374 EDAP TMS S.A. Parc Activite La Poudrette Lamartine 4/6 Rue du Dauphine 69120 Vaulx-en-Velin - France Indicate by check mark whether t

July 17, 2017 EX-99.1

EDAP Announces Withdrawal of 510(k) Application for Focal One® to be Followed by New Submission to Conform to FDA Review Rules

Exhibit 99.1 EDAP Announces Withdrawal of 510(k) Application for Focal One® to be Followed by New Submission to Conform to FDA Review Rules · New 510(k) With New Clinical Data to be Submitted for Focal One® · Initial 510(k) to be submitted for Ablatherm Fusion® LYON, France, July 17, 2017 (GLOBE NEWSWIRE) - EDAP TMS SA (Nasdaq:EDAP), the global leader in therapeutic ultrasound, today announced tha

July 17, 2017 6-K

EDAP TMS FORM 6-K (Current Report of Foreign Issuer)

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 17, 2017 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 fil

June 7, 2017 6-K

EDAP TMS FORM 6-K (Current Report of Foreign Issuer)

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 June 7, 2017 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

May 22, 2017 6-K

EDAP TMS FORM 6-K (Current Report of Foreign Issuer)

6-K 1 f6k052217.htm FORM 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 May 22, 2017 Commission File Number: 000-29374 EDAP TMS S.A. Parc Activite La Poudrette Lamartine 4/6 Rue du Dauphine 69120 Vaulx-en-Velin - France Indicate by check mark whether th

May 22, 2017 EX-99.1

EDAP Announces CMS Approval of New Reimbursement Code for HIFU Ablation of the Prostate

EX-99.1 2 exh991.htm PRESS RELEASE EXHIBIT 99.1 EDAP Announces CMS Approval of New Reimbursement Code for HIFU Ablation of the Prostate Billing code will take effect July 1st, 2017 LYON, France, May 22, 2017 (GLOBE NEWSWIRE) - EDAP TMS SA (Nasdaq:EDAP), the global leader in therapeutic ultrasound, announced today that the Centers for Medicare and Medicaid Services (CMS) have established a new bill

May 17, 2017 EX-99.1

EDAP TMS S.A. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Amounts in thousands of Euros and U.S. Dollars, except per share data)

Exhibit 99.1 EDAP TMS SA Reports 1Q 2017 Results Total revenue of EUR 8.7 million (USD 9.3 million) for Q1 2017 +16.5% growth in HIFU treatment driven recurring revenues Strong cash position of EUR 20.3 million (USD 21.7 million) as of March 31, 2017 CMS Medicare C-code submission for HIFU reimbursement in the U.S. Ablatherm Fusion World Premiere at AUA in Boston May 12-16 LYON, France, May 17, 20

May 17, 2017 6-K

EDAP TMS FORM 6-K (Current Report of Foreign Issuer)

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 May 17, 2017 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

April 5, 2017 S-8

2016 Stock Option Plan on Form S-8 dated April 5, 2017, File Number 333-217160

As filed with the Securities and Exchange Commission on April 5, 2017 Registration No.

April 5, 2017 EX-4.2

This is a free translation from the French language and is supplied solely for information purposes. Only the original version in French language has legal force. EDAP TMS (the “Company”) Capital of 3,782,319.97 Euros Headquarters : Parc d’Activité d

Exhibit 4.2 This is a free translation from the French language and is supplied solely for information purposes. Only the original version in French language has legal force. EDAP TMS (the “Company”) Capital of 3,782,319.97 Euros Headquarters : Parc d’Activité de La Poudrette Lamartine, 4, rue du Dauphiné, 69120 VAULX-EN-VELIN 316488204 RCS LYON FORM OF SHARE SUBSCRIPTION OPTION PLAN Extraordinary

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