Mga Batayang Estadistika
| 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)
Halaman ini menyediakan daftar lengkap dan kronologis dari Pengajuan SEC, tidak termasuk pengajuan kepemilikan yang kami sediakan di tempat lain.
| August 28, 2025 |
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 |
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| August 26, 2025 |
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 |
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| July 1, 2025 |
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 |
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| June 2, 2025 |
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 |
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| May 15, 2025 |
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 |
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| May 14, 2025 |
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 |
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| May 14, 2025 |
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 |
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| May 14, 2025 |
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. |
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| March 27, 2025 |
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 |
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| March 27, 2025 |
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 |
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| March 27, 2025 |
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 |
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| March 27, 2025 |
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 |
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| March 27, 2025 |
Table of Contents As filed with the Securities and Exchange Commission on March 27, 2025 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D. |
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| March 27, 2025 |
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 |
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| March 27, 2025 |
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 |
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| March 27, 2025 |
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. |
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| March 27, 2025 |
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 |
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| March 27, 2025 |
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 |
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| March 3, 2025 |
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 |
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| January 13, 2025 |
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 |
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| January 10, 2025 |
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 |
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| December 4, 2024 |
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 |
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| November 14, 2024 |
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 |
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| November 7, 2024 |
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 |
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| August 28, 2024 |
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 |
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| August 22, 2024 |
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 |
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| August 22, 2024 |
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 |
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| August 22, 2024 |
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 |
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| August 22, 2024 |
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. |
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| July 19, 2024 |
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 |
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| July 8, 2024 |
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 |
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| June 7, 2024 |
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 |
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| May 16, 2024 |
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 |
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| 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” |
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| April 5, 2024 |
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 |
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| April 5, 2024 |
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. |
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| April 5, 2024 |
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 |
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| March 28, 2024 |
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 |
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| March 28, 2024 |
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 |
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| March 28, 2024 |
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 |
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| March 28, 2024 |
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 |
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| March 28, 2024 |
Table of Contents As filed with the Securities and Exchange Commission on March 28, 2024 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D. |
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| March 28, 2024 |
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 |
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| March 28, 2024 |
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 |
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| March 28, 2024 |
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 |
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| March 27, 2024 |
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 |
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| March 4, 2024 |
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 |
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| February 2, 2024 |
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 |
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| January 2, 2024 |
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 |
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| December 7, 2023 |
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 |
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| November 9, 2023 |
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 |
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| August 24, 2023 |
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 |
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| June 6, 2023 |
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 |
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| May 17, 2023 |
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 |
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| April 7, 2023 |
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 |
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| April 7, 2023 |
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 |
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| April 7, 2023 |
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 |
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| April 7, 2023 |
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 |
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| April 7, 2023 |
Table of Contents As filed with the Securities and Exchange Commission on April 7, 2023 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D. |
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| April 7, 2023 |
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 |
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| April 7, 2023 |
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 |
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| March 30, 2023 |
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 |
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| February 14, 2023 |
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 |
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| November 16, 2022 |
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 |
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| November 9, 2022 |
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 |
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| November 9, 2022 |
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 |
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| November 9, 2022 |
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. |
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| September 28, 2022 |
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 |
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| September 28, 2022 |
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 |
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| September 26, 2022 |
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 |
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| September 26, 2022 |
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 |
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| September 23, 2022 |
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 |
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| September 23, 2022 |
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 |
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| September 23, 2022 |
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. |
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| September 22, 2022 |
TABLE OF CONTENTS The information in this preliminary prospectus supplement and the accompanying prospectus is not complete and may be changed. |
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| August 24, 2022 |
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 |
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| June 9, 2022 |
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 |
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| May 17, 2022 |
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 |
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| April 8, 2022 |
Table of Contents As filed with the Securities and Exchange Commission on April 8, 2022 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D. |
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| April 8, 2022 |
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 |
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| April 8, 2022 |
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 |
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| April 8, 2022 |
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 |
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| April 8, 2022 |
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 |
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| April 8, 2022 |
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 |
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| April 8, 2022 |
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, |
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| March 30, 2022 |
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 |
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| February 10, 2022 |
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 |
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| February 10, 2022 |
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 |
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| November 18, 2021 |
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 |
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| November 18, 2021 |
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. |
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| November 17, 2021 |
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 |
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| September 28, 2021 |
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 |
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| September 28, 2021 |
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 |
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| August 25, 2021 |
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 |
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| June 16, 2021 |
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 |
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| June 16, 2021 |
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 |
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| June 16, 2021 |
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. |
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| June 11, 2021 |
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 |
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| May 11, 2021 |
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 |
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| May 11, 2021 |
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 |
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| 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 Depositary Shares (Title of Class of Securities) 268311107 (CUSIP Number) April 23, 2021 (Date of Event Which Requires Filing of this Statement) |
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| April 28, 2021 |
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 |
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| April 26, 2021 |
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 |
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| April 26, 2021 |
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 |
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| April 23, 2021 |
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 |
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| April 23, 2021 |
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 |
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| April 22, 2021 |
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 |
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| April 22, 2021 |
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 |
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| April 22, 2021 |
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. |
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| 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 |
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| 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 |
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| April 7, 2021 |
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 |
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| April 7, 2021 |
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 |
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| April 7, 2021 |
TABLE OF CONTENTS As filed with the Securities and Exchange Commission on April 7, 2021 Registration No. |
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| April 7, 2021 |
Table of Contents ? As filed with the Securities and Exchange Commission on April 7, 2021 ? ? UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D. |
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| April 7, 2021 |
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 |
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| April 7, 2021 |
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 |
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| April 7, 2021 |
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 |
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| March 30, 2021 |
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 |
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| March 30, 2021 |
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 |
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| February 12, 2021 |
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 |
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| November 18, 2020 |
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 |
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| November 18, 2020 |
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 |
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| August 26, 2020 |
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 |
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| August 26, 2020 |
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 |
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| June 11, 2020 |
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 |
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| May 13, 2020 |
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 |
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| May 13, 2020 |
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 |
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| April 16, 2020 |
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 |
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| April 16, 2020 |
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 |
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| April 16, 2020 |
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 |
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| April 16, 2020 |
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/ |
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| April 16, 2020 |
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 |
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| April 16, 2020 |
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 |
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| April 16, 2020 |
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 |
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| March 30, 2020 |
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 |
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| March 30, 2020 |
EDAP Reports Record Full Year 2019 Results and Provides Operational Update - Record full year 2019 revenues of €44. |
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| February 14, 2020 |
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 |
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| November 13, 2019 |
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 |
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| November 13, 2019 |
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 |
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| November 7, 2019 |
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 |
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| August 28, 2019 |
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 |
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| August 28, 2019 |
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 |
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| July 25, 2019 |
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 |
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| July 25, 2019 |
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 |
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| June 12, 2019 |
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 |
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| May 15, 2019 |
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 |
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| May 15, 2019 |
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 |
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| April 12, 2019 |
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 |
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| April 12, 2019 |
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 |
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| April 12, 2019 |
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 |
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| April 12, 2019 |
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 |
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| April 12, 2019 |
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 |
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| April 12, 2019 |
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 |
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| April 12, 2019 |
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 |
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| April 1, 2019 |
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 |
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| April 1, 2019 |
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 |
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| November 14, 2018 |
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. |
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| November 14, 2018 |
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 |
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| September 26, 2018 |
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 |
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| August 29, 2018 |
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 |
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| August 29, 2018 |
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 |
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| June 7, 2018 |
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 ( |
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| June 7, 2018 |
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 |
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| June 5, 2018 |
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 |
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| May 14, 2018 |
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 |
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| May 14, 2018 |
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 |
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| April 30, 2018 |
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 |
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| April 30, 2018 |
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 |
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| April 30, 2018 |
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. |
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| April 30, 2018 |
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 |
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| April 30, 2018 |
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 |
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| April 30, 2018 |
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 |
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| March 27, 2018 |
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 |
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| March 27, 2018 |
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 |
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| November 15, 2017 |
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 |
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| November 15, 2017 |
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 |
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| October 4, 2017 |
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 |
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| October 4, 2017 |
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 |
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| September 21, 2017 |
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 |
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| September 11, 2017 |
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 |
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| September 11, 2017 |
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 |
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| August 23, 2017 |
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 |
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| August 23, 2017 |
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, |
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| July 31, 2017 |
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 |
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| July 31, 2017 |
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, |
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| July 17, 2017 |
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 |
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| July 17, 2017 |
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 |
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| June 7, 2017 |
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 |
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| May 22, 2017 |
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 |
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| May 22, 2017 |
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 |
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| May 17, 2017 |
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 |
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| May 17, 2017 |
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 |
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| April 5, 2017 |
Exhibit 24.1 POWER OF ATTORNEY Reference is hereby made to the proposed registration by EDAP TMS S.A. under the U.S. Securities Act of 1933, as amended, of common shares, nominal value ?0.13 each of EDAP TMS SA, that may be issued pursuant to the EDAP TMS S.A. 2016 Stock Option Plan (such common shares, the ?Option Shares?). Such Option Shares will be registered on a registration statement on Form |
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| April 5, 2017 |
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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| April 5, 2017 |
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. |
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| April 3, 2017 |
Exhibit 99.1 EDAP Achieves 63% Growth in HIFU Revenue in 2016 2016 Highlights ? Total revenue for 2016 reached double-digit growth, increasing to EUR 35.6 million (USD 39.3 million) ? Gross margin for 2016 expanded to 46.1% compared to 42.8% during the prior year period ? Strong cash position of EUR 22.0 million (USD 23.2 million) as of December 31, 2016 LYON, France, April 3, 2017 - EDAP TMS SA ( |
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| April 3, 2017 |
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 April 3, 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 |
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| April 3, 2017 |
EXHIBIT 1.1. EDAP TMS A stock company (société anonyme) with a capital of Euros 3.355.493,05 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 25, 2017 Articles of Association – January 25, 2017 English translation for information purposes only 1/14 TITLE |
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| April 3, 2017 |
As filed with the Securities and Exchange Commission on April 3, 2017 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D. |
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| April 3, 2017 |
Code of Ethics as amended as of January 25, 2017. EXHIBIT 11.1 Ethics Code Company values EDAP-TMS Table of Contents FOREWARD 3 WHAT IS THE PURPOSE OF THIS CODE? 4 TO WHOM DOES THIS CODE APPLY? 5 HOW IS THIS CODE USED? 5 WHAT IS THE MANAGER’S ROLE IN EDAP-TMS MEASURES? 6 RULES OF GOOD CONDUCT REGARDING PEOPLE 7 DIVERSITY AND EQUAL OPPORTUNITY 7 HARASSMENT 8 RESPECTING PRIVACY AND PERSONAL DATA PROTECTION 9 RESPECTING HYGIENE, SAFETY, AND THE ENVI |
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| April 3, 2017 |
Annual Certification Pursuant to Section 302 of 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 |
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| April 3, 2017 |
CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM EXHIBIT 15.1 CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM We hereby consent to the incorporation by reference in the Registration Statement on Form F-3 No. 333-195435 and on Form S-8 No. 333-188112 of EDAP TMS S.A. of our report dated April 3, 2017, relating to the financial statements and the effectiveness of internal control over financial reporting, which appears in this Form 20-F. |
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| April 3, 2017 |
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 |
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| April 3, 2017 |
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, 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 |
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| February 23, 2017 |
EDAP Announces Preliminary Unaudited Full Year 2016 Revenue EX-99.1 2 exh991.htm EXHIBIT 99.1 Exhibit 99.1 EDAP Announces Preliminary Unaudited Full Year 2016 Revenue · Full year 2016 revenue increased to approximately €35.6 million · 2016 HIFU revenues recorded over 63% growth · Strong cash position of €22 million · Company to announce fourth quarter and full year 2016 results April 3rd with accompanying conference call April 4th LYON, France, February 23 |
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| February 23, 2017 |
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 February 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 |
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| November 17, 2016 |
EDAP TMS FORM 6-K (Current Report of Foreign Issuer) EdgarFiling 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, 2016 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 f |
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| November 17, 2016 |
EDAP Achieves 79% Growth in HIFU Revenue for First Nine Months of 2016 EdgarFiling EXHIBIT 99.1 EDAP Achieves 79% Growth in HIFU Revenue for First Nine Months of 2016 Highlights at the end of September 30, 2016: Total cumulated revenue in 2016 up 22% year-over-year; Driven by HIFU growth, Gross Margin increases to 45%; 111% growth in HIFU revenues in Q3 of 2016 compared to Q3 2015; Company continues to show operating profit in 2016 at the end of Q3; Strong cash posit |
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| September 27, 2016 |
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 27, 2016 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 |
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| August 25, 2016 |
EDAP TMS FORM 6-K (Current Report of Foreign Issuer) 6-K 1 f6k082516.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 25, 2016 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 |
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| August 25, 2016 |
EDAP Reports 69% Growth in HIFU Revenues and Operating Profit for First Half 2016 EdgarFiling EXHIBIT 99.1 EDAP Reports 69% Growth in HIFU Revenues and Operating Profit for First Half 2016 Total EDAP revenue up 20.4% year-over-year in the first six months of 2016 Continued growth in HIFU system sales and treatment-driven revenue with strong margins Focal One® 510k under FDA review Solid cash position at €21.9 million as of June 30, 2016 LYON, France, Aug. 25, 2016 (GLOBE NEWSWI |
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| August 25, 2016 |
EDAP TMS FORM 6-K (Current Report of Foreign Issuer) 6-K 1 f6k082516.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 25, 2016 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 |
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| June 9, 2016 |
EDAP TMS FORM 6-K (Current Report of Foreign Issuer) 6-K 1 f6k060816.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 June 9, 2016 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 |
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| May 18, 2016 |
EDAP TMS FORM 6-K (Current Report of Foreign Issuer) EdgarFiling 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 18, 2016 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 |
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| May 18, 2016 |
EDAP First Quarter 2016 Revenue Increases 40% Year-over-Year to €8.7 Million EdgarFiling EXHIBIT 99.1 EDAP First Quarter 2016 Revenue Increases 40% Year-over-Year to ?8.7 Million First quarter 2016 HIFU Division revenue increased 102% year-over-year 37% growth in HIFU treatment driven revenues in Q1 2016 compared to Q1 2015 ?0.7 million operating profit, ?1.4 million net income in first quarter 2016 510(k) application for Focal One submitted to FDA LYON, France, May 18, 20 |
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| April 15, 2016 |
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 April 15, 2016 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 |
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| April 15, 2016 |
EdgarFiling EXHIBIT 99.1 EDAP TMS SA Closes $11.5 Million Registered Direct Offering Positions EDAP to Accelerate U.S. Sales and Marketing Expansion for HIFU Strengthens Financial Resources to Grow Global Operations LYON, France, April 14, 2016 (GLOBE NEWSWIRE) - EDAP TMS SA (Nasdaq:EDAP), a global leader in therapeutic ultrasound, announced the closing of its previously announced $11.5 million re |
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| April 14, 2016 |
EX-99.1 6 exh991.htm EXHIBIT 99.1 Exhibit 99.1 SECURITIES PURCHASE AGREEMENT This Securities Purchase Agreement (this “Agreement”) is dated as of April 7, 2016, between EDAP TMS S.A., a French société anonyme, with headquarters located at Parc d'activités la Poudrette-Lamartine, 4/6, rue du Dauphiné, 69120 Vaulx-en-Velin, France (the “Company”), and each purchaser identified on the signature pages |
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| April 14, 2016 |
Exhibit 4.1 WARRANTS FOR ORDINARY SHARES edap tms s.a. Warrants: Issue Date: April 14, 2016 Warrant Shares: Initial Exercise Date: October 14, 2016 THESE WARRANTS FOR ORDINARY SHARES (the “Warrant”) certify that, for value received, or its registered assigns (as the same may be registered from time to time in the books of the Custodian, the “Holder”) is entitled, upon the terms and subject to the |
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| April 14, 2016 |
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 April 14, 2016 Commission File Number: 000-29374 EDAP TMS S.A. Parc Activit? La Poudrette Lamartine 4/6 Rue du Dauphine 69120 Vaulx-en-Velin - France Indicate by check mark whether the registrant files or will |
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| April 14, 2016 |
430 Park Avenue | New York, New York 10022 | 212.356.0500 | www.hcwco.com Member: FINRA/SIPC EX-1.1 2 exh11.htm EXHIBIT 1.1 Exhibit 1.1 November 29, 2015 STRICTLY CONFIDENTIAL Mr. Marc Oczachowski Chief Executive Officer EDAP TMS SA 4-6, rue du Dauphine 69120 Vaulx-en-Velin France Dear Mr. Oczachowski: EDAP TMS SA (the “Company”) and H.C. Wainwright & Co., LLC (“HC Wainwright”) hereby agree that HC Wainwright shall serve as the exclusive placement agent for the Company on a reasonable bes |
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| April 8, 2016 |
Filed Pursuant to Rule 424(B)(5) Registration Statement No. 333-195435 Prospectus Supplement (To Prospectus Dated May 7, 2014) 3,283,284 Ordinary Shares in the form of American Depositary Shares Warrants to purchase up to 3,283,284 Ordinary Shares in the form of American Depositary Shares 3,283,284 Ordinary Shares in the form of American Depositary Shares issuable upon exercise of the Warrants Pur |
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| April 7, 2016 |
EDAP TMS SA to Raise $11.5 Million in Registered Direct Offering EdgarFiling EXHIBIT 99.1 EDAP TMS SA to Raise $11.5 Million in Registered Direct Offering LYON, France, April 07, 2016 (GLOBE NEWSWIRE) - EDAP TMS SA (Nasdaq:EDAP), a global leader in therapeutic ultrasound, announced that it has entered into definitive agreements with certain institutional investors for a registered direct placement of 3,283,284 ordinary shares in the form of American Depositary |
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| April 7, 2016 |
EDAP TMS FORM 6-K (Current Report of Foreign Issuer) EdgarFiling 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 For the month of April 2016 Commission File Number: 000-29374 EDAP TMS S.A. (Translation of registrant's name into English) Parc Activite La Poudrette Lamartine 4/6 Rue du Dauphine (Address of princ |
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| April 6, 2016 |
EDAP Submits 510(k) Application for FDA Clearance of Focal One HIFU EdgarFiling EXHIBIT 99.1 EDAP Submits 510(k) Application for FDA Clearance of Focal One HIFU LYON, France, April 06, 2016 (GLOBE NEWSWIRE) - EDAP TMS SA (Nasdaq:EDAP), the global leader in therapeutic ultrasound, today announced that it has submitted a 510(k) application to the U.S. Food and Drug Administration (FDA) for the clearance of its next generation HIFU device: the Focal One?. This submis |
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| April 6, 2016 |
EDAP TMS FORM 6-K (Current Report of Foreign Issuer) EdgarFiling 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 6, 2016 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 fil |
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| April 4, 2016 |
EX-99.1 2 exh991.htm PRESS RELEASE EXHIBIT 99.1 EDAP Reports 20% Revenue Growth to EUR 32.3 Million and EUR 0.5 Million Operating Profit for Full-year 2015 Obtained FDA clearance in November 2015 for Ablatherm Robotic HIFU; Fourth quarter 2015 HIFU Division revenues tripled over fourth quarter 2014; Overall fourth quarter 2015 revenues increased 82% over 2014 to EUR 11.8 million (USD 12.8 million) |
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| April 4, 2016 |
EDAP TMS FORM 6-K (Current Report of Foreign Issuer) EdgarFiling 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 Commission File Number: 000-29374 April 4, 2016 Commission File Number: 000-29374 EDAP TMS S.A. (Translation of registrant's name into English) Parc Activite La Poudrette Lamartine 4/6 Rue du Dauphi |
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| April 4, 2016 |
LIST OF EDAP TMS S.A. SUBSIDIARIES (as of April 4, 2016) EXHIBIT 8.1. LIST OF EDAP TMS S.A. SUBSIDIARIES (as of April 4, 2016) Name of Subsidiary Juridiction of Incorporation EDAP TMS France S.A.S. France EDAP Technomed S.r.l. Italy EDAP Technomed, Inc. United States EDAP Technomed Co. Ltd. Japan EDAP Technomed Sdn Bhd Malaysia EDAP TMS GmbH Germany |
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| April 4, 2016 |
EX-1.1 2 exh11.htm EXHIBIT 1.1 EDAP TMS A stock company (société anonyme) with a capital of Euros 3,348,018,57 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 April 1, 2016 Articles of Association – April 1, 2016 English translation for information purposes onl |
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| April 4, 2016 |
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 |
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| April 4, 2016 |
Annual Certification Pursuant to Section 302 of 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 |
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| April 4, 2016 |
Exhibit 4.2 Commercial Lease By and between: MAISON ANTOINE BAUD & EDAP TMS FRANCE Premises located at: 4 rue du Dauphiné, bâtiment B - VAUX-EN-VELIN (69120) Table of Contents Amicable termination of the existing lease 4 Commercial Lease 4 1. Description of the Leased Premises 5 2. Lease Term – 10 years, of which 9 years fixed 5 3. Use of the Leased Premises 5 4. Terms and Conditions 6 4.1. Delive |
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| April 4, 2016 |
EDAP / EDAP TMS S.A. / Linoa Holding AG - SC 13G/A Passive Investment OMB APPROVAL UNITED STATES OMB Number: 3235-0145 SECURITIES AND EXCHANGE COMMISSION Expires: February 28, 2009 Washington, D. |
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| April 4, 2016 |
As filed with the Securities and Exchange Commission on April 4, 2016 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D. |
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| April 4, 2016 |
Exhibit 4.1 Bail Commercial Entre : MAISON ANTOINE BAUD & EDAP TMS FRANCE Locaux situés : 4 rue du Dauphiné, bâtiment B - VAUX-EN-VELIN (69120) Sommaire Résiliation amiable du bail en cours 4 Bail Commercial 4 1. Désignation 5 2. Durée – Bail de 10 ans dont 9 ans ferme 5 3. Destination des lieux loués 5 4. Charges et conditions 6 4.1. État des lieux 6 4.2 Entretien et réparations 6 4.3 Travaux du |
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| April 4, 2016 |
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, 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 |
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| April 4, 2016 |
CONSENT OF INDEPENDENT AUDITORS EXHIBIT 15.1 CONSENT OF INDEPENDENT AUDITORS We hereby consent to the incorporation by reference in the Registration Statement on Form F-3 No. 333-195435 and on Form S-8 No. 333-188112 of EDAP TMS S.A. of our report dated April 4, 2016, relating to the financial statements and the effectiveness of internal control over financial reporting, which appears in this Form 20-F. Lyon, France, April 4, 20 |
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| February 2, 2016 |
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 February 2, 2016 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 |
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| November 19, 2015 |
EDAP TMS FORM 6-K FILING DOCUMENT (Current Report of Foreign Issuer) Form 6-K Filing 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, 2015 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 regist |
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| November 19, 2015 |
EDAP Reports Third Quarter 2015 Financial Results and Operational Update EDAP Reports Third Quarter 2015 Financial Results and Operational Update EXHIBIT 99. |
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| November 12, 2015 |
EDAP TMS FORM 6-K FILING DOCUMENT (Current Report of Foreign Issuer) 6-K 1 document.htm FORM 6-K FILING DOCUMENT 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 11, 2015 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 c |
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| November 12, 2015 |
EDAP Announces Dismissal of Class Action Lawsuit EDAP Announces Dismissal of Class Action Lawsuit EXHIBIT 99.1 EDAP Announces Dismissal of Class Action Lawsuit Deadline for Appeals Passes With no Notice of Appeal Filed LYON, France, Nov. 11, 2015 (GLOBE NEWSWIRE) - EDAP TMS SA (Nasdaq:EDAP), the global leader in therapeutic ultrasound, today announced that, further to U.S. District Court for the Southern District of New York dismissal of the sec |
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| November 9, 2015 |
EDAP Receives FDA Approval for Ablatherm HIFU EX-99 2 newsrelease.htm PRESS RELEASE EXHIBIT 99.1 EDAP Receives FDA Approval for Ablatherm HIFU LYON, France, Nov. 9, 2015 (GLOBE NEWSWIRE) - EDAP TMS SA (Nasdaq:EDAP), the global leader in therapeutic ultrasound, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market Ablatherm® Integrated Imaging HIFU in the U.S. for the ablation of prost |
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| November 9, 2015 |
EDAP TMS FORM 6-K FILING DOCUMENT (Current Report of Foreign Issuer) Form 6-K Filing 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, 2015 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 registr |
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| October 15, 2015 |
EDAP Direct De Novo for Ablatherm HIFU Replaced by 510(k) EDAP Direct De Novo for Ablatherm HIFU Replaced by 510(k) EXHIBIT 99.1 EDAP Direct De Novo for Ablatherm HIFU Replaced by 510(k) Clearance of Predicate HIFU Technology for Ablation of Prostatic Tissue Permits Streamlined 510(k) Pathway LYON, France, Oct. 15, 2015 (GLOBE NEWSWIRE) - EDAP TMS SA (Nasdaq:EDAP), the global leader in therapeutic ultrasound, today announced that it has withdrawn its De |
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| October 15, 2015 |
EDAP TMS FORM 6-K FILING DOCUMENT (Current Report of Foreign Issuer) Form 6-K Filing 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 15, 2015 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 registr |
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| September 25, 2015 |
6-K 1 gff6k092315.htm 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 25, 2015 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 c |
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| August 26, 2015 |
EDAP Reports Strong Year-over-Year Revenue Growth in Second Quarter 2015 EDAP Reports Strong Year-over-Year Revenue Growth in Second Quarter 2015 EXHIBIT 99. |
