Indicate by check mark whether the registrant files or will
file annual reports under cover of Form 20-F or Form 40-F.
Indicate by check mark if the registrant is submitting the Form
6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ____
Indicate by check mark if the registrant is submitting the Form
6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ____
SIGNATURES
Pursuant to the requirements of the Securities Act of 1934,
the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
Date: June 7, 2017
EDAP TMS S.A.
/s/ FRANCOIS DIETSCH
FRANCOIS DIETSCH
CHIEF FINANCIAL OFFICER
Dear EDAP Shareholders,
|
May 29, 2017
|
2016 was another successful
year for EDAP. We continued to expand the global reach of our breakthrough HIFU devices, allowing an ever-increasing number of
patients access to this revolutionary treatment option for early-stage prostate cancer. As a result of our dedicated team's continued
successful efforts, we reached a €35.6 million record revenue in 2016 and revenue from our HIFU division increased 63% over
2016.
U.S.
market penetration has started rapidly. At the beginning of 2016 we implemented a strategy that focused on targeting academic centers
to build awareness and global adoption of the technology. As a result, EDAP now has HIFU systems available in the most prestigious
institutions for prostate cancer management in the country such as USC in Los Angeles, University of Miami, Duke University, the
Cleveland Clinic and many others. While building the academic validation and recognition of our technology in 2016, we began to
partner with companies providing mobile services to Hospitals, Ambulatory Surgical Centers and private groups of urologists. These
partnerships offer an attractive alternative solution, enabling hospitals or centers to access the technology without a significant
investment. Thus, we can quickly penetrate rural areas, smaller private practices or large hospitals that would like to begin using
our technology without the administrative hassles or costs.
We
continue to see great traction and interest from the medical community. The current standard of care for prostate cancer must be
modernized. An alternative that is less severe than radical treatments but with more action than active surveillance (“wait
and see”) is sorely needed. Our HIFU technology fills this gap well, our focal approach facilitates efficacy akin to prostatectomy
with minimal impact to their quality of life.
2016 has also been a very
exciting and productive year in HIFU developments worldwide. Focal One device sales revenue increased by 96% while maintaining
steady growth in treatment-based revenues. We also continued to sustain our UDS segment, as lithotripsy remains the gold standard
for kidney stone treatments.
2017 will prove to be an
important year for EDAP, with multiple pending milestones including a conclusion to the FDA review of Focal One, the expansion
of our product offering with the Ablatherm Fusion worldwide. Very recently, we achieved another key strategic U.S. milestone with
CMS’s approval of a new reimbursement code for HIFU ablation of the prostate. This is a significant achievement and opens
the door to broader coverage from different payers, including private and commercial payers. We will now transition our efforts
toward expanding coverage and physician education to make our innovative technology available to all patients in the U.S.
We would like to thank
you, our shareholders and investors, for your continued support and confidence in EDAP’s long-term success.
Sincerely,
Philippe Chauveau
Chairman of the Board
EDAP TMS S.A.
Non binding, unofficial English translation
for information purposes only. Original in French.
EDAP
TMS
A corporation
with a share capital of 3,817,891.22 euros
Registered
office: Parc d’activité La Poudrette Lamartine
4, rue
du Dauphiné - 69120 Vaulx en Velin, France
Lyon Registry
of Commerce 316 488 204
Vaulx-en-Velin,
May 29, 2017
NOTICE
On Friday
June 30, 2017, the shareholders are convened to attend an Ordinary General Meeting of the shareholders of EDAP TMS S.A., to be
held:
at 10:30
am,
at EDAP
TMS’s headquarters
4, rue
du Dauphiné,
69120
Vaulx-en-Velin, France
to
consider the following agenda:
|
1.
|
Reading and approval of the special report of the Statutory Auditor
on the agreements referred to in article L. 225-38 of the French Commercial Code;
|
|
2.
|
Reading of the Board of Directors' report on the activity, the
situation and the financial statements of the Company relating to the fiscal year ended December 31, 2016; reading of the Board
of Directors' special report pursuant to Article L. 225-184, paragraph 1 of the French Commercial Code; reading of the Statutory
Auditor's report relating to the annual accounts for the fiscal year ended December 31, 2016; reading of the Statutory Auditor’s
report relating to the consolidated financial statements (US GAAP); approval of the statutory accounts and of the consolidated
financial statements (US GAAP) for the fiscal year ended December 31, 2016
;
granting of
a release to the members of the Board of Directors for their management;
|
|
3.
|
Allocation of net loss for the fiscal year ended December 31,
2016.
|
|
4.
|
Appointment of Mr. Marc Oczachowski as Member of the Board of
Directors of the Company.
|
Yours
sincerely,
The Board of Directors
Note:
As
per Depositary Agreement dated July 31, 1997 and amendment dated April 7, 2008, signed between Bank of New York Mellon (the “Depositary”)
and the Company, if no voting Instruction Form is received by the Depositary from a Holder with respect to any of the Securities
represented by American Depositary Shares (“ADSs”) on or before the Receipt Date (Record Date), or if the voting Instruction
Form is improperly completed or blank, or if the voting instructions included in the voting Instruction Form are illegible or unclear,
such Holder of ADSs shall be deemed to have instructed the Depositary to vote such ADSs and the Depositary shall vote such ADSs
in favor of any resolution proposed or approved by the Board of Directors of the Company and against any resolution not so proposed
or approved.
EDAP
TMS - Agenda/notice for the AGO - June 30 2017 ENGLISH
Non-binding, unofficial English
translation for information purposes only. Only the original version in French has legal force.
EDAP
TMS
A corporation
with a share capital of 3,817,891.22 euros
Registered
office : 4, rue du Dauphiné - Parc d’activité la Poudrette Lamartine
69120
Vaulx-en-Velin (France)
Lyon Trade
and Companies Register Number 316 488 204
Report
of the Board of Directors to the Ordinary Shareholders’ Meeting of June 30, 2017
Ladies and Gentlemen,
We have called this Ordinary Shareholders’
Meeting to vote on the following agenda:
|
1.
|
Reading and approval of the special report of the Statutory Auditor
on the agreements referred to in article L. 225-38 of the French Commercial Code;
|
|
2.
|
Reading of the Board of Directors' report on the activity, the
situation and the financial statements of the Company relating to the fiscal year ended December 31, 2016; reading of the Board
of Directors' special report pursuant to Article L. 225-184, paragraph 1 of the French Commercial Code; reading of the Statutory
Auditor's report relating to the annual accounts for the fiscal year ended December 31, 2016; reading of the Statutory Auditor’s
report relating to the consolidated financial statements (US GAAP); approval of the statutory accounts and of the consolidated
financial statements (US GAAP) for the fiscal year ended December 31, 2016
;
granting of
a release to the members of the Board of Directors for their management;
|
|
3.
|
Allocation of net loss for the fiscal year ended December 31,
2016.
|
|
4.
|
Appointment of Mr. Marc Oczachowski as Member of the Board of
Directors of the Company.
|
Management report on the Company’s
activity for the fiscal year ended December 31, 2016:
We invite
you to read the Board of Directors’ management report available pursuant to French laws and regulations and the Company’s
2016 Annual Report on the 2016 consolidated accounts, which is available on the Company’s website www.edap-tms.com, in the
“Investor Relations” – “Financial Information” section.
In order
to complete EDAP’s Board of Directors, it is proposed to appoint Mr. Marc Oczachowski as a Director of the Company for a
tenure of six years, expiring at the Ordinary Assembly Meeting of Shareholders approving accounts closed on December 31, 2022.
Mr. Oczachowski’s appointment to the Board will be effective on July 1, 2017.
In
this context, we ask you to vote on the aforementioned resolutions submitted to you by your Board of Directors.
EDAP TMS – Board report to AGM – June 30, 2017
|
1
|
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 corporation
with a share capital of
3,817,891.22 euros
Registered office: Parc d’activité
La Poudrette Lamartine
4, rue du Dauphiné - 69120 Vaulx-en-Velin,
France
Lyon Registry
of Commerce 316 488 204
|
DRAFT
RESOLUTIONS TO BE SUBMITTED
|
TO
THE ORDINARY SHAREHOLDERS’ MEETING HELD
|
ON
JUNE 30, 2017
|
|
Shareholders are invited to attend the
Ordinary Shareholders’ Meeting of EDAP-TMS S.A. (the “Company”) on June 30, 2017, at 10.30 am., at the Company’s
offices, 4 Rue du Dauphiné, 69120, Vaulx-en-Velin, France. The shareholders will deliberate on the following agenda:
|
1.
|
Reading and approval of the special report of the Statutory Auditor on the agreements referred
to in article L. 225-38 of the French Commercial Code;
|
|
2.
|
Reading of the Board of Directors' report on the activity, the situation and the financial statements
of the Company relating to the fiscal year ended December 31, 2016; reading of the Board of Directors' special report pursuant
to Article L. 225-184, paragraph 1 of the French Commercial Code; reading of the Statutory Auditor's report relating to the annual
accounts for the fiscal year ended December 31, 2016; reading of the Statutory Auditor’s report relating to the consolidated
financial statements (US GAAP); approval of the statutory accounts and of the consolidated financial statements (US GAAP) for the
fiscal year ended December 31, 2016; granting of a release to the members of the Board of Directors for their management;
|
|
3.
|
Allocation of net loss for the fiscal year ended December 31, 2016.
|
|
4.
|
Appointment of Mr. Marc Oczachowski as Member of the Board of Directors of the Company.
|
* * *
FIRST RESOLUTION
(
Reading
and approval of the special report of the Statutory Auditor on the agreements referred to in Article L. 225-38 of the French Commercial
Code)
After hearing the Statutory Auditor's special
report relating to the agreements referred to in article L.225-38 of the French Commercial Code (related party transactions), the
Shareholders’ Meeting approves the terms of the report, mentioning that there is no such agreements.
Draft of resolutions EDAP TMS AGO –
June 30, 2017
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1
/3
|
|
SECOND RESOLUTION
(
Reading
of the Board of Directors' report on the activity, the situation and the financial statements of the Company relating to the fiscal
year ended December 31, 2016; reading of the Board of Directors' special report pursuant to Article L. 225-184, paragraph 1 of
the French Commercial Code; reading of the Statutory Auditor's report relating to the annual accounts for the fiscal year ended
December 31, 2016; reading of the Statutory Auditor’s report relating to the consolidated financial statements (US GAAP);
approval of the statutory accounts and of the consolidated financial statements (US GAAP) for the fiscal year ended December 31,
2016; granting of a release to the members of the Board of Directors for their management)
The Shareholders’ Meeting, acting
in accordance with the quorum and majority criteria required for Ordinary Shareholders’ Meetings, and after having been read:
|
-
|
the Board of Directors' report on the activity, the situation and the financial statements of the
Company relating to the fiscal year ended December 31, 2016,
|
|
-
|
the Board of Directors' special report on stock-options pursuant to Article L. 225-184 paragraph
1 of the French Commercial Code,
|
|
-
|
the Statutory Auditor's report relating to the annual accounts relating to the fiscal year ended
December 31, 2016,
|
|
-
|
the Statutory Auditor’s report relating to the consolidated financial statements prepared
in accordance with U.S. generally accepted accounting principles (US GAAP) applying to companies listed on the Nasdaq.
|
Approves the annual accounts, i.e., the
balance sheet, income statement and the related note as of and for the period ended December 31, 2016 as they have been presented,
together with the transactions transcribed in the aforesaid financial statements and summarized in such reports.
Approves the consolidated financial statements
relating to the fiscal year ended December 31, 2016 established in accordance with US GAAP as applied to companies listed on the
Nasdaq market, as they have been presented in the 20-F Report filed with SEC on April 3, 2017, together with the transactions transcribed
in the aforesaid financial statements and summarized in such report.
The Shareholders’ Meeting therefore
grants a release to all members of the Board of Directors for their management during the fiscal year 2016.
THIRD RESOLUTION
(
Allocation
of net loss for the fiscal year ended December 31, 201)
The Shareholders’ Meeting, in accordance
with the quorum and majority criteria required for Ordinary Shareholders’ Meetings, acknowledges that the Company has recorded
a net loss (not consolidated) of €447,565 during fiscal year ended December 31, 2016.
The Shareholders’ Meeting, after
reading the Board of Directors report, decides to allocate the total net income €447,565 amount to the cumulated losses account,
reducing this account from (€13,359,495) to (€13,807,060).
Pursuant to Article 243 bis of the French
Tax Code, the Shareholders’ Meeting takes note that no dividend has been paid during the last three fiscal years.
The Shareholders’ Meeting, pursuant
to the Board of Directors' report, in accordance with article 223 quarter of the French Tax Code, takes note that no expenses,
nor charges concerned by article 39-4 of this Code, nor theoretical tax amount, will be recorded by the Company.
Draft of resolutions EDAP TMS AGO –
June 30, 2017
|
2
/3
|
|
FOURTH RESOLUTION
(Appointment
of Mr. Marc Oczachowski as Member of the Board of Directors of the Company)
The General Meeting, subject
to the quorum and majority voting rules applicable to ordinary shareholders’ meetings, upon the Board of Directors proposal,
and after having heard the report of the Board of Directors,
Resolves
to appoint Mr.
Marc Oczachowski as Member of the Board of Directors of the Company for a period of six years (i.e. until the ordinary shareholders’
meeting to be held to approve the financial statements for the year ended December 31
st
, 2022). This nomination will
be effective on July 1, 2017.
Mr. Marc Oczachowski has declared
that he would accept this appointment and that he complies with applicable rules relating to the plurality of offices.
*******
The Shareholders’ Meeting grants
all powers to the holder of an original, a copy or an extract of these meeting minutes in order to carry out all required or necessary
filing publicity and other formalities.
Draft of resolutions EDAP TMS AGO –
June 30, 2017
|
3
/3
|
|
Please sepa r ate ca r efully at the pe r fo r a tion and r etu r n just this p o r tion in the en v elope p r ovided. D a t e: Ordinary General Meeting of Shareholders of EDAP TMS S.A. June 30, 2017 See Voting Instruction On Reverse Side. Please make your marks like this: Use dark black pencil or pen only For Against Abstain 1. Reading and approval of the special report of the Statutory Auditor on the agreements referred to in article L. 225 - 38 of the French Commercial Code; 2. Reading of the Board of Directors’ report on the activity, the situation and the financial statements of the Company relating to the fiscal year ended December 31, 2016; reading of the Board of Directors’ special report pursuant to Article L. 225 - 184, paragraph 1 of the French Commercial Code; reading of the Statutory Auditor’s report relating to the annual accounts for the fiscal year ended December 31, 2016; reading of the Statutory Auditor’s report relating to the consolidated financial statements (US GAAP); approval of the statutory accounts and of the consolidated financial statements (US GAAP) for the fiscal year ended December 31, 2016; granting of a release to the members of the Board of Directors for their management; 3. Allocation of net loss for the fiscal year ended December 31, 2016. 4. Appointment of Mr. Marc Oczachowski as Member of the Board of Directors of the Company. Ordinary General Meeting of Shareholders of EDAP TMS S.A. to be held June 30, 2017 For Holders as of May 23, 2017 MAIL • Mark, sign and date your Voting Instruction Form. • Detach your Voting Instruction Form. • Return your Voting Instruction Form in the postage - paid envelope provided. All votes must be received by 5:00 pm, Eastern Time June 26, 2017 . PROXY TABULATOR FOR EDAP TMS S.A. P.O. BOX 8016 CARY, NC 27512 - 9903 EVENT # CLIENT # Authorized Signatures - This section must be completed for your instructions to be executed. Please Sign Here Please Date Above Please Sign Here Please Date Above Copyright © 2017 Mediant Communications Inc. All Rights Reserved
PR O X Y TABULATO R FO R EDAP TM S S . A . P . O . B O X 8016 C A R Y , N C 2 75 1 2 - 9 903 EDAP TMS S.A. Instructions to The Bank of New York Mellon, as Depositary (Must be received prior to 5:00 p.m. EST on June 26, 2017) The undersigned registered holder of American Depositary Receipts hereby requests and instructs The Bank
of New York Mellon, as Depositary, to endeavor, in so far as practicable, to vote or cause to be voted the Deposited EDAP TMS S . A . Shares represented by such Receipts registered in the name of the undersigned on the books of the Depositary as of the close of business on May 23 , 2017 at the Ordinary General Meeting of EDAP TMS S . A . to be held in France, on June 30 , 2017 at 10 : 30 am in respect of the resolutions specified in the enclosed Notice of Meeting . NOTES : Instructions as to voting on the specified resolutions should be indicated by an “X” in the appropriate box . If no Voting Instruction Card is received by the Depositary from an Owner with respect to any of the Shares represented by American Depositary Shares on or before the Receipt Date, or if the Voting Instruction Card is improperly completed or blank, or if the voting instructions included in the Voting Instruction Card are illegible or unclear, such Owner shall be deemed to have instructed the Depositary to vote such Shares and the Depositary shall vote such Shares in favor of any resolution proposed or approved by the Board of Directors of the Company and against any resolution not so proposed or approved . (Continued and to be marked, dated and signed, on the other side)