<SEC-DOCUMENT>0001171843-18-004514.txt : 20180607
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<ACCEPTANCE-DATETIME>20180607172516
ACCESSION NUMBER:		0001171843-18-004514
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		2
CONFORMED PERIOD OF REPORT:	20180607
FILED AS OF DATE:		20180607
DATE AS OF CHANGE:		20180607

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			EDAP TMS SA
		CENTRAL INDEX KEY:			0001041934
		STANDARD INDUSTRIAL CLASSIFICATION:	ELECTROMEDICAL & ELECTROTHERAPEUTIC APPARATUS [3845]
		IRS NUMBER:				000000000
		FISCAL YEAR END:			1231

	FILING VALUES:
		FORM TYPE:		6-K
		SEC ACT:		1934 Act
		SEC FILE NUMBER:	000-29374
		FILM NUMBER:		18887470

	BUSINESS ADDRESS:	
		STREET 1:		PARC D'ACTIVITES LA POUDRETTE LAMARTINE
		STREET 2:		4 RUE DU DAUPHINE
		CITY:			69120 VAULX EN VELIN
		STATE:			I0

	MAIL ADDRESS:	
		STREET 1:		PARC D'ACTIVITES LA POUDRETTE LAMARTINE
		STREET 2:		4 RUE DU DAUPHINE
		CITY:			69120 VAULX EN VELIN
		STATE:			I0
		ZIP:			69120
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<DESCRIPTION>FORM 6-K
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<P STYLE="font-size: 10pt; text-align: center; margin: 0pt 0">18UNITED STATES</P>

<P STYLE="font-size: 10pt; text-align: center; margin: 0pt 0">SECURITIES AND EXCHANGE COMMISSION<BR>
Washington, D.C. 20549</P>

<P STYLE="font-size: 10pt; text-align: center; margin: 0pt 0">FORM 6-K</P>

<P STYLE="font-size: 10pt; text-align: center; margin: 0pt 0">&nbsp;</P>

<P STYLE="font-size: 10pt; text-align: center; margin: 0pt 0">REPORT OF FOREIGN PRIVATE ISSUER</P>

<P STYLE="font-size: 10pt; text-align: center; margin: 0pt 0">&nbsp;</P>

<P STYLE="font-size: 10pt; text-align: center; margin: 0pt 0">PURSUANT TO RULE 13a-16 OR 15d-16<BR>
UNDER THE SECURITIES EXCHANGE ACT OF 1934</P>

<P STYLE="font-size: 10pt; text-align: center; margin: 0pt 0">&nbsp;</P>

<P STYLE="font-size: 10pt; text-align: center; margin: 0pt 0">June 7, 2018</P>

<P STYLE="font-size: 10pt; text-align: center; margin: 0pt 0">&nbsp;</P>

<P STYLE="font-size: 10pt; text-align: center; margin: 0pt 0">Commission File Number: 0-29374</P>

<P STYLE="font-size: 10pt; text-align: center; margin: 0pt 0">&nbsp;</P>

<P STYLE="font-size: 10pt; text-align: center; margin: 0pt 0">EDAP TMS S.A.<BR>
Parc Activite La Poudrette Lamartine<BR>
4/6 Rue du Dauphine<BR>
69120 Vaulx-en-Velin - France</P>

<P STYLE="font-size: 10pt; text-align: center; margin: 0pt 0">&nbsp;</P>

<P STYLE="font-size: 10pt; margin: 0pt 0">&nbsp;</P>

<P STYLE="font-size: 10pt; margin: 0pt 0">&nbsp;</P>

<P STYLE="font-size: 10pt; margin: 0pt 0">Indicate by check mark whether the registrant files or will file annual reports under
cover of Form 20-F or Form 40-F.</P>

<P STYLE="font-size: 10pt; margin: 0pt 0">&nbsp;</P>

<P STYLE="font-size: 10pt; margin: 0pt 0">Form 20-F [ x] &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Form 40-F [ &nbsp;]</P>

<P STYLE="font-size: 10pt; margin: 0pt 0">&nbsp;</P>

<P STYLE="font-size: 10pt; margin: 0pt 0">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): ____</P>

<P STYLE="font-size: 10pt; margin: 0pt 0">&nbsp;</P>

<P STYLE="font-size: 10pt; margin: 0pt 0">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): ____</P>

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<P STYLE="font-size: 10pt; text-align: center; margin: 0pt 0"><B>SIGNATURES</B></P>

<P STYLE="font-size: 10pt; margin: 0pt 0">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.</P>

<P STYLE="font-size: 10pt; margin: 0pt 0">&nbsp;</P>

<P STYLE="font-size: 10pt; margin: 0pt 0">Date: June 7, 2018<BR>
EDAP TMS S.A.</P>

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<P STYLE="font-size: 10pt; margin: 0pt 0"><U>/s/ FRANCOIS DIETSCH</U><BR>
FRANCOIS DIETSCH<BR>
CHIEF FINANCIAL OFFICER</P>

<P STYLE="font-size: 10pt; margin: 0pt 0">&nbsp;</P>

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<TYPE>EX-99.1
<SEQUENCE>2
<FILENAME>exh_991.htm
<DESCRIPTION>EXHIBIT 99.1
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<P STYLE="margin: 0; text-align: right"><B>Exhibit 99.1</B></P>

<P STYLE="margin: 0">&nbsp;</P>

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<P STYLE="font-size: 18pt; margin: 0pt 0; background-color: white; color: #333333">EDAP Announces FDA Clearance for Focal One&reg;</P>

<P STYLE="font-size: 24pt; margin: 0pt 0; color: #333333">&nbsp;</P>

<P STYLE="font-size: 10pt; margin: 0pt 0; background-color: white; color: #333333">AUSTIN, TX, LYON, FRANCE -- JUNE 7, 2018 --
EDAP TMS SA (Nasdaq: EDAP) (&ldquo;the Company&rdquo;), 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.&nbsp;</P>

<P STYLE="font-size: 10pt; margin: 0pt 0; background-color: white; color: #333333">&nbsp;</P>

<P STYLE="font-size: 10pt; margin: 0pt 0; background-color: white; color: #333333">The Focal One high intensity focused ultrasound
(HIFU) device is the first medical apparatus designed specifically for focal treatment of the prostate. Focal One fuses MR and
3D biopsy data with real-time ultrasound imaging, which allows urologists to view integrated, detailed 3D images of the prostate
on a large monitor and direct high intensity ultrasound waves to ablate the targeted area.</P>

<P STYLE="font-size: 10pt; margin: 0pt 0; background-color: white; color: #333333">&nbsp;</P>

<P STYLE="font-size: 10pt; margin: 0pt 0; background-color: white; color: #333333">With Focal One, urology surgeons can establish
precise contours around the diseased tissue and ablate an even smaller portion of the prostate. This lessens the damage to healthy
tissue, and minimizes side effects of incontinence and impotence for patients. Using Focal One, surgeons can customize the HIFU
procedure for each patient and each clinical condition.</P>

<P STYLE="font-size: 10pt; margin: 0pt 0; background-color: white; color: #333333">&nbsp;</P>

<P STYLE="font-size: 10pt; margin: 0pt 0; background-color: white; color: #333333">&ldquo;Focal One is a great step forward in
using this new and important ultrasound technology for prostate tissue ablation,&rdquo; said Dr. Brian Miles, Urologist, Professor
of Urology, Houston Methodist Hospital &ndash; Weill Cornell Medical College.&nbsp; &ldquo;Focal One&rsquo;s ability to merge MRI
images, ultrasound images and biopsy data in order to precisely outline and treat just the diseased tissue area of the prostate
is truly remarkable.&rdquo;</P>

<P STYLE="font-size: 10pt; margin: 0pt 0; background-color: white; color: #333333">&nbsp;</P>

<P STYLE="font-size: 10pt; margin: 0pt 0; background-color: white; color: #333333">&ldquo;We are thrilled that this innovative
technology will now be available to patients and physicians in the United States,&rdquo; said Marc Oczachowski, Chief Executive
Officer of EDAP. &ldquo;The FDA&rsquo;s clearance of Focal One validates not only the power of our technology but also the years
of hard work and dedication by our clinical trial investigators and EDAP&rsquo;s outstanding employees. Focal One&rsquo;s real-time
imaging and 3D robotic features allow for greater precision, leading to improved targeting and treatment planning, and we are excited
to be able to expand access to Focal One to the most important healthcare market in the world.&rdquo;</P>

<P STYLE="font-size: 10pt; margin: 0pt 0; background-color: white; color: #333333">&nbsp;</P>

<P STYLE="font-size: 10pt; margin: 0pt 0; background-color: white; color: #333333"><B>About EDAP TMS SA</B></P>

<P STYLE="font-size: 10pt; margin: 0pt 0; background-color: white; color: #333333">&nbsp;</P>

<P STYLE="font-size: 10pt; margin: 0pt 0; background-color: white; color: #333333">A recognized leader in the global therapeutic
ultrasound market for almost 40 years, EDAP TMS develops, manufactures, promotes and distributes worldwide minimally invasive medical
devices for urology using ultrasound technology. By combining the latest technologies in imaging and treatment modalities in its
complete range of Robotic HIFU devices, EDAP TMS introduced the Focal One&reg; in 2013 in Europe and in 2018 in the US as the answer
to all requirements for ideal prostate tissue ablation as a complement to the existing FDA-cleared Ablatherm&reg; Robotic HIFU
and Ablatherm&reg; Fusion. As a pioneer and key player in the field of extracorporeal shock wave lithotripsy (ESWL), EDAP TMS exclusively
utilizes the latest generation of shock wave source in its Sonolith&reg; range of ESWL systems. For more information on the Company,
please visit&nbsp;http://www.edap-tms.com, and us.hifu-prostate.com.</P>

<P STYLE="font-size: 10pt; margin: 0pt 0; background-color: white; color: #333333">&nbsp;</P>

<P STYLE="font-size: 10pt; margin: 0pt 0; background-color: white; color: #333333"></P>

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<P STYLE="font-size: 10pt; margin: 0pt 0; background-color: white; color: #333333"><B>Forward-Looking Statements</B></P>

<P STYLE="font-size: 10pt; margin: 0pt 0; background-color: white; color: #333333">&nbsp;</P>

<P STYLE="font-size: 10pt; margin: 0pt 0; background-color: white; color: #333333">In addition to historical information, this
press release may contain forward-looking statements. Such statements are based on management's current expectations and are subject
to a number of risks and uncertainties, including matters not yet known to us or not currently considered material by us, and there
can be no assurance that anticipated events will occur or that the objectives set out will actually be achieved. Important factors
that could cause actual results to differ materially from the results anticipated in the forward-looking statements include, among
others, the clinical status and market acceptance of our HIFU devices and the continued market potential for our lithotripsy device.
Factors that may cause such a difference also may include, but are not limited to, those described in the Company's filings with
the Securities and Exchange Commission and in particular, in the sections &quot;Cautionary Statement on Forward-Looking Information&quot;
and &quot;Risk Factors&quot; in the Company's Annual Report on Form 20-F.</P>

<P STYLE="font-size: 10pt; margin: 0pt 0; background-color: white; color: #333333">&nbsp;</P>

<P STYLE="font-size: 10pt; margin: 0pt 0; background-color: white; color: #333333">&nbsp;</P>

<P STYLE="font-size: 10pt; margin: 0pt 0; background-color: white; color: #333333">&nbsp;</P>

<P STYLE="font-size: 10pt; margin: 0pt 0; color: #333333"><B>Company Contact</B></P>

<P STYLE="font-size: 10pt; margin: 0pt 0; color: #333333">Blandine Confort</P>

<P STYLE="font-size: 10pt; margin: 0pt 0; color: #333333">Investor Relations / Legal Affairs</P>

<P STYLE="font-size: 10pt; margin: 0pt 0; color: #333333">EDAP TMS SA</P>

<P STYLE="font-size: 10pt; margin: 0pt 0; color: #333333">+33 4 72 15 31 50</P>

<P STYLE="font-size: 10pt; margin: 0pt 0; color: #333333">bconfort@edap-tms.com</P>

<P STYLE="font-size: 10pt; margin: 0pt 0; color: #333333">&nbsp;</P>

<P STYLE="font-size: 10pt; margin: 0pt 0; color: #333333"><B>Investor Contact</B></P>

<P STYLE="font-size: 10pt; margin: 0pt 0; color: #333333">Jeremy Feffer</P>

<P STYLE="font-size: 10pt; margin: 0pt 0; color: #333333">LifeSci Advisors, LLC</P>

<P STYLE="font-size: 10pt; margin: 0pt 0; color: #333333">212-915-2568</P>

<P STYLE="font-size: 10pt; margin: 0pt 0; color: #333333">jeremy@lifesciadvisors.com</P>

<P STYLE="font-size: 10pt; margin: 0pt 0; color: #333333">&nbsp;</P>

<P STYLE="font-size: 10pt; margin: 0pt 0; color: #333333">&nbsp;</P>

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