<SEC-DOCUMENT>0001171843-15-006132.txt : 20151110
<SEC-HEADER>0001171843-15-006132.hdr.sgml : 20151110
<ACCEPTANCE-DATETIME>20151109083040
ACCESSION NUMBER:		0001171843-15-006132
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		2
CONFORMED PERIOD OF REPORT:	20151109
FILED AS OF DATE:		20151109
DATE AS OF CHANGE:		20151109

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:		151214104

	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
</SEC-HEADER>
<DOCUMENT>
<TYPE>6-K
<SEQUENCE>1
<FILENAME>document.htm
<DESCRIPTION>FORM 6-K FILING DOCUMENT
<TEXT>
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		<title>Form 6-K Filing</title>
	</head>

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		<div align="center">
			<font size="2">UNITED STATES<br>
                                SECURITIES AND EXCHANGE COMMISSION<br>
				Washington, D.C. 20549</font>
			<p><font size="2">FORM 6-K</font></p>
			<p><font size="2">REPORT OF FOREIGN PRIVATE ISSUER</font></p>
			<p><font size="2">PURSUANT TO RULE 13a-16 OR 15d-16<br>
					UNDER THE SECURITIES EXCHANGE ACT OF 1934</font></p>
			<p><font size="2"><!--EDAP TMS S.A. Files on--><br>November 9, 2015</font></p>
			<p><font size="2">Commission File Number: 000-29374</font>
				<p><font size="2">EDAP TMS S.A.<br>
					Parc Activite La Poudrette Lamartine<br>
4/6 Rue du Dauphine<br>
69120 Vaulx-en-Velin - France
<br></font></p>
			</p>
		</div>
		<p><br>
		</p>
		<p><font size="2">Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.</font></p>
		<div align="center">
			<p><font size="2">Form 20-F [ x] &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Form 40-F [ &nbsp;]</font></p>
		</div>
		<p><font size="2">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): <u>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;</u></font></p>
		<!--<p><font size="2"><b>Note:</b> Regulation S-T Rule 101(b)(1) only permits the submission in paper of a Form 6-K if submitted solely to provide an attached annual report to security holders.</font></p>-->
		<p><font size="2">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): <u>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;</u></font></p>
		<!--<p><font size="2">Indicate by check mark whether the registrant by furnishing the information contained in this Form is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934.</font></p>-->
		<!--<div>
			<p><font size="2">Yes [ &nbsp;&nbsp;] &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;No [  x ]</font></p>
		</div>-->
		<!--<p><font size="2"><b>Note:</b> Regulation S-T Rule 101(b)(7) only permits the submission in paper of a Form 6-K if submitted to furnish a report or other document that the registrant foreign private issuer must furnish and make public under the laws of the jurisdiction in which the registrant is incorporated, domiciled or legally organized (the registrant's &quot;home country&quot;), or under the rules of the home country exchange on which the registrant's securities are traded, as long as the report or other document is not a press release, is not required to be and has not been distributed to the registrant's security holders, and, if discussing a material event, has already been the subject of a Form 6-K submission or other Commission filing on EDGAR.</font></p>-->
		<!--<p><font size="2">Indicate by check mark whether the registrant by furnishing the information contained in this Form is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934.</font></p>-->
		<!--<p align="center"><font size="2">Yes [ ] &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;No [ x ] &nbsp;.</font></p>-->

		<p><!--<hr noshade="1">
		<p><font size="2">On November 9, 2015 the Registrant issued a press release, a copy of which is attached hereto as Exhibit 99.1 and is incorporated herein by reference.<br><br><br>(c) &nbsp; &nbsp; Exhibit 99.1.  Press release dated November 9, 2015</font></p>--></p>
		<div align="center">
			<hr noshade="1">
			<b><font size="2">SIGNATURES</font></b></div>
		<p><font size="2">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.</font></p>
		<p><font size="2">Date: November 9, 2015<br>
			EDAP TMS S.A.</font></p>
		<p><br>
		</p>
		<p><font size="2"><u>/s/ MARC OCZACHOWSKI</u><br>
			MARC OCZACHOWSKI<br>
			CHIEF EXECUTIVE OFFICER</font></p>
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</DOCUMENT>
<DOCUMENT>
<TYPE>EX-99
<SEQUENCE>2
<FILENAME>newsrelease.htm
<DESCRIPTION>PRESS RELEASE
<TEXT>
<html><head><title>EDAP Receives FDA Approval for Ablatherm HIFU</title></head><body><p align="right">EXHIBIT 99.1</p><h3 align="center">EDAP Receives FDA Approval for Ablatherm HIFU</h3><p>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&#174; Integrated Imaging HIFU in the U.S. for the ablation of prostate tissue. EDAP expects to commercialize Ablatherm&#174; HIFU in the U.S. immediately.</p><p>
	Marc Oczachowski, EDAP Chief Executive Officer commented: "This is a tremendous achievement for the Company and the result of many years of hard work from our team. This clearance represents a unique opportunity for EDAP and its superior HIFU technology to penetrate the largest prostate market in the world in the same way it has emerged as the leading HIFU technology in Europe. With an established US sales and services infrastructure, the pieces are in place to begin deploying Ablatherm devices in the U.S. very quickly and we look forward to bringing the technology to urologists as well as patients in need."</p><p>
	<strong>About EDAP TMS SA</strong></p><p>
	EDAP TMS SA markets today Ablatherm&#174; for high-intensity focused ultrasound (HIFU) treatment of localized prostate cancer outside the U.S. HIFU treatment is shown to be a minimally invasive and effective option for prostatic tissue ablation with a low occurrence of side effects. Ablatherm-HIFU is generally recommended for patients with localized prostate cancer (stages T1-T2) who are not candidates for surgery or who prefer an alternative option, or for patients who failed radiotherapy treatment. Ablatherm-HIFU is approved for commercial distribution in Europe and some other countries including Mexico and Canada, and has received 510(k) clearance by the U.S. FDA. The Company also markets an innovative robot-assisted HIFU device, the Focal One&#174;, dedicated to focal therapy of prostate cancer. Focal One&#174; is CE marked but is not FDA approved. The Company also develops its HIFU technology for the potential treatment of certain other types of tumors. EDAP TMS SA also produces and distributes medical equipment (the Sonolith&#174; lithotripters' range) for the treatment of urinary tract stones using extra-corporeal shockwave lithotripsy (ESWL) in most countries including Canada and the U.S. For more information on the Company, please visit http://www.edap-tms.com, and http://www.hifu-planet.com.</p><p>
	<strong><i>Forward-Looking Statements</i></strong></p><p>
	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 "Cautionary Statement on Forward-Looking Information" and "Risk Factors" in the Company's Annual Report on Form 20-F.</p><pre>CONTACT: Blandine Confort
         Investor Relations / Legal Affairs
         EDAP TMS SA
         +33 4 72 15 31 72
         bconfort@edap-tms.com

         Investors:
         Lee Roth
         The Ruth Group
         646-536-7012
         lroth@theruthgroup.com</pre></body></html>
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</SEC-DOCUMENT>
