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 11, 2013
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 file annual reports under cover of Form 20-F or Form 40-F.
Form 20-F [ x] 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):
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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):
Note: 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 "home country"), 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.
This report on Form 6-K is hereby incorporated by reference in the following registration statements of EDAP TMS S.A. on Form F-3: file number 333-136811, 333-169793, 333-177224 and 333-179689.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: April 11, 2013
EDAP TMS S.A.
/s/ ERIC SOYER
ERIC SOYER
CHIEF FINANCIAL OFFICER
EXHIBIT 99.1
EDAP Announces 23% First Quarter 2013 Revenue Growth
- First quarter total revenue of approximately EUR 5.9 million (USD 7.8 million), up 23% year-over-year
- Ten lithotripsy devices sold in first quarter 2013
- Received FDA acceptance for PMA filing on March 26, 2013, for Ablatherm®-HIFU for treatment of low risk, localized prostate cancer
LYON, France, April 11, 2013 (GLOBE NEWSWIRE) -- EDAP TMS SA (Nasdaq:EDAP), the global leader in therapeutic ultrasound, announced today preliminary unaudited revenues for the first quarter ended March 31, 2013.
Preliminary total revenue for the first quarter 2013 is expected to be approximately EUR 5.9 million (USD 7.8 million), a 23% year-over-year increase. First quarter 2013 total revenue reflected the sales of ten lithotripters and one Ablatherm-HIFU device.
Marc Oczachowski, EDAP's Chief Executive Officer, commented, "Our first quarter 2013 revenue reflects the ongoing global demand for our innovative range of lithotripsy offerings. We are poised for continued growth as we expand our sales operations and increase our market penetration."
EDAP plans to hold a conference call to discuss its first quarter 2013 financial results on Thursday, May 16, 2013, at 8:30 am EDT.
About EDAP TMS SA
EDAP TMS SA markets today Ablatherm® for high-intensity focused ultrasound (HIFU) treatment of localized prostate cancer. HIFU treatment is shown to be a minimally invasive and effective treatment option 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 and commercialized in Europe as a treatment for prostate cancer and is currently under regulatory review in the U.S. following submission of the Pre-Market Approval Application in February 2013 after the completion of a multi-center U.S. Phase II/III clinical trial under an Investigational Device Exemption (IDE) granted by the FDA. The Company also develops its HIFU technology for the potential treatment of certain other types of tumors. EDAP TMS SA also produces and commercializes medical equipment (the Sonolith® range) for treatment of urinary tract stones using extra-corporeal shockwave lithotripsy (ESWL). For more information on the Company, please visit http://www.edap-tms.com, and http://www.hifu-planet.com.
Forward-Looking Statements
In addition to historical information, this press release may contain forward-looking statements that involve risks and uncertainties. Such statements are based on management's current expectations and are subject to a number of uncertainties, including the uncertainties of the regulatory process, and risks that could cause actual results to differ materially from those described in these forward-looking statements. Factors that may cause such a difference 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. Ablatherm-HIFU treatment is in clinical trials, but not FDA-approved or marketed in the United States.
CONTACTS: Blandine Confort
Investor Relations / Legal Affairs
EDAP TMS SA +33 4 72 15 31 72
bconfort@edap-tms.com
Investors:
Stephanie Carrington The Ruth Group
646-536-7017
scarrington@theruthgroup.com