FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER
PURSUANT TO RULE 13a-16 OR 15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
May 29, 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):
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):
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.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: May 29, 2013
EDAP TMS S.A.
/s/ ERIC SOYER
ERIC SOYER
CHIEF FINANCIAL OFFICER
EXHIBIT 99.1
Closes $12.0 Million Placement to Fully Redeem $8.0 Million Long-Term Debt
Positions Company to Invest in Expansion of U.S. Operations
LYON, France, May 29, 2013 (GLOBE NEWSWIRE) -- EDAP TMS SA (Nasdaq:EDAP), a global leader in therapeutic ultrasound, outlined today the strengthening of its financial profile with the closing of a $12.0 million registered direct placement of ordinary shares in the form of American Depositary Shares, at a price of $4.00 per share, with warrants attached. The Company intends to fully redeem its $8.0 million outstanding long-term debt by using a portion of the net proceeds from the offering. The expected debt repayment eliminates the 9% annual interest paid quarterly in either shares or cash, and removes the redemption obligation ahead of the June 2014 maturity. EDAP intends to utilize the remaining net proceeds balance to invest in the expansion of its U.S. operations in preparation of potential approval of its Ablatherm-HIFU for the treatment localized prostate cancer as the Pre-Market Approval (PMA) application is currently under review by U.S. FDA.
Marc Oczachowski, Chief Executive Officer, commented, "This offering streamlines our balance sheet by enabling the early repayment of the long-term debt and is significant news for the Company and its shareholders. Additionally, the funds provide expansion capital for our U.S. operations as we continue to advance the PMA application for our Ablatherm-HIFU device. We are particularly satisfied with the participation in the offering by existing shareholders and historical investors as it underscores their belief in our long term business strategy both in the U.S. and around the globe. EDAP is now positioned to leverage its potential milestones for commercial success."
H.C. Wainwright & Co., LLC, acted as the exclusive placement agent for the transaction.
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-HIFUis 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 contains 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.
CONTACT: 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