Hugo Embert, Marketing Director of EDAP TMS, added, "We strongly believe that, in the upcoming years, the focal approach will become more and more prominent in the management of prostate cancer as it is already the case for other organs. This is the reason why we combined the latest imaging modalities with cutting-edge proprietary HIFU technology into one unique device, Focal.One. Thanks to the latest improvements of MR-Imaging in the diagnostic of prostate cancer, HIFU precision combined with a highly performing ultrasound tool to validate treatment efficiency, Focal.One is the first device that meets the need for an optimal focal therapy of prostate cancer while preserving patient quality of life."
Mr. Embert concluded, "By adding Focal.One to our well-established Ablatherm ® device, we expanded our range of HIFU devices for localized prostate cancer and have now the capacity to answer a wide array of treatment options and to address every population of urologists by bringing them the right solution for their prostate cancer practice. This is unique to EDAP TMS and the result of many years of R&D expertise and HIFU clinical experience."
EDAP expects to file for CE mark for Focal.One in the second quarter of 2013 and to pursue commercial distribution in Europe thereafter. A global regulatory program will be implemented to pursue requisite approvals across key global markets.
About EDAP TMS SAEDAP 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.
CONTACT: Blandine Confort Investor Relations / Legal Affairs EDAP TMS SA +33 4 72 15 31 72 firstname.lastname@example.org Investors: Stephanie Carrington The Ruth Group 646-536-7017 email@example.com