LYON, France, March 7, 2013 (GLOBE NEWSWIRE) -- EDAP TMS SA (Nasdaq:EDAP), the global leader in therapeutic ultrasound, announced today that the U.S. Food and Drug Administration (FDA) has provided a positive administrative acceptance review notification for the Company's Pre-Market Approval (PMA) application for its Ablatherm Integrated Imaging HIFU (High Intensity Focused Ultrasound) device for treatment of low risk, localized prostate cancer. The FDA conducted an administrative acceptance review of EDAP's PMA application and found it to contain all of the necessary elements and information needed to proceed with filing review. Based on the FDA PMA Review Process, the administrative acceptance review is the first step in the multi-step process and the next step is the filing review. Both of these reviews access the completeness of the application and not the clinical outcomes of the study, which begins after a positive filing review. Marc Oczachowski, Chief Executive Officer of EDAP-TMS, remarked, "We are pleased to continue to move through the PMA Review Process for the application submitted for Ablatherm Integrated Imaging HIFU PMA. We look forward to keeping investors informed as we continue to advance through the FDA process." About Ablatherm-HIFU Ablatherm-HIFU is an ultrasound guided HIFU device for the treatment of organ-confined prostate cancer. The device consists of a treatment module, a control table with a computer and a computer screen, and a diagnostic ultrasound device connected to the treatment module. After insertion of an endorectal probe, the physician visualizes the prostate and defines the area to be treated. The computer automatically calculates the optimum treatment distribution of lesions. During the treatment, the transducer automatically moves and fires at each predefined lesion until the entire area has been treated, while controlling and imaging the treatment in real time due to its integrated imaging system. Cell destruction by HIFU is accomplished by a combination of thermal and cavitation effects caused by focused application of piezoelectric-generated high-intensity ultrasound. The procedure is performed under general or spinal anesthesia.
Ablatherm-HIFU is cleared for distribution in the European Union, South Korea, Canada, Australia, South Africa, New Zealand, the Philippines, Taiwan, Mexico, Argentina, Brazil and Russia. As of December 31, 2012, more than 32,000 prostate cancer treatments successfully performed clinical outside the U.S. with Ablatherm-HIFU and results have been published in 60 peer-reviewed scientific publications.About EDAP TMS SA EDAP TMS SA develops and markets Ablatherm(R), the most advanced and clinically proven choice 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. Approved in Europe as a treatment for prostate cancer, Ablatherm-HIFU (High Intensity Focused Ultrasound) is currently undergoing evaluation in a multi-center U.S. Phase II/III clinical trial under an Investigational Device Exemption (IDE) granted by the FDA, the ENLIGHT U.S. clinical study. The Company also is developing this technology for the potential treatment of certain other types of tumors. EDAP TMS SA also produces and commercializes medical equipment (the Sonolith(R) 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.
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