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EDAP Receives U.S. FDA Administrative Acceptance Review Notification For Ablatherm(R)-HIFU Pre-Market Approval Application

Stocks in this article: EDAP

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. 

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