EDAP Receives South Korean FDA Approval for Sonolith i-move Lithotripter

EDAP TMS SA (Nasdaq:EDAP), the global leader in therapeutic ultrasound, reported today the approval of its new lithotripter Sonolith i-move by South-Korean Food and Drug Administration (KFDA).

South Korea is the second largest market in Asia for lithotripsy devices after Japan. This approval marks another milestone in EDAP's strategy to aggressively gain market share and reinforces the Company's 24-year presence in the South Korean market.   Through the 24 years, the Company has maintained its leading position as provider of high-end lithotripter devices. EDAP has one of the largest lithotripter installed base in South Korea, with more than 50 fully installed devices.

Mr. Y.H. Park, Managing Director of EDAP's direct and wholly owned representative office in Seoul, South-Korea, commented, "EDAP's new Sonolith i-move, with its revolutionary infrared stereo-vision system for stone localization and its modular configurations, really positions the equipment to fully answer current Korean hospital needs. Its innovative features will clearly facilitate the renewal of our strong Sonolith Praktis installed base. Sonolith i-move's superiority is definitively a huge and unique advantage that will allow EDAP to take more market share from the competition, hence strengthening our prominent position in South Korea."

Marc Oczachowski, Chief Executive Officer, added, "The approval of our new Sonolith i-move by the Korean FDA is another step forward in introducing our innovative Sonolith i-move technology in major markets worldwide. It also confirms our capacity to navigate approval processes in various countries to further maintain our leading position in major lithotripsy markets. As we successfully advance in our regulatory milestones, we continue to make progress in view of approval of our Sonolith i-move device by Japanese authorities and US FDA."

The innovative Sonolith i-move is a compact and modular lithotripter with a revolutionary infrared stereo-vision system for real-time, three-dimensional ultrasound free line localization of urinary stones. With its various and flexible configurations, the Sonolith i-move offers a wide range of treatment procedures for clinical sites and hospitals. Its patented and unique electro-conductive technology has proved successful and demonstrated the highest efficiency rates, thus definitely bringing significant benefits to patients and users.

About EDAP TMS SA

EDAP TMS SA develops and markets Ablatherm, 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 multicenter U.S. Phase II/III clinical trial under an Investigational Device Exemption 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 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, http://www.hifu-planet.com.

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