Healthcare Industry News:  ultrasound 

Devices Urology

 News Release - November 10, 2011

EDAP Generates First U.S. Sonolith i-move Lithotripter Sale

Empire Litho to Utilize Compact Lithotripter on Mobile Basis at Six New York City Metro Hospitals

US Sale Recorded Three Months Following U.S. FDA 510(k) Clearance


LYON, France, Nov. 10, 2011 -- (Healthcare Sales & Marketing Network) -- EDAP TMS SA (Nasdaq:EDAP ), the global leader in therapeutic ultrasound, announced it has sold its first Sonolith i-move lithotripter in the United States to Empire Litho. The sale was recorded three months following the receipt of U.S. FDA 510(k) marketing clearance in August 2011. Empire Litho partners with hospitals and physicians to provide urological and orthopedic patient services to physicians and hospitals. Empire Litho expects to use the Sonoloth i-move on a mobile basis at its six New York City metropolitan area hospital partners.

Marc Oczachowski, EDAP's Chief Executive Officer, commented, "Completing the first Sonolith i-move sale in the U.S. just three months after receiving marketing clearance is a significant achievement. It leverages the U.S. market presence that our team established in advance of the FDA clearance by showcasing our state-of-the-art compact lithotripter at the AUA meeting in Washington DC in May and by expanding our marketing efforts immediately following FDA clearance in August that included a demonstration of our device in September. We completed this sale in a condensed timeframe as compared to the typical medical device sales cycle that traditionally takes approximately 12 to 24 months. We are continuing our aggressive U.S. sales initiatives to promote the Sonolith i-move and have generated a solid pipeline of sales leads that we plan to continue to cultivate in the coming months."

Marc Oczachowski continued, "The U.S. sale validates the potential for rapid adoption of the Sonolith i-move by the U.S. urology community, demonstrating significant interest in EDAP's advanced and innovative device. The Sonolith i-move was designed to respond to unmet needs by bringing innovation and advanced technological features to the market."

Mr. Daniel Conley, President of Empire Litho, stated, "We are very excited to purchase the new Sonolith i-move and utilize it on a mobile basis across our lithotripsy partners at six leading hospitals in the New York City market. EDAP's lithotripsy devices feature significant technological innovation that provides improved treatment precision by providing urologists with improved targeting, continuous monitoring and shockwave consistency."

Sonolith i-move is a compact lithotripter with a revolutionary infrared stereo-vision system for real-time, three-dimensional ultrasound localization of urinary stones. With its various modular configurations, Sonolith i-move will replace Sonolith Praktis, an earlier generation lithotripter, and complements the Company's high-end Sonolith I-sys lithotripter, an integration of x-ray and ultrasound localization systems. Sonolith i-move received European (CE) approval in April 2010, Japanese approval in June 2011 and U.S. marketing clearance in August 2011.

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 contains forward-looking statements that involve risks and uncertainties. These include statements regarding the Company's growth and expansion plans, the conclusiveness of the results of and success of its Ablatherm-HIFU clinical trials, expectations regarding the IDE submission to and approval by the FDA of the Ablatherm-HIFU device and the market potential for the Sonolith i-move device. 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.


Source: EDAP TMS

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