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

Last updated: 22:39 13 Dec 2010 GMT, First published: 23:39 13 Dec 2010 GMT

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EDAP TMS SA (NASDAQ:EDAP), a developer of medical devices based in Vaulx-en-Velin, France, announced today that it has received approval from the South-Korean Food and Drug Administration for its new lithotripter, Sonolith i-move. 

The patented Sonolith i-move is a modular lithotripter with an infrared stereo-vision system that helps to locate urinary stones.

According to the company, South Korea is the second largest market in Asia for lithotripsy devices after Japan.  EDAP has about 50 lithotripters installed in South Korea.

The Sonolith i-move has also previously received approval in Japan and the U.S.  

Besides the Sonolith i-move, the company also developed the Ablatherm, an ultrasound-based device that is used to treat prostate cancer.  The device, which has been approved in Europe, is currently in a U.S. Phase II/III clinical study. 

The company’s share price was slightly down by 0.2% to trade at $5.01 as of 12:26 pm EST.  Over the past year, the company’s shares have rallied almost 60%.

 

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