EDAP TMS S.A. (EDAP)

[BioSpecialist]

EDAP read to Explode ..

Market cap : 55 M
Cash : 11 M

Price: 5 $
Shares Out : 11 M

Infos about HIFU
http://www.wjgnet.com/2218-4333/full/v2/i1/8.htm
http://www.cancercurecoalition.org/articles/hifu.htm


EDAP - On The Move
11/15/2010 6:25 AM ET

(RTTNews) - Shares of French medical device company EDAP TMS SA (EDAP: News ) have gained more than 30% over the past one week as the regulatory decision on its Sonolith i-move lithotripsy device for treatment of urinary tract stones draws closer.

The company submitted 510 (k) application for Sonolith i-move to the FDA on August 19, and is awaiting marketing clearance. Usually the FDA can clear or deny a 510(k) premarket notification within 90 days of submission of the application.

Sonolith i-move was approved in Europe in April of this year. Sonolith i-move is a compact, stand alone lithotripter with an infrared stereo-vision system for real-time, three-dimensional ultrasound localization of urinary stones.

Last August, the company's Sonolith i-sys, a predecessor to Sonolith i-move, received marketing clearance from the FDA, and in March of this year, won the regulatory approval in Japan.

In addition to lithotripsy devices, EDAP sells Ablatherm devices , a non-invasive treatment option, for localized prostate cancer. Ablatherm, a Class III device, which uses HIFU (High Intensity Focused Ultrasound), is currently approved in Europe, Canada, Russia, Australia and South East Asia. In the U.S., Ablatherm is undergoing multicenter phase II/III clinical trial under an Investigational Device Exemption granted by the FDA.

EDAP is also evaluating the HIFU technology in patients with metastatic liver cancer. Last month, the company successfully completed a preliminary trial of HIFU in liver cancer. Following the successful preliminary trial, the company has planned to conduct a second larger trial with the new HIFU device.