(EDAP) EDAP TMS SA Lithotriptors Cleared in Asia

EDAP TMS SA (EDAP), a worldwide leader in therapeutic ultrasound, recently revealed  approval of its Sonolith i-move lithotripter by the health authorities in Japan. The company also announced the approval of its Sonolith i-sys high-end integrated lithotripter in Taiwan.

The Japanese lithotripsy market has the topmost position, on a global basis, with the highest count of installed lithotripters. With the health authorities in Japan granting EDAP marketing authorization for its new Sonolith i-move device, EDAP will now provide a wide range of lithotripters to clinics and hospitals in that country.

The EDAP range stretches from the compact Sonolith i-move line to a totally integrated, robot-like high-end Sonolith i-sys device. EDAP’s sales team is dedicated to address the requirements of the Japanese market.

With the approval for its Sonolith i-sys in Taiwan, EDAP will gain additional ground in this developed market. It is estimated that Taiwan has more than one hundred installed lithotripters. The distribution of the Sonolith i-sys will be done by Lotus Meditec, a well-known collaborator with experience in the field. The health authorities in Taiwan are, at this time, examining the marketing application for EDAP’s next-generation lithotripsy device, Sonolith i-move.

EDAP has developed Ablatherm, a sophisticated and clinically effective selection for high-intensity focused ultrasound (“HIFU”) therapy of localized cancer of the prostate. HIFU therapy is recognized as a less invasive treatment option with a lower probability of side effects. Ablatherm-HIFU is suggested for victims with localized prostate cancer who are not candidates for surgery or who prefer another choice, or for victims who failed radiotherapy treatment.

Ablatherm-HIFU is at present under evaluation in a multi-center U.S. phase II and III clinical trial under an Investigational Device Exemption (“IDE”) provided by the Food and Drug Administration (“FDA”). It has been approved in Europe for treatment of prostate cancer. The company is also developing this know-how for the treatment of other types of tumors.

EDAP develops and markets medical devices for therapy of urinary tract stones using extra-corporeal shockwave lithotripsy (“ESWL”).

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