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EDAP Announces Launch of Clinical Study Combining HIFU and Chemotherapy for Localized Aggressive High Risk Prostate Cancer

LYON, France, Aug. 17 /PRNewswire-FirstCall/ -- EDAP TMS S.A. (Nasdaq: EDAP), the global leader in High Intensity Focused Ultrasound (HIFU) treatment of prostate cancer, is currently conducting clinical investigations in France under an approved clinical trial combining the company's Ablatherm-HIFU device with chemotherapy using docetaxel.

The study is a primary treatment therapy program for men suffering from clinically localized but aggressive high risk prostate cancer typically classified as stage T2c. The study began in late 2006 and will enroll a total of 30 men, of which more than 10 have already been treated.

"Combination therapy is well documented as a treatment protocol for men suffering more aggressive prostate cancers," said Dr. Albert Gelet, Edouard Herriot Hospital, Lyon. "Ablatherm-HIFU is a proven effective treatment for localized prostate cancer already with strong clinical support. This study aims to evaluate its use under an additional dedicated protocol for men in the T2c cancer stage where the tumors are known to be more aggressive, creating a higher risk of relapse if the patient is treated with only a localized therapy. It was demonstrated in pre-clinical studies that HIFU improves chemotherapy drug efficacy in the area around burned tissues."

Under the approved protocol by French Ethical Committee, patients are administered a dose of docetaxel 30 minutes prior to a standard primary indication HIFU session lasting an average of two hours. The Ablatherm-HIFU ablates the prostate tissue according to conventional procedures and protocols. All treatments are administered at Edouard Herriot Hospital in Lyon, France.

"EDAP has a strong scientific and clinical base underlying the Ablatherm-HIFU, with constant work to enhance and extend the capabilities of the device," said Pr John Rewcastle, Medical Director for EDAP. "With already well documented specialized protocols for primary therapy, HIFU retreatment and salvage therapy following radiation failure, EDAP offers patients and physicians a statistical consistency of outcomes unmatched by traditional therapies. We intend to document the strength of Ablatherm-HIFU not only as a standalone focal treatment, but also in combination with other choices, giving doctors an enhanced arsenal in the fight against prostate cancer while preserving patient quality of life."

"EDAP continues to expand its market opportunity through rigorous and consistent clinical evaluation of the Ablatherm-HIFU system," said Marc Oczachowski, CEO of EDAP. "This test demonstrates the opportunity for Ablatherm to work in concert with other therapies for higher risk patients, expanding the potential population for whom Ablatherm-HIFU may be a solution."


EDAP TMS S.A. 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. The company is also developing this technology for the potential treatment of certain other types of tumors. EDAP TMS S.A. also produces and commercializes medical equipment for treatment of urinary tract stones using Extra-corporeal Shockwave Lithotripsy (ESWL).

For more information on the Company, contact Magnolia Investor Relations at (972) 801-4900, the Corporate Investor Relations Dept at +33 (0)4 78 26 40 46 or see the Company's Web sites at and

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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. Such statements are based on management's current expectations and are subject to a number of uncertainties 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. Ablatherm-HIFU treatment is in clinical trials but not yet FDA approved or marketed in the United States.

CONTACT: EDAP TMS S.A. Magnolia Investor Relations

Blandine Confort Matt Kreps

+33 4 78 26 40 46 469 362 5960


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