EDAP Expands Ablatherm-HIFU Into China by Entering Exclusive Distribution Agreement

EDAP TMS SA (Nasdaq:EDAP), the global leader in therapeutic ultrasound, announced today that it will expand into the rapidly growing Chinese healthcare market with its Albatherm HIFU device for the treatment of prostate cancer. Ablatherm HIFU will be distributed throughout China by Shaw Han Biomedical Co. Ltd.  This exclusive distribution agreement underscores EDAP's global expansion strategy for HIFU in what is the fastest growing medical device market.  With the largest population in the world, China represents a significant market for prostate cancer treatment as cancer detection rates rise, awareness of treatment options increases and the expanding aging population garners greater access to healthcare. It is an opportune time to commence the regulatory and marketing process in China for EDAP's robotized, quality-of-life preserving device. 

Marc Oczachowski, Chief Executive Officer of EDAP TMS, commented, "This partnership affords a significant market opportunity for EDAP to tap into the rapidly growing medical device market in China. We undertook extensive due diligence to identify the optimal distribution partner to address the large, dynamic and complex Chinese market. This exclusive agreement will involve a two-stage process.  Initially, Shaw Han will be responsible for processing the marketing clearance application with China's State Food and Drug Administration (SFDA) for Ablatherm-HIFU for localized prostate cancer treatment.  Following receipt of SFDA clearance, Shaw Han will lead the promotion, marketing, and distribution of the device in China for four years post approval. As part of the agreement, Shaw Han has committed to purchase a minimum number of Ablatherm HIFU units during the period covered by the two-stage process."

EDAP's distribution partnership with Shaw Han will officially be announced at the Asian Congress of Urology (ACU) to be held in Taiwan on August 27-28, 2010. Together with its partner, EDAP will showcase its state-of-the-art HIFU and lithotripsy technologies at the ACU.

About EDAP TMS SA

EDAP TMS SA 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. Approved in Europe as a treatment for prostate cancer, Ablatherm-HIFU (High Intensity Focused Ultrasound) is currently undergoing evaluation in a multicenter U.S. Phase II/III clinical trial under an Investigational Device Exemption granted by the FDA. 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 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, http://www.hifu-planet.com.

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