EDAP installs first Ablatherm robotic HIFU device in The Netherlands continuing European expansion

Lyon 10 September 2008EDAP TMS SA, a global expert in therapeutic ultrasound, has launched initial high-intensity focused ultrasound (HIFU) services at Amphia Hospital, in Breda, the first Ablatherm robotic HIFU treatment centre in The Netherlands. Amphia Ziekenhuis is the first hospital of the country equipped with Ablatherm and treatments have successfully started in August 2008. Ablatherm is now available in 23 countries worldwide in 192 treatment centres and 16750 treatments performed as of the end of August 2008.

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Dr. Harald Janssen, Head of the Urology Deptartment at Amphia Hospital in Breda, The Netherlands, commented: "The Ablatherm device will enable our centre to be at the forefront of the treatment of prostate cancer with the latest technologies. I have been impressed with the technology and the minimally invasive approach of the Ablatherm-HIFU system. Our first patients were successfully treated with no complications, following a comprehensive training programme under EDAP's leadership. We have additional patients scheduled for treatment and I look forward to expanding the number of treatment volumes at Amphia Ziekenhuis to those patients suffering from localized prostate cancer."

"We are excited to launch the first HIFU site in The Netherlands offering patients the opportunity to benefit from the advantages of Ablatherm-HIFU therapy in the treatment of localized prostate cancer", stated Jean-Franvmp:ccedil;ois Bachelard, EDAP's Business Unit Director. "Clinical teams in The Netherlands are very enthusiastic about the technology and the benefits offered to patients. We expect to expand our HIFU revenue per procedure (RPP) services to several sites in The Netherlands using Amphia's Ablatherm system on a mobile basis. Two hospitals have already commenced EDAP's training programme and expect to start treating patients within the next few weeks. Other clinical sites are also expected to participate in the coming months."

Marc Oczachowski, EDAP's Chief Executive Officer, commented: "We are very pleased by the growing adoption of Ablatherm-HIFU across Europe, as exemplified by our opening of a new country to the benefits of Ablatherm as a proven non-invasive therapeutic solution for prostate cancer. This marks a clear milestone for our technology and serves as a clear recognition of EDAP's growth potential for entering new European markets. We look forward to driving HIFU treatment volumes in The Netherlands with the expected addition of two new centres in the country on a mobile RPP basis. We are excited to see the positive success of our sales and marketing strategy that continues to increase the awareness and adoption of our products throughout Europe."

EDAP TMS SA develops and markets Ablatherm, the most advanced and clinically proven choice for 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 is currently undergoing evaluation in a multi-centre United States Phase II/III clinical trial under an Investigational Device Exemption granted by the Food and Drug Administration (FDA). The company also is developing this technology for the potential treatment of certain other types of tumours. EDAP TMS SA also produces and commercializes medical equipment for treatment of urinary tract stones using extra-corporeal shockwave lithotripsy (ESWL).


Leslie Versweyveld

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