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Devices Oncology

 News Release - April 8, 2009

EDAP Announces Association of Italian Urologists Recommends HIFU as a Standard of Care for Prostate Cancer Treatment

LYON, France, April 8, 2009 -- (Healthcare Sales & Marketing Network) -- EDAP TMS SA (NasdaqGM:EDAP ), the global leader in therapeutic ultrasound, announced today that the Association of Italian Urologists (AURO) has recommended High Intensity Focused Ultrasound (HIFU) as a standard of care for the treatment of prostate cancer as part of the Association's new guidelines on prostate cancer diagnosis and therapy.

The recommendation and updated guidelines on the use of HIFU for prostate cancer are based on the significant number of HIFU patients treated in Europe to date and on a comprehensive review of the current literature highlighting the positive clinical outcomes and acceptable follow-up.

AURO is recommending HIFU as a standard of care treatment for localized prostate cancer, highlighting its major advantage as a minimally invasive approach and because side effects following a HIFU procedure have proven to be very low, preserving patient quality of life. AURO recommends the use of HIFU for primary care patients with localized prostate cancer (T1-T2 stages) and for those who are not suitable for, failed or rejected radiotherapy or surgery. Italian urologists also consider the use of HIFU for locally advanced tumors (T3 stage), based on preliminary positive results. Finally, HIFU is also used in case of local relapse of cancer after radical prostatectomy or radiotherapy as no other alternative is being offered to these patients and also as a palliative treatment for other forms of the disease.

Sergio Pontecorvi, Managing Director of EDAP Italy, commented, ``I am extremely pleased with these updated recommendations as they will clearly help in positioning our minimally invasive HIFU option with urologists eager to offer the best treatment options to their patients with prostate cancer. These guidelines confirm the growing adoption of HIFU as a valid alternative to existing therapies while preserving patient quality of life. The low side effects associated with a HIFU procedure are significant benefits to highlight when a patient is considering a treatment option for his cancer.''

Marc Oczachowski, EDAP's Chief Executive Officer, commented, ``The AURO recommendations are fully in line with the French Association of Urology's recent publication which further validates HIFU's position as a new standard of care for the treatment of localized prostate cancer. The clear and concrete support from 2 major scientific and clinical communities in Europe is a major step forward in favor of our program to focus on driving deeper adoption of our HIFU technology among the urology community. Ablatherm-HIFU continues to build momentum in Europe and we also remain dedicated to our focus on increasing awareness of HIFU's benefits to patient quality of life.''


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 EnLight US clinical Study. 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, and

Forward-Looking Statements

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 FDA-approved or marketed in the United States.

Source: EDAP TMS

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