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EDAP TMS’ Ablatherm Study Relevant to FDA Clinical Investigation

High Intensity Focused Ultrasound (HIFU) is competitive with currently accepted non-surgical standards of care, such as radiotherapy, but results in milder side effects, reveals the first long-term study of HIFU for the treatment of localized prostate cancer. In an editorial accompanying the published article, Dr. Vincenzo Ficarra from the University of Padua, Italy said, "These oncologic results can be considered competitive with those reported after radical prostatectomy or external-beam radiation therapy. Beyond the oncologic outcomes, the article by Blana et al confirmed the very promising functional data of HIFU treatments in terms of urinary continence and recovery of erectile function." The study followed 140 patients treated at multiple sites in Europe between 1997 and 2001. 86% of participants achieved negative biopsies following Ablatherm treatment. Prostate-Specific Antigen (PSA) tests showed that 77% of patients had low or stable levels of the tumor marker after five years. The Ablatherm is a HIFU-based device developed and manufactured by EDAP TMS subsidiary EDAP SA. The treatment is performed transrectally, generally under spinal anesthesia. A probe is placed in the rectum. This probe emits a beam of high intensity convergent ultrasound. In the point where the ultrasound is focused the sudden and intense absorption of the ultrasound beam heats destroys pathogenic tissue in a targeted area. Ablatherm is approved for commercial distribution in the E.U., Canada, South Korea and Russia. As of April 2007 more than 13,000 patients have been treated; the device obtained the CE mark in 2000. In the U.S., HIFU is an investigational device and is being studied under an FDA approved IDE investigation. The data from this study is relevant to the U.S. study as it demonstrated that short-term results are indicative of longer term cancer control. The company recently raised $20 million through a convertible pipe to completely finance the FDA clinical investigation. Prostate cancer affects approximately 200,000 American men each year.

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