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EDAP's Ablatherm-HIFU Offers Reliable Therapy for Localized Prostate Cancer

Munich Study Concludes 15 Year Outcome Data May Warrant Closing of Investigational Phase for HIFU

 EDAP TMS SA, the global leader in therapeutic ultrasound, announced today new long term data demonstrating high rates of both cancer-specific survival, and freedom from salvage therapy for patients treated with high-intensity focused ultrasound (HIFU) therapy.

The study was performed by Drs.Stefan Thürroff andChristian Chaussy and evaluated the cancer control and morbidity of HIFU, in combination with transurethral resection of the prostate prior to treatment, over a 15 year period. The study was electronically published inFebruary 2013 by theJournal of Urology, theOfficial Journal of theAmerican Urological Association.The study, titled "Evolution and outcomes of 3 MHz High intensity focused ultrasound therapy for localized prostate cancer over 15 years," examined 704 patients treated from 1995 to the end of 2009 at the Munich-Harlaching Clinic located in Munich, Germany. Within the study population, 78.5% of men had intermediate- or high-risk disease. Data showed a cancer-specific survival rate after treatment of 99% and a metastasis-free survival rate of 95%. The salvage treatment-free rates were 98% for low-risk, 72% for intermediate-risk, and 68% for high-risk disease. The overall survival of the patients in the study did not differ across risk groups and was identical to current local (Bavarian) population survival statistics.

Stefan Thüroff, M.D., Primary Investigator and Vice Chairman of the Department of Urology at the Harlaching Clinic, said, "These study results show that HIFU offers men with localized prostate cancer a standardized, reliable therapy with a low rate of perioperative co-morbidity and an absence of serious morbidity. Importantly, we found that salvage therapy was not required by 98% of low-risk patients. This outcome is extremely important from the perspective of the patient, and clearly demonstrates the extent of cancer control afforded by HIFU therapy."

Dr. Thüroff concluded, "HIFU has remained investigational because the published research on the therapy has not yet reached sufficient maturity to be considered definitive. The authors of this study concur that the collected data of 15 year outcomes may warrant the possible closing of the investigational phase of whole gland HIFU. The confidence this study provides in the ability to ablate prostate cancer may also encourage the use of focal therapy."

John Rewcastle, Ph.D., Medical Director of EDAP-TMS, commented, "This is an extremely important publication as it not only further establishes the safety, efficacy, and long term durability of HIFU as a prostate cancer treatment, it also demonstrates reproducibility. Cancer control outcomes are similar to those recently published by a separate German research group that reported outcomes over a 14 year period. Importantly, within this larger and longer independent study, prostate cancer did not appear to reduce the life expectancy of those men diagnosed with the disease who underwent HIFU. Impressively, this was achieved with less than 2% of low-risk patients seeking salvage treatment and in absence of serious morbidity. This is an impressive further validation of Ablatherm-HIFU as treatment for prostate cancer."

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