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EDAP's Ablatherm-HIFU Demonstrates Long-Term Efficacy and Safety Over Fourteen-Year Period

Longest Retrospective Study of HIFU Patients to Date Published Confirms Benefits of Treatment
EDAP TMS SA, the global leader in therapeutic ultrasound, announced today new data demonstrating the safety and long-term efficacy of Ablatherm-HIFU, an ultrasound guided HIFU device for the treatment of localized prostate cancer. The data was electronically published inJanuary 2013 by theBritish Journal of Urology, International.

Roman Ganzer, M.D., Primary Investigator and Associate Professor of Urology at the University of Regensburg in Germany, summarized, "We studied a large consecutive patient series that underwent primary HIFU for localized prostate cancer, gathering data over the longest follow-up period in current literature, with data extending out to 14 years. Our results improve the understanding of the long term cancer control of HIFU as a primary therapy for prostate cancer as well as the morbidity associated with the procedure. The study solidifies the fact that HIFU is a safe and effective therapeutic option for patients with localized prostate cancer of low and intermediate risk profile. The morbidity experienced by patients was reasonable and, specifically, the rate of serious side effects such as recto-urethral fistulae is very low."

The study, titled "Fourteen-year oncological and functional outcomes of high-intensity focused ultrasound in localized prostate cancer," was a fourteen year retrospective single-center study of 538 patients with localized prostate cancer who underwent primary Ablatherm-HIFU for clinically localized prostate cancer between November 1997 and September 2009 at the University Hospital of Regensburg (Germany). The study had a mean follow-up of 8.1 years and a range of up to 14 years. The findings included favorable oncological outcomes with biochemical disease-free survival rates at five and 10 years of 88% and 71% for low risk patients and 83% and 63% for intermediate risk patients, respectively.

John Rewcastle, Ph.D., Medical Director of EDAP TMS, remarked, "This is a landmark publication as it contains a report of 10 year biochemical outcomes with follow-up extending to 14 years. The biochemical disease free survival rates are comparable with those reported following other prostate cancer treatments and this is balanced with an attractive morbidity profile. This represents the longest follow-up of any series to date, and validates the outcomes of Ablatherm-HIFU as first line, whole gland treatment for prostate cancer."

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