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Jan 19, 2016
EDAP Announces Results of World's First Focal HIFU Trial

EDAP Announces Results of World's First Focal HIFU Trial

100% Cancer Specific Survival, 94% Continence Preservation and 80% Potency Preservation

EDAP TMS, today announced the publication of long term results of Ablatherm Focal HIFU in the peer reviewed journal "Prostate Cancer and Prostatic Diseases," part of the Nature Publishing Group.

This pioneering prospective study of HIFU hemiablation of prostate cancer was conducted by Professor Roland van Velthoven, Head of the Urology Department at renowned Institut Bordet Oncology Center, Brussels, Belgium. With the initial patient treated in early 2007, it is the first prospective study of focal HIFU to enroll patients a follow-up extending to 8 years. The publication reports a 100% cancer specific survival at 5 years, a 94% rate of continence preservation and 80% rate of potency preservation.

Pr. van Velthoven commented: "We are extremely encouraged by the results of this prospective study initiated in 2007, at a time when multi-parametric MRI and ultrasound guided biopsies were simultaneously available. The availability of these technologies allowed us to identify the sub-group of patients presenting localized, unilateral and significant index lesion eligible for a treatment with curative intent. Low morbidity associated with favorable oncological outcome enables us to keep these patients under close monitoring of PSA and MRI imaging when necessary. This approach enabled us to spare patients from unnecessary iterative biopsy policies, as well as from the costs and side effects of hormonotherapy or radiotherapy aimed at local control of a limited disease."

Marc Oczachowski, EDAP TMS Chief Executive Officer, added: "We are very pleased with the published results from this study, the first and the longest follow up Focal HIFU trial in the technology's history. It confirms the leadership of our HIFU technology for the ablation of prostatic tissue."

Oczachowski, concluded: "These high level clinical outcomes are very encouraging, as they were obtained using the exact Ablatherm Robotic HIFU device that was recently cleared by the FDA in the United States. They are consistent with other single and multicenter studies of focal Ablatherm HIFU. This demonstration of reproducibility of outcomes is important and clearly indicates that similar high quality results can be duplicated commercially in the U.S."