News | December 09, 2007

EDAP Ablatherm Clinical Study Begins At Vanderbilt Medical

December 10, 2007 - EDAP TMS S.A. a leader in high intensity focused ultrasound treatment of prostate cancer, announced the launch of Ablatherm HIFU treatments at Vanderbilt University Medical Center, Nashville, TN as part of EDAP's ongoing Phase II/III U.S. Clinical Study program seeking FDA approval as the first HIFU device for prostate cancer in the U.S.

The first patient was successfully treated with Ablatherm-HIFU at Vanderbilt in November, after securing all necessary approvals with the center to initiate the study.

"HIFU using the Ablatherm brings a unique approach to minimally invasive treatment that appears to be well tolerated by the patient," said Sam Chang, M.D., associate professor of Urologic Surgery and VUMC's principal investigator. "Vanderbilt is the only center in the region participating in this clinical trial. As leaders in prostate cancer research we need to evaluate and pursue new techniques such as HIFU which could offer additional choices to patients. The European peer data is encouraging and provides a well documented history of development and use for the Ablatherm device covering more than 10 years. We are excited to be recognized as a participant in this trial, and look forward to examining the patient results achieved in the Clinical Study program."

"Vanderbilt is a leading prostate cancer research center, and a location EDAP is pleased to have as a part of the U.S. clinical program," said Dr. John Rewcastle, Medical Director of EDAP. "EDAP continues its commitment to clinical excellence with the addition of Dr. Chang, a very well respected and widely published urologist with fellowship training, and his fellow co-investigators. Vanderbilt is the first of several sites now coming online adding depth and speed to our U.S. program following the successful funding of the entire clinical study recently announced by EDAP."

"My situation was such that I needed a prostate cancer treatment that had quick recovery time and offered a low chance of side effects," said Greer Simonton, the first Vanderbilt patient treated under the program. "I studied all the options and felt HIFU was right for me. When I learned that Dr. Chang and The Vanderbilt University Medical Center were beginning clinical trials I decided that was where I wanted to be. I hope that this trial will enable HIFU to gain FDA approval so others like me will have this option in the U.S."

For more information: www.clinicaltrials.gov

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