December 5, 2007
EDAP Ablatherm Clinical Study Begins At Vanderbilt Medical; Center is First in Tennessee to Evaluate New HIFU System for Prostate Cancer
LYON, France, Dec. 5, 2007 (PRIME NEWSWIRE) -- EDAP TMS S.A. (Nasdaq:EDAP), the global leader in High Intensity Focused Ultrasound treatment of prostate cancer, announced the launch of Ablatherm HIFU treatments at Vanderbilt University Medical Center, Nashville, TN. The treatments are 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 United States.
First patient was successfully treated with Ablatherm-HIFU at Vanderbilt in November, after securing all necessary approvals with the center to initiate the study."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."
"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."
"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."
Marc Oczachowski, CEO, highlighted: "Our clinical team in the United States continues to make significant progress. Shortly we will have all the Ablatherm units needed to complete the trial mobilized to efficiently serve all study sites. Awareness of the trial among prostate cancer patients will be increased with the experienced support of Fleishman Hillard, a specialized PR agency recently engaged to promote the trial. EDAP has the financial and technical means to successfully complete this study program for its goal of U.S. approval to make Ablatherm available to American men desiring an alternate treatment choice to traditional options available today."
Further treatments are scheduled to follow immediately at multiple centers, with enrollment again open to patients meeting the study criteria. The study is currently enrolling men over age 60 diagnosed with clinical stage T1a, b or c or T2a localized prostate cancer. HIFU is a noninvasive therapy using highly focused ultrasound energy to ablate the prostate tissue. Details of the study and background on Ablatherm-HIFU can be found online at www.clinicaltrials.gov by searching for "Ablatherm."
About EDAP TMS S.A.
EDAP TMS S.A. develops and markets Ablatherm, the most advanced and clinically proven choice for High Intensity Focused Ultrasound (HIFU) treatment of localized prostate cancer. HIFU treatment is shown to be a minimally invasive and effective treatment option with a low occurrence of side effects. Ablatherm-HIFU is a treatment for patients with newly diagnosed localized prostate cancer or who have failed radiotherapy treatment. The company is also developing this technology for the potential treatment of certain other types of tumors. EDAP TMS S.A. also produces and commercializes medical equipment for treatment of urinary tract stones using Extra-corporeal Shockwave Lithotripsy (ESWL).
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In addition to historical information, this press release contains forward-looking statements that involve risks and uncertainties. These include statements regarding the Company's growth and expansion plans. Such statements are based on management's current expectations and are subject to a number of uncertainties and risks that could cause actual results to differ materially from those described in these forward-looking statements. Factors that may cause such a difference include, but are not limited to, those described in the Company's filings with the Securities and Exchange Commission. Ablatherm-HIFU treatment is in clinical trials but not yet FDA approved or marketed in the United States.
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CONTACT: EDAP TMS S.A. Blandine Confort +33 4 78 26 40 46 Magnolia Investor Relations Matt Kreps 469 362 5960