Healthcare Industry News: EnLight
News Release - May 13, 2008
EDAP Adds Premiere M.D. Anderson Cancer Center for Phase II/III Ablatherm-HIFU Clinical Trial
LYON, France, May 13, 2008 (Healthcare Sales & Marketing Network) -- EDAP TMS SA (NasdaqGM:EDAP ), the global leader in therapeutic ultrasound, announced today that The University of Texas M.D. Anderson Cancer Center in Houston, Texas received Institutional Review Board (IRB) approval to participate in EDAP's ongoing EnLight Phase II/III clinical trial of Ablatherm(r)-High Intensity Focused Ultrasound (HIFU) in patients with localized prostate cancer.M.D. Anderson is one of the world's most respected centers. Over the last 60 years, the Center has built a reputation for excellence based on its devotion to patient care, clinical and basic science research, educating the next generation of physicians and striving to prevent rather than cure human malignancy. In 2007, U.S. News and World Report's ``America's Best Hospitals'' survey ranked M. D. Anderson as the #1 hospital in the nation for cancer care. M. D. Anderson has achieved the #1 ranking in five of the past eight years and has been rated by the magazine as one of the top two cancer hospitals. This same survey has also consistently ranked The Department of Urology at M. D. Anderson is consistently rated as one of the top 10 Urology centers in the Nation.
Marc Oczachowski, EDAP's Chief Executive Officer, stated, ``We are delighted that another one of the world's leading cancer centers is participating in our EnLight trial. EDAP aims to attract the most reputable academic centers and private practices to evaluate our innovative and minimally invasive HIFU technology with the goal of completing enrollment in the timeliest manner. Given the approval of eleven HIFU sites, which include some of the most reputable prostate cancer centers in the world, we are well-positioned to continue accelerating patient enrollment. With eleven of the thirteen Ablatherm sites now recruiting patients for our multicenter study, we have generated substantial momentum to drive accrual efforts.''
About the EnLight Study
The prospective non-inferiority study is designed to evaluate the safety and efficacy of EDAP's Ablatherm-HIFU system versus Cryotherapy for the treatment of low-risk, localized prostate cancer. The clinical trial is currently enrolling men over age 60 diagnosed with clinical stage T1a, b, or c or T2a localized prostate cancer. The primary outcome measure of the trial will be a statistically significant reduction and stability of the prostate-specific antigen (PSA) throughout a 24-month follow-up period. Details of the study and background on Ablatherm-HIFU can be found online at http://www.ClinicalTrials.gov by searching for ``Ablatherm.''
About EDAP TMS SA
EDAP TMS SA 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 generally recommended for patients with localized prostate cancer (stages T1-T2) who are not candidates for surgery or who prefer an alternative option, or for patients who failed radiotherapy treatment. Approved in Europe as a treatment for prostate cancer, Ablatherm-HIFU (High Intensity Focused Ultrasound) is currently undergoing evaluation in a multicenter U.S. Phase II/III clinical trial under an Investigational Device Exemption granted by the FDA. The Company also is developing this technology for the potential treatment of certain other types of tumors. EDAP TMS SA also produces and commercializes medical equipment for treatment of urinary tract stones using extra-corporeal shockwave lithotripsy (ESWL). For more information on the company, please visit http://www.edap-tms.com and http://www.hifu-planet.com or http://www.urotoday.com
Source: EDAP TMS
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