EDAP Looking to Accelerate US Study Enrollment With the Upcoming Addition of McMaster University Hospital
Posted on: Friday, 1 June 2007, 12:00 CDT
LYON, France, June 1 /PRNewswire-FirstCall/ -- EDAP TMS S.A. , the global leader in High Intensity Focused Ultrasound (HIFU) treatment of prostate cancer, reports further intentions to accelerate its clinical trial study enrollment with the upcoming addition of the McMaster University Hospital near Toronto, Ontario, to the participating sites. William L. Orovan, M.D., FRCSC, FACS, Professor and Chair Department of Surgery McMaster University, Ontario, Canada has been treating Ablatherm patients from North America at a private center since 2005.
"Ablatherm-HIFU is by far the best HIFU technology available with excellent cancer control. It has proven to be the superior HIFU device from the perspectives of precision, imaging capacity and safety," stated Dr. Orovan. "The technique is simple, highly effective and clearly offers tremendous advantages. In our experience over several hundred treatments, we are extremely pleased with the outcomes, which match the clinical data already widely reported in leading journals. Our patients have been very satisfied with Ablatherm therapy, and most are able to resume normal activity within 24 hours of treatment since Ablatherm is less invasive with fewer side-effects."
"Ablatherm offers top safety protocols active throughout the robotic treatment so the device stops application instantly if any parameter becomes a concern, as compared to other devices requiring manual intervention, which may not provide as rapid of a response for patient safety," Dr. Orovan continued. "Considering that Ablatherm-HIFU is proven repeatable and has no therapeutic impasse, this gives patients the most complete ability to preserve quality of life and all medical options in treating localized prostate cancer."
"This is another step in our stated plans to accelerate our US trials," said Marc Oczachowski, CEO of EDAP. "During the recent AUA Congress EDAP was approached by numerous centers, including the top US institutions in cancer care, about joining our study based on the strong clinical evidence already documented from the approved use of Ablatherm-HIFU outside the US where it shows more than 10 years of clear success on more than 12,000 treatments. We will meet those requests in the coming months. This will help EDAP fully enroll the study with centers of unmatched prestige in the US. We are also excited to now include international centers already using Ablatherm to create a positive treatment experience for patients demanding better options."
The Ablatherm-HIFU Phases II/III clinical study is currently enrolling men 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 http://www.clinicaltrials.gov/ by searching for "Ablatherm." Ablatherm-HIFU is proven effective comparable to other standard nonsurgical treatments of localized prostate cancer, but often offers fewer side effects.
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 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. 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).
For more information on the Company, contact Magnolia Investor Relations at (972) 801-4900, the Corporate Investor Relations Dept at +33 (0)4 78 26 40 46 or see the Company's Web sites at http://www.edap-tms.com/ and http://www.hifu-planet.com/.
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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.
CONTACT: EDAP TMS S.A. Magnolia Investor Relations Blandine Confort Matt Kreps +33 4 78 26 40 46 972 801 4900
EDAP TMS S.A.
CONTACT: Blandine Confort of EDAP TMS S.A., +33 4 78 26 40 46; or MattKreps of Magnolia Investor Relations, +1-972-801-4900
Web site: http://www.edap-tms.com/http://www.clinicaltrials.gov/http://www.hifu-planet.com/
Source: PRNewswire-FirstCall
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