LYON, France, May 9 /PRNewswire-FirstCall/ -- EDAP TMS S.A. , the global leader in High Intensity Focused Ultrasound (HIFU) treatment of prostate cancer, announced the continuation of its US Phase II/III clinical trial with treatment of an additional two patients at Virginia Urology Center, Richmond, Virginia. Anthony Sliwinski, MD, and David Miller, MD, are leading the study at the site.
“We continue to work with our centers accelerating recruitment of patients eligible to participate in this important study of a new but well documented method for treating localized prostate cancer,” said Marc Oczachowski, CEO of EDAP. “Ablatherm-HIFU has a 10-year record of successful outcomes and low side effects with significant clinical studies already published. We are pleased these centers in the US are helping bring forward the necessary clinical work to make these benefits available to US patients in the future. We are working closely with all centers and adding new sites.”
“We were very excited when approached with this opportunity,” said Sliwinski. “We are a highly motivated practice when it comes to the care of our patients. We have our own Research Department here at Virginia Urology, and are always interested in pursuing projects that may lead to a better quality of life. HIFU presented such an opportunity. The EDAP Ablatherm-HIFU equipment is very easy to use. The ultrasound technology and safety features of the equipment make my part effortless. Thus far, we have treated four men using this technology. Our first two patients had a very positive experience and an immediate reduction in their PSA results. Both men have been enthusiastic spokesmen for this procedure. Our most recent treatments lasted shortly over two hours and immediate results seem excellent. This procedure appears to be a wonderful alternative to the many current treatment options for prostate cancer.”
The study is currently enrolling men over age 50 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.”
“While seeking US approval, Ablatherm-HIFU continues its steady advance in Europe where EDAP is the recognized dominant HIFU provider based on clear consensus of the medical community that this therapy is a good selection for nonsurgical patients,” said Oczachowski. “We see positive ongoing response to the rollout of Ablatherm-HIFU in major European markets with strong expectations for treatment growth as these education efforts progress. We are clearly committed to significant treatment increases under EDAP’s industry leading Revenue Per Procedure program making HIFU therapy rapidly accessible to any center wishing to offer this key option to their patients.”
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, for EDAP TMS S.A.
