Healthcare Industry News: Ablatherm
News Release - April 9, 2007
EDAP Concludes HealthTronics AgreementCompany Reclaims Full US Market Rights; Ablatherm-HIFU Trial to Resume Immediately
LYON, France, April 9 (HSMN NewsFeed) -- EDAP TMS S.A. (Nasdaq: EDAP ), the global leader in High Intensity Focused Ultrasound (HIFU) treatment of prostate cancer and the international leader in the development, production, and distribution of a wide portfolio of minimally invasive medical devices primarily for the treatment of urological diseases announced it has concluded its prior US clinical relationship with HealthTronics. Under terms of the agreement, HealthTronics will provide cash and equipment to EDAP with a total value of approximately $2.0 million. EDAP also regains full rights for its global leading Ablatherm-HIFU prostate cancer therapy device in the important US medical market, pending future FDA approval.
"We are very pleased to reclaim the US market directly for EDAP at a time when HIFU is better known and well regarded on a global basis thanks to our ongoing commitment to long-term clinical documentation of the Ablatherm-HIFU's repeatable efficacy, low side effects and medical cost efficiency," said Hugues de Bantel, in charge of the US FDA programs for EDAP. "We look forward to immediately resuming the approved IDE program. Our centers are fully trained and actively recruiting for this important study. Additionally, we are adding more centers as doctors become aware of HIFU's global experience and want to participate in evaluating it for the US clinical study. Interest from the medical and patient communities continues to grow as people are educated about HIFU through the proper medical channels and clinical data."
"We clearly see the value of the US market is far in excess of the short- term investment to immediately restart the clinical study," said de Bantel. "Since Ablatherm-HIFU's global credibility has made significant progress since this program began in 2004, we find ourselves today in a very strong position. As the largest, and often most technologically driven, medical market in the world we are eager to secure a successful study outcome in the US. We look forward to progressing the studies with the highest levels of professionalism at these US centers of excellence. EDAP's position as the undisputed global HIFU leader gives us confidence in the execution of these trials with our partner centers."
EDAP thanks its clinical centers for their ongoing dedication during the transition process and its shareholders for their continuous support in making Ablatherm-HIFU a new standard in prostate cancer therapy.
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.
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.
Source: EDAP TMS
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