EDAP Concludes HealthTronics Agreement
April 09 2007 - 8:57AM
PR Newswire (US)
Company Reclaims Full US Market Rights; Ablatherm-HIFU Trial to
Resume Immediately LYON, France, April 9 /PRNewswire-FirstCall/ --
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/. To sign up for alerts please
visit: http://www.b2i.us/irpass.asp?BzID=1053&to=ea&s=0 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. DATASOURCE: EDAP
TMS S.A. CONTACT: Blandine Confort of EDAP TMS S.A., +33 4 78 26 40
46; or Matt Kreps of Magnolia Investor Relations, +1-972-801-4900
Web site: http://www.edap-tms.com/ http://www.hifu-planet.com/
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