EDAP Ablatherm-HIFU Presents at American Urology Association Accelerates US Study Enrollment
May 23 2007 - 7:59AM
PR Newswire (US)
LYON, France, May 23 /PRNewswire-FirstCall/ -- EDAP TMS S.A.
(NASDAQ:EDAP), the global leader in High Intensity Focused
Ultrasound (HIFU) treatment of prostate cancer, reports the
continuing advancement of its clinical trial and education programs
at the American Urology Association Congress in Anaheim May 19-22,
2007. EDAP's booth was well attended with inquiries about its
Ablatherm-HIFU line for localized prostate cancer, currently in US
clinical trials, and its well established lithotripsy business
which unveiled the next generation lithotripter intended for
European and USA sales. "We received very strong interest from the
urology community in both our newly unveiled Sonolith I-sys and the
Ablatherm-HIFU's continuing strong clinical results," said Marc
Oczachowski, CEO of EDAP. "The S.I-sys received high marks for its
features and ease of use. With more than 25 years in the urology
market, EDAP is a well known name. The S.I-sys will begin European
delivery in September of this year. This device is designed to
address the high demand needs of lithotripsy centers and support
broader awareness of EDAP." As announced previously, EDAP will
accelerate its ongoing US clinical trial of the Ablatherm-HIFU
device with strong awareness and outreach under its direction with
full ownership of the study. Based on strong results recently
released in Europe showing sustainable outcomes at 8 years and
growing US interest in the clinical program by urologists, EDAP is
currently fielding several inquiries from centers wishing to join
the study and deploying greater resources to the clinical program.
EDAP hosted its first investigator meeting since assuming full
control of the study with strong support and commitment from the
centers. EDAP's participation in the AUA event included poster
presentations on: * EDAP's ongoing long term clinical success
including a video presentation of outcomes from the first 10 years
of Ablatherm-HIFU therapy in Germany, attended by more than 300
urologists, * a cost comparison concluding Ablatherm-HIFU can be
lower in cost than six common therapies such as robotic surgery,
external radiation or brachytherapy, and * preliminary outcomes in
a study of Ablatherm combined with hormone and radiation therapies
for metastatic cancers and use of Ablatherm-HIFU as a documented
salvage therapy option of proven success. "EDAP continues the
advancement of HIFU therapy in localized prostate cancer," said
Oczachowski. "With the strong enthusiasm of our US clinical centers
to conduct the Ablatherm US study more rapidly, we have every
expectation of success in bringing Ablatherm-HIFU to American
patients seeking high quality of life as well as effective
treatment. Many of the best centers in the US have contacted EDAP
with interest in joining the study as additional sites, and we are
presently discussing options with them as well as securing the
necessary approvals. In the interim, we continue to educate
urologists on our study as well as the ideal indications making
Ablatherm an established consideration for patients with localized
prostate cancer." 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." The therapy generally requires one session of two to
three hours and a minimum of recuperative time. Ablatherm-HIFU is
proven effective comparable to other standard nonsurgical
treatments of localized prostate cancer, but often with lower side
effects. The highly robotized procedure offers clear statistically
predictive outcomes without any impasse to future care if it should
be required. Ablatherm is also the HIFU system with proven
dedicated protocols for treatment of recurrent prostate cancer
following failed radiation 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. CONTACT: EDAP
TMS S.A. Magnolia Investor Relations Blandine Confort Matt Kreps
+33 4 78 26 40 46 972 801 4900 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, for EDAP TMS S.A.
Web site: http://www.edap-tms.com/
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