| EDAP Reports Publication of Head-to-Head Study of Ablatherm-HIFU Versus
Other HIFU Technology for Prostate Cancer
Journal of Endourology Highlights Ablatherm's Unique Sustainable
Long-Term Clinical Data
Ablatherm's Superior Safety and Efficacy Confirmed
LYON, France, Feb. 14, 2008 (PRIME NEWSWIRE) -- EDAP TMS SA (Nasdaq:EDAP),
the global leader in therapeutic ultrasound, announced today that the Journal
of Endourology published results in its February 2008 issue from a
head-to-head study entitled "Transrectal High-Intensity Focused Ultrasound
Devices: A Critical Appraisal of Available Evidence." Based on a thorough
review of the existing medical literature, the objective of the study was to
evaluate clinical outcomes and unique characteristics comparing EDAP's
Ablatherm(r)-HIFU versus Sonablate500(r) for the treatment of prostate cancer.
The article highlights the clinical superiority of Ablatherm in terms of
present and longer-term data available. For the purposes of the study,
clinicians referenced six publications on Ablatherm-HIFU featuring 2,032
patients treated, compared to three publications relating to Sonablate500 with
287 patients treated. Reviewed published articles have included Ablatherm
patients with up to 10 years of follow up, whereas disease-free rate cannot be
reported beyond five years for the competitive technology. Clinicians note
that Ablatherm has been used in a greater number of centers for a longer
period of time, providing more clinical information regarding its effects. The
article also demonstrates the need for additional clinical studies for the use
of other HIFU devices in order to draw the same short-term treatment success
results as Ablatherm.
The article concludes that the availability of more short- and long-term
oncologic outcomes with the Ablatherm device creates less uncertainty about
the actual efficacy of the device-specific treatment.
Although both HIFU devices are built on the same scientific foundation,
critical differences exist. Ablatherm-HIFU is unique in offering three
specific treatment protocols addressing each of the targeted types of prostate
cancer patients: (i) patients diagnosed with prostate cancer who have yet to
undergo any previous treatment (primary treatment), (ii) patients who failed
radiotherapy and HIFU being their only available therapeutic option, and (iii)
patients with recurrence of their cancer. In addition, Ablatherm's probe
integrates two ultrasound transducers, one for localizing and imaging the
tumor and one for HIFU treatment, thus offering the best imaging quality,
while ensuring a safe and efficient treatment.
John Rewcastle, medical director of EDAP, commented, "We are pleased this
review, in addition to several other positive publications, provides further
validation of Ablatherm-HIFU's unique technological merits in comparison to
other HIFU devices. Substantial and longer-term data following Ablatherm-HIFU
is increasingly available, which allows physicians to accurately discuss
outcomes as they guide patients through the treatment selection process. With
over 15,000 treatments performed worldwide, we believe Ablatherm is the
standard-of-care in HIFU treatment of localized prostate cancer."
Marc Oczachowski, EDAP's chief executive officer, said, "We are delighted
this review confirms both the unique expertise and experience of our Ablatherm
device in treating localized prostate cancer. We are pleased this review has
been published at a time when we are actively recruiting patients for our U.S.
Phase II/III clinical trial of Ablatherm-HIFU. We are confident that the
results of this published study could have a positive effect on the enrollment
pace in our ongoing trial. We look forward to confirming Ablatherm's efficacy
and safety in the U.S. market and are pleased with the progress to-date."
EDAP's Ablatherm-HIFU is not approved for the treatment of prostate cancer
in the United States and currently is undergoing evaluation in a multicenter
Phase II/III clinical trial under an Investigational Device Exemption granted
by the FDA.
About EDAP TMS SA
EDAP TMS SA 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.
Ablatherm-HIFU treatment is in clinical trials, but not FDA-approved or
marketed in the United-States. The company also is developing this technology
for the potential treatment of certain other types of tumors. EDAP TMS SA also
produces and commercializes medical equipment for treatment of urinary tract
stones using extra-corporeal shockwave lithotripsy (ESWL). For more
information on the company, please visit and
or .
Forward-Looking Statements
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
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CONTACT: EDAP TMS SA
Investor Relations / Legal Affairs
Blandine Confort
+33 4 72 15 31 72
bconfort@edap-tms.com
The Ruth Group
Investors:
Stephanie Carrington
646-536-7017
scarrington@theruthgroup.com
R.J. Pellegrino
646-536-7009
rpellegrino@theruthgroup.com
(END) Dow Jones Newswires
02-14-08 0905ET |
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