EDAP Introduces Focal.One(R): A New Robotic HIFU Device for Focal Therapy of
Focal.One World Premiere at European Association of Urology Annual Congress
LYON, France, March 14, 2013 (GLOBE NEWSWIRE) -- EDAP TMS SA (Nasdaq:EDAP),
the global leader in therapeutic ultrasound, announced today the launch of
Focal.One^®, its new and innovative robotic HIFU device fully dedicated to
focal therapy of prostate cancer. Focal.One^® will be showcased for the first
time at the European Association of Urology (EAU) 28^th Annual Congress to be
held in Milan, Italy on March 15-19, 2013 (booth # D41).
Marc Oczachowski, Chief Executive Officer of EDAP TMS, commented, "We are very
excited to present to the urological community our latest HIFU technology
bringing together many of the latest innovations to fulfill the focal strategy
for the treatment of prostate cancer. Focal.One is the first and only device
specifically designed to fully answer the need from urologists for a
non-invasive, robotic device that fully addresses the quality of life
preservation concerns of prostate cancer patients who are increasingly better
informed about treatment options."
Focal.One is the first device dedicated to the focal approach for prostate
cancer therapy. It combines the three essential components to efficiently
perform a focal treatment: (i) state-of-the-art imaging to localize tumors
with the use of magnetic resonance imaging (MRI) combined with real-time
ultrasound, (ii) utmost precision of HIFU treatment focused on identified
targeted cancer areas only and (iii) immediate feedback on treatment efficacy
utilizing Contrast-Enhanced Ultrasound Imaging.
As the prostate cancer patient profile has evolved over recent years with
earlier diagnosis and life expectancy significantly increasing, men with
prostate cancer want to preserve their quality of life more than ever. Until
today, those patients are mainly offered two options to address their prostate
cancer: either a radical treatment approach with the surgical removal or
irradiation of the entire prostatic gland, usually associated with high risk
of side effects such as incontinence and impotence, or a "watchful waiting"
approach with the monitoring of disease evolution through regular PSA testing
and biopsies, usually associated with a high degree patient stress and anxiety
ultimately resulting in the necessity for a radical treatment. Between
"over-aggressive treatment" and "no treatment," there is definitely a need for
a non-invasive therapeutic alternative that offers a control over the disease
while focally treating the cancer tumors only.
Hugo Embert, Marketing Director of EDAP TMS, added, "We strongly believe that,
in the upcoming years, the focal approach will become more and more prominent
in the management of prostate cancer as it is already the case for other
organs. This is the reason why we combined the latest imaging modalities with
cutting-edge proprietary HIFU technology into one unique device,
Focal.One.Thanks to the latest improvements of MR-Imaging in the diagnostic
of prostate cancer, HIFU precision combined with a highly performing
ultrasound tool to validate treatment efficiency, Focal.One is the first
device that meets the need for an optimal focal therapy of prostate cancer
while preserving patient quality of life."
Mr. Embert concluded, "By adding Focal.One to our well-established Ablatherm^®
device, we expanded our range of HIFU devices for localized prostate cancer
and have now the capacity to answer a wide array of treatment options and to
address every population of urologists by bringing them the right solution for
their prostate cancer practice. This is unique to EDAP TMS and the result of
many years of R&D expertise and HIFU clinical experience."
EDAP expects to file for CE mark for Focal.One in the second quarter of 2013
and to pursue commercial distribution in Europe thereafter. A global
regulatory program will be implemented to pursue requisite approvals across
key global markets.
About EDAP TMS SA
EDAP TMS SA markets today Ablatherm® 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 is approved and commercialized in Europe as a
treatment for prostate cancer and is currently under regulatory review in the
U.S. following submission of the Pre-Market Approval Application in February
2013 after the completion ofa multi-center U.S. Phase II/III clinical trial
under an Investigational Device Exemption (IDE) granted by the FDA. The
Company also develops its HIFU technology for the potential treatment of
certain other types of tumors. EDAP TMS SA also produces and commercializes
medical equipment (the Sonolith® range) for treatment of urinary tract stones
using extra-corporeal shockwave lithotripsy (ESWL). For more information on
the Company, please visit http://www.edap-tms.com, and
In addition to historical information, this press release may contain
forward-looking statements that involve risks and uncertainties. Such
statements are based on management's current expectations and are subject to a
number of uncertainties, including the uncertainties of the regulatory
process, 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 and in
particular, in the sections "Cautionary Statement on Forward-Looking
Information" and "Risk Factors" in the Company's Annual Report on Form 20-F.
Ablatherm-HIFU treatment is in clinical trials, but not FDA-approved or
marketed in the United States.
CONTACT: Blandine Confort
Investor Relations / Legal Affairs
EDAP TMS SA
+33 4 72 15 31 72
The Ruth Group
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