EDAP Delivers Focal One(R) Device for Focal Treatment of Prostate Cancer to Hospital in Poland
12 February 2014 - 12:30AM
EDAP TMS SA (Nasdaq:EDAP), the global leader in therapeutic
ultrasound, announced today the installation of its Focal One
device at the ESKULAP Private Hospital in Bydgoszcz, Poland. Focal
One is the first robotic HIFU device dedicated to the focal
approach for prostate cancer therapy. It combines the three
essential components to efficiently perform a focal treatment:
state-of-the-art imaging to localized tumors with the use of
magnetic resonance imaging (MRI) combined with real-time
ultrasound, utmost precision of robotic HIFU treatment focused only
on identified targeted cancer areas, and immediate feedback on
treatment efficacy utilizing Contrast-Enhanced Ultrasound Imaging.
EKSULAP has over 20 years of experience providing healthcare
services in Poland. In 2012 it established its own hospital to
provide minimally invasive procedures in various pathologies. With
the acquisition of its first Focal One device, the Hospital is
equipped to address localized prostate cancer with a focused
therapeutic approach that will minimize patient side effects.
Prof. Stanislaw Molski, Director of ESKULAP, commented, "We are
very excited about the integration of this Focal One HIFU device
within our therapeutic arsenal, as it will provide our patients
with an alternative to traditional therapies and will help to
preserve the quality of their lives. With the recent acquisition of
an MRI device in our hospital, we will be able to combine a highly
efficient localization of patient cancer with this Focal One
innovative ultrasound identification of tumors. The Focal One HIFU
device is a unique treatment option for the management of localized
prostate cancer and we look forward to utilizing this as part of
our arsenal of innovative diagnostic and treatment options."
Marc Oczachowski, EDAP TMS Chief Executive Officer added,
"Following the introduction of Focal One to the market last year,
we are expanding our strategy with an additional placement in
Europe. There is strong interest for such a focal therapeutic
approach to treating prostate cancer. Our exclusive HIFU technology
combined with MRI images and our dynamic fusion capability for an
effective and precise ultrasound guidance of the robotic probe
gives Focal One the unique capability to destroy cancerous cells
while leaving the healthy part of the prostate untouched. There is
indeed a clear need for less radical options in treating localized
prostate cancer and we believe Focal One is the safe and unique
solution that fits this need for both urologists and patients."
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 of a multi-center U.S. Phase II/III clinical trial under
an Investigational Device Exemption (IDE) granted by the FDA. In
February 2013, the Company introduced a new innovative HIFU device,
the Focal One® dedicated to focal therapy of prostate cancer. Focal
One® is CE marked but is not FDA approved. 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 http://www.hifu-planet.com.
Forward-Looking Statements
In addition to historical information, this press release may
contain forward-looking statements. Such statements are based on
management's current expectations and are subject to a number of
risks and uncertainties, including matters not yet known to us or
not currently considered material by us, and there can be no
assurance that anticipated events will occur or that the objectives
set out will actually be achieved. Important factors that could
cause actual results to differ materially from the results
anticipated in the forward-looking statements include, among others
the uncertainties of the U.S. FDA approval process, the clinical
status and market acceptance of our HIFU devices and the continued
market potential for our lithotripsy device. Factors that may cause
such a difference also may 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.
ESKULAP hospital web page:
www.szpitaleskulap.pl
CONTACT: Blandine Confort
Investor Relations / Legal Affairs
EDAP TMS SA
+33 4 72 15 31 72
bconfort@edap-tms.com
Investors:
Stephanie Carrington /David Burke
The Ruth Group
646-536-7017/7009
scarrington@theruthgroup.com
dburke@theruthgroup.com
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