EDAP Reports Installation of Ablatherm Robotic HIFU at University of Southern California
10 December 2015 - 12:30AM
EDAP TMS SA (Nasdaq:EDAP), the global leader in therapeutic
ultrasound, today announced the first installation of Ablatherm
Robotic HIFU at University of Southern California, Keck Medicine of
USC, which will become the first reference and training center for
Ablatherm Robotic HIFU in the U.S.
Dr. Inderbir Gill, M.D., Professor & Chairman, USC Institute
of Urology at Keck Medicine of the University of Southern
California (USC) in Los Angeles, commented: "FDA clearance of
HIFU is a tremendous milestone for the urology community. We are
delighted to be the first in the U.S. to treat patients on a
routine basis with the Ablatherm Robotic HIFU, on December 10 and
11, 2015. We look forward to helping appropriate patients using
this groundbreaking technology, thus opening new options and
horizons for prostate ablation procedures."
Marc Oczachowski, EDAP TMS Chief Executive Officer, added: 'We
are thrilled to have the first installation of Ablatherm Robotic
HIFU following FDA clearance at such a prestigious university
hospital as USC Keck Medical Center, which was one of the first
facilities to purchase the device in the U.S. It is an honor to be
working with the world class urology team led by Dr. Inderbir Gill,
one of the top urologists in the world, and to collaborate with
them on the establishment of a state-of-the-art training and
reference center for Ablatherm Robotic HIFU in the U.S."
About EDAP TMS SA
EDAP TMS SA markets today Ablatherm® for high-intensity focused
ultrasound (HIFU) for prostate tissue ablation in the U.S. and for
treatment of localized prostate cancer in the rest of the world.
HIFU treatment is shown to be a minimally invasive and effective
option for prostatic tissue ablation 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 for
commercial distribution in Europe and some other countries
including Mexico and Canada, and has received 510(k) clearance by
the U.S. FDA. The Company also markets an innovative robot-assisted
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 distributes medical equipment (the Sonolith®
lithotripters' range) for the treatment of urinary tract stones
using extra-corporeal shockwave lithotripsy (ESWL) in most
countries including Canada and the U.S. 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 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.
CONTACT: Blandine Confort
Investor Relations / Legal Affairs
EDAP TMS SA
+33 4 72 15 31 72
bconfort@edap-tms.com
Investors:
Lee Roth
The Ruth Group
646-536-7012
lroth@theruthgroup.com
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