EDAP Reports Sale of Ablatherm Robotic HIFU to Sylvester Comprehensive Cancer Center
December 21 2015 - 7:30AM
EDAP TMS SA (Nasdaq:EDAP), the global leader in therapeutic
ultrasound, today announced the sale of an Ablatherm Robotic HIFU
device to Sylvester Comprehensive Cancer Center, part of UHealth –
the University of Miami Health System.
Dipen J. Parekh, M.D., a robotic surgeon and
urologic oncologist at Sylvester, commented: “We are pleased to add
Ablatherm Robotic HIFU to our range of prostate ablation tools, as
it complements our existing strength in robotic surgery.” Parekh,
who is also professor and chair of the Department of Urology and
director of Robotic Surgery at the University of Miami Miller
School of Medicine adds, “With the recent FDA clearance of HIFU for
prostate tissue ablation, this is an exciting time for the urology
community and an opportunity to make a meaningful difference in the
lives of prostate cancer patients. This is a truly non-invasive
technique with the potential of significantly reduced side effects
related to surgery and radiation. We look forward to working with
EDAP to bring the system online and initiating patient
treatments.”
Marc Oczachowski, EDAP TMS Chief Executive
Officer, added: “We are excited to have Sylvester and the
University of Miami’s Department of Urology among the first
academic users of Ablatherm Robotic HIFU in the U.S. This sale is
extremely important in our U.S. expansion strategy, which is
focused on collaborating with leading academic and scientific
centers to further establish the technology and accelerate its
clinical recognition. We are honored to be working with such a
respected robotic surgeon, urologist and Gold Cystoscope winner as
Dr. Dipen Parekh and are looking forward to supporting him and his
team.”
About EDAP TMS SAEDAP 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 StatementsIn
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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