EDAP Announces Sale of First Focal One(R) HIFU Device in North America
2015年3月31日 - 9:30PM
EDAP TMS SA (Nasdaq:EDAP), the global leader in therapeutic
ultrasound, today announced the first sale of Focal One HIFU device
to Jewish General Hospital, Montreal, Canada. This sale occurs only
two months after the Company gained Health Canada's approval to
market its Focal One HIFU device for focal treatment of prostate
cancer.
The Montreal Jewish General Hospital is one of the leading
institutions for the treatment of Prostate Cancer in the Eastern
part of Canada. The Department of Uro-Oncology at Montreal Jewish
General Hospital is headed by prominent urologist Franck Bladou,
MD, also Professor of Surgery and Oncology at the prestigious
McGill University.
Pr. Franck Bladou commented: "The concept of focal therapy for
prostate cancer is a very promising treatment and appears to be the
missing link between surveillance and robotic surgery for early
stage prostate cancer patients. Focal One, together with its
innovative MRI – ultrasound image fusing capabilities, is the only
device capable of ablating the cancerous tissue within the
prostate, using high-precision targeting, in a non-invasive way,
sparing the rest of the prostate, and therefore minimizing the risk
of side effect. The Jewish General Hospital is proud to be the
first clinical site in the Americas to offer this therapeutic
option to its patients."
Marc Oczachowski, EDAP's Chief Executive Officer, added, "We are
very pleased to achieve this first sale of Focal One in Canada only
two months after receiving marketing approval from Health Canada.
This is an important validation of our innovative device dedicated
to Focal therapy of prostate cancer from one of the leading
hospitals in the region. Importantly, it allows us to further
establish our HIFU technology in North America and offer this
non-invasive focal solution to a larger number of prostate cancer
patients in need."
Additionally, the Company announced that it plans to issue a
press release announcing its financial results for the fourth
quarter and twelve months ended December 31, 2014 on April 1, 2015
after the close of market. The Company previously announced that
the press release would be issued during pre-market hours on April
2, 2015. The conference call to discuss fourth quarter and
full-year 2014 results will take place as originally scheduled, at
8:30 a.m. ET on April 2, 2015. To participate in the call, please
dial 1-888-348-6419 in the U.S., or 1-412-902-4235 internationally.
The conference ID number is 10062222. A live webcast of the
conference call will be available on the investor relations page of
the Company's corporate website at www.edap-tms.com.
About EDAP TMS SA
EDAP TMS SA markets today Ablatherm® for high-intensity focused
ultrasound (HIFU) treatment of localized prostate cancer outside
the U.S. 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 for commercial
distribution in Europe and some other countries including Mexico
and Canada. EDAP TMS is currently pursuing a Direct De Novo 510(K)
petition in parallel of a PMA for Ablatherm 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 uncertainties of the U.S. FDA clearance 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-cleared or marketed in the United States.
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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