REVA Announces Dr. David Muller as Co-Principal Investigator for RESTORE II Clinical Trial
13 September 2012 - 11:25AM
REVA Medical, Inc. (ASX:RVA) ("REVA" or the "Company") is pleased
to announce the appointment of Dr. David Muller, Director, Cardiac
Catheterization at St. Vincent's Hospital, Sydney, as co-principal
investigator for the Company's upcoming RESTORE II clinical trial,
which is expected to begin enrolling patients in the first quarter
of 2013. Dr. Alexandre Abizaid of Dante Pazzanese Institute of
Cardiology, who successfully led REVA's initial RESTORE pilot
study, will continue as a co-principal investigator with Dr. Muller
for the RESTORE II trial.
Dr. Muller is a renowned interventional cardiologist and leads
the stenting efforts at one of Australia's largest and most
prestigious centers. "I am most pleased to join an excellent
group of physician colleagues to evaluate the performance of REVA's
unique ReZolve2 drug-eluting bioresorbable scaffold," commented Dr.
Muller. "I am honored to join Dr. Abizaid as Co-PI in
overseeing REVA's expanding trial efforts in numerous countries
around the world."
Commented Chairman and CEO Robert Stockman, "We are so pleased
to add Dr. Muller to the roster of exceptional clinicians who have
helped us pioneer the development of our unique product. We
have looked forward to Australia's participation as a leading
center of clinical trial excellence for REVA and with Dr. Muller at
Australia's helm we couldn't be in better hands."
The RESTORE II trial is a multicenter safety and performance
study of REVA's ReZolve2 sirolimus-eluting bioresorbable coronary
scaffold that will enroll 125 patients at up to 30 clinical centers
in Australia, Austria, Brazil, Germany, New Zealand and
Poland. Data gathered from the RESTORE II trial will be used
as the basis to support CE mark application of the ReZolve2
scaffold.
Forward Looking Statements
This announcement contains or may contain forward-looking
statements that are based on management's beliefs, assumptions and
expectations and on information currently available to management.
All statements that are not historical, including those statements
that address future operating performance and events or
developments that we expect or anticipate will occur in the future,
are forward-looking statements. You should not place undue reliance
on these forward-looking statements. Although management believes
these forward-looking statements are reasonable as and when made,
forward-looking statements are subject to a number of risks and
uncertainties that may cause our actual results to vary materially
from those expressed in the forward-looking statements, including
our ability to obtain the regulatory approvals required to market
our ReZolveĀ® scaffold, our ability to timely and successfully
complete our clinical trials, our ability to protect our
intellectual property position, our ability to commercialize our
products if and when approved, our ability to develop and
commercialize new products, and our estimates regarding our capital
requirements and financial performance, including profitability.
Other risks and uncertainties that may cause our actual results to
vary materially from any forward-looking statements are described
in the "Risk Factors" section of our Annual Report on Form 10-K
filed with the United States Securities and Exchange Commission
(the "SEC") on February 28, 2012, as updated in our Quarterly
Report on Form 10-Q filed with the SEC for the periods ended March
31, 2012 and June 30, 2012. We may update our risk factors from
time to time in our periodic reports or other current reports filed
with the SEC. Any forward-looking statements in this announcement
speak only as of the date when made. REVA does not assume any
obligation to publicly update or revise any forward-looking
statements, whether as a result of new information, future events,
or otherwise.
About REVA
REVA is a development stage medical device company incorporated
in Delaware, USA, that is focused on the development and eventual
commercialization of its proprietary, bioresorbable stent products.
REVA's initial product, the ReZolveĀ® scaffold, which is in a
clinical study phase, combines REVA's proprietary stent design with
a proprietary polymer that is metabolized and cleared from the
body. The ReZolve scaffold is designed to offer full x-ray
visibility, clinically relevant sizing and a controlled and safe
resorption rate. In addition, by early encapsulation of the stent
in the artery tissue coupled with the loss of scaffold structure
over time, the ReZolve scaffold may reduce the incidence of late
forming blood clots, or thrombosis, a rare but serious problem
associated with drug-eluting metal stents currently on the market.
REVA will require clinical results and regulatory approval before
it can begin selling the ReZolve scaffold.
The REVA Medical, Inc. logo is available at
http://www.globenewswire.com/newsroom/prs/?pkgid=8505
CONTACT: United States
Investor and Media Enquiries:
Cheryl Liberatore
Director, Investor Relations and Marketing
REVA Medical, Inc.
+1 858 966-3045
Australia
Investor Enquiries:
Kim Jacobs or Alan Taylor
Inteq Limited
+61 2 9231 3322
Media Enquiries:
Katie Mackenzie or Rebecca Wilson
Buchan Consulting
+61 3 9866 4722
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