Initial Clinical Enrollment of ReZolve is Completed
July 12 2012 - 8:47PM
REVA Medical, Inc. (ASX:RVA) ("REVA" or the "Company") announced
today that it has completed clinical enrollment with the ReZolve®
drug-eluting bioresorbable scaffold. A total of 26 patients have
been enrolled and there are no major adverse coronary events
("MACE") reported to date. The first patient in the study was
enrolled in December 2011. REVA plans to provide an update on data
from these patients at the Transcatheter Cardiovascular
Therapeutics (TCT) 2012 Conference, which will be held in October
in Miami, Florida.
The Company anticipates resumption of clinical trials in the
fourth quarter of 2012, when patients will be treated with REVA's
lower profile (6Fr guide compatible) ReZolve2 scaffold. ReZolve2
will be evaluated at up to 25 clinical study sites in Brazil,
Europe, Australia and New Zealand.
Principal Investigator Dr. Alexandre Abizaid of the Dante
Pazzanese Instituto de Cardiologie in Sao Paulo, Brazil commented,
"We are very pleased to have implanted the current ReZolve scaffold
in patients with no reported MACE to date, and are eager to resume
clinical trials with the ReZolve2 scaffold later this year."
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 principal product, the ReZolve®2 scaffold, combines REVA's
proprietary stent design with a proprietary polymer that is
metabolized and cleared from the body. The ReZolve2 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 ReZolve2 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 ReZolve2
scaffold.
The REVA Medical, Inc. logo is available at
http://www.globenewswire.com/newsroom/prs/?pkgid=8505
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 ReZolve2 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 period ended March
31, 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.
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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