Early Follow-Up Imaging Assessment of ReZolve(R) Scaffold
25 October 2012 - 9:33AM
REVA Medical, Inc. (ASX:RVA) ("REVA" or the "Company") announces
that the first follow-up imaging assessment of the ReZolve®
scaffold was presented during a live case session at the
Transcatheter Therapeutics Conference being held this week in
Miami, Florida. The images included angiography, intravascular
ultrasound (IVUS), and optical coherence tomography (OCT) and were
presented by Dr. Alexandre Abizaid, the Company's principal
investigator for the RESTORE clinical trial, from the Dante
Pazzanese Institute de Cardiologie, located in Sao Paulo, Brazil.
The angiography, IVUS, and OCT images revealed excellent
scaffold apposition and a widely patent vessel. The unique
radiopacity of the scaffold enabled it to be fully visible under
all three imaging modalities.
"This early follow-up confirms our confidence that the ReZolve
scaffold is performing well in our patients," commented REVA's CEO,
Bob Stockman. "We look forward to additional imaging assessments
scheduled to begin 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 initial product, the ReZolve® 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
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 ReZolve® 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.
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:
Haley Price or Rebecca Wilson
Buchan Consulting
+61 3 9866 4722
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