Presentation of Interim Clinical Results at TCT Conference
24 October 2012 - 8:45AM
REVA Medical, Inc. (ASX:RVA) ("REVA" or the "Company") is pleased
to announce that a clinical update on patients from its RESTORE
pilot study is being presented at the Transcatheter Therapeutics
Conference, the world's largest interventional cardiology meeting,
which is being held this week in Miami, Florida. Reporting on the
results is Dr. Ricardo Costa from the Dante Pazzanese Institute de
Cardiologie, a leading enrollment center for the trial located in
Sao Paulo, Brazil.
A total of 22 patients were implanted with the Company's
ReZolveĀ® scaffold at six hospitals in four countries. The first
patient treated is 10 months post-implant and remains event free.
To date, there have been no reported blood clots (thrombosis), no
reported incidences of myocardial infarction (heart attack), and a
low rate of major adverse coronary events.
"We continue to be encouraged with the results in the RESTORE
pilot study," commented REVA's CEO, Bob Stockman. "One-year results
on a subset of patients, which will include angiographic follow-up
to evaluate the performance of the scaffold, will be announced at
the EuroPCR conference to be held next May in Paris, France."
The presentation materials delivered at the conference are
posted on REVA's website at www.revamedical.com.
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
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.
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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