San Diego, California and Sydney, Australia (Thursday 22 December 2011, AEDT) – REVA
Medical, Inc. (ASX: RVA) (“REVA” or the “Company”) is pleased to announce that it has
initiated patient enrollment in a pilot clinical study designed to evaluate its ReZolve™
Bioresorbable Sirolimus-Eluting Coronary Scaffold. The RESTORE Trial (Pilot Study of the
ReZolve Sirolimus-Eluting Bioresorbable Coronary Scaffold) will evaluate the safety and
performance of ReZolve in 50 patients at multiple leading heart centers in Brazil and Europe.
ReZolve is a fully bioresorbable polymer scaffold designed to provide all of the proven benefits
of a metal drug-eluting stent, with the advantage of dissolving from the body after it is no longer
needed, leaving the patient free of a permanent implant.
The first patient implant was performed by the study’s principal investigator, Dr. Alexandre
Abizaid, Chief of Coronary Interventions at the Instituto Dante Pazzanese de Cardiologia in Sao
Paulo, Brazil. Dr. Abizaid is a renowned interventional cardiologist and the institute is one of the
world’s leading heart centers.
“The procedure went very smoothly in a 90% occluded coronary artery utilizing standard
practices that are used to implant conventional metallic stents around the world today. The REVA
fully bioresorbable polymer scaffold deployed and became well-apposed against the artery wall
and we were able to visualize the entire scaffold under standard x-ray imaging, which was very
helpful,” commented Dr. Abizaid. “While we will need to continue to gather data over the
coming year to measure the safety and efficacy of this device, I was pleased with the outcome of
today’s procedure; the ReZolve scaffold delivered and deployed as designed.” Dr. Abizaid also
added, “bioresorbable scaffolds represent an exciting new frontier to the treatment of coronary
artery disease due to their potential to return the vessel to normal function after restoring blood
flow. I am excited about the potential clinical benefits ReZolve may provide our patients and my
team looks forward to enrolling additional patients in the RESTORE trial.”
Commenting on the initiation of the study, REVA’s Chairman and CEO, Bob Stockman said,
“The start of our clinical trial, after months of deliberate technology refinement, is the most
important event in our company’s history. Today culminates the hard work of our very dedicated
team at REVA over a number of years. REVA now joins other pioneering companies who have
advanced the treatment of coronary artery disease. We are especially grateful to be associated with Dr. Abizaid and his expert team, and we are most excited to join Dr. Abizaid in the evaluation of this novel and highly anticipated technology.”
Data from the RESTORE trial will become available throughout 2012. Assuming acceptable
results from this trial, REVA will initiate a larger scale clinical trial that will provide the data
needed to apply for CE Mark approval in Europe.
About the RESTORE Trial
The RESTORE trial is a prospective, multi-center study designed to evaluate the safety and performance of the
ReZolve™ scaffold in 50 patients at multiple centers in Brazil and Europe. The treatable population consists of
patients with symptomatic coronary artery disease due to one or more discrete areas of blockage. The study’s
primary endpoint is freedom from symptomatic target lesion revascularization (retreatment) at a six-month clinical
evaluation. This will be followed by imaging of the stented area at twelve months to measure various quantitative
parameters such as Late Loss and Restenosis Rate. Patients will be followed for five years, evaluating overall MACE
(Major Adverse Coronary Events) including myocardial infarction (heart attack) and death.
REVA is a development stage medical device company incorporated in Delaware, USA, that is focused on the
development and eventual commercialisation of its proprietary, bioresorbable stent products. REVA’s lead product,
the ReZolve™ scaffold, combines REVA’s proprietary scaffold design with a proprietary polymer that is metabolised
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.
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 30 March 2011, as updated in our Quarterly Reports on Form 10-Q filed with the SEC for the periods
ended 31 March 2011, 30 June 2011 and 30 September 2011. 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.
Investor and Media Enquiries:
Director, Investor Relations and Marketing
REVA Medical, Inc.
+1 858 966-3045
David Allen or Alan Taylor
+61 2 9231 3322
Katie Mackenzie or Rebecca Wilson
+61 3 9866 4722