5/20/2014

Coronary Scaffold / REVA Medical, Inc.

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Coronary Artery Disease
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Coronary Scaffold
Information Center

The coronary arteries, which supply blood to the heart

muscle, are susceptible to the buildup of plaque, which
can block or inhibit blood flow, a condition known as
coronary artery disease (CAD). If the coronary arteries
become too narrow, cardiac tissue can become starved
of nutrients and oxygen, resulting in severe chest pain
known as angina. As artery narrowing becomes more
severe, death of cardiac muscle downstream from the
blockage can occur due to the lack of oxygen. The sudden
death of cardiac muscle can result in a myocardial

An accumulation of plaque in
arteries supplying blood to
the heart causes constriction
of blood flow.

infarction, commonly known as a heart attack.

Conventional Coronary Stents

Today stents, which are small, tube-like devices permanently implanted into an artery after
angioplasty, are commonly used to treat CAD. They provide patients with minimally invasive
and effective treatment, avoiding the need for patients to undergo invasive bypass procedures.
All permanent stents are made of metal and help stabilize diseased coronary arteries by
propping them open and restoring blood flow. When a metal stent is placed inside the vessel, it
serves as a permanent scaffold. Although rare, placement of a permanent metal stent can
result in long-term complications.

ReZolve2 Sirolimus-Eluting Bioresorbable Coronary Scaffold

The ReZolve2 scaffold integrates a proprietary drug-eluting polymer and a novel design to
create a temporary scaffold with metal-like performance out of a polymer material. The
scaffold restores blood flow and supports the artery through healing, then completely dissolves
from the body, leaving the patient free of a permanent implant.

The ReZolve2 Bioresorbable Coronary Scaffold restores, remodels and resorbs

REVAs Proprietary Polymer Composition

The ReZolve2 scaffold incorporates a proprietary
desaminotyrosine polycarbonate polymer, which
was developed specifically for bioresorbable
scaffold performance and provides adequate
strength both initially and over time. Unlike
permanent metal alloys, the REVA polymer
dissolves from the body after the artery has healed,
providing additional treatment options in the future.
http://www.teamreva.com/coronary-stent.shtml

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Coronary Scaffold / REVA Medical, Inc.

Another unique feature of the polymer is that it is visible under x-ray, allowing the entire scaffold
to be visualized during the implant procedure and at follow up. Other bioresorbable polymer
scaffolds are invisible and require permanently attached radiopaque markers to enable their
limited visibility.

Optimal Drug Delivery

ReZolve2 is a drug-eluting scaffold coated with sirolimus, a therapeutic agent that inhibits
restenosis, or renarrowing of the artery, which can occur in the area of scaffold implantation.
The drug delivered by the scaffold is chosen from the family of anti-restenotic pharmaceuticals
most preferred by physicians and industry experts. The abluminal surface of the scaffold is
coated using a polymer solution containing sirolimus. The polymer used for the coating is the
same polymer used in the scaffold structure. There is a controlled release of the drug over 30
days, with the majority of the drug released within 90 days. This early and slow release
characteristic may help with the healing process.

Clinical Program
The RESTORE Trial (Pilot Study of the ReZolve Sirolimus-Eluting Bioresorbable Coronary
Scaffold) is evaluating the safety and performance of the first-generation ReZolve scaffold in 26
patients that were enrolled between December 2011 and July 2012 at multiple centers in Brazil
and Europe. 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.
The ReZolve2 scaffold, a lower profile and sheathless version of the original ReZolve scaffold,
is being evaluated clinically in the RESTORE II Trial. Up to 125 patients will be enrolled in the
trial at multiple centers in Australia, Brazil, Europe and New Zealand to provide the data needed
to apply for European CE Marking. The CE Mark allows for commercial sales in Europe and
other countries that recognize the mark. Patient enrollments with ReZolve2 began in March
2013.

REVA Medical, Inc.

http://www.teamreva.com/coronary-stent.shtml

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