REVA Medical, Inc. (ASX:RVA) ("REVA" or the "Company") declared it has initiated patient enrollment with its Fantom™ bioresorbable drug-eluting scaffold.
The first patient implants were performed by Dr. Alexandre Abizaid,
Director of Invasive Cardiology at Institute Dante Pazzanese of
Cardiology in Sao Paulo, Brazil. Dr. Abizaid is co-principal
investigator for the Fantom clinical trial program.
Jeff Anderson, REVA's Senior Vice President of Clinical and Regulatory
Affairs, as in previous clinical studies, was present for the implants.
"During these first procedures, the unique features of the Fantom
scaffold were evident," stated Mr. Anderson. "The scaffold was easily
delivered and the procedure was aided by the visibility of the scaffold
under x-ray, a feature that we believe provides physicians with a
valuable tool for confirming proper placement during implant."
"The initiation of our Fantom clinical program as set forth in
our recent communications is an important and valuable milestone for the
Company," further commented REVA's Chairman and Chief Executive
Officer, Bob Stockman.
Fantom is a fully bioresorbable sirolimus-eluting coronary
scaffold that is designed to dissolve over time, leaving the artery free
of a permanent implant and thereby allowing the artery to return to its
natural movement, or "vasomotion." Fantom is made from REVA's
proprietary polymer that was developed specifically for scaffold
performance. The unique properties of REVA's polymer provide for
excellent scaffold strength in a thin-strut design, ease-of-use features
like single-step inflation, and complete visibility of the scaffold
under x-ray, an attribute unique to REVA among bioresorbable scaffolds.
About REVA
REVA is a development stage medical device company located in San
Diego, California, USA, that is focused on the development, testing, and
eventual commercialization of its proprietary bioresorbable stents,
which are called "scaffolds" because of their temporary nature. The
Company's scaffolds are currently in clinical studies and have been
developed as an alternative to metal stents, which are small tube-like
devices permanently implanted into an artery to treat coronary artery
disease. Scaffolds provide restoration of blood flow, support the artery
through the healing process, then disappear (or "resorb") from the body
over a period of time. This resorption allows the return of natural
movement and function of the artery, a result not attainable with
permanent metal stents. The Company's initial intended commercial
product, the FantomTM scaffold, has been designed to
offer distinct ease-of-use features including complete scaffold
visibility under x-ray, expansion with one continuous inflation, and no
procedural time limitations. REVA will require successful clinical trial
results and regulatory approval before it can commercialize Fantom or any other products.
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 statements of historical fact, 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, such as those statements regarding our
ability to obtain regulatory approvals, timely and successfully complete
our clinical trials, protect our intellectual property position,
commercialize our products if and when approved, develop and
commercialize new products, and estimates regarding our capital
requirements and financial performance, including profitability. 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 the risks and uncertainties that 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 March 17,
2014, and as updated in our periodic reports since then. 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.
Wednesday, 3 December 2014
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