REVA Implants First Patients with Fantom Scaffold
San Diego, California (Wednesday, December 3, 2014, PST) – REVA Medical, Inc. (ASX: RVA) (“REVA” or the “Company”) is pleased to announce 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 coprincipal 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.
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.
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.
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