SAN DIEGO, Sept. 16, 2014 (GLOBE NEWSWIRE) -- REVA Medical, Inc. (ASX:RVA) ("REVA" or the "Company") is pleased to announce that Dr. Alexandre Abizaid, Director of Invasive Cardiology at Institute Dante Pazzanese of Cardiology, in Sao Paulo, Brazil, presented information today on the Company's Fantom™ bioresorbable scaffold program at the Transcatheter Cardiovascular Therapeutics ("TCT") Conference, which is being held September 13th through 17th in Washington, DC.
Bioresorbable scaffolds ("BRS") have emerged as a new medical device class that provides an alternative to metal stents, which are small, tube-like devices permanently implanted into an artery to treat coronary artery disease. BRS are designed to provide the same benefits as permanent stents by allowing restoration of blood flow and supporting the artery through the healing process. However, they disappear from the body over a period of time once the artery heals, allowing the return of natural movement and function of the artery, a result not attainable with permanent metal stents.
The clinical community is awaiting the arrival of REVA's Fantom BRS due to its distinct ease-of-use features – complete scaffold visibility under x-ray, expansion of the scaffold with one continuous inflation, no procedural time limitations, and standard storage and handling – all of which will allow clinical cases to proceed with increased efficiency and confidence. First patient implants of Fantom are planned for late this year.
The presentation materials delivered at the conference are posted under the Investor Relations section of REVA's website at www.revamedical.com.
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 stent products, also called "scaffolds." Utilizing its stent designs and proprietary polymers, the Company designs its scaffolds to offer full x-ray visibility, clinically relevant sizing, and a controlled and safe resorption rate. The Company has conducted clinical studies of its scaffold technologies and its next generation scaffold FantomTM is in the development and testing phase. A total of 112 patients were enrolled in its most recent clinical trial in Australia, Brazil, Europe, and New Zealand; they will be followed for a total of five years, with primary data to be obtained at nine and 12 months. First human implants of Fantom are planned for late 2014 at multiple centers in Brazil and Europe. REVA will require successful clinical results and regulatory approval before it can commercialize Fantom or any of its 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 raise financing to fund our operations on terms favorable to us or at all, our ability to obtain the regulatory approvals, 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. 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. 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.