SAN DIEGO, Feb. 23, 2015 (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 regarding the Company's bioresorbable scaffold program today at the Cardiovascular Research Technologies (CRT) 2015 conference. The conference is being held through February 24 th at the Omni Shoreham Hotel in Washington, DC.
Dr. Abizaid is co-principal investigator for the Company's FANTOM clinical trial program. The Fantom™ bioresorbable scaffold utilizes REVA's advanced proprietary polymer that allows for thinner strut thickness and enhanced deliverability, while maintaining its unique ease-of-use properties including complete visibility under x-ray, expansion of the scaffold with one continuous inflation, no procedural time limitations, and standard storage and handling.
The FANTOM I clinical trial, which began enrolling patients with Fantom in December 2014, is being conducted at two clinical sites in Brazil and Poland to provide early clinical data on the device. In patients implanted to-date, the acute performance of the scaffold has been demonstrated, verifying the Company's readiness to initiate a CE trial. The CE trial, named FANTOM II, is planned to begin enrollment this quarter. FANTOM II will enroll a minimum of 110 patients at multiple clinical sites in eight countries. The data from this trial is intended to be used in a CE mark application in mid-2016.
Dr. Abizaid also presented previously released information at the conference regarding the Company's transition from its earlier generation scaffold ReZolve2 to the current Fantom scaffold.
The presentation materials delivered at the conference are posted under the Investor Relations section of REVA's website at www.revamedical.com . A copy of these materials has also been lodged with the Australian Securities Exchange and will be filed with the U.S. Securities and Exchange Commission.
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 Fantom TM 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.
United States Investor & Media Enquiries: REVA Medical, Inc. Cheryl Liberatore Director, Investor Relations +1 858-966-3045 Australia Investor Enquiries: Inteq Limited Kim Jacobs +61 2 9229 2700 Australia Media Enquiries: Buchan Consulting Rebecca Wilson +61 3 9866 4722 Annabel Murphy +61 2 9237 2800
