SAN DIEGO, May 22, 2014 (GLOBE NEWSWIRE) -- At the Paris Course on Revascularization ("EuroPCR") being held this week in Paris, France, REVA Medical, Inc. (ASX:RVA) ("REVA" or the "Company") sponsored a symposium entitled, Advancing Bioresorbable Scaffolds through Innovative Biomaterials, where information regarding the Company's proprietary technology and bioresorbable scaffold programs was presented. The symposium was chaired by Dr. Alexandre Abizaid, Director of Invasive Cardiology at Institute Dante Pazzanese of Cardiology, in Sao Paulo, Brazil, and featured three separate presentations.
Marian Rippy, MS, DVM, PhD, of Rippy Pathology Solutions in Woodbury, Minnesota, presented data regarding vascular healing following implantation of bioresorbable scaffolds made from REVA's propriety polymer family. REVA's bioresorbable scaffolds are made from a unique radiopaque polycarbonate polymer family that has demonstrated excellent biocompatibility, benign tissue response, and safe resorption through full degradation. These materials form the foundation for REVA's advanced bioresorbable scaffold, Fantom™.
The Fantom sirolimus-eluting bioresorbable scaffold is designed to meet physician's expectations for an advanced bioresorbable scaffold; including full visibility under x-ray, excellent deliverability, expansion with one smooth and continuous inflation, with no procedural time limits or special storage requirements. Dr. Alexandre Abizaid presented information regarding REVA's high-performance biomaterials that enable these advances in scaffold performance. The first patient implants of the Fantom scaffold are planned for Q4 2014.
At the symposium Dr. David Muller, Director, Cardiac Catheterization at St. Vincent's Hospital, Sydney, and co-principal investigator for the Company's RESTORE II clinical trial, also presented acute performance data and an interim major adverse cardiac event ("MACE") rate of 5.6% through six-months in patients implanted with the ReZolve2 bioresorbable scaffold. As previously announced the Company will follow all patients in the RESTORE trials through the planned five-year time point. Insights gained from ReZolve2 clinical evaluations have been incorporated into the Fantom scaffold program.
The presentation materials delivered at the symposium are available in 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, which are also called "scaffolds." The Company's technologies combine its stent designs with its proprietary polymer; these products are designed to offer full x-ray visibility, clinically relevant sizing, and a controlled and safe resorption rate. The Company has several products in clinical study phase. A total of 112 patients were enrolled in its most recent 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. REVA will require successful clinical results and regulatory approval before it can commercialize any of its 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.