SAN DIEGO, Oct. 28, 2013 (GLOBE NEWSWIRE) -- REVA Medical, Inc. (ASX:RVA) ("REVA" or the "Company") announced initial clinical results from patients treated with its ReZolve2 sirolimus-eluting bioresorbable coronary scaffold at Transcatheter Therapeutics 2013 ("TCT"), the world's leading interventional cardiology conference, which is being held this week in San Francisco, California. The ReZolve2 trial is currently enrolling up to 125 patients at multiple centers in Australia, Brazil, Europe, and New Zealand to provide the data needed to apply for European CE Marking. Patient enrollment was initiated in March 2013 and is currently ongoing.
Reporting on the results was Dr. Ricardo Costa from the Institute Dante Pazzanese of Cardiology in Sao Paulo, Brazil, a leading enrollment center for the trial. "I am pleased to report that in the first 65 patients treated with ReZolve2 who have completed 30-day follow-up, there has been no reported Major Adverse Coronary Events (MACE), with no incidences of ischemic target revascularization (TLR), myocardial infarction (heart attack), or stent thrombosis. In this preliminary analysis, the scaffold is performing well and investigators in the trial continue to appreciate the complete visibility of ReZolve2 as well as the ability to expand the scaffold to the desired implant size with a single inflation." Dr. Costa also spoke about REVA's pipeline products. These include new and thinner bioresorbable scaffolds for coronary and peripheral applications that feature the x-ray visibility and distinctive product features of the ReZolve platform.
"These early results in patients treated with ReZolve2 represent an important step toward CE Marking and eventual commercialization of REVA's first commercial product," commented REVA's CEO, Bob Stockman. "We look forward to presenting 30-day data on the remaining patients enrolled in the trial as well as longer-term data at the Paris Course on Revascularization ("EuroPCR"), which will be held next May in Paris, France."
The presentation materials delivered at the conference are posted under the Investor Relations section of REVA's website at www.revamedical.com
Dr. Costa will present 12-month data on patients enrolled in the RESTORE clinical trial, which is a pilot study evaluating the safety and performance of the first generation ReZolve® sirolimus-eluting bioresorbable coronary scaffold, during TCT's bioresorbable oral abstract session on Tuesday, October 29, 2013 PDT.
REVA is a development stage medical device company incorporated in Delaware, USA, that is focused on the development and eventual commercialization of its proprietary bioresorbable stent products. The ReZolve® product family, which is in a clinical study phase, combines REVA's proprietary stent design with a proprietary polymer that is metabolized and cleared from the body. REVA's anticipated initial commercial product, the ReZolve2 scaffold, is designed to offer full x-ray visibility, clinically relevant sizing, and a controlled and safe resorption rate. In addition, by early encapsulation of the stent in the artery tissue coupled with the loss of scaffold structure over time, the ReZolve2 scaffold may reduce the incidence of late forming blood clots or otherwise reduce long-term disease progression, potential benefits of bioresorbable scaffolds that have yet to be proven. REVA will require clinical results and regulatory approval before it can begin selling the ReZolve2 scaffold.
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 the regulatory approvals required to market our ReZolveÒ scaffold, 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, which risks and uncertainties 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 February 29, 2013. 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.
CONTACT: United States Investor and Media Enquiries: Cheryl Liberatore Director, Investor Relations and Marketing REVA Medical, Inc. +1 858 966-3045 Australia Investor Enquiries: Kim Jacobs Inteq Limited +61 2 9229 2700 Media Enquiries: Haley Price or Rebecca Wilson Buchan Consulting +61 3 9866 4722
Source:REVA Medical, Inc.