SAN DIEGO, Oct. 23, 2012 (GLOBE NEWSWIRE) -- REVA Medical, Inc. (ASX:RVA) ("REVA" or the "Company") is pleased to announce that a clinical update on patients from its RESTORE pilot study is being presented at the Transcatheter Therapeutics Conference, the world's largest interventional cardiology meeting, which is being held this week in Miami, Florida. Reporting on the results is Dr. Ricardo Costa from the Dante Pazzanese Institute de Cardiologie, a leading enrollment center for the trial located in Sao Paulo, Brazil.
A total of 22 patients were implanted with the Company's ReZolve® scaffold at six hospitals in four countries. The first patient treated is 10 months post-implant and remains event free. To date, there have been no reported blood clots (thrombosis), no reported incidences of myocardial infarction (heart attack), and a low rate of major adverse coronary events.
"We continue to be encouraged with the results in the RESTORE pilot study," commented REVA's CEO, Bob Stockman. "One-year results on a subset of patients, which will include angiographic follow-up to evaluate the performance of the scaffold, will be announced at the EuroPCR conference to be held next May in Paris, France."
The presentation materials delivered at the conference are posted on REVA's website at www.revamedical.com.
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. REVA's initial product, the ReZolve® scaffold, 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. The ReZolve 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 ReZolve scaffold may reduce the incidence of late forming blood clots, or thrombosis, a rare but serious problem associated with drug-eluting metal stents currently on the market. REVA will require clinical results and regulatory approval before it can begin selling the ReZolve scaffold.
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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 historical, 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. 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 our ability to obtain the regulatory approvals required to market our ReZolve® 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. Other risks and uncertainties that may cause our actual results to vary materially from any forward-looking statements 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 28, 2012, as updated in our Quarterly Report on Form 10-Q filed with the SEC for the periods ended March 31, 2012 and June 30, 2012. We may update our risk factors from time to time in our periodic reports or other current reports filed with the SEC. 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 or Alan Taylor Inteq Limited +61 2 9231 3322 Media Enquiries: Haley Price or Rebecca Wilson Buchan Consulting +61 3 9866 4722
Source:REVA Medical, Inc.