SAN DIEGO, Jan. 13, 2014 (GLOBE NEWSWIRE) -- REVA Medical, Inc. (ASX:RVA) ("REVA" or the "Company") is pleased to announce that it has completed enrollment in the clinical trial of the ReZolve2 drug-eluting bioresorbable scaffold. A total of 112 patients have been enrolled in the trial to provide the data needed to apply for European CE Marking. The Company anticipates that it will file the CE Mark application before the end of 2014, as previously announced.
Commenting on the conclusion of enrollment, REVA's SVP of Clinical and Regulatory Affairs, Jeff Anderson stated, "Patient enrollment of the ReZolve2 scaffold at clinical sites on three continents went smoothly and represents an important milestone for the Company. We are encouraged by the positive early clinical data reported previously from this trial and look forward to providing an update on data from these patients at the Paris Course on Revascularization (EuroPCR), which will be held in May in Paris, France."
The Company is also pleased to announce that its Chairman and CEO, Bob Stockman, is scheduled to present at the 32nd Annual J.P. Morgan Healthcare Conference at 12:30 p.m. US PST on Thursday, January 16, 2014. The conference is being held January 13 through 16 at The Westin St. Francis Hotel in San Francisco, California. The presentation materials will be available in the Investor Relations section of REVA's website at www.revamedical.com on the day of the presentation.
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 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. 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 27, 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.