REVA Medical, Inc. (ASX:RVA) ("REVA" or the "Company") announced today that it has completed clinical enrollment with the ReZolve® drug-eluting bioresorbable scaffold. A total of 26 patients have been enrolled and there are no major adverse coronary events ("MACE") reported to date. The first patient in the study was enrolled in December 2011. REVA plans to provide an update on data from these patients at the Transcatheter Cardiovascular Therapeutics (TCT) 2012 Conference, which will be held in October in Miami, Florida.

The Company anticipates resumption of clinical trials in the fourth quarter of 2012, when patients will be treated with REVA's lower profile (6Fr guide compatible) ReZolve2 scaffold. ReZolve2 will be evaluated at up to 25 clinical study sites in Brazil, Europe, Australia and New Zealand.

Principal Investigator Dr. Alexandre Abizaid of the Dante Pazzanese Instituto de Cardiologie in Sao Paulo, Brazil commented, "We are very pleased to have implanted the current ReZolve scaffold in patients with no reported MACE to date, and are eager to resume clinical trials with the ReZolve2 scaffold later this year."  

About REVA

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 principal product, the ReZolve®2 scaffold, combines REVA's proprietary stent design with a proprietary polymer that is metabolized and cleared from the body. 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 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 ReZolve2 scaffold.  

The REVA Medical, Inc. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=8505

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 ReZolve2 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 period ended March 31, 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:
         Katie Mackenzie or Rebecca Wilson
         Buchan Consulting
         +61 3 9866 4722
Reva Medical (ASX:RVA)
Historical Stock Chart
From Mar 2024 to Apr 2024 Click Here for more Reva Medical Charts.
Reva Medical (ASX:RVA)
Historical Stock Chart
From Apr 2023 to Apr 2024 Click Here for more Reva Medical Charts.