SAN DIEGO, May 21, 2013 (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") released 12-month data on a subset of patients enrolled in the RESTORE clinical trial. The RESTORE trial is evaluating the safety and performance of the first-generation ReZolve® sirolimus-eluting bioresorbable coronary scaffold, which was implanted in 22 patients between December 2011 and July 2012.
In an analysis of patients that completed 12-month angiographic follow-up to-date (8 of 22), imaging results demonstrated a mean in-stent late lumen loss ("late loss") of 0.20 mm. A finding of 0.20 mm means there was very little change in the lumen area between the time of treatment when blood flow was restored and the time of follow-up. Permanent drug-eluting stents have historically exhibited late loss values in the range of 0.20 mm to 0.40 mm, which has generally corresponded to positive long-term outcomes.
Commenting on the results, principal investigator Dr. Alexandre Abizaid, Director of Invasive Cardiology at the Instituto Dante Pazzanese de Cardiologia in Sao Paulo, Brazil, stated, "The 12-month late loss demonstrated to-date with the ReZolve scaffold is well within the range of safety and performance of drug-eluting metal stents and bioresorbable scaffolds that are used today. This preliminary analysis is very encouraging as it indicates that the ReZolve scaffold has the potential to successfully treat coronary artery disease, with the added benefit of resorbing from the body over time, allowing the artery to return to its natural function."
Since REVA's most recent report of clinical data, which included an analysis of all patients through a six-month follow-up, two additional patients were retreated for focal in-stent restenosis, or renarrowing of the artery at the implant site, and an additional patient died from unknown causes. "We learned a great deal from this initial trial," commented REVA's Chairman and CEO, Bob Stockman. "The low late lumen loss is a very positive indication of the effectiveness of the ReZolve product platform, and we remain very encouraged by this result. The adverse clinical events relating to restenosis occurred in patients that were enrolled in the early stages of the study; the learning from these early cases led to improved lesion preparation techniques for optimal bioresorbable scaffold placement, as well as design enhancements in REVA's commercial product, ReZolve2, which began clinical enrollment earlier this year."
ReZolve2 is a lower profile and sheathless version of the first-generation ReZolve scaffold that offers significantly improved deliverability and an approximate 30% increase in scaffold strength to provide increased support to significant coronary artery lesions before being resorbed by the body. REVA began implanting ReZolve2 in patients in March 2013. The initial three clinical sites enrolled eight patients during the first month of the study; enrollment with ReZolve2 will expand to approximately 30 clinical centers, including additional sites in Australia, Germany, and New Zealand. REVA expects to enroll 125 patients with ReZolve2 by September of this year to provide the data needed to apply for European CE Marking, which will allow for commercial sales in Europe and other countries that recognize the mark.
Physicians have been pleased with the improved deliverability of ReZolve2 and have successfully implanted the scaffold using both the traditional femoral and the increasingly common radial approach, which delivers the scaffold through an artery in the arm.
Prof. Dr. med. Norbert Frey, Chief of the Department of Cardiology at the University of Kiel in Germany, was the first physician in Germany to implant the ReZolve2 scaffold. "We have been pleased with the procedural outcomes in our first cases using the ReZolve2 scaffold. The improved deliverability has allowed us to expand the number of patients that are eligible to participate in the study and we look forward to enrolling additional patients with this newest bioresorbable scaffold."
At EuroPCR, REVA presented a scientific poster, REVA RESTORE Trial: Interim 12-Month Clinical Results of the ReZolve Bioresorbable Scaffold and ReZolve2 Clinical Program Update, which provided additional details regarding REVA's clinical trial results to date. A copy of the poster is available on REVA's website at www.revamedical.com.
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. 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 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.
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 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 9231 3322 Media Enquiries: Haley Price or Rebecca Wilson Buchan Consulting +61 3 9866 4722
Source:REVA Medical, Inc.