Early Follow-Up Imaging Assessment of ReZolve(R) Scaffold
SAN DIEGO, Oct. 24, 2012 (GLOBE NEWSWIRE) -- REVA Medical, Inc. (ASX:RVA) ("REVA" or the "Company") announces that the first follow-up imaging assessment of the ReZolve® scaffold was presented during a live case session at the Transcatheter Therapeutics Conference being held this week in Miami, Florida. The images included angiography, intravascular ultrasound (IVUS), and optical coherence tomography (OCT) and were presented by Dr. Alexandre Abizaid, the Company's principal investigator for the RESTORE clinical trial, from the Dante Pazzanese Institute de Cardiologie, located in Sao Paulo, Brazil.
The angiography, IVUS, and OCT images revealed excellent scaffold apposition and a widely patent vessel. The unique radiopacity of the scaffold enabled it to be fully visible under all three imaging modalities.
"This early follow-up confirms our confidence that the ReZolve scaffold is performing well in our patients," commented REVA's CEO, Bob Stockman. "We look forward to additional imaging assessments scheduled to begin later this year."
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.