SAN DIEGO, May 14, 2015 (GLOBE NEWSWIRE) -- REVA Medical, Inc. (ASX:RVA) (“REVA” or the “Company”) is pleased to announce that the FANTOM II clinical trial is now enrolling patients with the Fantom™ sirolimus-eluting bioresorbable scaffold in Australia. This is in addition to previously announced sites in Brazil and Europe. The first patient implant in Australia was performed by Dr. David Muller, Director, Cardiac Catheterization at St. Vincent’s Hospital, Sydney.
“As an ASX-listed Company, we are very excited to begin patient enrollment in Australia,” commented Bob Stockman, REVA’s Chairman and Chief Executive Officer. “We expect Australia to play an important role in the Fantom clinical trial program.”
The Fantom scaffold, made from REVA’s advanced proprietary polymer, is designed to allow the restoration of blood flow in patients being treated for coronary artery disease, then resorb from the body over time.
The FANTOM II trial is enrolling patients to support a European CE Mark application, which is expected to occur by mid-2016.
About REVA
REVA is a development stage medical device company located in San Diego, California, USA, that is focused on the development, testing, and eventual commercialization of its proprietary bioresorbable stents, which are called “scaffolds” because of their temporary nature. The Company’s scaffolds are currently in clinical studies and have been developed as an alternative to metal stents, which are small tube-like devices permanently implanted into an artery to treat coronary artery disease. Scaffolds provide restoration of blood flow, support the artery through the healing process, then disappear (or “resorb”) from the body over a period of time. This resorption allows the return of natural movement and function of the artery, a result not attainable with permanent metal stents. The Company’s initial intended commercial product, the FantomTM scaffold, has been designed to offer an ideal balance of thinness and strength, and distinct ease-of-use features including complete scaffold visibility under x-ray, expansion with one continuous inflation, and no procedural time limitations. REVA will require successful clinical trial results and regulatory approval before it can commercialize Fantom or any other products.
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 regulatory approvals, timely and successfully complete our clinical trials, protect our intellectual property position, commercialize our products if and when approved, develop and commercialize new products, recruit and retain our key personnel, and 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, including the risks and uncertainties that 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 March 30, 2015, and as may be updated in our periodic reports thereafter. 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 & Media Enquiries: REVA Medical, Inc. Cheryl Liberatore Director, Communications +1 858-966-3045 Australia Investor Enquiries: Inteq Limited Kim Jacobs +61 2 9229 2700 Australia Media Enquiries: Buchan Consulting Rebecca Wilson +61 3 9866 4722 Annabel Murphy +61 2 9237 2800
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