SAN DIEGO, Oct. 15, 2015 (GLOBE NEWSWIRE) -- REVA Medical, Inc. (ASX:RVA) (“REVA” or the “Company”) is pleased to announce that Dr. J. Ribamar Costa from the Institute Dante Pazzanese of Cardiology, in Sao Paulo, Brazil, presented results from REVA’s clinical trial program for its Fantom® sirolimus-eluting bioresorbable scaffold at the Transcatheter Cardiovascular Therapeutics (“TCT”) Conference, which is being held October 11th through 15th in San Francisco, California.
Dr. Costa presented data from both the FANTOM I pilot study and the FANTOM II CE Mark clinical trial during the Bioresorbable Vascular Scaffolds, Part 2 session, which was held on Thursday, October 15th.
The FANTOM I pilot study enrolled seven patients, all of whom have now completed their follow-up evaluations through the six-month time point, including the primary imaging assessment at four months. The FANTOM II CE Mark clinical trial has completed enrollment of 110 patients who will have their primary follow-up evaluations during the next six months. Results released on both sets of patients showed excellent acute procedural outcomes and safety results for Fantom. Additionally, the initial results confirm sustained restoration of blood flow and very low reported Major Adverse Cardiac Events (“MACE”) to date.
Data from the FANTOM II six-month primary endpoint is scheduled to be presented at EuroPCR, which will be held next May in Paris, France. This data will be the basis of REVA’s CE Mark application, which is planned for mid-2016.
The presentation materials delivered at the Bioresorbable Vascular Scaffolds session are available in the Investor Relations section of REVA’s website at www.revamedical.com and are being filed with the Australian Securities Exchange and the U.S. Securities and Exchange Commission.
About REVA
REVA is a clinical stage medical device company located in San Diego, California, USA, that is working to commercialize its proprietary bioresorbable stents, which are called “scaffolds” because of their temporary nature. The Company’s scaffolds 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 product, the Fantom® 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. You should not place undue reliance on forward-looking statements. Although management believes 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 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 US 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.
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Australia
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