SAN DIEGO, April 22, 2015 (GLOBE NEWSWIRE) -- REVA Medical, Inc. (ASX:RVA) (“REVA” or the “Company”) is pleased to announce that the FANTOM II clinical trial, which began enrolling patients with the Fantom™ sirolimus-eluting bioresorbable scaffold in March in Brazil, is now enrolling patients in Europe. 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 first patient implant in Europe was performed by Dr. Jens Flensted Lassen from Rigshospitalet, University of Copenhagen, Denmark. “I was impressed with the ease of delivery of Fantom to the lesion site, and further appreciated the ability to clearly visualize the complete scaffold during the procedure,” stated Dr. Lassen. “Fantom was simple to implant and the angiographic result was excellent. I look forward to playing a significant role in treating patients’ coronary artery disease with the Fantom scaffold.”
Commenting on behalf of REVA, Bob Stockman, Chairman and Chief Executive Officer, stated, “We are most appreciative to Dr. Lassen for his support in commencing the clinical evaluation of Fantom in Europe. We look forward to presenting initial data from the Fantom clinical trial program at EuroPCR.”
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, 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. 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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