SAN DIEGO, Sept. 30, 2015 (GLOBE NEWSWIRE) -- REVA Medical, Inc. (ASX:RVA) is pleased to announce that it has enrolled the first cohort of 110 patients in the FANTOM II clinical trial. Achievement of this milestone is key to the Company’s planned CE Mark application of its Fantom® sirolimus-eluting bioresorbable scaffold. The CE Mark application, planned for mid-2016, will be based upon data from these patients through the six-month time point.
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, thus allowing the vessel to reestablish its ability to move naturally.
Didier Carrié, MD, PhD and Bernard De Bruyne, MD, PhD, two leading investigators from the trial commented on their experience using the Fantom scaffold. Dr. Carrié, from the Service de Cardiologie, CHU Toulouse Rangueil in France, commented, “I have been very pleased with how easy Fantom is to implant. The delivery to the target lesion has been successful in our cases and the single-step inflation reduces the overall procedure time.” Dr. De Bruyne, from the Cardiovascular Center Aalst in Belgium further stated, “The ability to visualize the scaffold under x-ray sets Fantom apart from other bioresorbable scaffolds. This unique feature will make it easier for physicians to incorporate bioresorbable scaffold use into their practice.”
“Enrollment of these 110 patients represents a significant accomplishment for the Company,” commented Reggie Groves, REVA’s Chief Executive Officer. “It moves us one step closer to our goal of commercializing Fantom, which we believe offers the performance and ease-of-use features that will enable physicians to provide the best possible care for their patients.”
An update on the FANTOM clinical trial program will be presented at the Transcatheter Cardiovascular Therapeutics (“TCT”) Conference, which will be held October 11th through 15th in San Francisco, California.
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.