REVA to Expand FANTOM II Trial to More Complex Cases
Fantom bioresorbable scaffold to be evaluated in patients with long lesions and multi-vessel disease
San Diego, California (Thursday, March 23, 2017, PDT) – REVA Medical, Inc. (ASX: RVA) (“REVA” or the “Company”) is pleased to announce that it has been granted approval to conduct an expanded clinical trial for its Fantom bioresorbable scaffold in Germany. 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 (“CAD”), then resorb from the body over time.
The recent approval allows REVA to expand the scope of the FANTOM II clinical trial, which successfully enrolled 240 patients between March 2015 and March 2016. The primary objective of the expanded study is to evaluate the safety and effectiveness of Fantom in a more complex patient population, treating up to two lesions in one or more coronary arteries and lesions in excess of 20mm in length.
"The clinical results we’ve seen in our first 240 patients treated with Fantom have been excellent,” commented Reggie Groves, REVA’s Chief Executive Officer. “But we know that CAD patients often have complicated disease, with longer lesions, and disease in multiple vessels. We believe Fantom’s unique features including a more forgiving implant technique, and the ability to visualize the complete scaffold structure under x-ray, will be advantageous when treating these more complex cases. We are excited to begin this next phase of clinical evaluation."
Approval for the expanded trial was granted by the Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM). Dr. Norbert Frey, a FANTOM II trial investigator from the University of Kiel, will serve as the lead investigator.
Patient enrollment will begin shortly, with the first cases to be highlighted at the upcoming EuroPCR conference, which will be held in May in Paris.
REVA is a clinical stage medical device company located in San Diego, California, USA, that is working to commercialize its proprietary bioresorbable scaffolds, as an alternative to metal stents, 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 Fantom® scaffold has been designed to offer an ideal balance of thinness and strength, with 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 regulatory approval before it can commercialize Fantom or any other product.
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 February 27, 2017. 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 forwardlooking statements, whether as a result of new information, future events, or otherwise.
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