Company discusses positive long-term data, expanded clinical trials, and plans for growth
SAN DIEGO, May 17, 2017 (GLOBE NEWSWIRE) -- Today at the Paris Course on Revascularization (“EuroPCR”), REVA
Medical, Inc. (ASX:RVA) (“REVA” or the “Company”) sponsored a symposium entitled, Fantom: performance gains and
clinical data for a next generation BRS, which highlighted the recently announced clinical data from the FANTOM II
trial. Information regarding the Company’s newly initiated clinical trials and plans for expansion was also presented.
Dr. Alexandre Abizaid, Director of Invasive Cardiology at Institute Dante Pazzanese of Cardiology in Sao Paulo,
Brazil, provided a thorough review of the 12-month clinical results from the FANTOM II trial, which were released by the Company
yesterday. The results, which included a very low 4.2% rate of Major Adverse Cardiac Events (“MACE”), demonstrate a strong safety
profile for Fantom through a sustained timeframe.
Dr. Neils Holm from the Skejby-Aarhus University Hospital in Aarhus, Denmark expanded on the nine-month Optical
Coherence Tomography (“OCT”) results that were also released by the Company yesterday. The OCT imaging results in a subset of
patients treated with Fantom demonstrated vessel patency (maintenance of a wide open artery) and sustained healing with
greater than 99% strut coverage at nine months.
Dr. Lukasz Koltowski from the Medical University of Warsaw in Poland and Dr. Matthias Lutz from
Universitätsklinikum Schleswig-Holstein in Kiel Germany presented a selection of patient case examples from REVA’s recently
initiated clinical trials. The FANTOM II Cohort C trial is evaluating the use of Fantom in longer lesions and in multiple
vessels. FANTOM AMI is evaluating Fantom in patients that present with an acute myocardial infarction (“AMI”). Each of
these trials is designed to evaluate the safety and performance of Fantom in more complex cases. Positive results will
support indication expansion for Fantom, allowing physicians to confidently expand their use of the product in their
patients.
Dr. Gregg Stone from the Columbia University Medical Center and the Cardiovascular Research Foundation closed
the symposium with an overview of REVA’s future plans for geographic expansion, including information regarding the Company’s
proposed trials in the United States and Japan. In addition, Dr. Stone announced REVA’s plans for a thinner version of
Fantom (sub-100 micron strut thickness) that is targeted for 2018. This device is being developed to address the issues
associated with the use of bioresorbable scaffolds in smaller vessels, and will be a significant addition to the Fantom
family of products.
The presentation materials delivered at the symposium are available in the Investor Relations section of REVA’s
website at www.revamedical.com.
About REVA
REVA is a medical device company located in San Diego, California, USA, that has developed a proprietary
bioresorbable scaffold, 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.
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 the projections and timing
surrounding our plans to commence commercial operations and sell products, conduct clinical trials, develop pipeline products,
incur losses from operations, list our securities for sale on a U.S. stock exchange, and assess and obtain future financings for
operating and capital requirements. Readers 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 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 28, 2017, and as 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.
United States Investor & Media Enquiries: REVA Medical, Inc. Cheryl Liberatore Director, Communications +1 858-966-3045 Australia Investor Enquiries: Inteq Limited Kim Jacobs +61 438 217 279 Andrew Cohen +61 408 333 452 Australia Media Enquiries: Buchan Consulting Rebecca Wilson +61 3 9866 4722
