SAN DIEGO, Sept. 22, 2018 — REVA Medical, Inc. (ASX: RVA) (“REVA” or the “Company”), a leader in bioresorbable polymer technologies for vascular applications, presented four key data sets demonstrating the capabilities of the Company’s Fantom® bioresorbable scaffold (“BRS”) at the Transcatheter Cardiovascular Therapeutics (“TCT”) conference being held September 21st through September 25th in San Diego, California, USA. The presentations included new procedural data from an indication expansion study in patients experiencing acute heart attacks as well as positive clinical and imaging results of the Fantom BRS through two years.
FANTOM STEMI Procedural Results
New data from the FANTOM STEMI pilot study showed procedural success and clinical utility of the Fantom bioresorbable scaffold in a series of nine patients with acute heart attacks called ST-segment elevated myocardial infarction (“STEMI”). Patients experiencing a STEMI are a new patient population for Fantom. While these patients have a higher risk of complications than stable patients, the characteristics of their arterial blockages are typically well suited to BRS. The data were presented by Dr. Lukasz Koltowski from the Medical University of Warsaw in Warsaw, Poland.“The first priority when treating heart attack patients is removing the arterial blockage to restore blood flow to the heart,” said Dr. Koltowski. “The data presented today demonstrate that Fantom, which is x-ray visible and easy to use, works effectively during these emergency procedures. Many heart attack patients are young with single blockages in their arteries, and the Fantom bioresorbable scaffold creates an opportunity for recovery without the risk of a permanent metal drug-eluting stent.”FANTOM II Clinical Results
Two-year clinical results from the FANTOM II study were presented by Dr. Yuichi Saito from the Yale University School of Medicine in New Haven, Connecticut, USA. The data demonstrated safety and efficacy of Fantom at two years with the following outcomes:Low 5.0% rate of Major Adverse Cardiac Events (“MACE”)A single very late scaffold thrombosis event for a rate of 0.4%FANTOM II Imaging Results
Two-year optical coherence tomography (“OCT”) imaging results from the FANTOM II study were presented by Dr. Neils Holm from the Aarhus University Hospital in Aarhus, Denmark. The data showed an excellent healing profile for Fantom with sustained vessel lumen patency and no evidence of chronic scaffold recoil through two years.FANTOM Clinical Review
Dr. Ulf Landmesser, Professor of Cardiology at Charité Universitätsmedizin Berlin in Berlin, Germany delivered a comprehensive presentation of the Fantom BRS program. In addition to reviewing available clinical data, Dr. Landmesser provided an update on the Fantom Post Market Trial which is currently enrolling in Europe to evaluate the safety of Fantom in routine clinical practice.The presentation materials delivered at the conference are available in the Investor Relations section of REVA’s website at www.ir.revamedical.com.About Fantom and Fantom Encore
Fantom and Fantom Encore are sirolimus-eluting bioresorbable scaffolds developed as alternatives to metallic stents for the treatment of coronary artery disease. Scaffolds provide restoration of blood flow, support the artery through the healing process and then disappear (or “resorb”) from the body over a period of time. This resorption is intended to allow the return of natural function of the artery and reduce the risk of adverse events associated with a permanent metallic drug-eluting stent. Fantom and Fantom Encore are the only coronary bioresorbable scaffolds made from Tyrocore, REVA’s proprietary tyrosine-derived polymer designed specifically for vascular scaffold applications. Tyrocore is inherently radiopaque, making Fantom and Fantom Encore visible under x-ray fluoroscopy. Fantom and Fantom Encore are designed with thin struts while maintaining strength and with distinct ease-of-use features such as x-ray visibility and expansion with one continuous inflation.About REVA Medical
REVA Medical is a medical device company focused on the development and commercialization of bioresorbable polymer technologies for vascular applications. The Company’s lead products are the Fantom and Fantom Encore bioresorbable vascular scaffolds for the treatment of coronary artery disease. REVA is currently selling Fantom in Germany, Switzerland, Austria, the Netherlands, Belgium, Luxembourg, Italy and Turkey. REVA is based in San Diego, California, and employs more than 50 people in the U.S. and Europe.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 plans or performance and events or developments that may occur in the future, are forward-looking statements, such as those statements regarding the projections and timing surrounding commercial operations and sales, clinical trials, pipeline product development, and future financings. No undue reliance should be placed 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 March 7, 2018, 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.
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