SAN DIEGO, June 18, 2018 (GLOBE NEWSWIRE) — REVA Medical, Inc. (ASX:RVA) (“REVA” or the “Company”), a leader in bioresorbable polymer technologies for vascular applications, today announced it has received CE Mark approval for its full Fantom® Encore product line. This covers Fantom Encore in the 3.0 and 3.5 mm diameters, expanding the approved product line beyond the 2.5 mm diameter scaffold, which has a market-leading strut profile of 95 microns.
Fantom Encore is REVA’s third-generation coronary bioresorbable scaffold. Commercialization of Fantom, a second-generation product line that previously received CE Mark approval, began in the second quarter of 2017 in Germany and has expanded to additional countries, including Switzerland, Austria, and Turkey. REVA is actively engaged in continuing its sales expansion in Europe, the Middle East and South America with distribution partners as previously announced.
“With this approval we have reached an important milestone in our commercial growth plan for our coronary scaffolds,” said Reggie Groves, REVA’s CEO. “In addition to pursuing distribution partnerships and increasing our clinical evidence to support marketing activities, we have extended our technological lead in this area. We are on track to launch the Fantom Encore product line later this year.”
Fantom Encore offers a thinner strut profile compared to Fantom without compromising strength or visibility under x-ray. Thinner strut profiles have been associated with improved outcomes and ease-of-use, which are critical for broader adoption of bioresorbable scaffold technology.
Like Fantom, Fantom Encore is made from Tyrocore™, REVA’s proprietary bioresorbable polymer. Fantom and Fantom Encore are second- and third-generation scaffolds, respectively, offering differentiated features compared to first-generation scaffolds such as Absorb, including thinner profiles, improved ease-of-use, and full x-ray visibility. These advantages are derived from Tyrocore, which is different from the polylactic acid polymer used to construct Absorb.
REVA recently reported positive two-year results with Fantom from the FANTOM II trial. These results included a low 5.0% rate of major adverse cardiac events (“MACE”) in 240 patients. MACE is a stringent definition of safety and efficacy combining all events related to cardiac death, myocardial infarction, and target lesion revascularization. The endpoint of target lesion failure (“TLF”) is similar to MACE but only includes myocardial infarction events that are related to the treated vessel. Following this definition, the two-year TLF rate from 240 patients in the FANTOM II trial was 4.6%. This compares favorably to two-year TLF rates for Absorb of 11.0% and Xience of 7.9% in the 2,008-patient ABSORB III trial.
About Fantom and Fantom Encore
Fantom and Fantom Encore are sirolimus-eluting bioresorbable scaffolds developed as an alternative 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 risk of adverse events associated with a permanent metallic implant. Fantom and Fantom Encore are the only 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 the first and only bioresorbable scaffolds that are visible under 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, and Turkey. REVA is based in San Diego, California, and employs more than 50 people in the U.S. and Europe.
Fantom, Fantom Encore, and Tyrocore are trademarks of REVA Medical, Inc.
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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