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REVA Announces Commercial Launch of the Fantom Encore Bioresorbable Scaffold

First Fantom Encore Implanted in the FANTOM Post Market Trial

SAN DIEGO, Oct. 31, 2018 (GLOBE NEWSWIRE) -- REVA Medical, Inc. (ASX: RVA) (“REVA” or the “Company”), a leader in bioresorbable polymer technologies for vascular applications, announced the commercial launch of the Fantom Encore bioresorbable scaffold (“BRS”) and the first implant of Fantom Encore in the FANTOM Post Market Trial. The implant procedure was performed by Dr. Matthias Lutz at the Universitätsklinikum Schleswig-Holstein in Kiel, Germany.

Fantom Encore is a third-generation coronary BRS with a market-leading thin strut profile compared to other commercially available, CE Mark BRS. Fantom Encore is immediately available in all countries where the Company is currently selling its second-generation Fantom coronary BRS, including Germany, Switzerland, Austria, Belgium, the Netherlands, Luxembourg, Italy and Turkey.

“My experience with Fantom Encore is that it is easy to use due to its thinner strut profile, x-ray visibility, and strength,” said Dr. Lutz, co-principal investigator of the FANTOM Post Market Trial. “With these device improvements and the investment in the FANTOM Post Market Trial, REVA is partnering with physicians to advance the field of bioresorbable scaffolds.”

Fantom Encore offers differentiated features compared to first-generation BRS such as Absorb, including thinner profiles, improved ease-of-use, and full x-ray visibility. These advantages are derived from REVA’s Tyrocore polymer, which is different from the polylactic acid polymer used to construct Absorb. Fantom Encore’s advanced features including thinner strut profiles have been associated with improved outcomes and ease-of-use, which are critical for broader adoption of bioresorbable scaffold technology.

“The commercial launch of Fantom Encore solidifies REVA’s technological lead in bioresorbable scaffolds,” said Reggie Groves, CEO of REVA Medical. “No other company has a thin strut profile, x-ray visible BRS. With a leading product and clinical data generated through the FANTOM clinical trials, we are positioned for success in the coronary BRS market.”

The FANTOM Post Market Trial is a single arm trial to assess the continued safety and performance of Fantom and Fantom Encore. The primary endpoint is Target Lesion Failure (TLF) at 12 months and patients will be followed through five years. The FANTOM Post Market Trial is currently enrolling with a target of 1,500 patients at 50 to 100 European centers.

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. After restoration of blood flow, bioresorbable scaffolds 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 strut profiles 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 and Fantom Encore 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.

Fantom, Fantom Encore, and Tyrocore are trademarks of REVA Medical, Inc.

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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Wednesday, October 31, 2018 - 19:19