REVA Announces First Implant of the Fantom Encore Bioresorbable Scaffold in Italy

SAN DIEGO, Dec. 03, 2018 (GLOBE NEWSWIRE) -- REVA Medical, Inc. (ASX: RVA) (“REVA” Or The “Company”), a leader in bioresorbable polymer technologies for vascular applications, announced the first implant of its recently launched Fantom Encore bioresorbable scaffold (BRS) in Italy. The implant procedure was performed by Professor Antonio Colombo at the Columbus Clinic Center in Milan, Italy.

“The patient I treated today was young, only 53 years old, and a perfect candidate for bioresorbable scaffolds,” said Prof. Colombo. “During the procedure, I was impressed by Fantom Encore’s ease-of-use owing to its thinner strut profile and strength. Bioresorbable scaffolds are an important therapy to pursue and I think that Fantom Encore has the potential to become a go-to treatment option for many patients.”

Fantom Encore is a third-generation coronary BRS with a market-leading thin strut profile compared to other commercially available, CE Mark BRS. These advantages are derived from REVA’s Tyrocore polymer, which is different from the polylactic acid polymer used to construct first-generation BRS. 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 (for more information visit www.revamedical.com).

“Fantom Encore is the most advanced bioresorbable scaffold technology that is commercially available today,” said Reggie Groves, CEO of REVA Medical. “We are working with Bio Vascular Group as our distribution partner to bring Fantom Encore to physicians and patients in Italy and are actively working to expand geographic access through new partnerships in other regions of Europe and Asia that accept CE Mark.”

Valued at $220 million, the market for interventional cardiology devices in Italy is one of the largest in Europe. Approximately 150,000 percutaneous coronary intervention procedures are performed in the country every year¹. The partnership with Bio Vascular Group expands REVA’s commercial activities to Italy and builds on sales efforts already underway in Germany, Switzerland, Austria, Belgium, the Netherlands, Luxembourg, and Turkey.

About Fantom Encore
Fantom Encore is a sirolimus-eluting bioresorbable scaffold developed as an alternative 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 Encore is made from Tyrocore, REVA’s proprietary tyrosine-derived polymer invented for vascular scaffold applications. Tyrocore is inherently radiopaque, making Fantom Encore visible under x-ray fluoroscopy. Fantom Encore is designed with a thin strut profile 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 products include the Fantom Encore and MOTIV bioresorbable vascular scaffolds for the treatment of coronary artery disease and below-the-knee peripheral artery disease, respectively. REVA is currently selling Fantom Encore in Germany, Switzerland, Austria, the Netherlands, Belgium, Luxembourg, Italy and Turkey. REVA is based in San Diego, California, and employs 45 people in the U.S. and Europe.

1) Medtech 360: Interventional Cardiology Devices Europe 2016 Market Analysis, Decision Resources Group

Fantom Encore, MOTIV, 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.