REVA Announces First Implant of the Fantom Bioresorbable Scaffold in Italy

SAN DIEGO, Jan. 24, 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 the Fantom bioresorbable scaffold (“BRS”) in Italy. The procedure was conducted by Dr. Bernardo Cortese at the Fatebenefratelli Hospital in Milan.

“Fantom is new-generation BRS technology offering the novel Tyrocore polymer, thin struts, and visibility under x-ray angiography,” said Dr. Cortese. “During the procedure, I was able to experience first-hand the benefits of x-ray visibility for easy scaffold delivery and accurate implantation. This is an important advance for bioresorbable scaffolds, which have the potential to offer patients the benefits of a metallic stent without the complications of a life-long implant.”

Fantom is the only bioresorbable scaffold made from Tyrocore, REVA’s proprietary tyrosine-derived polymer designed specifically for vascular scaffold applications. Tyrocore is visible under x-ray, making Fantom the first and only BRS that is x-ray visible. Additionally, Fantom offers a thin profile while retaining radial strength. Thinner profiles have been shown to improve deliverability and support vessel healing. Previously reported results from the FANTOM II clinical study have shown low Major Adverse Cardiac Event (“MACE”) rates of 4.2% at 12 months in 240 patients and 5.6% at 24 months in an interim, 125 patient data set.

“When physicians have first-hand experience with Fantom, they see the ease-of-use and clinical benefits of a thin-profile, x-ray visible, bioresorbable scaffold made with the Tyrocore polymer,” said Reggie Groves, CEO, REVA Medical. “The first implant of Fantom in Italy with Dr. Cortese is an important step in preparing for commercialization in Italy.”

About Fantom

Fantom is a sirolimus-eluting bioresorbable scaffold 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 movement and function of the artery. Fantom is the only bioresorbable scaffold made from Tyrocore, REVA’s proprietary tyrosine-derived polymer designed specifically for vascular scaffold applications. Tyrocore is inherently radiopaque, making Fantom the first and only BRS that is visible under fluoroscopy. Fantom is designed with thin struts while maintaining strength and with distinct ease-of-use features such as 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 product, the Fantom bioresorbable scaffold, received European CE Marking on April 3, 2017 for the treatment of coronary artery disease. REVA is located in San Diego, California, USA and employs over 50 people in the U.S. and Europe.

Fantom, 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 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.