REVA Announces Commercial Expansion and the First Implant of the Fantom Bioresorbable Scaffold in Switzerland

SAN DIEGO, Oct. 16, 2017 -- REVA Medical, Inc. (ASX:RVA) (“REVA” or the “Company”) announced today the commercial expansion of its bioresorbable scaffold (“BRS”), Fantom^®, with the first implant in Switzerland. The first implant of Fantom in Switzerland was conducted at Kantonsspital Baselland in Liestal, Switzerland by Dr. Gregor Leibundgut. 

“Following my experience with Fantom, I have been able to see first-hand how Fantom’s technology with the Tyrocore™ polymer offers simplified deliverability, single-step inflation for ease of use, and radiopacity for accurate scaffold placement,” said Dr. Leibundgut. “Bioresorbable scaffolds have the potential to offer comparable short-term treatment without the long-term complications of a permanent metallic stent. This is an important treatment option and we are happy to offer it to our patients.”

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. Additionally, Fantom offers thin 125 micron struts while retaining radial strength. Thinner struts have been shown to improve deliverability and support vessel healing. Imaging data from the FANTOM II study showed that vessel patency was maintained at 6 and 9 months with 0% malapposition and 99% strut coverage. 

“Fantom, made with REVA’s novel polymer called Tyrocore, is an exciting advancement in bioresorbable scaffold technology that has the potential to positively impact clinical practice for physicians and patients,” said Reggie Groves, CEO, REVA Medical. “With the launch of Fantom in Switzerland, REVA continues to execute on our growth plan with direct selling efforts in the first phase of Fantom’s targeted launch.”

About REVA

REVA is a medical device company located in San Diego, California, USA, that has developed and commercialized a proprietary bioresorbable scaffold, as an alternative to metal stents, to treat coronary artery disease. Scaffolds provide restoration of blood flow, support the artery through the healing process, 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. The Company’s Fantom® scaffold received European CE Marking on April 3, 2017. It is designed with thin struts while maintaining strength and distinct ease-of-use features including complete scaffold visibility under x-ray and expansion with one continuous inflation.

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.