SAN DIEGO, Jan. 07, 2019 (GLOBE NEWSWIRE) — REVA Medical, Inc. (ASX: RVA) (“REVA” or the “Company”), a leader in bioresorbable polymer technologies for vascular applications, announced the geographic expansion of its commercial operations in seven European countries with the addition of four new distribution partnerships. These partnerships will allow REVA to expand access to its Fantom Encore drug-eluting bioresorbable scaffold, building on existing distribution partnerships and direct-selling efforts already underway.
REVA will work with the following companies for expanded commercial distribution: A care a.s. in Czech Republic and Slovakia, Polimed in Poland, Technoproject, Ltd. in Russia, and Danmeda in Lithuania, Estonia and Latvia. Together, these countries represent a $290 million medical device market with over 350,000 percutaneous coronary intervention procedures performed annually1.
“These new distribution partnerships deliver on our commitment to expand geographic access to Fantom Encore,” said Reggie Groves, CEO of REVA Medical. “These partners were selected based on their proven track records and their local knowledge of the coronary and peripheral interventions markets. We expect that they will add to the commercial momentum that we have already seen with Fantom Encore.”
Similar to REVA’s existing distribution partnerships in Italy and Turkey, each distributor will be responsible for all sales, marketing, customer training and support in their respective regions. REVA is currently working with each distributor on local regulatory registrations and expects to begin commercialization during the next three to twelve months following local approval and successful completion of REVA’s training program by distributor personnel.
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 market-leading 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.
1) Medtech 360: Interventional Cardiology Devices Europe 2016 Market Analysis Supplemental, 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.
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