SAN DIEGO, July 15, 2018 (GLOBE NEWSWIRE) — REVA Medical, Inc. (ASX:RVA) (“REVA” or the “Company”), a leader in bioresorbable polymer technologies for vascular applications, is expanding commercial access to the Fantom® Bioresorbable Scaffold with a new distribution partnership in Italy. REVA will work with Bio Vascular Group S.R.L. (“Bio Vascular”) on commercial activities nationwide. Following this agreement, the first commercial implant procedure in Italy was conducted by Dr. Bernardo Cortese of Clinica San Carlo – Casa di Cura Polispecialistica in Paderno Dugnano MI.
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 expands REVA’s commercial activities to Italy and builds on sales efforts already underway in Germany, Switzerland, Austria and Turkey.
“In Italy, we stay on the leading edge of technology to offer the best possible care to our patients,” said Dr. Cortese. “During the implant procedure, I was able to see the technical advantages of Fantom over first-generation bioresorbable scaffolds such as x-ray visibility and ease-of-use. Second-generation, thin strut bioresorbable scaffolds like Fantom have the potential to improve outcomes, and we are excited to have this treatment option available for Italian patients.”
Under the terms of the partnership, Bio Vascular will be REVA’s distribution partner for the Fantom and Fantom Encore bioresorbable scaffolds in Italy. Bio Vascular will be responsible for all sales, marketing, customer training, and support. Commercial sales are expected to ramp-up in the fourth quarter of 2018, following successful completion of REVA’s training program by Bio Vascular personnel.
“With this partnership we are delivering on our ongoing commitment to expand geographic access to Fantom,” said Reggie Groves, REVA’s CEO. “Bio Vascular offers country-wide distribution coverage in Italy. The company’s proven track record with interventional cardiology devices, demonstrated relationships with physicians and commitment to patient care make it an ideal partner for us.”
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. 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 function of the artery and reduce risk of adverse events associated with a permanent metallic implant. Fantom and Fantom Encore are the only 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 the first and only bioresorbable scaffolds that are visible under fluoroscopy. Fantom and Fantom Encore are designed with thin struts 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 in Germany, Switzerland, Austria, Italy and Turkey. REVA is based in San Diego, California, and employs more than 50 people in the U.S. and Europe.
1) Medtech 360: Interventional Cardiology Devices Europe 2016 Market Analysis, Decision Resources Group
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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