SAN DIEGO, May 15, 2018 (GLOBE NEWSWIRE) — REVA Medical, Inc. (ASX:RVA) (“REVA” or the “Company”), a leader in bioresorbable polymer technologies for vascular applications, announced today launch of the Fantom bioresorbable scaffold in Turkey with implants conducted during the first week of introduction at three separate hospitals. The procedures were conducted in Istanbul and Antalya by Prof. Bilal Boztosun, Chief of Cardiology at the Mega Medipol University Hospital, Prof. Ömer Göktekin, Chief of Cardiology at the Memorial B. Evler Hospital, and Prof. Ismail Ates, Chief of Cardiology at the Medical Park Hospital.
Turkey is an important market for bioresorbable scaffolds. It is a large country with a population that is similar to Germany and has approximately 100 hospitals performing cardiac catheterizations in Istanbul alone. REVA previously announced a commercial distribution partnership with Kardionet HealthCare and Foreign Trading, Ltd (“Kardionet”) in Turkey. Fantom procedures were successfully conducted at all three centers with excellent acute patient outcomes. The physicians implanting Fantom provided the following feedback:
Prof. Bilal Boztosun recounted his experience saying, “During the implant procedure I was impressed with how easy Fantom was able to be delivered to the target location in comparison to first generation bioresorbable scaffolds. The x-ray visibility enabled me to visualize Fantom and accurately place the device with ease.”
Prof. Ömer Göktekin stated, “In Turkey, we strive to offer our patients the most advanced therapies. Bioresorbable scaffolds like Fantom have the potential to improve long-term outcomes compared with metal drug-eluting stents and are an important treatment option for my patients. During the implant procedure in a highly complex case, Fantom’s x-ray visibility enabled me to place two Fantom scaffolds edge-to-edge in order to completely cover the diseased arterial segment.”
Prof. Ismail Ates, shared, “Fantom is different from first generation bioresorbable scaffolds due to its thinner strut profile and x-ray visibility provided by the Tyrocore polymer, and I was able to see the benefits during the procedure. Bioresorbable scaffolds have the potential to reduce long-term complications compared to metallic drug eluting stents and represent the future of PCI therapy for Turkish patients.”
Fantom is a second-generation bioresorbable scaffold made from Tyrocore, REVA’s proprietary bioresorbable polymer, which is different from the polylactic acid polymer used to construct first generation scaffolds such as Absorb. The use of Tyrocore allows Fantom to offer differentiated features compared to first generation scaffolds including thinner profiles, improved ease-of-use, and full x-ray visibility.
“Our experience with Kardionet so far indicates that we chose the right partner for commercialization in Turkey,” said Reggie Groves, CEO, REVA. “We have hit all of our second quarter milestones including local registration approval, training, product shipments, and now the first implants. The successful approach we have established in Turkey will be our model for several additional commercial distribution partnerships we plan to initiate in the next six to twelve months.”
About Fantom and Fantom Encore
Fantom and Fantom Encore are sirolimus-eluting bioresorbable scaffolds 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 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 fully visible under x-ray. Fantom and Fantom Encore are designed with thin strut profiles 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 products are the Fantom and Fantom Encore bioresorbable vascular scaffolds 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, Fantom Encore, and Tyrocore are trademarks of REVA Medical, Inc.
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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