OPSENS granted approval to sell Optowire II in Europe
Quebec City, Quebec, November 12, 2015 – Opsens Inc. ("Opsens" or the "Company") (TSXV:OPS) (OTCQX:OPSSF) is pleased to announce it has been granted CE marking for the OptoWire II, the improved version of its pressure guidewire (OptoWire I) developed to measure Fractional Flow Reserve (“FFR”) in patients with coronary artery disease. CE marking allows Opsens to sell OptoWire II in Europe, the world’s second largest market.
OptoWire II chosen for large-scale commercialization
Pressure guidewires on the market have been the object of continuous improvement over the last 15 years and therefore have, in our opinion, reached a maturity that limits continued advance. As soon as the OptoWire I was launched, Opsens received rave reviews that placed its product on the forefront, when compared with existing FFR technologies. As part of its continuous improvement process aiming to provide interventional cardiologists with the most efficient tools, Opsens added a hydrophilic coating and increased the flexibility profile of its guidewire for easier navigation through the vascular system. This new version, the OptoWire II, recently approved in Europe, is following the regulatory path at an accelerated pace in other jurisdictions and will be marketed on a large scale.
"The hydrophilic coating and the increased flexibility profile should facilitate the evaluation of complex coronary blockages, helping cardiologists in deciding on the most appropriate treatment. This ease of use could help to promote the use of the FFR and further expand access to this diagnostic that improves patient outcomes," said Claude Belleville, Opsens’ Vice President, Medical Devices.
"Obtaining regulatory approval to market our product in Europe represents another very important step for us," said Louis Laflamme, President and CEO of Opsens." We have designed an exceptional offer for cardiologists and look forward to large-scale commercialization. Meanwhile, we do need to respond to an expected significant increase in demand for our FFR products and are preparing to our move into a state-of-the-art facility that will accommodate the equipment and the employees needed to increase production in early 2016," said Mr. Laflamme.
Opsens aims to become a key player in the guidewire FFR market with the OptoWire, a nitinol-based optical guidewire. The OptoWire provides intra-coronary blood pressure measurements with unique, patented optical pressure guidewire technologies. It is immune to adverse effects related to blood contact, and allows easy and reliable connectivity that leads to reliable FFR measurements in extended conditions of usage. The OptoWire is also designed to provide cardiologists with a guidewire that provides optimal performance to navigate coronary arteries and cross blockages with ease and safety. Based on industry sources, the FFR market represented more than US$300 million in sales in 2014 and is expected to reach US$1 billion in the medium-term.
Opsens focuses mainly on the measure of Fractional Flow Reserve ("FFR") in interventional cardiology. Opsens offers an advanced optical-based pressure guidewire (OptoWire) that aims at improving the clinical outcome of patients with coronary artery disease. Opsens is also involved in industrial activities. The Company develops, manufactures and installs innovative fibre optic sensing solutions for critical applications such as the monitoring of oil wells and other demanding industrial applications.
Forward-looking statements contained in this press release involve known and unknown risks, uncertainties and other factors that may cause actual results, performance and achievements of Opsens to be materially different from any future results, performance or achievements expressed or implied by the said forward-looking statements.
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Thierry Dumas, CPA, CA,
Chief Financial Officer,
Louis Laflamme, CPA, CA,
President and Chief Executive Officer,