OPSENS RECEIVES HEALTH CANADA APPROVAL TO COMMERCIALIZE ITS FFR PRODUCTS
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Quebec City, Quebec, July 21, 2015 – Opsens Inc. (“Opsens” or the “Company”) (TSXV:OPS) (OTCQX:OPSSF) today announced it has received Health Canada’s approval to commercialize the OptoWire and OptoMonitor, its products developed to measure Fractional Flow Reserve (“FFR”). FFR is used to optimize the diagnosis and guide the treatment of patients with coronary heart disease.
Opsens’ FFR products, which have already earned the necessary regulatory approvals to commercialize in the United States, Japan and Europe, received an enthusiastic welcome from the cardiology community. The use of Opsens’ FFR products by internationally renowned cardiologists in regular clinical procedures and in live presentations has demonstrated to wide audiences the no-drift measurement, the constant reliability of the connection and the support of the OptoWire as well as the overall high performance of Opsens’ FFR products.
“Opsens’ FFR products are eagerly expected in Canada, where the products already have supporters, as it is in Quebec and Canada that were conducted the first studies on humans”, said Claude Belleville, Vice President, Medical Devices of Opsens.
“With Opsens’ FFR products and their advanced fiber-optic technology, it will be easier and more reliable to assess coronary flow reserve and to decide whether patients require intervention or not”, said Dr Olivier F. Bertrand at Quebec Heart-Lung Institute, Laval Hospital. “The interventional cardiology community has been eagerly waiting to have access to such improved technology. In today’s world, this will help us provide optimized care”, added the cardiologist.
“Obtaining Health Canada’s approval faster than expected once again demonstrates the attention to details, the expertise and dedication of Opsens’ team. We are very proud of having achieved this milestone. In the coming months, we will focus our efforts on increasing Opsens’ production capability by hiring a significant number of employees and by relocating our medical activities in a new facility and by expanding the limited market release of our FFR products”, said Mr. Louis Laflamme, President and CEO of Opsens.
Opsens aims to become a key player in the guidewire FFR market with the OptoWire, a nitinol-based optical guidewire for FFR. 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 delivering optimized performances 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 is confident that it is well positioned to capitalize on this significant growth opportunity.
About Opsens Inc. (www.opsens.com or www.opsensmedical.com)
Opsens focuses mainly on two large and growing markets: interventional cardiology with a focus on Fractional Flow Reserve (“FFR”) and the industrial, oil and gas segment. 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. In the industrial, oil & gas segment, Opsens 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.
Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
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For further information, please contact:
Thierry Dumas, CPA, CA, Chief Financial Officer, 418.682.9996
Louis Laflamme, CPA, CA, Chief Executive Officer, 418.682.9996