OPSENS granted approval to sell Optowire II in Japan
Quebec City, Quebec, November 26, 2015 – Opsens Inc. (“Opsens” or the “Company”) (TSXV:OPS) (OTCQX:OPSSF) is pleased to announce that its Japanese partner has received Shonin approval from the Japanese Ministry of Health, Labor and Welfare (“MHLW”) to sell the OptoWire II.
OptoWire II for Improved Navigation in the Most Tortuous and Calcified Vessels
In its quest to offer the most effective products to measure Fractional Flow Reserve (“FFR”) to cardiologists, Opsens has upgraded on its original OptoWire by adding a hydrophilic coating that improves navigation in the most tortuous and calcified vessels. This product, the OptoWire II, is following the regulatory path at an accelerated pace. Two weeks ago, Opsens announced receipt of CE marking, which grants permission to sell the OptoWire II in Europe. Clearance in the U.S. is expected shortly. Opsens’ FFR products are designed to optimize the diagnostic and guide treatment in patients with coronary heart disease.
“We are constantly looking for new ways to improve on our products. The addition of a hydrophilic coating is an upgrade that facilitates navigation even more in tortuous and calcified vessels. OptoWire II makes assessment of complex coronary blockages easier and will help cardiologists decide whether patients require intervention or not. This ease of use could help promote the use of FFR further and widen access to this diagnostic method that improves patient outcomes and helps avoid unnecessary medical procedures,” said Claude Belleville, Vice-President, Medical Devices. “Shonin approval for the OptoWire II was a highly rigorous process as our product, which is intended to be inserted into the human body, near the heart, was scrutinized in-depth to insure patient safety. We have to credit the excellent work of our Japanese partner and of Opsens’ team for this speedy receipt,” Belleville added.
Receipt of Shonin Approval Launches Expansion of Commercial Activities for FFR Products
“Our Japanese partner, a player in interventional cardiology in Japan, is directing a well-organized distribution network that helped grow Opsens’ FFR sales in the first quarter of fiscal 2016. Opsens expects that its sales will grow even more in the coming quarters, with an expansion of our commercial activities in the Japanese market and now that Opsens is taking measures to ramp-up production,” said Louis Laflamme, Chief Executive Officer and President of Opsens.
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, 418.682.9996
Louis Laflamme, CPA, CA, President and Chief Executive Officer, 418.682.9996