Opsens Receives 510(K) Clearance for the Optomonitor II Providing Extended Indication
Quebec City, Quebec, September 26, 2016 - Opsens Inc. ("Opsens" or the "Company") (TSXV:OPS) (OTCQX:OPSSF) announces 510(k) clearance from the U.S. Food and Drug Administration ("FDA") for the OptoMonitor II, a new multimodality monitor combining the ability to measure Fractional Flow Reserve ("FFR") along with measuring intravascular and intracatheter pressure.
In the United States, Opsens already sells its products to measure FFR for the diagnostic and treatment guidance in patients with coronary heart disease. The OptoMonitor II is now indicated to be used with FDA cleared Occlusion Perfusion Catheter® (OPC) from Advanced Catheter Therapies, Inc. ("ACT") and its partner Toray Industries, Inc. ("Toray"). The OPC is indicated for localized infusion or irrigation diagnostic and therapeutic agent to the peripheral vasculature.
"We are pleased to provide our products and technologies to partners like ACT and Toray for opportunities with strong potential such as OPC,” said Louis Laflamme, President and CEO of Opsens. “This product is designed for the infusion of therapeutic agents in the peripheral vasculature. Marketing of the OPC will create a synergy with our FFR activities through the deployment of a larger number of now multimodal OptoMonitor, helping Opsens build critical mass," 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 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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For further information, please contact:
Thierry Dumas, CPA, CA, Chief Financial Officer, 418.781.0333
Louis Laflamme, CPA, CA, Chief Executive Officer, 418.781.0333