OPSENS GETS CLEARANCE TO SELL FFR PRODUCTS IN THE UNITED STATES
Quebec City, Quebec, June 15, 2015 – Opsens Inc. (TSXV:OPS) (OTCQX:OPSSF) (“Opsens” or the “Company”) today announced 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the OptoWire and OptoMonitor, its products developed to measure Fractional Flow Reserve (“FFR”). This measure is used to optimize the diagnostic and guide the treatment of patients with coronary heart disease. This clearance gives Opsens permission to sell its FFR products in the United States, the world’s largest FFR market.
“We are very pleased to announce that the Company has been granted US clearance for its FFR products. Now that we are cleared to sell our FFR products in the world’s most valuable market, we are committed to becoming the first choice for cardiologists by delivering new, innovative guidewire technologies to measure FFR and improve the clinical outcome of patients with coronary artery disease”, stated Claude Belleville, Opsens’ Vice President Medical Devices.
The OptoWire is a nitinol-based optical guidewire for FFR that provides intra-coronary blood pressure measurements with unique, patented optical pressure guidewire technologies. Its immunity to the adverse effects related to blood contact allows easy and reliable connectivity that leads to reliable FFR measurements in extended conditions of use. The OptoWire is also designed to provide optimized performances to navigate coronary arteries and reach blockages with ease.
Opsens is excited to offer its FFR products to a broader customer base. In 2014, the FFR market reached US$300 million. Market stakeholders expect it will reach US$1 billion in the medium term, creating an outstanding opportunity for Opsens. Penetrating the FFR market will have a major impact on the Company’s sales.
“Obtaining 510(k) clearance is a major regulatory achievement allowing Opsens to bring its products to the vital US market. The team members deserve the warmest congratulations for their successful execution of the rigorous provisions and directives. Their attention to details has enabled the rapid receipt of approvals in the US, in Japan and in Europe. We are proud of these milestones and committed to earning clinical and commercial success in all our markets”, concluded Louis Laflamme, Opsens’ President and Chief Executive Officer.
About Opsens Inc. (www.opsens.com) or Opsens Medical Inc. ()
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 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.
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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