Opsens Gets CE Marking
Quebec City, Quebec, November 19, 2014 – Opsens Inc. (TSXV:OPS) (“Opsens” or the “Company”) is pleased to announce that it has been granted CE marking for OptoWire and OptoMonitor, which allows these Fractional Flow Reserve (FFR) products for patients with coronary artery disease to be marketed in
Europe, the world’s second largest market.
“Following the recent Shonin approval in Japan, getting regulatory approval to market our products in Europe represents another very important step for us. We are now focusing our efforts on commercialization, with the imminent launch of our products in these territories. We are looking optimistically forward to the next regulatory steps, which include receiving 510(k) approval from the US Food and Drug Administration (FDA), and Medical Device Licence from Health Canada” explained Louis
Laflamme, president and CEO of Opsens.
Penetrating part of the FFR market will have a major impact on the Company’s sales. In 2013, the FFR market had already exceeded US$250 million, and market stakeholders expect it to reach US$1 billion in the medium term.
The OptoWire is an optical pressure guidewire that measures intra-coronary blood pressure using unique patented technologies. Its sensing technology imperviousness to the undesirable effects of contact with blood and other fluids, coupled to effective and reliable connectivity provides reliable FFR readings in extended conditions of usage. The OptoWire is also designed to give cardiologists a guidewire that offers optimized performance for navigating inside coronary arteries and reaching blockages easily.
About Opsens Inc. (www.opsens.com)
Focusing on two main growth markets, FFR in medical instrumentation and oil and gas, Opsens develops, manufactures and installs systems to measure pressure, temperature and others parameters using fiber optic sensing technologies. These systems are designed around patented technologies that are effective and durable in extreme conditions.
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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.
For further information, please contact:
Thierry Dumas, CPA, CA, Chief Financial Officer, 418.682.9996
Louis Laflamme, CPA, CA, President and Chief Executive Officer, 418.682.9996