OPSENS RECEIVE SHONIN APPROVAL TO MARKET FFR PRODUCTS IN JAPAN
Quebec City, Quebec, October 2, 2014 – Opsens Inc. (“Opsens”) (TSX-V: OPS) is pleased to announce that its Japanese distributor received Shonin approval from the Japanese Ministry of Health, Labor and Welfare (“MHLW”) to market the OptoWire and the OptoMonitor, our products that measure Fractional Flow Reserve (“FFR”) in patients with coronary artery disease.
“This approval marks a pivotal milestone in our strategic growth plan to become a key player in the FFR market,” stated Louis Laflamme, President and Chief Executive Officer of Opsens. “Our Japanese distributor filed our FFR products with the MHLW back in January 2014. The approval came nine months later, which clearly demonstrates that our verification and validation process is complying with the most rigorous standards of the Japanese regulatory agency. The fast receipt of the approval can also be credited to the quality of our production installations and to the effectiveness of the quality control systems in place. The speed at which approval was granted allows us to anticipate with optimism the approval in other key geographies”.
Obtaining Shonin approval was the final condition for the release of a milestone payment worth US$1 million from our Japanese partner. The cash reception of this milestone payment is expected to happen in the next few weeks.
“Now that Opsens’ FFR products are cleared for commercialization in Japan, Opsens and its partner will proceed with a pre-commercial product launch within a limited number of institutions in that territory. Our Japanese partner, a key player in interventional cardiology in Japan, is at the head of well-established distribution channels, which should facilitate penetration of Opsens’ products in the Asian market,” said Claude Belleville, Vice-President, Medical.
Opsens aims to become a key player in the guidewire FFR market with the OptoWire, a patented nitinol-based optical guidewire for FFR. The OptoWire provides intra-coronary blood pressure measurements with a unique, patented optical sensor. It is immune to adverse effects related to blood contact, and allows easy and dependable connectivity that leads to reliable FFR measurement. The OptoWire is also designed to provide cardiologists with a guidewire delivering optimized performance to navigate coronary arteries and reach blockages with ease. Based on industry sources, the FFR market represented over US$250 million in sales in 2013 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)
Focusing on two main growth markets, FFR in medical instrumentation and oil and gas, Opsens develops, manufactures and installs systems to measure pressure and temperature as well as other parameters using fiber optic sensing technologies. These systems are designed around patented technologies that are effective and durable in extreme conditions.
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.
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