First regulatory filing toward 2014 FFR commercialization
Quebec City, Quebec, January 7, 2014 – Opsens Inc. (“Opsens” or “the Company”) (TSX-V:OPS) is pleased to announce it has taken another leap toward commercializing its products that measure Fractional Flow Reserve (“FFR”) in patients suffering from coronary artery disease, as its Japanese distributor has submitted the application for Shonin approval to the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan’s Ministry of Health, Labour and Welfare (MHLW). Once approval has been secured, Opsens will be allowed to sell its FFR products in Japan.
FFR products on the fast-track to a market launch before December 31, 2014
“Opsens has put the development of its FFR products line on the fast track, which has allowed us to file a full five months ahead of schedule in Japan,” stated Louis Laflamme, president and CEO. “We are confident that the quality of our products will allow Opsens to bite into this fast-growing FFR market,” Laflamme added.
Filing for FDA clearance in the United States, Medical Device License in Canada and for CE Marking approval in Europe will be the next steps in our regulatory work. All filings for regulatory approvals are expected to be completed in Opsens’ 2014 fiscal year.
Opsens aims to become a key player in the FFR market with the OptoWire, a nitinol-based optical guidewire for FFR. The OptoWire is designed to provide cardiologists with a pressure guidewire to navigate coronary arteries and reach blockages with ease, while also measuring intra-coronary blood pressure. The pressure guidewire contains a unique, patented optical sensor, which is immune to the adverse effects related to blood contact. Thanks to the innovative fiber optic sensor, the OptoWire allows accurate pressure measurements that lead to reliable FFR measurements. Penetration of a fraction of the FFR market will have a major impact on Opsens’ consolidated sales. Since 2008, the FFR market had a compound annual growth rate of 43%. In 2012, the FFR market was already above the US$200-million mark. Market participants estimate the FFR market will reach US$1 billion in a foreseeable future.
Opsens’ OptoWire and OptoMonitor are getting closer to entering this exciting market. “Our Japanese partner, a player in interventional cardiology in Japan, was one of Opsens’ first supporters when Opsens began talking about FFR,” said Claude Belleville, vice-president, medical. “They carefully reviewed our products and timeline before acquiring the distribution rights for Opsens’ FFR products for Japan, Taiwan and Korea in a US$5-million agreement. The fact that our partner is at the head of well-established distribution channels should facilitate penetration of Opsens’ products in the Asian market,” he added. In 2013, the Japanese market represented approximately 18% of the world’s FFR market.
Opsens is looking forward to working closely with its Japanese partner in this endeavour. Shonin approval will be yet another stepping stone for Opsens toward worldwide commercialization of its FFR products. Approval will also release a US$1-million payment to Opsens from its Japanese partner, a condition stated in the distribution agreement.
About Opsens Inc. (www.opsens.com)
Focusing on two main growth markets, oil and gas and FFR in medical instrumentation, 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.
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, President and Chief Executive Officer, 418.682.9996