A Regulatory Hat-Trick: Opsens OptoWire Cleared for Sale in Japan, Europe, and now U.S

This morning, Quebec City-based Opsens (Opsens Stock Quote, Chart, News: TSXV:OPS) announced it had received FDA 510(k) clearance to market its fractional flow reserve (FFR) technology, OptoWire, in the United States. The 510(k) clearance comes on the heals of earlier regulatory clearances for OptoWire in Europe and Japan.

FFR is used by interventional cardiologists to assess the degree of occlusion or stenosis in coronary arteries. The U.S. market is dominated by St. Jude and to a lesser degree Philips, which recently acquired Volcano Corp. Both companies use electronic sensors in their FFR products, whereas OptoWire is the first FFR product to use optical sensors. In today’s press release, Opsens cites the advantages of OptoWire versus the competition as ”Its immunity to the adverse effects related to blood contact” and “easy and reliable connectivity that leads to reliable FFR measurements in extended conditions of use”.

The real proof of the advantages of OptoWire will be determined by the pace of adoption by interventional cardiologists. However, Opsens has yet to tell investors how it plans to market OptoWire in the U.S. In fact, the company hasn’t clearly stated how it will commercialize OptoWire in Europe either, and they received clearance, called a CE Mark, there in late 2014.

Perhaps the company is working on a global distribution agreement and the 510(k) is necessary to consummate a deal? A quick scan of the company’s most recent MD&A finds references to both “expanding and investing in FFR-focused sales force and distribution channels”. Whether it is building their own sales organization, signing distribution agreements, or a combination of both, the commercial launch for OptoWire will certainly be where investors focus next. In the meantime, today’s news is clearly a positive for the company as it completes a regulatory hat-trick with clearances in the three areas that make up almost 90% of the global FFR market, Japan, Europe and now the U.S.