Mr. Thierry Dumas reports

OPSENS GRANTED APPROVAL TO SELL OPTOWIRE II IN JAPAN

Opsens Inc.'s Japanese partner has received Shonin approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) to sell the OptoWire II.

OptoWire II for improved navigation in the most tortuous and calcified vessels

In its quest to offer the most effective products to measure fractional flow reserve to cardiologists, Opsens has upgraded on its original OptoWire by adding a hydrophilic coating that improves navigation in the most tortuous and calcified vessels. This product, the OptoWire II, is following the regulatory path at an accelerated pace. Two weeks ago, Opsens announced receipt of CE marking, which grants permission to sell the OptoWire II in Europe. Clearance in the United States is expected shortly. Opsens's FFR products are designed to optimize the diagnostic and guide treatment in patients with coronary heart disease.

"We are constantly looking for new ways to improve on our products. The addition of a hydrophilic coating is an upgrade that facilitates navigation even more in tortuous and calcified vessels. OptoWire II makes assessment of complex coronary blockages easier and will help cardiologists decide whether patients require intervention or not. This ease of use could help promote the use of FFR further and widen access to this diagnostic method that improves patient outcomes and helps avoid unnecessary medical procedures," said Claude Belleville, vice-president, medical devices. "Shonin approval for the OptoWire II was a highly rigorous process as our product, which is intended to be inserted into the human body, near the heart, was scrutinized in depth to ensure patient safety. We have to credit the excellent work of our Japanese partner and of Opsens's team for this speedy receipt," Mr. Belleville added.

Receipt of Shonin approval launches expansion of commercial activities for FFR products

"Our Japanese partner, a player in interventional cardiology in Japan, is directing a well-organized distribution network that helped grow Opsens's FFR sales in the first quarter of fiscal 2016. Opsens expects that its sales will grow even more in the coming quarters, with an expansion of our commercial activities in the Japanese market and now that Opsens is taking measures to ramp-up production," said Louis Laflamme, chief executive officer and president of Opsens.

Opsens aims to become a key player in the guidewire FFR market with the OptoWire, a nitinol-based optical guidewire. The OptoWire provides intracoronary blood pressure measurements with unique, patented optical pressure guidewire technologies. It is immune to adverse effects related to blood contact, and allows easy and reliable connectivity that leads to reliable FFR measurements in extended conditions of usage. The OptoWire is also designed to provide cardiologists with a guidewire that provides optimal performance to navigate coronary arteries and cross blockages with ease and safety. Based on industry sources, the FFR market represented more than $300-million (U.S.) in sales in 2014 and is expected to reach $1-billion (U.S.) in the medium term.

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