Opsens receives FDA 510(k) clearance for the OptoWire II

Opsens Inc. (TSXV: OPS, OTCQX: OPSSF) announced the 510(k) clearance from the U.S. Food and Drug Administration  for the OptoWire II, an optical guidewire developed to measure Fractional Flow Reserve (“FFR“). FFR measurement is used for the diagnostic of the severity of coronary stenosis for guiding the treatment of patients with coronary artery disease.
According to the news:

Opsens had already received FDA clearance to sell the OptoWire I, the first generation of its optical guidewire. This approval allows Opsens to market the OptoWire II in the world’s largest market. The OptoWire II is a new design comprising a hydrophilic coating that further improves the performances of the guidewire in different scenarios, such as in highly calcified and tortuous vessels. The OptoWire II should foster the acceptance rate of Opsens’ optical guidewire.

Louis Laflamme, President and Chief Executive Officer of Opsens commented:

Obtaining 510(k) clearance is a significant milestone in our plan to expand the commercialization of our FFR products. In the past few months, we have taken the necessary steps for a successful launch in the U.S. and in other targeted markets. Specific to the American market, we brought together a strong team with experience and expertise in the sale of FFR products in the U.S. The team has started to deploy our sales and marketing strategy that will lead to the full product launch in the U.S. territory. Also, we are glad to report that we have now successfully completed our move into a new state-of-the-art facility that will allow us to increase production and meet the growing demand for our FFR products,” Laflamme added. “After a few weeks of relocation activities, production will resume soon. This short break will temporarily affect Opsens’ revenue growth, but it is a necessary step to bring forward our long term plan.

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