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Opsens Fiber Optic System Utilized by FFR Pioneers in Europe and Japan
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Opsens Medical

Opsens' OptoWire for FFR
Opsens' OptoWire for FFR
January 21, 2015 -- Opsens Inc. (TSXV:OPS) recently announced that its innovative entry into the fractional flow reserve (FFR) market, the OptoWire and OptoMonitor, received its first use in Europe. The OptoWire system was granted CE Mark approval back in November.

And the first use of this new system was significant in that the operator was one of the "founding fathers" of FFR, Dr. Bernard De Bruyne of the Cardiovascular Center Aalst in Belgium. Dr. De Bruyne, along with Dr. Nico Pijls of the Catharina Hospital, Eindhoven, the Netherlands, were first to describe the modern concept of fractional flow reserve (FFR).

Dr. De Bruyn
Dr. Bernard De Bruyne

So, it was significant to have Dr. De Bruyne say of his experience:

"It was a pleasure to use the OptoWire in several patients, some of them with complex disease. It allowed me to appreciate its impressive zero drift performance during all cases performed while also acknowledging the constant connection reliability as well as its support during percutaneous coronary intervention."

Reportedly, Dr. Nico Pijls will soon be utilizing the OptoWire in cases at Catharina Hospital.

Dr. Shigeru Saito
Dr. Shigeru Saito

And last month, the OptoWire system was demonstrated in Japan by Dr. Shigeru Saito at his 21st annual Kamakura Live Demonstration Course, who said:

"Opsens' FFR products fit very well with this vision given the important benefits that they provide for efficiency and effectiveness in the treatment of coronary lesions. It was a great experience for me to demonstrate this new FFR system and I intend to continue using it."

The Opsens story is an interesting one.

When talking about medical devices in development, one usually makes references to "what's in the pipeline." But, in the case of Opsens Inc., that reference is not metaphorical at all but quite literal. Opsens, Inc. is known for its fiber optic pressure and temperature sensing technology in the oil fields of Canada. And the company has miniaturized its technology and applied it to catheters and wires that can be threaded into the coronary arteries to help determine whether or not a blockage needs to be opened with a stent. Oil pipelines, blood pipelines: it's a matter of scale!

The press release from Opsens, Inc. follows:

Opsens Announces First Use of Its FFR Products in Europe with Dr. De Bruyne

January 12, 2015 -- Quebec City, Quebec -- Opsens Inc . ("Opsens ") (TSXV:OPS) is pleased to announce the first use of its Fractional Flow Reserve ("FFR") products in Europe by the "founding fathers" of FFR, namely Dr. Bernard De Bruyne at the Cardiovascular Center Aalst, Belgium and, shortly, by Professor Nico Pijls, at the Catharina Hospital, Eindhoven the Netherlands. The OptoWire and OptoMonitor are Opsens' products for FFR measurements to optimize the diagnosis and guide the therapy in patients with coronary heart disease.

"The arrival of an optical FFR guidewire such as the OptoWire on the market is positive for interventional cardiologists who need to obtain reliable FFR measurements. It was a pleasure to use the OptoWire in several patients, some of them with complex disease. It allowed me to appreciate its impressive zero drift performance during all cases performed while also acknowledging the constant connection reliability as well as its support during percutaneous coronary intervention", said Dr. Bernard De Bruyne from the Cardiovascular Center Aalst.

"Dr. Pijls and De Bruyne collaborated extensively to establish FFR as the gold standard in the evaluation of coronary lesions. Consequently, we are proud seeing Dr. De Bruyne, one of the most globally recognized cardiologists and an investigator in the FAME clinical studies on FFR, using our products in practice. Opsens already obtained regulatory approvals for Japan and Europe. We are now entering our commercial phase with a controlled launch with several institutions in Europe and Japan." said Louis Laflamme, President and CEO of Opsens.

Opsens aims at becoming a key player in the guidewire FFR market with the OptoWire, a nitinol-based optical guidewire for FFR. The OptoWire provides intra-coronary 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 delivering optimized performances 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.
Opsens focuses mainly on two large and growing markets: interventional cardiology with a focus on Fractional Flow Reserve ("FFR") and the oil and gas and industrial industry. In interventional cardiology, Opsens offers an advanced optical-based pressure guidewire that aims at improving the clinical outcome of patients with coronary artery disease. Opsens also develops, manufactures and installs innovative fibre optic sensing solutions for critical applications such as the monitoring of oil wells and other demanding industrial applications.

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.

Reported by Burt Cohen, January 21, 2015