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Opsens Inc
Symbol OPS
Shares Issued 90,599,942
Close 2021-02-18 C$ 1.77
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Opsens receives CE marking for OptoWire III

2021-02-18 09:51 ET - News Release

Mr. Louis Laflamme reports

OPSENS OBTAINS CE MARKING FOR THE OPTOWIRE III

Opsens Inc. has received CE marking for the OptoWire III, the latest generation of its flagship product. CE Marking allows the OptoWire III to be marketed in the European Union, the Middle East and Africa (EMEA).

"We are pleased to obtain CE mark approval for the OptoWire III in EMEA," said Louis Laflamme, president and chief executive officer of Opsens. "This is another milestone for the company. Thanks to the OptoWire's new design, our guidewire is even more user friendly and reliable, which may increase its adoption with EMEA physicians and expand the assessment of cardiovascular artery stenoses using indices like fractional flow reserve (FFR) and diastolic pressure ratio (dPR). This could result in better diagnoses and treatment for more patients," concluded Mr. Laflamme.

Prof. Pim Tonino, at Catharina Hospital in Eindhoven (the Netherlands), has extensive experience with all the pressure guidewires in the market and particularly with the OptoWire Deux. He is the first interventional cardiologist to use the OptoWire III in Europe. "I have been using the OptoWire for many years and I consider it an excellent pressure guidewire to access coronary lesions, measure their severity with great accuracy, treat them when indicated and confirm effectiveness of the percutaneous coronary interventions (PCI). The OptoWire III provides steerability comparable to workhorse guidewires while providing even more accurate, reliable and repeatable measurements. I also appreciate the possibility it offers to measure a variety of indices from FFR to non-hyperemic pressure ratios such as Opsens's dPR," he added.

"I am a firm believer in coronary physiology pre- and post-PCI," commented Dr. Piroth Zsolt from Goki Hospital in Budapest (Hungary). "Usage of pressure guidewires has remained limited worldwide mostly due to device limitations. This wire is really unique and further supports what the clinical studies and medical societies recommend," concluded Dr. Zsolt.

Accurate assessment of the severity of coronary artery disease is essential and pressure guidewires have been shown to improve clinical outcomes when used to diagnose coronary artery stenosis. Based on Fidela, Opsens's second-generation fibre optic sensor, the company has developed the OptoWire III, the most-efficient pressure guidewire in the industry, a product that fulfills several unmet needs of cardiologists for their most complex cases and their demands for performance, accuracy and reliability.

Since the launch of the first OptoWire version, Opsens has continued and will continue to invest in research to further develop its product and offer a choice between hyperemic indices, such as FFR, which is performed while the heart is stimulated by the injection of medication and non-hyperemic indices, such as dPR, a measurement performed without heart stimulation and where accuracy is of the utmost importance.

About Opsens Inc.

Opsens focuses primarily on coronary artery stenosis measurement in interventional cardiology. The company offers an advanced optical-based pressure guidewire that aims at improving the clinical outcome of patients with coronary artery disease. Its flagship product, the OptoWire, is a second-generation fibre optic pressure guidewire designed to provide the lowest drift in the industry and excellent lesions access. The OptoWire has been used in the diagnosis and treatment of over 100,000 patients in more than 30 countries worldwide. It is approved for sale in the United States, Japan, Canada, Europe, Middle East and Africa.

Opsens is also involved in industrial activities in developing, manufacturing and installing innovative fibre optic sensing solutions for critical applications.

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