Opsens receives Health Canada approval for dPR intended for the diagnosis of coronary stenosis with the heart at rest

Tuesday, November 27, 2018 Heart Disease News
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QUEBEC CITY, Nov. 27, 2018 /CNW Telbec/ - Opsens Inc. ("Opsens") (TSX: OPS) (OTCQX: OPSSF)  announced today that it has obtained

approval from Health Canada to market its dPR Proprietary Resting Index,  which measures intracoronary pressure and establishes a diagnosis with the heart at rest to guide the treatment of patients with coronary heart disease. dPR stands for Diastolic
Pressure Ratio.

The measurement of Fractional Flow Reserve ("FFR") as a method of assessing intracoronary pressure is now the gold standard among medical professionals and has gained credibility and popularity following the publication of clinical studies demonstrating better clinical outcomes. This measurement is taken in the context where the heart is stimulated. Opsens' dPR has been developed to meet the demand by cardiologists for a way to measure intracoronary pressure with the heart at rest.

Medical publications have highlighted the equivalence of several algorithms using the measurement of pressure at rest. These publications are expected to accelerate the adoption of resting pressure measurement indices in the interventional cardiology community.

"We are pleased to now be able to offer our diastolic pressure ratio to Canadian cardiologists, who have shown great support for our FFR products," said Louis Laflamme, President and CEO of Opsens. "Accuracy of the pressure measurement becomes even more critical when pressure is measured with the heart at rest. The OptoWire is designed to provide the lowest drift in the industry. Now, combined with our resting index, it stands out for its accuracy and ease of use," added Mr. Laflamme.

"The approval of Opsens' dPR is a milestone, as it provides us access to a new growing segment of the market. dPR is now authorized for sale in Canada and Japan and is under review with regulatory agencies in the United States and Europe," concluded Mr. Laflamme.

About Opsens Inc. (www.opsens.com or www.opsensmedical.com)

Opsens focuses mainly on the measure of FFR and dPR in interventional cardiology. Opsens offers an advanced optical-based pressure guidewire that aims at improving the clinical outcomes of patients with coronary artery disease. Its flagship product, the OptoWire, is a second-generation fiber 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 50,000 patients in more than 30 countries. It is approved for sale in the United States, the European Union, Japan, and Canada.

Opsens is also involved in industrial activities in developing, manufacturing and installing innovative fibre optic sensing solutions for critical 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 nor its Regulation Services Provider (as that term is defined in the policies of the TSX) accepts responsibility for the adequacy or accuracy of this release.



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