Opsens - dPR Gets CE Marking to Sell in Europe

Published
Wednesday, January 9, 2019

Quebec City, Quebec, January 9, 2019 – Opsens Inc. (“Opsens” or the "Company") (TSX:OPS) (OTCQX:OPSSF) has been granted CE marking for its diastolic pressure algorithm (“dPR”). Opsens’ dPR algorithm has been designed to assess intracoronary pressure with the heart at rest to diagnose coronary disease without the injection of heart-stimulating medication. Opsens’ diastolic pressure ratio will work in combination with the OptoWire and the OptoMonitor.

The measurement of Fractional Flow Reserve (“FFR”), as a method of assessing intracoronary pressure, has gained credibility and popularity following the publication of clinical studies demonstrating its benefits for patients’ health. This measurement is done in the context where the heart is stimulated. With the expansion of the use of cardiac physiology, cardiologists have expressed a growing interest in measuring intracoronary pressure with the heart at rest. In addition, medical literature has demonstrated the equivalence of several algorithms using resting pressure measurement, which should accelerate the adoption of resting gradients.

"We are pleased to differentiate from most competitors and now offer a complete physiology solution with FFR and our dPR resting index to European cardiologists. Our customers appreciate our FFR technology that offers the lowest drift in the industry, and several were asking for a resting index and were impatient to perform this measure with our OptoWire," said Louis Laflamme, President and CEO of Opsens. "Pressure measurement accuracy is becoming even more critical for resting indices and cardiologists can count on the ease of use and the performance of our second-generation fiber optic pressure guidewire to deliver proper diagnostic to their patients," said Mr. Laflamme.

Opsens had already received approval and has begun to commercialize its proprietary resting index in Japan in July and Canada in November and can now offer it to European interventional cardiologists.

"The arrival of Opsens’ dPR is exciting because it allows us to access a part of the European market that was inaccessible to us before CE approval. We look forward to the completion of the regulatory process in United States in order to have our dPR available in all the major markets," 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 outcome of patients with coronary artery disease. Its flagship product, the OptoWire, is a 2nd-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, European Union, Japan, and Canada.

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.

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