Opsens Receives dPR Clearance from the FDA

Thursday, December 19, 2019 Medical Gadgets
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Product approval will bolster U.S. commercial efforts  

QUEBEC CITY, Dec. 19, 2019 /CNW Telbec/ - Opsens Inc. ("Opsens" or the "Company") (TSX: OPS) (OTCQX: OPSSF) announces 510(k) clearance from the U.S. Food and Drug Administration ("FDA") to market its diastolic pressure algorithm ("dPR").

Coronary physiology has been in constant evolution with the expanded use of Fractional Flow Reserve ("FFR") and the support of strong clinical data and cardiology societies recommendations. More recently, the option for coronary physiology without hyperemia induced by the injection of heart stimulating drugs has emerged. Opsens has developed its proprietary diastolic pressure ratio (dPR) to meet this need. Non-Hyperemic Pressure Resting indices ("NHPR"), such as Opsens' dPR, are beneficial for some patients as they reduce procedure time, costs and discomfort.


Opsens is excited to offer its drug-free solution to the U.S. market. "This new feature is an important part of our U.S. market penetration plan. dPR has been a major factor in the significant growth of our revenues in other regions, where it is already approved. Opsens has experienced solid growth in the U.S. in recent quarters and this key new product will further support our growth plans." said Louis Laflamme, Opsens' President and CEO.

Dr Ziad Ali, MD, Columbia University Medical Center/New York-Presbyterian Hospital, is the first dPR user in the U.S. "Opsens' OptoWire is a pressure guidewire that differentiates from competitive products by its superior steerability and accuracy performance that are needed for longer, more complex cases. So far, the usage of the OptoWire was mostly limited to FFR measurements. Opsens' dPR has long been expected by our team. We were glad to use it today for several patients," said Dr Ali. "The staff enjoyed the speed and ease of use of the dichotomic single cut-off algorithm displayed on the OptoMonitor. Opsens' dPR index and dPR pullback are key additions to Opsens' portfolio for the diagnostic and treatment of patients with coronary diseases," concluded Dr Ali.

"Literature has shown that accuracy of pressure measurement is even more crucial for non-hyperemic indices. International cardiologists greatly appreciate the opportunity to combine our dPR with the OptoWire, which is known for its steerability and certainly for the unsurpassed accuracy of its 2nd generation pressure sensor. We are excited to bring our solution to the U.S. market where we expect even higher growth," concluded Mr. Laflamme. 

Opsens' dPR is approved in Japan, Canada, Europe and now the U.S.

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

Opsens focuses mainly on physiological measurements, such as 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 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 80,000 patients in more than 30 countries. It is approved for sale in the United States, European Union, Japan, and Canada.

Opsens is also involved in industrial activities in developing, manufacturing and installing innovative fiber 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.

SOURCE OPSENS Inc.



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