OPSENS RECEIVES dPR CLEARANCE FROM FDA
Opsens Receives dPR Clearance from the FDA
Product approval will bolster U.S. commercial efforts
Quebec City, Quebec, December 19, 2019 – 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 new dichotomic single cut off algorithm approval will further support our growth plans.” said Louis Laflamme, Opsens’ President and CEO.
Dr Ziad Ali, MD DPhil, 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 itself by its superior steerability and accuracy. So far, the usage of the OptoWire has been limited to FFR measurements. We are glad to see the availability of a resting index on Opsens technology.” said Dr Ali. “The team appreciated the speed and ease of use of a physiological assessment without the use of adenosine and the OptoMonitor display that was clear and easy to use. Opsens’ dPR resting index and dPR pullback are major additions to the Opsens’ portfolio,” 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.
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.
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For further information, please contact:
Louis Laflamme, CPA, CA, Chief Executive Officer, 418.781.0333
Robin Villeneuve, CPA, CA, Chief Financial Officer, 418.781.0333