Opsens receives FDA approval of OptoWire III - Improved handling and lower cost of production
Opsens receives FDA approval of OptoWire III
improved handling and lower cost of production
Quebec City, Quebec, January 13, 2020 – Opsens Inc. (“Opsens” or the “Company”) (TSX:OPS) (OTCQX:OPSSF) today announced 510(k) clearance from the U.S. Food and Drug Administration (“FDA”) to market its OptoWire III, a coronary pressure guidewire for physiological measurements such as Fractional Flow Reserve (“FFR”) and Diastolic Pressure Ratio (“dPR”). The OptoWire III is the latest version of OptoWire.
The OptoWire family of products are used to diagnose and guide the treatment of patients with coronary heart disease.
“Opsens is pleased to receive this important regulatory approval as we continue to optimize both the performance and production of our flagship product family.” said Louis Laflamme, President and Chief Executive Officer of the Company. “Physicians will appreciate a design with increased maneuverability, strength and a shorter flexible tip, particularly in challenging and complex cases.” added Mr. Laflamme. “In addition to design and mechanical improvements, Opsens has also improved the efficiency of the manufacturing process of its flagship product, which will result in improved gross profit margins going forward,” Mr. Laflamme added.
Dr Morton Kern, MD, MSCAI, FACC, FAHA, Chief of Medicine at Long Beach VA Medical Center, California, has extensive experience with the OptoWire II. He was the first interventional cardiologist to use the OptoWire III in the U.S. “I have been using the OptoWire for many years and consider it to be the best pressure guidewire on the market to access, measure, treat and confirm percutaneous coronary interventions (“PCI”) in patients with coronary disease,” said Dr Kern. “The OptoWire III provides unexpected improvements over the OptoWire II – steerability is on par with workhorse guidewires while providing even more accurate and sustainable measurements. I also appreciate the ability to measure a variety of indices from FFR to Non-Hyperemic Pressure Ratios such as Opsens dPR,” added Dr Kern. “I am a firm believer in coronary physiology pre- and post-PCI, and although usage has remained limited mostly due to device limitations. This product is unique and further supports what the clinical studies and medical societies recommend,” concluded Dr Kern.
Securing 510(k) is an important step in Opsens’ plan to grow revenues in the U.S., as the Company is constantly improving its products to increase penetration in the U.S. and other targeted markets.
In addition to the United States and Canada, Opsens has also filed applications for approval in Japan, and Europe.
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 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.
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