Quebec City, Quebec, April 26, 2022 – OpSens Inc. (“OpSens” or the “Company”) (TSX:OPS) (OTCQX:OPSSF), a medical device cardiology-focused company delivering innovative solutions based on its proprietary optical technology, today announced that it has received Health Canada approval for the SavvyWire™, its new guidewire for transcatheter aortic valve replacement procedures, or TAVR.
“For OpSens, Health Canada’s approval is an important milestone on the path to the commercialization of the SavvyWire, which was specifically designed and developed to facilitate the procedure for transcatheter aortic valve replacement,” commented Louis Laflamme, President and CEO of OpSens. “The introduction of a next-generation guidewire with the ability to deliver a prosthetic valve and designed for rapid-pacing while allowing continuous measurement of hemodynamic pressure during the procedure is considered a significant benefit as the number of TAVR procedures is rapidly growing. We are prepared to initiate a phased commercialization in Canada over the coming months with a full launch expected toward the back half of 2022,” concluded Mr. Laflamme.
The SavvyWire, a third-generation, intelligent, pre-shaped, structural guidewire with integrated pressure monitoring, aims at improving procedural efficiency and clinical outcomes by allowing multiple steps over the same device without exchange. This device is designed to support the growing minimalist TAVR approach. With the SavvyWire, physicians can expect to implant the percutaneous valve over the same device while obtaining continuous and accurate hemodynamic measurements to assist their diagnosis.
The Evolution of TAVR
Aortic valve stenosis occurs when the heart’s aortic valve narrows, preventing it from opening completely and restricting blood flow from the heart to the main artery (aorta) and then to the rest of the body.
The TAVR procedure was initially only indicated for inoperable patients with severe symptomatic aortic stenosis, and later for patients at high surgical risk. Clinical programs such as PARTNER and COREVALVE have since shown better or equivalent clinical outcomes in intermediate and low surgical risk patients. The TAVR procedure is rapidly evolving toward a minimalist approach that advances the procedure and allows patients to leave the hospital earlier, sometimes the same day.
The TAVR procedure is growing rapidly globally, driven by the aging population and recent studies that demonstrate its benefits for a broader array of patients. The global TAVR market is currently estimated at over 200,000 procedures and is expected to reach 400,000 in 2027.
About OpSens Inc. (www.OpSens.com or www.OpSensmedical.com)
OpSens focuses mainly in interventional cardiology. The Company 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 150,000 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.
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
