OpSens to unveil the SavvyWire, the first and only sensor-guided Transcatheter Aortic Valve Replacement (TAVR) solution

OpSens will present its latest innovations including the SavvyWire, at booth 743, and sponsor a scientific breakfast Satellite Program presented by an expert panel of leading, global interventional cardiologists on September 18 , at 6:30 AM ET

QUEBEC CITY , Sept. 14, 2022 /CNW Telbec/ - 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 will present its latest innovations and sponsor a scientific program at Transcatheter Cardiovascular Therapeutics (TCT) September 16-19, 2022 , held at the Boston Convention and Exhibition Center in Boston , MA. The TCT is an annual scientific symposium of the Cardiovascular Research Foundation (CRF) and the premier educational meeting specializing in interventional cardiovascular medicine, attracting more than 10,000 attendees from over 90 countries around the world.

Visit OpSens at booth 743 at the Boston Convention and Exhibition Center to experience and learn firsthand more about its latest innovations, including the SavvyWire™ (SavvyWire), OptoWire™ III, OptoMonitor 3, and TAVR software.

OpSens will also be sponsoring a scientific breakfast Satellite Program titled: Lifetime Patient Management and the Importance of TAVR Hemodynamics, on Sunday, September 18, 2022 , from 6:30 AM to 7:30 AM ET in Presentation Theater 1, Room 052, Exhibition Level, Boston Convention and Exhibition Center. The symposium will feature moderators Drs Philippe Genereux and Martin B. Leon . The expert panel of leading, global interventional cardiologists include Drs Anita W. Asgar , Nicolas M. Van Mieghem , Thomas E. Waggoner, and David A. Wood .

OpSens to Unveil the SavvyWire, the First and Only Sensor-Guided Transcatheter Aortic Valve Replacement (TAVR) Solution

During the TCT 2022 OpSens will unveil the SavvyWire, the first and only sensor-guided TAVR solution, designed to optimize TAVR workflow and support lifetime patient management. The SavvyWire enables significant TAVR procedural benefits by supporting multiple steps over the same device without exchange, while delivering continuous, accurate hemodynamic measurements and display.

SavvyWire - Approved by Health Canada, Pending Clearance from U.S. FDA

OpSens' SavvyWire was submitted in December 2021 for 510(k) regulatory clearance from the U.S. Food & Drug Administration (FDA). Upon clearance of the SavvyWire, OpSens will begin a limited market release in the United States . The SavvyWire received approval from Health Canada in April 2022 and is being well-received by leading heart centers in Canada . OpSens is planning a full commercial launch of its SavvyWire in Canada later this month.

"OpSens has designed the SavvyWire to help drive continued optimization of TAVR procedures without compromise, focusing on incorporating critical functions on the guidewire powered by our patented premier Fidela™ second generation fiber optic sensor technology," said Louis Laflamme , President and Chief Executive Officer of OpSens.

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.

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