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Classified in: Health, Science and technology
Subject: FDA

OPSENS ANNOUNCES FIRST SAVVYWIREtm PROCEDURE IN NEW ZEALAND


QUEBEC CITY, Nov. 29, 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 Dr. Sanjeevan Pasupati, Director of Structural Heart Disease & Cardiovascular Research at Waikato Hospital in Hamilton, New Zealand and his team, performed the first transcatheter aortic valve replacement (TAVR) procedures using SavvyWire in New Zealand.

The launch in New Zealand represents the third commercial market for SavvyWire, after the United States and Canada, which are covered by OpSens' direct sales force. OpSens considers entry into New Zealand to be of strategic importance, as cardiologists seek the latest technology solution, and this territory provides the perfect combination of conditions that will help OpSens validate its commercial distribution model and provide a footprint in the rapidly growing Pacific region.

"I am extremely pleased with the performance of the SavvyWire," said Dr. Pasupati. "We successfully treated patients with a variety of anatomies and levels of complexity including bicuspid valve, severe vessel tortuosity, horizontal aorta, failed prior surgical valve (valve-in-valve) using both balloon-expandable and self-expandable valves, and balloon valvuloplasty. There is no doubt the SavvyWire allowed us to optimize our efficiency and workflow, while maintaining excellent accuracy and patient safety. I am excited to collaborate with OpSens to bring this innovative technology to patients."

"We are honored that Dr. Pasupati and the structural heart team at Waikato Hospital performed the first series of SavvyWire procedures in New Zealand. Dr. Pasupati's prior work has been instrumental to the advancement and expansion of the TAVR field, and we are excited to be partnering with him and his team to streamline procedures and improve patient outcomes," said Louis Laflamme, President and CEO of OpSens. "This positive start confirms once more the value that SavvyWire brings to the rapidly-growing TAVR field."

SavvyWire is more than a wire, as the world's first and only sensor-guided TAVR solution. It uniquely provides a 3-in-1 solution for stable aortic valve delivery and positioning, continuous accurate hemodynamic measurement during the procedure, and reliable left ventricular pacing without the need for adjunct devices or venous access.

About OpSens Inc. (www.OpSens.com or www.OpSensmedical.com)

OpSens focuses mainly on 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 more than 200,000 patients in more than 30 countries. It is approved for sale in the United States, European Union, Japan, and Canada.

OpSens has recently received FDA clearance and Health Canada approval to commercialize the SavvyWire for transcatheter aortic valve replacement procedures (TAVR).

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.

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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