A new step for OpSens | Press

OpSens, a Quebec company specializing in medical instrumentation in cardiology, is making a new move at an opportune time as management prepares to meet with influential cardiologists.

Posted on September 16

Richard Dufour

Richard Dufour

OpSens just received clearance from the US Food and Drug Administration (FDA) for use of its new guidewire in catheter-based aortic valve replacement procedures.

“We already had approval in Canada, but the biggest market is the US market,” says OpSens CEO Louis Laflamme.

Our product may have multiple features that can eliminate steps. It’s something that doesn’t exist today.

Louis Laflamme, CEO of OpSens

The OpSens SavvyWire Guidewire is promoted as a unique 3-in-1 solution for prosthetic aortic valve catheterization, providing continuous pressure measurement during the procedure and providing ventricular pacing that requires no assistive devices or venous access.

The product opens the door to a market worth more than $4 billion and offers a path that could allow the company to grow its sales from $35 million to $100 million by 2025, according to Stifel/GMP analyst Justin Keywood.

The fiber does the work of several products, including shortening the duration of medical procedures, he notes.

As approval by US authorities mitigates the level of risk associated with OpSens, this expert estimates that the Quebec company is more likely to become an acquisition target for a major medical device company.

Potential buyers

American giant Edwards Lifesciences, whose shares are listed on the New York Stock Exchange, is the largest maker of aortic valves in the world, but it does not market a guide wire that allows its valves to be installed with a catheter. According to M Partners analyst Nicholas Cortellucci, Edwards Lifesciences is a natural buyer for OpSens.

In the past, when a patient had problems with the aortic valve, cardiologists performed open-heart surgery. “They opened the chest and went straight to work on the heart. After such an operation, the recovery period is long. Catheter methods were developed to replace valves and that’s when this replacement procedure gained popularity,” explains Louis Laflamme.

The number of catheter-based aortic valve replacement procedures will double to 400,000 worldwide by 2027 due to an aging population and studies showing its benefits for more patients.

At 400,000 surgeries, Nicholas Cortellucci points out that the market value would reach $10 billion.

OpSens management is meeting with prominent cardiologists in Boston this weekend at the annual Transcatheter Cardiovascular Therapeutics (TCT) conference, where it will be able to raise awareness of its product.

“The timing of the FDA approval is excellent because it allows us to speak more freely. It is the most important American congress in cardiology,” says Louis Laflamme.

He adds that the company will launch “limited” marketing of its SavvyWire to “influential” doctors in the coming weeks.

Shares of OpSens rose 12% to $3.12 on the Toronto Stock Exchange on Thursday following the announcement of the FDA approval. The stock peaked above $3.70 last fall.

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