OpSens, a Quebec-based medical device specialist in cardiology, is taking a new step at an opportune time as management prepares to meet influential cardiologists.
Posted on September 16
OpSens has just received approval from the United States Food and Drug Administration (FDA) for the 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 more features that can eliminate steps. That’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 does not require assistive devices or venous access.
This 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 analyst Justin Keywood of the firm Stifel/GMP.
Konac does the work of several products, including reducing the duration of medical procedures, he points out.
Since the approval of the US authorities reduces the level of risk associated with OpSens, this expert estimates that the likelihood of the Quebec company becoming a target for acquisition by a major medical device company is increasing.
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 does not sell the guide wire that allows its valves to be implanted with a catheter. That’s what makes Edwards Lifesciences a natural buyer for OpSens, according to M Partners analyst Nicholas Cortellucci.
In the past, when a patient had aortic valve problems, cardiologists performed open-heart surgery. “They opened the chest and went directly to work on the heart. The recovery period after such an operation is long. Catheter methods were developed to replace the valves and then this replacement procedure became popular,” explains Louis Laflamme.
The number of catheter-based aortic valve replacement procedures is expected to double to 400,000 worldwide by 2027 due to an aging population and studies showing its benefits for more patients.
At 400,000 procedures, 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 they will be able to raise awareness of their product.
“The timing of FDA approval is great 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 begin “limited” marketing of its SavvyWire to “influential” doctors in the coming weeks.
Shares of OpSens rose 12% to $3.12 on Thursday in the Toronto Stock Exchange after the announcement of the FDA approval. Shares peaked at over $3.70 last fall.