Quebec-based cardiology medical instrumentation company OpSens is making a new move at an opportune time as management prepares to meet influential cardiologists.
Posted at 12:00 p.m
OpSens has just received United States Food & Drug Administration (FDA) approval for use of its new guidewire in catheter-based aortic valve replacement procedures.
“We already had an approval in Canada, but the largest market is the American market,” says OpSens CEO Louis Laflamme.
Our product can have multiple functions, which can eliminate steps. It’s something that doesn’t exist today.
Louis Laflamme, CEO of OpSens
The OpSens SavvyWire Guidewire is advertised as a unique 3-in-1 solution for catheterizing prosthetic aortic valves, continuously measuring pressure during the procedure and providing ventricular pacing that does not require auxiliary devices or venous access.
This product opens the doors to a market worth more than $4 billion and offers a path that could increase the company’s sales from $35 million to $100 million by 2025, argues Stifel/GMP analyst Justin Keywood.
The thread does the job of several products, including reducing the duration of medical procedures, he points out.
As US regulatory approval reduces the risk associated with OpSens, this expert estimates that the Quebec company is more likely to become a takeover target by a major medical device company.
The American giant Edwards Lifesciences, whose shares are listed on the New York Stock Exchange, is the world’s largest manufacturer of aortic valves, but does not market a guidewire that allows its valves to be installed by catheter. That makes Edwards Lifesciences a natural buyer for OpSens, according to M Partners analyst Nicholas Cortellucci.
In the past, cardiologists performed open-heart surgery on patients with aortic valve problems. “They opened up the chest and went straight to the heart. The recovery time after such an operation is long. Catheter methods were developed to replace valves, and this is when this replacement method was gaining popularity,” explains Louis Laflamme.
The number of catheter-based aortic valve replacement procedures worldwide will double to 400,000 by 2027 as the population ages and studies show the benefits for more patients.
With 400,000 procedures, Nicholas Cortellucci points out that the market value would reach $10 billion.
OpSens management is meeting with distinguished 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 for cardiology,” says Louis Laflamme.
He adds that the company will begin “limited” marketing of its SavvyWire to “influential” physicians in the coming weeks.
OpSens shares rose 12% to $3.12 on the Toronto Stock Exchange on Thursday after announcing FDA approval. The stock had peaked above $3.70 last fall.