Health Canada clears first-in-man study of OpSens guidewire

OpSens (TSX:OPS; OTCQX:OPSSF) received Health Canada’s approval to begin a first in-man study with its SavvyWire, a guidewire developed specifically for transcatheter aortic valve replacement (TAVR). 

The SavvyWire is the first guidewire intended to both deliver the aortic valve prosthesis while allowing continuous hemodynamic pressure measurement during the procedure.

“The SavvyWire has the potential to bring important innovation to physicians performing the TAVR procedure and could become a key advancement in performing the procedure,” Louis Laflamme, president and CEO of OpSens, said in a statement.

Studies have demonstrated the benefits of TAVR to a wide range of patients with severe aortic stenosis. Aortic valve stenosis occurs when the heart’s aortic valve narrows, which prevents the valve from opening fully, restricting blood flow from the heart into the aorta and to the rest of the body.

Mr. Laflamme said Health Canada’s approval is an important milestone for the company and an important step towards filing for 510(k) clearance with the FDA. “We remain on track to submit for regulatory approval in the United States in early 2022,” he added.

OpSens plans to begin a 20-patient study shortly at two cardiology institutions that contributed to the development of the SavvyWire.  Dr. Josep Rodés-Cabau at The Quebec Heart and Lung Institute Research Centre and Dr. Réda Ibrahim at The Montreal Heart Institute will be primary investigators.

Separately, Raymond James analyst, Rahul Sarugaser, Ph.D., raised his price target for OpSens to $6 from $2.75. The stock was quoted at $2.59 near mid-day on Sept. 20.

Dr. Sarugaser said Edwards Lifesciences (NYSE:EW) has a two-thirds share of the TAVR market, but no guidewire to place its own valves, suggesting Edwards could be a “natural acquirer of OpSens.” As a result, cardiologists tend to use primarily Medtronic and Boston Scientific guidewires to place Edwards’ valves.

While OpSens has a steady underlying business marketing its pressure-sensing FFR technology, particularly with large U.S. group-purchasing organization contracts gaining traction, “we see OpSens accessing the fast-growing TAVR market with its superior, first-in-class SavvyWire device as a transformative opportunity for the company,” Dr. Sarugaser said.