BioTuesdays

OpSens files 510(k) submission for new guidewire for TAVR procedure

OpSens (TSX:OPS; OTCQX:OPSSF) filed a 510(k) submission with the FDA for regulatory clearance of its new SavvyWire guidewire for transcatheter aortic valve replacement, or TAVR procedures. OpSens previously filed for approval with Health Canada. “The SavvyWire has been designed and developed to improve the workflow in transcatheter aortic valve replacement,” Louis Laflamme, president and CEO of OpSens, said in a statement.

“The introduction of a novel and advanced guidewire that has the ability to both deliver a valvular prosthesis while allowing continuous hemodynamic pressure measurement during the procedure is considered to be a significant benefit to the medical community, especially given the rapid growth in TAVR procedures,” he added.

“We look forward to the agencies review of our application and will continue to prepare our organization for an anticipated approval in late summer or fall of 2022,” Mr. Laflamme said. 

In a new report, Raymond James analyst, Rahul Sarugaser, Ph.D., predicted a $5-billion market for the TAVR opportunity, growing to $10-billion by 2028.

“While we expect today’s news to impel significant momentum in the stock, now that FDA and Health Canada submissions have been made, the next potential catalysts—approvals from these agencies—are four-to-six months away, so with a few quiet news months ahead, there is potential for a short-term drift downward in OpSens stock,” Dr. Sarugaser said.

“Given our strong conviction in the likelihood of these approvals, the $10-billion total addressable market of the TAVR opportunity, plus a possible acquisition by one of the bigger players at any time, we recommend clients use any stock price weakness over the next few months as an opportunity to add positions,” Dr. Sarugaser added.

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