Opsens Inc T.OPS

RBC

[retiredcf]

December 13, 2021

Outperform

Speculative Risk

Opsens Inc.

Announced approval submissions with US FDA and Health Canada for new guidewire (SavvyWire)

Our view: Opsens today announced that it has filed a 510(k) submission with the US FDA for its new guidewire (SavvyWire) to be used in TAVR procedures. The company has also made a separate submission with Health Canada. The submission timeline is ahead of the initial timeframe but in line with the timelines disclosed during the FQ4/21 earnings call (23-Nov) following the completion of the 20-patient in-man study. Opsens expects US approval for SavvyWire in late summer or fall of 2022. 

First impression:

Submission of SavvyWire with US and Canadian regulators: Opsens today announced that it has filed a 510(k) submission with the US FDA for the approval of its new guidewire (SavvyWire) to be used in TAVR procedures. The company has also made a separate submission with Health Canada. SavvyWire is a novel and advanced guidewire that has the ability to both deliver a valvular prosthesis while allowing for continuous hemodynamic pressure measurement. The submission timeline is ahead of the initial timeframe but in line with the timelines disclosed during the FQ4/21 earnings call on 23-Nov following the completion of the 20-patient in-man study. Opsens anticipates US approval for SavvyWire in late summer or fall of 2022. Management has highlighted the TAVR market is currently close to ~US$5B and is expected to reach $8B by 2025.

Additional trials may be conducted based on feedback from KOLs: During the FQ4/21 earnings call, Opsens noted that it might run additional clinical studies for SavvyWire based on the data from the 20-patient study and the feedback from discussions with KOLs. Management expects the cost of the trials to be in the range of ~$3MM-$5MM.

SavvyWire could potentially become a new standard of care as part of the TAVR procedure: Today, the TAVR procedure typically requires the use of an echocardiogram and pacemaker in addition to a guidewire. SavvyWire can deliver the valve and perform continuous pressure measurement simultaneously. We believe time/cost savings and efficacy benefits could allow OPS to ultimately command a 35-40%+ share of TAVR guidewire supply in its current markets (US, Canada, EMEA and Japan). For patients with symptomatic aortic valve stenosis, TAVR is a less invasive option vs. surgical replacement. TAVR is a ~US$4B+ global market which we estimate to grow at an 11-12% CAGR to ~US$7B by calendar 2025, with the number of procedures increasing from RBCe ~200K in 2020E to 300K+ in 2025E.

See our in-depth note here for more detail on our positive outlook for OpSens’s SavvyWire.

[tannin]

Thank retiredcf....RBC opines OPS could achieve 35-40% of TAVR mkt ( $4 billion now, 7 in '25 )... omgosh....omgosh

[GoldenArm]

I hope they have more good news soon. I got in again but watching the slide to sub $3

[tannin]

Hope your feeling happier today GoldenArm. Imo, way underpriced.....

[GoldenArm]

Yeah better. I've was in the stock when it was under $2 and sold when it went over $2 because of another opportunity which paid off. Now I'm back and if this company gets on Nasdaq main board then we'll see double digits. They continue to perform and everything looks solid.