Opsens Inc T.OPS

Healthcare Medical Devices

OpSens Inc. is a medical device cardiology-focused company. The Company offers an advanced optical-based pressure guidewire that aims at improving the clinical outcome of patients with coronary artery disease. The Company’s segments include Medical and Industrial. The Medical segment focuses on physiological measurements, such as Fractional Flow Reserve (FFR) and Diastolic Pressure Ratio (dPR) in the coronary artery disease market and also supplies a range of miniature optical sensors to measure pressure and temperature to be used in a range of applications that can be integrated into other medical devices. The Industrial segment develops, manufactures and installs fiber optic sensing solutions for critical and demanding industrial applications. Its flagship product, the OptoWire, is a second-generation fiber optic pressure guidewire designed to provide the lowest drift in the industry and lesions access. It is approved for sale in the United States, European Union, Japan and Canada.

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Opsens Inc > RBC

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Post by retiredcfon Dec 14, 2021 8:47am

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Post# 34228153

RBC

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.

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