Highlights from the TCT conference - potential for SavvyWire to become a "workhorse" guidewire
TSX: OPS | CAD 3.04 | Outperform | Speculative Risk | Price Target CAD 4.00
Sentiment: Positive
Our View: We attended the TCT conference in Boston this weekend where OpSens exhibited its new guidewire, SavvyWire (FDA approval received last week). The company also hosted a symposium titled: Lifetime Patient Management and the Importance of TAVR Hemodynamics on Sunday (18-Sep). The symposium featured moderators Drs Philippe Genereux and Martin B. Leon. The expert panel included leading global interventional cardiologists Drs Anita W. Asgar, Nicolas M. Van Mieghem, Thomas E. Waggoner, and David A. Wood. After attending the TCT conference and the symposium, we feel more confident on SavvyWire's ability to become a "workhorse" guidewire (as noted by two symposium presenters) in TAVR procedures. Although the company has indicated it will pursue a limited market release post FDA approval to attract additional KOLs, similar to the market strategy it adopted during the Canadian launch, we believe the ramp-up of SavvyWire should pick-up in H2/CY23 once the company implements a full commercial launch of SavvyWire in the US and more patient data are available.
Takeaways from TCT symposium: The docs presenting at the symposium believed SavvyWire could become a workhorse wire that should increase the efficiency of high-throughput practices. One key variable that will likely impact the adoption and ramp-up of SavvyWire in US TAVR procedures is the use of left ventricle (LV) pacing during TAVR. Currently, only 10% of US surgeons use LV pacing during TAVR procedures, while this percentage is significantly higher in Canada and Europe.
FDA approval for SavvyWire received: OPS received FDA clearance for SavvyWire last week (here). The company noted that it will initiate a limited market release to a select number of physician thought-leaders during the coming weeks. OPS has also submitted the regulatory filing for SavvyWire approval in Europe.
Dr. Leon proposes using SavvyWire as one of the guidewires in a new 4,000 patient trial. During the panel Q&A session, Dr. Leon proposed utilizing the newly approved SavvyWire as one of the guidewires in a soon to commence 4,000 patient trial to study pacing type and efficiency. While the data and outcomes would likely take several years to be generated, it could present a significant future opportunity for the device.
SavvyWire launch well-received in Canada; full commercial launch in Canada expected later this month: OPS received Health Canada approval for its new guidewire, SavvyWire, in Apr-22 and started the commercialization as a limited release. Management has noted the SavvyWire launch is being well-received by leading heart centres in Canada. On the last earnings call (14-Jul), OPS noted that ~40 CDN procedures had been completed since the limited rollout launch with no technical or safety issues. The company is planning a full commercial launch in Canada later this month.
Significant opportunity with the new guidewire. We see a strong opportunity related to OPS’s new TAVR guidewire (SavvyWire). In our view, SavvyWire could potentially become a workhorse guidewire 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, perform continuous pressure measurement, and also conduct rapid pacing simultaneously. We believe time/cost savings and efficacy benefits could allow OPS to ultimately command material TAVR guidewire supply in its current markets (US, Canada, EMEA, and Japan). Management has noted that the global TAVR market is currently estimated at ~200,000+ procedures and is expected to reach ~400,000 procedures by 2027.