TSX: OPS | CAD 2.84 | Outperform | Speculative Risk | Price Target CAD 3.50
Sentiment: Neutral
Our view: We attended the TCT conference in San Francisco this week, where OPS exhibited its newly approved guidewire, SavvyWire. The company also hosted a symposium titled: Minimalistic TAVI with SavvyWire: Optimizing without Compromising on Wednesday (10/25). The symposium featured moderator Dr. Philippe Genereux (Morristown Medical Center) along with speakers including Dr. Ander Regueiro (Hospital Clinic de Barcelona), Dr. James Harvey (WellSpan York) and Dr. Samuel Horr (Centennial Heart). After attending the TCT conference and the symposium, we remain confident in SavvyWire's positioning and the growth of the TAVR market to 2025 and beyond. However, we label sentiment Neutral as stock direction will be tied to the sale process, in our view. Separately, as OPS set the shareholder vote for Dec 1 (record date is today), the circular should be out in next ten days, suggesting we are likely to see it later next week.
Takeaways from TCT symposium: The docs presenting at the 2022 symposium last year believed SavvyWire could become a workhorse wire that should increase the efficiency of high-throughput practices. A year later, physicians indicated this was still the case and mentioned it was being used in a wide variety of cases (including difficult calcified situations) and the physicians have noted increasing confidence in the wire and its efficiencies to their practices. Dr. Genereux noted that instead of his day finishing at 6pm, the team can now finish 1-2 hours earlier with the same number of cases (he also noted the ability to complete 12 cases a day in two rooms given the efficiency). Last year, we highlighted one key variable that would likely slow the adoption and ramp- up of SavvyWire in US TAVR procedures which was 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. We expect this to change over time, especially given data such as those generated in the SAFE-TAVI trial and published recently. (see highlights below). Dr. Genereux expects that US TAVR procedure volumes should shift to LV pacing over time given its benefits over RV pacing, and expects significantly higher share of TAVR procedures using LV pacing in the next two years. Interestingly, he also noted that TAVR growth is likely to accelerate in 2025/2026 as more TAVR in TAVR and TAVR in SAVR occur.
Positive clinical results from the SAFE-TAVI study conducted in Europe. OPS announced positive clinical results from the SAFE-TAVI study. The clinical results were presented on Wednesday (10/24) by Dr. Ander Regueiro from the Hospital Clinic Barcelona, during an emerging clinical science and research session at the TCT. Dr. Regueiro noted the successful use of SavvyWire in a large variety of anatomies, implanting valves from all major companies including Edwards Lifesciences, Medtronic, Abbott, Boston Scientific, and Meril Life.
The SAFE-TAVI study was a prospective, multicenter study to evaluate left ventricular (LV) rapid pacing using SavvyWire in transcatheter aortic valve implantation (TAVI) procedures, in a real-world patient population. A total of 121 patients (mean age: 82.2±5.9 years, 50% women) were included in the study and 119 (98.3%) patients were finally treated with SavvyWire. SavvyWire was used for left ventricular (LV) pacing to evaluate the potential benefits of eliminating the need for venous access, reducing procedure time, and avoiding potential complications associated with right ventricular (RV) pacing.
The SAFE-TAVI study demonstrated that pacing with the SavvyWire led to a significant reduction of systolic aortic pressure below 60mmHg in 98.3% of patients, along with successful valve positioning in 99.2% patients. In combination with the OptoMonitor 3, the SavvyWire enabled invasive hemodynamic assessment without any additional catheter exchanges in 99.2% patients. From a safety perspective, 99.2% of patients were also free from major complications related to SavvyWire, with only one case of pacing loss due to movement of the wire during deployment, which other physicians noted can be easily corrected. The results were published in JACC: Cardiology Interventions (here). The SAFE-TAVI clinical study was conducted as part of CE Mark clinical strategy for the commercialization of SavvyWire in Europe. Management has previously noted EU approval of SavvyWire by end of CY23 and stood by this outlook when discussed today.
Significant opportunity with the newly approved guidewire. We see a strong opportunity related to OPS’s newly approved TAVR guidewire (SavvyWire). Today, the TAVR procedure typically requires the use of an echocardiogram and rapid pacing in addition to a guidewire. SavvyWire provides a 3-in-1 solution for stable aortic valve delivery and positioning, continuous accurate hemodynamic measurement during the procedure, and left ventricular (LV) pacing without the need for adjunct devices or venous access, making it a first in class TAVR guidewire to carry out all three procedures simultaneously. We believe time/cost savings and efficacy benefits could allow SavvyWire to ultimately command material TAVR guidewire share. Management estimates global TAVI (TAVR) market to exceed 600,000 procedures by 2030.