Opsens Inc. (OTCQX:OPSSF) Q4 2022 Earnings Conference Call November 22, 2022 11:00 AM ET
Company Participants
Robert Blum – Lytham Partners, LLC
Louis Laflamme – President and Chief Executive Officer
Robin Villeneuve – Chief Financial Officer
Conference Call Participants
Rahul Sarugaser – Raymond James Ltd.
Justin Keywood – Stifel Nicolaus Canada Inc.
Douglas Miehm – RBC Capital Markets
Scott McAuley – Paradigm Capital
Operator
Good morning, and welcome to the Opsens Incorporated Fourth Quarter and Fiscal Year 2022 Financial Results. All participants will be in a listen-only mode today. [Operator Instructions] After today’s presentation, there will be an opportunity to ask questions. [Operator Instructions] Please note that this event is being recorded.
I would now like to turn the conference over to Robert Blum with Lytham Partners. Please go ahead, sir.
Robert Blum
All right. Thank you very much and thank you all for joining us today for the Opsens fourth quarter fiscal year 2022 conference call for the period ending August 31, 2022.
With us on the call representing the Company today are Louis Laflamme, Opsens’ President and Chief Executive Officer; and Robin Villeneuve, Opsens’ Chief Financial Officer. At the conclusion of today’s prepared remarks, we will open the call for a question-and-answer session.
Before we begin with prepared remarks just a couple of comments. Today’s call will contain forward-looking statements that are based on current assumptions and are subject to risks and uncertainties that could cause actual results to differ materially from those projected and the Company undertakes no obligation to update these statements, except as required by law.
Information about these risks and uncertainties are included in the Company’s filings, as well as periodic filings with regulators in Canada and the United States, which you can find on SEDAR and Opsens’ website. In addition, the Company will be providing certain information on number of accounts and units shipped to SavvyWire for informational purposes on the initial launch, but will not necessarily be provided on a go-forward basis.
Today’s discussion will include adjusted financial measures, which are non-IFRS measures. These should be considered as a supplement to and not as a substitute for IFRS financial measures.
Finally, today’s event is being recorded and will be available for replay through both the webcast and conference call dial-in information provided in the press release.
With that said, let me turn the call over to Louis Laflamme, President and Chief Executive Officer for Opsens. Louie, please proceed.
Louis Laflamme
Thank you, Robert, and good morning to all of you. Opsens is entering into a new era, which is making us excited to speak with you today to discuss the developments within the business. Let me also take a minute to greet the French speaking audience. [Foreign Language]
This is an exciting call for us today because it marks the beginning in many ways of the next phase of growth for Opsens, following the recent regulatory clearances in the U.S. and Canada for our SavvyWire, an innovative guidewire for TAVR. This is a tremendous opportunity for Opsens in the U.S. and in Europe to improve outcomes with a new treatment that improves workflows for [cardiologists].
As we enter fiscal 2023, Opsens will be moving forward with a much stronger platform having two leading synergic products; OptoWire and SavvyWire, targeting similar interventional cardiology customers. The SavvyWire is providing Opsens with the new opportunity in the large and quickly growing TAVR market.
The TAVR market is growing at a CAGR of more than 40% between 2019 and 2025 with analysts expecting it to reach 8 billion by 2025. The global TAVR market is currently estimated at over 200,000 procedures annually and is expected to double in the next five years with the trend of expanding to younger cardiology patients with this minimally invasive procedure.
So as I mentioned this really is the beginning of Opsens’ next phase of growth. Our long-term goal is commercial adoption by cardiologists with the movement towards SavvyWire becoming the gold standard treatment option for patient undergoing TAVR procedures. Given the technological advantages that SavvyWire processes has the first and only Sensor-Guided TAVR solution, including its unique 3-in-1 ability for stable aortic valve delivery and positioning, continuous accurate hemodynamic measurement during the procedure, and the ability to provide reliable left ventricular pacing without the need for adjunct devices or venous access becoming the standard treatment option is highly reasonable in our opinion.
However, it’s not our opinion that matters. It is that of physicians, industry leaders in cardiology. From the time that SavvyWire was first introduced into the market, the feedback has been universally positive as Dr. Philippe Genereux, Director of the Structural Heart Program at Morristown Medical Center in New Jersey, whose team performed the first use of SavvyWire in a TAVR procedure in the United States. Commented, we successfully treated 10 consecutive patients with a variety of anatomies and levels of complexity, including bicuspid valve, severe vessel tortuosity, horizontal aorta, failed prior surgical valve, valve-in-valve, using both balloon-expandable and self-expandable valves, and balloon valvuloplasty. There is no doubt the SavvyWire allowed us to optimize our efficiency and workflow, while enhancing accuracy and patient safety.
Doctors in Canada have had similar feedback with Dr. Rodés-Cabau at Quebec Heart and Lung Institute, commenting that the SavvyWire optimized the intervention in line with the evolution of TAVR via the minimally approached. The SavvyWire has unique properties that open the door to effective pacing without the need for adjunctive devices or venous access and Dr. Ibrahim at the Montreal Heart Institute saying that the SavvyWire allows me to have an efficient workflow while providing continuous and accurate hemodynamic measurements in an integrated manner in our cath lab.
Opsens products supports our return to the accuracy of invasive pressure measurement while making the procedure safer and more efficient. Beyond these positive comments, the SavvyWire was clearly one of the stars of the TCT conference, which was held in Boston in mid-September. We hosted a breakfast Satellite Program titled, Lifetime Patient Management and the Importance of TAVR Hemodynamics. The symposium features moderators, doctors, Philippe Genereux and Martin Leon. The expert panel of leading, global interventional cardiologists include Drs Anita Asgar, Nicolas Van Mieghem, Thomas Waggoner, and David Wood. They described SavvyWire real life experiences, procedural benefit, and discussed other potential views for SavvyWire outside TAVR procedure.
So with that as a backdrop, let’s expand on our SavvyWire commercialization process and the progress made in just the first few months. We completed the 60 initial cases as part of the limited market release in Canada ahead of our original expectations. The excitement from the physician community has been excellent, but most importantly during the limited market release is that the SavvyWire showed excellent device performance while improving workflows. We have now transitioned to an expanded, but still highly controlled market release in Canada. We want to make sure to fine tune the rollout process, including training, installation of monitors in operating room, coordination with administration to ultimately achieve maximum penetration in account.
As of today, we have launched SavvyWire to nine accounts in Canada. We are close to 200 units shipped so far. Most of the time for initial customer orders, we ship about 10 to 20 units in the first order, so far more than half of the customer have already placed a reorder. This is a strong indicator that they are utilizing the product and having success, giving us confidence, we are achieving better than expected market acceptance.
Operationally, our direct sales team in Canada has been systematically going from hospital-to-hospital due to the capabilities of the SavvyWire. The company has been obtaining pricing at or above our original expectations so far. Further, we have heard commentary that due to the OptoMonitor now being able to support both OptoWire and the SavvyWire, it is improving the decision making process for adoption and installation that much easier and it is exactly in line with the strategy we have discussed over the years.
This is a bit more relevant for the future of the U.S. market, but it is a good marker for Canada as well. This supports our long-term commercialization vision to sell multiple products to the same customer group and is part of the reason we have made the investment of late into our sales and marketing efforts.
Let’s now transition to the U.S. where we receive regulatory 510(k) clearance by the FDA in mid-September. Since obtaining clearance about eight weeks ago, we have now entered and completed our limited market release phase in the U.S. As you may recall, I mentioned last quarter as opposed to just two or three centers in Canada conducting the limited market release. We have broadened our focus in the U.S. with additional procedure center conducting procedure with a goal to have more than 60 cases completed in the U.S. before we move to Phase I of commercial release.
We are now moving to the next stage of our controlled commercialization where we have already extended commercialization to close to 10 centers. Everything has gone well as we are entering the wave one of the full market release. We are well in advance of the plan that we have been communicating to you for the past few quarters regarding our commercialization efforts.
In summary for U.S., nine accounts close to 200 units sold, strong pricing overall commercialization status well in advance to the original schedule. With the next stage of commercialization in Canada and the U.S. moving full steam ahead, our team is also turning its attention to Europe. In late October, we announced the successful completion of the first cases in a clinical study, named SAFE-TAVI, studying SavvyWire in Europe. This study is part of our pre-CE mark clinical strategy that will lead to the commercialization of SavvyWire in Europe. Overall, 14 cases have already occurred in Europe. Please recall that the SAFE-TAVI study will enroll 120 patients in total. So we are well on our way.
In summary of SavvyWire, we are well ahead of our commercialization plan originally communicated to all of you, including having received Canadian and U.S. clearance ahead of expectations, launch and completed our Canadian and U.S. limited market release ahead of schedule, launch the next phase or wave one of our commercialization efforts. In Canada, earlier than expected with initial results indicating strong acceptance by physicians and hospitals with limited pressure on pricing and rapid reorder rate in the first few weeks.
In the U.S., we have completed our limited market release well ahead of expectation. We are now moving our attention toward wave one of the full market release which should provide us the opportunity to have more than 20 U.S. centers using the SavvyWire. Operationally, our sales and marketing group led by our Chief Commercial Officer, Brad Davis, has put a robust plan in place and to date as achieved or exceeded nearly every key objective in the plan.
We understand that there is a tremendous amount of work ahead of us, but I simply could not be more pleased with the progress that our team has made to date. I truly believe we have a potential game changer for the TAVR industry in our end and are completely focused on the successful commercialization commercial execution of this innovative medical product.
Circling back to our OptoWire solution, which makes up the majority of the of sales, the second half of the year was quite stronger than the first half as the substance of the pandemic resulted in a commensurate uptake in hospital procedure volumes, particularly those that leverage the OptoWire.
Overall revenue for the year was $35.3 million in fiscal 2022, an increase of 2%, however, sales growth in the second half of the fiscal year was 11% compared to a decrease of 5% in the first half of the fiscal year. Robin, will hit on this in more detail, but it’s important to note that total revenues were reduced by $600,000 due to negative foreign exchange impact. More specifically, the coronary artery disease product, which again is primarily OptoWire. Sales growth in the second half of the fiscal year was up 6% compared to a decrease of 16% in the first half of the fiscal year. So fiscal year 2022 was really a tail of pre-pandemic and post-pandemic.
Additionally, due to some of the supply chain disruptions that had occurred in the first half of the year, there was some large fluctuations between quarters, particularly in Japan. Please remember that we made a large shipment to Japan during the third quarter, which was a bit of a catch up order. We communicated that we would revert to more normal levels in the fourth quarter, which did in fact occur. So the sequential change you saw from two Q3 to Q4 of this year is largely tied to Japan.
Looking around the world, the investments we have made in the U.S. continues to show results both in our preparation of our SavvyWire full market launch, but also with OptoWire. We saw year-over-year and sequential growth in the U.S. driven by continued adoption by our direct sales team and GPO agreements.
We continue to believe the GPOs will be a key driver for us going forward and then seeing the adoption and utilization of the OptoWire in the U.S. We believe this also sets the foundation for SavvyWire as well. In Canada, we saw year-over-year growth of 9% in coronary artery disease sales. We continue to benefit from a multi-year contract we received where we were selected as the main coronary pressure guidewire for the eastern part of the province of Quebec.
The trend in EMEA were similar to Canada as well year-over-year. While we work on the distribution model in this region as opposed to a direct selling model, our team has done a tremendous job of improving the performance of distributors through enhanced educational activities. I believe the work that has been accomplished in the last couple of quarters will continue to bode well for continued improvement in EMEA. Again, in Japan we were up compared to the year-ago, quarter by 18%, but down sequentially due to the large catch up order that shipped during Q3 2022.
As we look to the first quarter, we think we will see continued growth in the U.S., Canada, and EMEA sequentially from FFR, which will also mark strong year-over-year growth. As a whole, we will show strong year-over-year growth, but likely down slightly sequentially entirely due to nuances in Japan shipments.
Transitioning to our business partnerships for a moment where several companies are integrating Opsens sensors into their product using medical application. We believe there was a unique and positive development for Opsens during the quarter and that was Johnson & Johnson announced acquisition of Abiomed. For those not familiar to recall that we have a multi-year relationship with Abiomed to supply sensors into Abiomed’s Impella heart pump, including a four-year extension of the recent signing of a critical supply agreement that runs through April, 2028.
It is our belief and that of industries analyst that the acquisition was made for growth purposes and that this may very well provide added growth for Opsens. But in the near-term, the supply agreement remains strong with us having delivered about $2.2 million in product for partnerships during the fourth quarter with a significant percentage of those sales going to Abiomed.
Let us now transition to our Industrial segment, which leverages our fiber optic sensing technology and knowledge by offering key solutions in optical temperature, pressure, strain and other critical parameters for various industries, including aerospace, nuclear and power electronics. For the quarter revenue was $981,000 compared to $671,000 in the year-ago quarter. This $900,000 to a million in industrial revenue has been relatively consistent throughout the year.
Looking forward, the long-term opportunity in this segment continues to remain attractive as we are working on an increasing number of potentially significant projects where Opsens, proprietary fiber optic sensing components could be integrated into these critical projects, including the International Thermonuclear Experimental Reactor and the fuel monitoring for aerospace with leading aviation manufacturers seeking solution to reduce weight and improve operational efficiencies and many others.
Before I turn it over to Robin for a more detailed review of the financials, let me quickly summarize. As I mentioned, in many ways this is the beginning of the next phase of growth for Opsens following regulatory clearance of SavvyWire in both Canada and the U.S. We remain ahead of schedule on nearly every key commercial aspect of SavvyWire. Early indication are that SavvyWire is being well received, adoption is strong, and that reorders are tracking strong in Canada, and as we move to the U.S., our team is mobilized to aggressively market the product as we enter the next stage of commercial development.
Finally, regarding SavvyWire we are moving forward with European registration to obtain the CE mark. OptoWire growth in the U.S. continues to be strong along with many other parts of the world. However, shipment reliability in Japan is causing near-term fluctuations that are impacting revenue growth. On our licensing and industrial projects, we think the agreements between J&J and Abiomed provides upside opportunity in the long-term and our industrial team is gearing up for some exciting new project in the coming years, including fuel monitoring for the aviation industry and finish fiscal 2022 on a strong note.
And finally, what I think is always something important to point out, our balance sheet remains strong, allowing us to execute on our strategies to drive value creation going forward. As always, I want to thank all our employees for their hard work and dedication. We have accomplished important milestone and development with many more opportunities ahead.
Let me now turn the call over to Robin for a further review of the financial results. Robin?
Robin Villeneuve
Thank you, Louis, and thanks to everyone joining us on the call. As Louis hit on the few of these items, I would try to add additional details where I can. For the year, we reported sales of $35.3 million. This was broken down as $21.8 million in our coronary artery disease lines of business or FFR and dPR, $9.8 million in our optical medical systems, which is mainly our agreement with Abiomed for integration of our pressure sensor in their Impella pump. The first $0.1 million for SavvyWire and about $3.6 million in our Industrial segment.
For the quarter we had sales of $9.1 million, broken down at $5.7 million in coronary artery disease, $2.3 million in our optical medical systems, the first $0.1 million for our SavvyWire and about $1 million in our Industrial segment.
When you look at gross margins for the year, there were 50% compared to 54% last year. The decrease is primarily due to the end of production of the OptoWire 2. The supply chain issues affecting production costs and negative currency FX. For the quarter, they were 48% compared to 50% in Q4 of last year. Again, the decrease was caused by the cost related to the phase out of OptoWire 2 production and non-recurring supply chain cost affecting our production cost. These margins are consistent with what I communicated to you last quarter.
As we look forward, we anticipate gross margin percentage will increase since the following factors. First, increase weight of OptoWire revenues coming from direct markets following improvement in the U.S. performance. Second, SavvyWire revenues a product generating higher margin than OptoWire and third increase critical mass.
From an operating expenses standpoint, as planned overall operating expenses increased by $3.1 million during the fourth quarter of fiscal 2022 compared to the fourth quarter of fiscal 2021 and up about $600,000 sequentially. The increase is largely explained by our investment in sales and marketing teams as we are ramping up our sales efforts to continue growing market share in the U.S. along with increases in our R&D cost.
As we explained, we are making additional investments in sales and marketing and research and development over the coming quarters to capitalize on the opportunities to accelerate growth of our OptoWire and to prepare the commercialization of our SavvyWire, which we define as net income less plus income taxes, financial expenses, depreciation of PP&E and right-of-use-assets, amortization of intangible assets and stock-based compensation costs was a negative $3.3 million in the fourth quarter of 2022 compared to a negative $0.5 million in the fourth quarter of 2021. The decrease is mainly due to higher operating expenses of $3.1 million as previously explained.
Net loss was $4 million in the fourth quarter of 2022 compared with the net loss of $1.2 million in the fourth quarter of last year. The increase in loss of $2.8 million is primarily the result of increase operating expenses to drive growth in our coronary products and the preparation for the full scale launch of the SavvyWire. For the year, net loss was $11.4 million compared with the net loss of $1.2 million in financial year 2021. The change is primarily due to the increase in operating expenses associated with the aforementioned SavvyWire regulatory clearance and planned commercial launch.
Finally, on the balance sheet, we ended August 31, 2022 with $23.8 million in cash and cash equivalents.
With that, I will turn the call over to Louis.
Louis Laflamme
Thank you, Robin. As previously announced, Robin will be leaving us on December 9. Robin has played an important leadership role in finance and we are greatly appreciative of his many contributions to Opsens. With that said, he has built a strong finance team that gives me great confidence in their ability to support our growth efforts as we conduct a comprehensive search for our new CFO. Thank you to all our investors for their continued interface and support of Opsens. We are working every day to capitalize on the opportunities ahead of us to position Opsens for long-term success.
Operator, let me now turn the call over to any questions.
Question-and-Answer Session
Operator
We will now begin the question-and-answer session. [Operator Instructions] And our first question here will come from Rahul Sarugaser with Raymond James. Please go ahead.
Rahul Sarugaser
Good morning, Louie. Good morning, Robin. Thank you so much for taking our questions as always.
Louis Laflamme
Good morning, Rahul.
Rahul Sarugaser
Good morning. So it sounds like the – you are [red-hot off the blocks] in terms of commercial ramp on SavvyWire. You gave us a little bit of clarity – some detail in terms of 20 centers in the U.S., recognizing that you’ve not yet planned to provide guidance on revenue. Maybe you can give us some way points in terms of how we should be thinking about the revenue ramp in 2023 particularly given that this is going to be the early stages, it’s going to be more about traction and adoption than that necessarily translating revenue. But of course, the company is valued on revenue. So we’d like to get a just a little more color on how we should be thinking about revenue going into the next year.
Louis Laflamme
Okay. Well first, thanks for your question, Rahul. And as I mentioned earlier today, we could not be more pleased about where we are with SavvyWire. I mean the feedback is great. We are getting really strong pricing. Manufacturing ramp up is happening here. So we feel we are at a really good place. And from a revenue standpoint, as you mentioned is that, our strategy is we need to go deep instead of going wide too rapidly. So we want to make sure that we get good adoption within the accounts where we are. This being said, obviously entering into the controlled wave 1 phase is going to generate additional revenues, if you think about Q1, and it will be even more important in Q2, Q3, and sequentially like this.
In terms of giving guidance, I would say that we are not providing guidance to the Street. This being said with the success we had so far, with the demand that we are seeing, we are confident that SavvyWire will represent more than 10% of our revenues for the current fiscal year. And when we look forward the vision, if you recall the vision of Opsens of achieving $100 million in sales, we think that at least 40% of our revenues will come from the SavvyWire.
Rahul Sarugaser
That’s very helpful. Thank you very much, Louie. Now turning to the other side of the equation in terms of costs, we certainly see in sales and marketing and other costs go up associated primarily of course with SavvyWire. And if we sort of adjust for some accounting and with [indiscernible] burn was around $4 million and with around $24 million cash, could you maybe give us a sense for how we should be thinking about the interplay in balance between that burn, which we would estimate likely to go up as you continue to wrap your commercial efforts relative to your current cash position?
Louis Laflamme
Okay. Well, first, before talking about cost in terms of sales and marketing, R&D and administration, I would talk about the gross margin. As Robin mentioned, when we look forward, we do expect to see an increase in term of the gross margin rate, which obviously will generate more cash for us to absorb other SG&A costs. And when we look at Q4 on top of all the elements that were mentioned by Robin, when you are in ramp up production or starting a production of a new product, there is all kind of inefficiencies or cost. But again, SavvyWire production is going well. So we think that rapidly we will be able to show in our quarterly results the improved gross margin rate. So this is the first thing that we have to consider.
When we talk about other costs, I would say that let’s say R&D costs, what we had in Q3 and Q4, we should remain on that path for the following quarters. In term of sales and marketing expenses, we put in place the team that we need. So you may see a slight increase sequentially, but this will be mostly driven by the fact that we’ll generate more sales, and this will consequently generate some additional compensation to the sales team.
So when we summarize about this, we feel we are in a really good financial position. The burn rate in the year should decrease gradually quarter-over-quarter. And in that context, I mean we are following the plan. We feel we are in a great position to create value for shareholders because SavvyWire will become a reality and because the strategic effect between SavvyWire and OptoWire will also be – happening in the field.
Rahul Sarugaser
Terrific. Thanks very much, Louie. That’s all from us today and wishing you the best of luck as you move on to your next stage.
Louis Laflamme
Thank you, Rahul.
Operator
And our next question will come from Justin Keywood with Stifel. Please go ahead.
Justin Keywood
Good morning. Thanks for taking my call.
Louis Laflamme
Good morning, Justin.
Justin Keywood
On the higher OpEx and within the press release, it mentioned substantial investment in the salesforce to launch Savvy, are you able just to provide some additional context there on how many sales reps have been hired, let’s say in the last six months, and how those sales reps are split as far as geography focused in Canada and in the U.S.?
Louis Laflamme
Well, first, in terms of geography, I would say that most of the hiring has been done in the U.S. market. And in terms of the magnitude of the hiring that we’ve done, we almost doubled the size of the sales team. So this was a significant investment that we felt we had to do in Q4 2022 to prepare for the launch. So that’s one reason why once we got clearances either from Canada and U.S. that we were able to make some progress. So right now, we feel we have the proper sales and marketing team to execute. We may [benefit] with one additional person in Canada, but in general, we feel that we are at the right place to succeed.
Regarding the coverage in U.S., I would say that’s an area where we really are data-driven. So we’ve been looking at volume per different state to make sure that we were putting our sales people at the right location to be really successful. And overall, you can imagine that we are covering all major U.S. cities.
Justin Keywood
Thank you. And just for context, the doubling of the salesforce, was that around – was it 10 to 15 reps prior?
Louis Laflamme
Yes. In your question you were referring I think to something like in the, let’s say six to 12 months behind. So at some point we were close to 10, and now we are approximately 20 people.
Justin Keywood
And do you feel that’s enough to execute on the U.S. opportunity? I know there’s also the strategy with the group purchasing organizations and are these sales reps focused on going direct to the cath labs or are they going to be working in conjunction with the GPOs?
Louis Laflamme
Yes. So the first question is, okay, do we feel that it is the right number to capitalize on the opportunity? The answer is yes. Okay. We feel we have the right team to tackle the most significant volume centers in both TAVR and coronary artery disease. So this is the first part of your question.
The other part regarding GPOs, I mean the GPOs, this is strategic for us because they lower the bar with the administration of hospitals. This being said, our sales team, what they have to do, they have to sell our products directly to the cath lab, to the doctors. And once we get the support from doctors, doctors will seek support from an [institution]. So being under GPO agreement, and by the way, right now our GPO agreements are covering 90% of the cath lab in U.S. This is providing us the possibility to be faster in the execution.
Justin Keywood
Understood. And maybe just one more question on the salesforce. Are they fully ramped up at this point as far as the training and it’s pretty much a direct outreach exercise, or is there still some more ramp up time required?
Louis Laflamme
The team is fully trained, thus we will identify additional training down the road, I mean properly, but right now, they would be – we are ready to go. This being said, we still want to go in a control manner because there is not only the training for us, but we also need to think about the training that we do with the cath lab, with the doctors, the nurse and so on. And again, we have a strategy of going deep with customers and we think this is what will lead us to the biggest, the most important market share down the road. And we think that’s the way we will create the most value for shareholders.
Justin Keywood
Thank you. And then maybe just a quick question for Robin. If I heard correctly, there was a $600,000 foreign exchange headwind impact in the quarter. Is that correct?
Robin Villeneuve
For the year, the $600,000 negative impact.
Justin Keywood
Do you have that for the quarter that number?
Robin Villeneuve
For the quarter, it was basically neutral because the strong U.S. offset the negative mostly the negative…
Justin Keywood
Okay, understood. Thank you for taking my questions.
Robin Villeneuve
Welcome.
Operator
Our next question will come from Doug Miehm with RBC Capital Markets. Please go ahead.
Douglas Miehm
Good morning, Louie. Good Morning, Robin. I’m just curious, when you think about benchmarking as you start to launch and you’re in Phase I and going to Phase II, what are the items that you’re going to be studying? I imagine they’re going to be the number of centers, the number of doctors using at a center, reordering patterns, but could you expand on what specifically you’re attempting to identify and benchmark on?
Louis Laflamme
Yes. So I mean you are right on in term of – of course, we look at the number of centers. We look at the market share within those centers. We look at the reordering rate from those centers. And as we mentioned earlier today, I mean, we are really pleased right now with the reordering rate that we get in Canada. And in U.S., we have the impression we are anticipating that it’ll be even better because the value proposition, the economical environment of TAVR in the U.S. is really in the favor of using the SavvyWire.
So I would say those are some key metrics. We also – when we were doing the first cases in those different countries, we were asking to physicians, okay their estimation of the time saving that they were having with the SavvyWire, also number of steps that they were able to eliminate. So this feedback that we got from customers really put us – increase our confidence in the value position of the SavvyWire. And we think those tools will be used down the road when we will get to full commercialization mode.
Douglas Miehm
Okay. Perfect. And then my second question has to do with LV pacing and the differences in various parts of the world. I think it’s widely adopted in Europe and certainly more so in Canada, but in the U.S., I think the market share of LV pacing is quite low. Do you see that limiting the initial opportunity for the device hoping that clinical trials will prove out that LV pacing works very well, or do you think that you’re going to see pretty good adoption of your device irrespective of what’s going on today with LV pacing?
Louis Laflamme
Yes. So good question and you being attending to TCT conference, the symposium that we had, that was a tremendous success for us. And this was a subject of discussion. Just to make sure that everybody understands that in the value proposition of the SavvyWire, okay, there is the fact that we can deliver the valve. There is the fact that we can measure pressure, so provide a more dynamic information. There is also the fact where we can do heart stimulation or if you prefer left ventricle pacing. And as you mentioned, Doug, this practice is not necessarily at the same adoption stage all over the world because as you mentioned, I would say using the left part of the heart in Europe is, is kind of the standard.
While in U.S. today, often they will use a different device than the device that they are using to deliver the valve, and they will stimulate the right portion of the heart. We think for us to the fact that left ventricle pacing is not necessarily common in U.S. is a good thing for us because when you evaluate the SavvyWire, the value proposition is higher because when you use the SavvyWire, you don’t need to pay for another device for the stimulation of the right part of the heart, you don’t need to do another insertion. So those are some kind of cost and steps that we can eliminate. But of course, as you can anticipate is that the backdrop of this is that – and that’s one reason why we want to be close of our customers at the beginning. There is a certain learning phase with that, but overall, we think it’s an advantage to us, it’ll help the penetration of the SavvyWire with the backdrop that we need to be sure that we do proper training.
Douglas Miehm
Okay, great. That’s very helpful. Thanks very much and good luck.
Louis Laflamme
Thank you, Doug.
Operator
[Operator Instructions] Our next question will come from Scott McAuley with Paradigm Capital. Please go ahead.
Scott McAuley
Good morning, gentlemen. Congrats on the quarter and thanks again for taking the questions. I just wanted to kind of circle back on some of the numbers you gave on the kind of limited U.S. SavvyWire release, just to make sure I got them down right. So you’re saying that the 60 cases, that was kind of your goal for the limited market release and that – those 60 cases are completed, and that those 60 cases have been run at 10 centers that are currently using the SavvyWire. Is that right?
Louis Laflamme
No. I think, maybe I was not perfectly clear. So the 60 cases, those were done in five centers. And once we complete this initial phase of the release, we were able to expand to another group of centers that, I mean, they were ready to go. We just wanted this step to be behind. So right now we are in nine centers and we think that rapidly we will be able to progress where each territory manager that we have will be able to have one account using the SavvyWire. So this will bring us closer to the figure of 20, but right now there is nine centers that are capable of using the SavvyWire in U.S. And this is not related to the 60, again, the first 60, it was four or five centers.
Scott McAuley
Perfect. Thanks for that additional detail. And in terms of kind of the utilization, I know the first user was saying that he had performed 10 consecutive procedures using the SavvyWire. I believe he’s kind of a high power user in terms of these early cases or early centers. Can you speak to kind of the utilization rate that you’re seeing and what your expectation is kind of going forward?
Louis Laflamme
Yes. So I mean, two components as an answer to this and me personally, I’ve been attending to good number of those cases. So when the centers were starting to use the SavvyWire, I was there really to obtain directly from the personnel – the feedback on the product and the feedback has been really, really positive. So doctors, they rapidly can appreciate the performance of the wire to deliver the valve. They also greatly appreciate the availability and the accuracy of the pressure information. And the pacing component that we just discussed with Doug has been there also.
And as I mentioned earlier today, we were seeking information from customers about that they were able to eliminate some steps which consequently can help them to save time. And the response on that was really positive. So in term of utilization, I mean, this can vary by the volume that the centers are doing, but what I can say to you is that in term of market share, either it’s an account that does 800 TAVR in a year or an account that does 200 cases. The point is that they were really positive in using in a really significant percentage of their procedure, the SavvyWire.
Scott McAuley
Got it. Yes. That’s great. And then in terms of switching over a bit to the OptoWire, I think you had mentioned, I just want to kind of confirm, you’d said you’re expecting kind of strong year-over-year growth in Q1, but that could be down sequentially just on some of the issues you’re facing. Is that correct?
Louis Laflamme
Yes, it’s correct. And what we can say, and this is in line with the strategy that we are doing. I mean in Q4, the U.S. performance was really good from an OptoWire standpoint. And unfortunately it was not the same for the Japanese as we explain. So somehow we don’t see in Q4 results the strong performance that we get in U.S. We expect this trend to continue with the OptoWire, as we do the rollout with the SavvyWire because as we mentioned previously, we have a broader team. On top of that, we established a relationship with GPOs that are covering 90% of the hospital.
And on top of that, there is a huge synergy between the SavvyWire and the OptoWire. Both products are tackling completely different applications, but they are using the same monitor that is available in the room. So you can expect to see in Q1, I mean year-over-year growth in coronary artery disease. But sequentially, it won’t be the case. This being said, those are non-recurring comparison. We really feel that we are in a position where Opsens market share with the OptoWire will increase in U.S. significantly.
Scott McAuley
That’s great. And that growth – just lastly on the OptoWire, is that coming from new accounts? Like you say you have the new boots on the ground knocking on doors for both SavvyWire and OptoWire. So kind of opening new accounts, getting them using both products versus kind of expanding usage in accounts that are currently using the OptoWire?
Louis Laflamme
I would say it’s a combination of both. There is a certain number of new accounts that have been attracted because they saw the SavvyWire and they wanted to use both product. There is also, I would think, an increased usages in the existing accounts.
Scott McAuley
Got it. Thanks a lot gentlemen. Thanks for taking the questions.
Louis Laflamme
Thank you.
Operator
This concludes our question-and-answer session. I’d like to turn the conference back over to management for any closing remarks.
Louis Laflamme
Well, many thanks to everyone for participating on today’s call. We look forward to hopefully speaking with all of you again shortly. And in summary, Opsens is at the right place, and we are really excited about our growth plan. Thank you, and have a good day.
Operator
The conference has now concluded. Thank you very much for attending today’s presentation. You may now disconnect your lines.
Be the first to comment