Good morning, and welcome to the OpSens Inc. Fourth Q2 2023 Financial Results Conference Call. All participants will be in listen only mode. If you need assistance, please signal conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star then on your telephone keypad. To withdraw your question, please press star then two. Please note this event is being recorded. I would now like to turn the conference over to Robert Blum with Lytham Partners. Please go ahead. All right. Thank you very much, and thank you all for joining us today for the OpSens Q2 Fiscal Year 2023 Conference Call for the period ending March 28, 2023. With us on the call representing the company today are Louis Laflamme, OpSens President, Chief Executive Officer, Brad Davis, company's Chief Commercial Officer, and John Hannigan, the company's recently appointed 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 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 U.S., which you can find on SEDAR and OpSens' website. 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. 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. Let me turn the call over to Louis Laflamme, President, Chief Executive Officer for OpSens. Louis, please proceed. Thank you, Robert, Good morning to all of you. We are excited to speak with you today following another strong quarter of growth across all of our business lines. Let me also take a minute to greet the French-speaking audience. Bonjour et bienvenue à notre conférence téléphonique du deuxième trimestre de l'exercice 2023. Merci de vous joindre à nous. At a high level, I'm pleased with the results of the quarter, which reflect record quarterly revenues of CAD 10.8 million, up to 33% from the same period last year, driven by all three key components of our medical segment, including our OptoWire for coronary artery disease, SavvyWire for structural heart TAVR procedure, as well as our optical sensors for business partnerships. This was also an increase of 5% sequentially from the Q1, which was, at that time, our previous record high quarter. The positive momentum continues to build. With coronary artery disease, performance has been solid in North America with a 24% increase compared to the Q2 2022. The product portfolio synergies we discussed last quarter by now having both OptoWire and SavvyWire in our commercial teams offering has been supporting the effort of our broader team. EMEA and Asia Pacific market served through distributors generated a 13% increase despite headwinds from currency exchange rates and other factors. Japan has been a challenging market recently. In the current quarter, this territory was up 61% compared to Q2 2022, also up 64% on quarter one 2023. The comparative periods for Japan were quite low, and we still have work to do to get back to our historical peak levels. Nonetheless, it is encouraging to see progress being made in this key market, which accounts for about a quarter of our OptoWire sales. On the structural heart side of the business, we remain on track with our commercialization plan, which we have outlined to you previously. Last week, we achieved a significant milestone for the company as the SavvyWire has been successfully used by physicians in 1,000 procedures. Our sales team is operating at a high level as they educate cardiologists on the benefits of the SavvyWire to expand the number of accounts and drive adoption. As the world's first and only sensor-guided TAVR solution, we have taken a step-by-step commercialization approach following our clearances in the U.S. and Canada. The approach started with a limited market release in Canada and the U.S., which then moved to a more, an expanded but still controlled market release. As stated previously, we are taking a similar strategy that many other companies have successfully taken with recently cleared devices by moving very systematically in the early commercialization process to ensure complete success by the physicians. We are now ramping up our commercialization plans for this concept in TAVR, achieving two live cases at the CRT conference during the Q2, which was a great achievement at such an early phase of commercialization. These events are preparing the market for the next stage of our commercialization plan, coupled with new GPO agreements, are expected to drive continuous incremental growth in the coming quarters. We all recognize rapid sales growth is very important. We clearly believe this is coming. From a long-term business perspective, we want to ensure complete physician satisfaction in these early stages so that the word of mouth around the physician community is positive, which has a troubling effect on near-term growth. That said, it doesn't mean we are not growing sales, which were up 31% on Q1 2023. It just means we want to do it in a measured and controlled way initially before we fully unleash our sales team. To that point, following what we believe were successful early steps in the controlled market rollout, we are now moving forward with a more expanded market release. I have once again asked Brad Davis, who leads our global commercial team and has a strong track record of launching new medical device products into the market that have ultimately achieved market share leadership to share some insights on the commercial strategy. I would state however, that going forward, we are expecting to see continuous growth each quarter as we, at the same time, look to expand adoption, but also make sure that we are achieving complete success along the way. For the rest of the year, we believe we'll have double-digit top-line growth in Q3 and Q4. As I stated last quarter, our goal is to avoid any major unforeseen hiccups in the initial rollout. Once we enter full market release, we certainly expect sales to ramp beyond this. Furthermore, we are seeing some commonality in terms of customers who are using both SavvyWire and OptoWire products. This aligns with our commercial strategy. We believe our playbook is sound and based on the initial positive feedback from physicians. We continue to believe we have an absolute winner on our hands with SavvyWire. Transitioning to our business partnership division. We continue to experience strong performance as end market demand for key products within this division shows signs of growth. Led by our multi-year supply agreement of our second generation fiber optic sensing technology for ventricular assist devices, sales in this division were up 43% to CAD 3.4 million, a new record for this division. For those not familiar, we have a multi-year relationship 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. We believe this step up in revenues, which started last quarter, should be sustainable going forward based on the positive conversation we are having with our current customers. Our industrial business continues to operate in a consistently strong manner with sales of CAD 0.9 million. While this was down marginally from the past few quarters, this division continues to operate profitably and is well-positioned to be at the leading edge of some revolutionary new applications that have the potential to be big winners in the industry, including in the world of fuel monitoring for aeronautics. Again, at high-level, I'm pleased with the progress made this quarter. On the top line, we had record revenues once again with strong progress across all of our medical divisions. Operationally, we are making great progress moving through the stages of our commercialization strategy for SavvyWire, which Brad will expand on here in a moment. Finally, something important that I will expand on shortly is the continued improvement in our growth margins, which were up 5.4% on quarter two, 2022, highlighting the leverage in the model as we improve product mix coupled with more direct sales and overall higher volume sales. With that, let me now turn it over to Brad Davis, our Chief Commercial Officer, to expand on the success we are seeing in our SavvyWire commercialization strategy. I will then return to add some additional color to his comments and review the financial results in more detail. Brad, please proceed. Good morning, everyone. I'm excited to expand upon Louis' comments regarding the SavvyWire launch. We'll share some insights from our controlled market release. I will first provide some comments on the overall TAVR market. As you know, the TAVR addressable market served by SavvyWire is large and growing. The current global TAVR market is estimated to be over 200,000 procedures and expected to double in the next 5 years, driven by aging population and indication expansions from ongoing studies for moderate aortic stenosis and asymptomatic patients. As treated patients get younger, the importance of standardized invasive hemodynamics provided by SavvyWire and related lifetime patient management will only continue to increase. OpSens is well-positioned to capitalize on this large and growing market opportunity with the world's first and only sensor-guided TAVR solution. We have doubled the size of our direct sales force, conducted robust training, and are executing our launch plan to ensure long-term commercial success. In Q2 2023, we expanded from our initial limited market releases in Canada and the U.S. to expand to a controlled re-market release in each country, where this excitement from the physician community remains strong and continues to build. One example is from the CRT conference in February, where the first two live cases were successfully performed with SavvyWire in front of a global audience of hundreds of healthcare professionals. Dr. Thomas Waggone r from Tucson Medical Center highlighted the procedural efficiency and workflow gains from SavvyWire in a balloon valvuloplasty procedure to reduce time and device exchanges. Lowell Satler, another physician from Washington Hospital Center, chose to use SavvyWire in a TAVR procedure where there was extensive discussion about the benefits and insights provided by real-time standardized invasive hemodynamics, as well as the benefits of reliable left ventricular rapid pacing. These are just but a few examples of the momentum building with SavvyWire in the physician community that we also continue to highlight as part of our broad-based digital and social media strategy to drive awareness and adoption. As part of our controlled market release, we have refined our launch process to include device display and procedure training, monitor installation in procedure rooms, software upgrades, and coordination with administration to achieve maximum penetration in each account. Our field team spends approximately one month at each hospital to train physicians and staff ahead of their first SavvyWire cases, then partners with them during dedicated TAVR days, where we're in the procedure room for cases to reinforce best practices. We gain valuable lab access from these dedicated TAVR days at each account, which allows us to reinforce the benefits and cycle through educating the various teams of techs and nurses that are supporting the cases. Our goal is to get the hospital TAVR teams fully functional and independent to conduct the cases successfully themselves. This allows our field team to then partner with their next target customer to repeat the same in-depth launch process to ensure clinical and commercial success. I'm very pleased to share that we achieved several important commercial milestones in Q2 as part of our controlled release. First, as Louis mentioned, we recently announced an important patient milestone that over 1,000 patients have been served with SavvyWire, demonstrating robust adoption for our game-changing technology. Second, we signed our first group purchasing organization contract with SavvyWire with Premier, one of the industry's largest GPOs with 4,400 US hospitals. As a reminder, with OptoWire, we have GPO contracts in place covering over 90% of US hospitals and plan on obtaining the same level of coverage with SavvyWire by the end of this calendar year. Third, while the value analysis committee process can be lengthy and challenging, we have signed our first three-year contract with several large hospital systems that provide access to 12 TAVR sensors. Moreover, we continue to be successful in achieving premium pricing by demonstrating the value proposition of sensor-guided TAVR with SavvyWire and delivering value to the overall TAVR procedure. SavvyWire has now been launched in over 30 hospitals in North America, with strong demand from future customers supporting our future growth. Another key enabler to our go-deep strategy is that our same OptoMonitor supports both OptoWire and SavvyWire cases. This allows us to leverage the efficiency of our field footprint and capital deployment to improve the decision-making process for installation and adoption. To that end, we are pleased to share a key metric that two-thirds of our SavvyWire hospitals are also OptoWire customers, which we will continue to leverage to drive growth in both franchises. From a clinical perspective, we as OpSens are committed to medical evidence that advances the field. We would like to thank Dr. Jorge Cabo and all European investigators for the rapid completion of patient enrollment in the SAFE-TAVI study, with 120 patients enrolled at 9 hospitals, including 8 renowned centers in Spain and 1 in Canada. As a reminder, the study focused on SavvyWire for left ventricular pacing and TAVR procedures, with results planned to be published by early fall. This study is important because it supports our pre-CE mark clinical strategy that will lead to the clearance of SavvyWire in Europe later this calendar year. We look forward to sharing information on additional studies demonstrating efficiency and clinical and economic benefits over the coming quarters. In summary, we are very pleased with the overall SavvyWire performance and are out of the gate extremely strong and aligned with our expectations. With over 1,000 total SavvyWire cases across four countries, including over 30 centers in North America, we are well-positioned to transition from our controlled release into a full launch in the H2 of this fiscal year to drive double-digit growth for both OptoWire and SavvyWire. I would like to thank our talented global commercial team for their passion, commitment, and launch execution of this game-changing technology as we simultaneously grow our core OptoWire business. I will now turn the call back over to Louis. Thank you, Brad, for that overview. As you can hear from Brad's excitement, we believe we are systematically executing against and delivering on our commercialization plans. As those of you that have followed the company closely now, we have met or surpassed nearly every key commercialization milestone associated with SavvyWire from Canadian and U.S. regulatory approvals to the completion of our limited market release in Canada and the U.S. We are now ahead of our internal expectation for this current stage, with more than 30 hospitals using the SavvyWire, with a goal to be fully commercialized at the end of this year. As the world only three-in-one solution for stable aortic valve delivery and positioning, with continuous accurate hemodynamic measurement during the procedure and reliable left ventricular pacing without the need for adjunct devices or venous access, we believe our device will ultimately transform the way TAVR procedures are conducted. It is just a matter of time. As Robert mentioned at the introduction to the call, joining us today is John Hannigan, our new Chief Financial Officer. John is a highly experienced financial executive with more than 22 years of proven financial expertise with domestic and international companies. John also has experience with healthcare company and has held various senior financial management positions for a publicly traded company. We look forward to building off the progress made by our finance team as we look at new and innovative ways to advance our financial and overall growth strategies. John, let me turn it over to you to further introduce yourself. Thank you, Louis. As you mentioned, I have served in a number of senior finance positions over the past two decades. Having started my career at KPMG Ireland, where I worked with a large number of private and public companies, I joined the group which had acquired IPL Plastics in Canada. I moved to Canada in 2017. IPL Plastics listed on the TSX in mid-2018 and was acquired in late 2020. I have followed OpSens' progress for some time now. When I was approached about the opportunity, I immediately was excited by the overall prospects, especially with the recent launch of SavvyWire. I am excited to participate in OpSens' development, with the ultimate goal being to create value for our shareholders by capitalizing on OpSens' unique core competencies and technologies. The company is well-positioned to provide its innovative sensing technology to cath labs around the world. I very much look forward to connecting with all of you investors in the coming quarters. Let me turn it back over to you, Louis. Thank you, John. We certainly share your enthusiasm. Since John only joined us a couple of weeks ago, I will once again run through some of the key items on the balance sheet and income statement, discuss our outlook for the Q3 and full year, and will then turn it over to your question. As I mentioned, the Q2 was highlighted by record revenues. Revenue of CAD 10.8 million, an increase of 33% compared to the Q2 of 2022. Growth from our optical medical products segment, coupled with the addition of TAVR sales, were key drivers. As we look to the Q3, we continue to make strong progress in a number of our key geographies as well as the extended launch of SavvyWire. The gross margin was 56.9%, an increase of 5.4% on the Q2 of 2022. The increase was driven by more direct sales compared to distributor sales, better product mix, and strong industrial business. Similar to last quarter, on a midterm basis, as we see more sales coming from areas where we sell direct, such as the U.S. and Canada, and as we see growth in SavvyWire, we expect to see gross margins continue to rise. We are also benefiting from critical mass in the factory, which is driving operational improvements. That said, we are making certain investments in our manufacturing facilities to improve the operating and production efficiencies of our devices going forward and to meet higher demand from our customers. From an operating expenses standpoint, overall operating expenses were $9.3 million, compared with $6.4 million in the Q2 of 2022. Breaking this down, sales and marketing was $4.4 million versus $2.5 million. R&D was $2.5 million versus $2 million, and G&A was $2.4 million versus $1.9 million. The $2.9 million increase was mainly due to an increase in sales and marketing activities, including an increase in our direct U.S. sales force in advance of the launch of SavvyWire, an increase in administrative expenses, coupled with an increase in R&D due to structural heart and coronary artery projects. Looking forward, we think that sales and marketing expenses will be pretty similar to the most recent quarter and likely increase slightly due to increased commission expenses on sales growth as we make continued investment to capitalize on the opportunities to accelerate growth of our OptoWire and SavvyWire products. Our administrative expenses should be stable in the remaining quarters of fiscal year 2023. For R&D, it will be similar for the remaining quarters of fiscal year 2023. We will continue to be a company that is innovating. As I alluded to last quarter, one key opportunity we see as possible next stage of growth will be generating value-added information and data using artificial intelligence in future products and technologies. We are investing in products that will likely be coming to the market in the next 24 months. I hope to be able to share more with you in the future on this topic. Additionally, OpSens has been invited by key physicians and leading life science companies to participate in clinical studies to access the SavvyWire for additional catheter procedures. We believe these studies could open new market opportunities for the company. On the balance sheet, we completed a CAD 11.5 million bond deal financing in December, which brought our ending cash balance to CAD 21.9 million. Our working capital balance was CAD 34.6 million at the end of the quarter. Inventory levels have increased during the quarter, due in part to the anticipated sales growth in the two remaining quarters of the year. To wrap up things, we are pleased with the progress made during the Q2 on nearly all fronts. Revenues were a new quarterly record, building off a record quarter during Q1. We had strong operational performance with record OptoWire sales in North America with increased sales of 24%. We are seeing a step up in our optical medical products division, which we believe will be sustainable in the future. We achieved or surpassed every operational metric we had in the approval and early commercialization plans for SavvyWire with very strong end market response. We saw 31% sequential growth during Q2 and expect continued sequential double-digit increases for the rest of the year. Our gross margin increased by 5.4% as we are capturing synergies in our operation and the benefits of the investment we are making in sales and marketing. Our balance sheet remains strong. Our outlook for Q3 2023 and the rest of the year shows growth across various operating areas. As always, I want to thank all our employees for their hard work and dedication. They have accomplished important milestones and development with many more opportunities ahead. Without further, let me now turn the call over to any questions. We will now begin the question and answer session. To ask a question, you may press star then 1 on your telephone keypad. If you're using a speakerphone, please pick up your handset before pressing the keys. To withdraw your question, please press star then 2. At this time, we will pause momentarily to assemble our roster. Our first question will come from Rahul Sarugaser with Raymond James. You may now go ahead. Hi there. This is Michael Freeman on for Rahul today. Hello, Louis, Brad, and welcome, John. Congratulations on setting some new revenue high-water marks, all while driving a solid new market release. This is very impressive. My first question is on the first 1,000 SavvyWire procedures. First of all, congratulations on executing this. Second, I wonder what learnings have come from these your interactions with these physicians that have engaged these procedures. I'm wondering if the SavvyWire has been used solely for TAVR procedures or if there has been some expansion of use through those 1,000 procedures. Thanks. Okay. Well, thank you, Michael. It's, it's good to receive a question for you. In term of learnings, I would say, clearly the, the biggest, and I'm not sure it's necessarily a learning, but it's, it was a confirmation. We were impressed about the, the recognition of the value proposition for the SavvyWire. When we think about, values, example or testimonial from doctors that are saying, "Listen, with the, with the SavvyWire, I really, appreciate having, real-time hemodynamic information that, with information that I can trust to do the best work I can for the patient. In addition to this, I can save time, save steps in the procedure that result in time saving. I would say this was probably the biggest, you know, conclusion that we got from those first 1,000. I would say the second important conclusion that we saw is that, I mean, having an interface, a monitor that is really easy to use is something that is of interest for doctors. As Brad mentioned, I mean, the software that we have right now is already a really, really good product, but our R&D team found different ways to make this even faster and easier to use for nurse and doctors. We are going to roll out this in the next few months. This was probably the second conclusion. Regarding your question about where it has been used, I would say probably 95% or 98% of the cases were TAVR cases, so transcatheter aortic valve replacement. You can include in there some balloon valvuloplasty, some valve-in-valve procedure. What's missing between the 98% and the 100%, there was a couple of mitral cases that were done using the SavvyWire. Our product is cleared for such application, even if it's not necessarily the primary focus of our commercial team. Right now our focus is really to demonstrate the benefits of our solution in TAVR. Excellent. I appreciate that. That cross valid-- compatibility is really interesting. My second question is perhaps for Brad, talking about the launch of the SavvyWire. I recognize that the... Until now, the launch has been somewhat restricted, looking to move into the next phase and there was a mention of being c-fully commercialized by the end of this fiscal year. Right now you say you're operating in or active in 30 hospitals. What would that number be by what you call f-being fully commercialized? Are there other metrics you'll be measuring to gauge whether you are indeed fully commercialized? Sure. Good morning, and thank you for the question. To clarify, my comment was that we're moving into our full launch after being in a controlled release. We're in over 30 hospitals now in North America. We would anticipate by the end of the year that we would approximately double the number of accounts that we're in to achieve our goals and metrics for the balance of the fiscal year. In terms of other key metrics, while still early, we look to achieve, you know, full penetration in each account, which we would define as being, you know, the primary TAVR wire used in that account. We'll certainly look at reorder rates as those become more meaningful and we have quarters of orders under our belt from each one of the customers. Excellent. I appreciate that clarity. If I could just wedge one more question is I wonder if you have seen any benefits from the GPO agreements that include the SavvyWire so far, and any benefits related to the bundling of the OptoWire and the SavvyWire? Thanks very much. Sure. In terms of GPO agreements, as I mentioned, we're on the Premier agreements. We'll be on all of the major GPO contracts here by the end of the year, which really gives us the license to hunt, if you will, and the opportunity to then sign local agreements. We've already seen that that has resulted in part of our strategy that we have two-thirds of our SavvyWire hospitals also ordering OptoWire. As I mentioned also, those types of contracts give us the access to sign more local deals. For example, the hospital systems where we've signed contracts now that are 3-year contracts with pricing in place to provide access to 12 hospitals that do large volume TAVR. Those are a few of the early indications of both the opportunity for committed contracts as well as the benefits from cross-selling. All right. Excellent. Thank you very much. Congratulations. I'll jump back in the queue. Thank you. Our next question will come from Doug Miehm with RBC Capital Markets. You may now go ahead. Thanks very much. First question just has to do with the launch and the company's ability to, you know, start to change, launch characteristics in terms of ramping up. I guess my first question is, are you still gonna have to spend a month each site to achieve what you need to, or is that period going to decrease, as you expand the offering to more hospitals? I think, thanks for your question, Doug. We should clarify this. One thing is that, I mean, we are not spending one month full time in the hospital, but, you know, some of our customers, they have one day dedicated to TAVR. This may represent, when we say a month, it's over a period of a month, but it may cover just four or five days. This being said, as we do more training, education with our team, with doctors and nurses, we are confident that the left ventricular pacing component will become more known in North America. As you know, it's well used in Europe, while in North America it's fairly new or the use is really limited. To your question, yes, we are confident we can get the customer independent faster and really quickly to have a business model that would provide shareholders value, that would provide gross margin growth and with reasonable cost. We don't see any issue with this. As I mentioned, having a software that is really easy to use will also be a value driver to make this happen. Okay. That's helpful. Next, question just has to do with clinical trials that the device is being used in, you know, post-approval, certainly in North America. What type of presentations of incremental data may we see through the year? Okay. I mean, we right now we are hoping, as we mentioned, we have advanced discussion with different key opinion leaders around the world that are driving or that are going to drive some clinical studies where those studies are based on the interest in having hemodynamic information. I'm confident that we should be in a position to make some announcement before the next conference call on this, at least for one, I mean, really important study in the field. In term of data that will be produced on clinical studies solely driven by OpSens, clearly the SAFE-TAVI, as you saw, we completed the enrollment. We were really glad about the capability to enroll 120 patients quickly in Spain. I mean, we are hoping that the principal investigator will be able to publish those data somewhere before the end of the fiscal year 2023, or really early at the beginning of 2024. Perfect. I think I will leave it there for now. Thanks very much. Okay. Thank you, Doug. Our next question will come from Justin Keywood with Stifel. You may now go ahead. Good morning. Thanks for taking my call. Just want to circle back on the expectation for double digit growth, if I heard that correctly. Would that be consolidated revenue? I assume that's on a year-over-year basis. Yes. I mean the, if the comparative revenues for Q3 2022 is CAD 10.1 million. I mean, the confidence of OpSens of having double-digit growth over that number is really good. Yes. When we compare, it means that we'll have, again, in Q3, a record quarter from a revenue standpoint. We, we see this happening for Q3 and Q4. Got it. That's clear. On the gross margins, obviously pretty strong in the quarter, and I was surprised to hear that there's still opportunity to expand. I also assume that this is related to the SavvyWire and getting better pricing. My question is, how do you balance accelerating sales with that pricing equation? If the pricing is received pretty favorably right now, would you keep it the same and continue to sell at the rate you're going, or would you perhaps lower the pricing to accelerate SavvyWire sales at a greater rate? I can respond at high level and after that, Brad can complete, can possibly add some additional insight on our strategy with customer. At high level, you know, when we released the Q1 results with the gross margin of 58%, at that time, the financial market said to us, "Well, you've done this only for one quarter," because if you compare with the previous year where we were around 50%. We are glad to show that this is clearly a new level for us. There were various drivers behind this. You can think about, obviously, our plan is to have a SavvyWire being a product that will drive higher gross margin than our average gross margin that we have on our product, or if you compare this only with OptoWire. SavvyWire is having a positive impact. We are also seeing with the investment in direct markets in U.S. and Canada, the weight of direct sales is increasing. This is having a positive impact on the gross margin on a consolidated basis. You can add also on this that, I mean, having higher sales volume is giving us some additional efficiency from a manufacturing standpoint. We feel that the current gross margin is good. It's in line with our plan. We are seeing in the future opportunities to do more because, let's say if I take the example of SavvyWire, we are still in the early phase from a manufacturing standpoint, and we are seeing various opportunities to reduce the cost of goods sold of that device. We are seeing this, I would say, in general, on the overall product portfolio for OpSens. I would stop there. Brad, maybe you can add on your the strategy that you are executing from a pricing standpoint when we have to manage volume and pricing. Sure. Thank you, Louis, and thanks Justin for the question. I would first start out with reiterating that to date in the launch we've had significant premium pricing over what would be considered standard catheter guide wires that are in the market today, because we're really creating an entirely new category of devices that doesn't exist since we're covering both delivering the valve, doing hemodynamics, and doing pacing that today you have to buy three different and multiple components to support that as part of accessories for the, for the procedure itself. Our value proposition really is supported by a comparison and reduction in what the, what devices might not be used as part of the procedure, plus time savings, and then also the procedural benefits of avoiding complications that occur with RV pacing. That's what's allowed us to drive the value proposition that we have in the market. To Louis' point, what we are seeing now is the opportunity with the excitement around SavvyWire to drive committed volume agreements where in exchange for a higher share level that we would provide reduced pricing associated with that based on the share and the volume for the account. The opportunity to then, you know, bundle that in with OptoWire as well. We're still very early on in the launch with that in terms of getting through the initial evaluations and customer interest and feedback, but that is the direction that we head, and we have plenty of room to run to be able to hit our gross margin targets while simultaneously driving committed volume deals that will provide predictability to our revenue growth. Great. Thank you for the thorough answer. Our next question will come from Scott McAuley with Paradigm Capital. You may now go ahead. Good morning, thanks for taking the questions. I wanted to start across the pond in Europe. Great to see that trial wrapping up and potential for getting the CE mark, you know, in the not too distant future. In terms of the commercial strategy for SavvyWire in Europe, you know, have the current OptoWire distributors kind of already put up their hands saying that they're interested in SavvyWire? Are you looking for new distributors? Can you talk a bit about that strategy going forward? Louis, would you like for me to answer? I'll take the answer. Brad, you can complement if you want. Okay. The idea here is really in general, as Brad mentioned, the strategy is to use the same commercial channels for both products. We are seeing a synergy with customers using the same monitor. Same thinking should apply to the distributor selection in Europe. There is maybe a couple of cases where for different reason, a distributor may be good for OptoWire and not as good for SavvyWire. In those cases, we may select different partner. Overall, the idea is to use a similar team. The only follow-up that I would provide on that is. We're taking all of the learnings from how you first onboard and train first our reps and now in this case, distributors, and have been able to do that as part of the SAFE-TAVI trial as well, to start getting them up to speed, and then we're gonna be doing our first cases here in the Middle East, with distributors here in Q3. We'll be able to make sure that we take those learnings and how we launch effectively at accounts in North America and apply those same learnings as we launch through distributors into Europe and the Middle East. That's great. For the current, you know, 30-plus hospitals that are currently using SavvyWire in North America, do you have a sense of what the proportion of cases that they're doing, are using SavvyWire? I know you said the goal is to kinda become the dominant wire that they use in each account. Currently, is that, you know, 10%, 25%? Can you kinda speak to the percentage for the moment? You know, I would say it's a, it's a difficult question to answer because all those customer are not necessarily at the same stage, where some are doing their first couple of cases, while some have been with us, with SavvyWire since multiple months. I would say that for more mature customer that have been with us since a couple of months, we are able to achieve, you know, really, really good market share. you know, something that maybe around 35%-50% of their total volume today. That's great. Just lastly for me is on kind of the path to profitability. You know, great to see the top-line growth, great to see the margin growth and kind of the expected kind of stabilization of expenses. I don't know if you have just kind of any comments on that and the, you know, obviously the strength and balance sheet is great, and whether or not the current balance sheet is enough to get you to that point. Yeah. Scott, the vision is as we communicated before, we made significant investment in our sales and marketing team and our R&D team in the last few quarters. When you look forward, those costs should remain stable. As we continue grow to grow revenues and gross margin, obviously the net result, the bottom-line results will improve. We feel we are having the right financial position, the right balance sheet position to execute our business plan and to get to this breakeven point. That's great. Thank you very much. Our next question will come from David Martin with Bloom Burton. You may now go ahead. Good morning and congratulations on your progress. First question, looking forward to the SAFE-TAVI results later this year, since it is a single arm trial, I'm wondering what you consider to be the hurdles to beat RV pacing, right ventricular pacing, both from the key safety and efficacy endpoints. Then in the 30 hospitals that are using SavvyWire right now, are they all using the LV pacing function? Yeah. I will start with the short one. I mean, our customer today that are using the SavvyWire, you know, they are all to my knowledge using left ventricular pacing over the SavvyWire, which is a great recognition of the value proposition of this feature within our product. Regarding the SAFE-TAVI endpoint, the spirit of that study is to demonstrate the safety in using the SavvyWire with left ventricular pacing. You know, historically, I mean, in the overall picture, there is a certain morbidity rate of when you do right ventricular pacing. Just being non-inferior to that could be positive for doctors in the context of the improved workflow. Okay, great. If I might add one more comment to that. Just, some of the data that we use is from, a randomized controlled trial as well that has already occurred in Europe, whereas, you know, it's the dominant paradigm to left ventricular pace. That was as the EASY-TAVI study, which was a prospective multicenter, you know, single-blinded superiority RCT that compared RV pacing and left ventricular pacing. At a high level, the conclusion of that study was it was statistically significant that there was a reduction in procedure duration fluoroscopy time, which is important from a radiation exposure and cost. It was similar from an efficacy and safety, you know, with time savings and lower complication rates associated with LV pacing versus RV pacing. We've already seen that in the market and used those data in the U.S. because we're the only device that's indicated in the U.S. to be able to promote and train for left ventricular pace. Thanks for that added color. At the 30 hospitals, would they mainly be major teaching hospitals? You mentioned the types of treatment procedures that SavvyWire is being used in. Is it also being used diagnostically? Brad, maybe you can give at high level the profile of our customers. Sure. We are targeting the largest centers, with. In the U.S. as well as Canada, have had success getting into centers that would be meaningful for us, both first from a TAVR standpoint and procedural volume, provide a beachhead, then also have an after wire opportunity. Certainly teaching hospitals, large volume, reference centers where it's important to get those key opinion leaders and those that are recognized within the field as having efficient programs with good outcomes. That's been the target for our launch to date. The second part of your question, I believe was, is it being used from a diagnostic standpoint? You know, they certainly can use that and use it as a diagnostic pre-TAVR. There's also other data that we're looking at and being able to to collect over time of how we might use it to assess aortic stenosis, you know, prior to a TAVR procedure independently as well. Certainly our label indications support that. Our focus to date really has been on the TAVR procedure itself. Okay. Does the economic value proposition work differently in big and small hospitals? I would imagine it probably works better in the big hospitals. How do you manage that in the smaller hospitals if the economic proposition is not as attractive? Well, I would say. Well, I think as I mentioned... Oh, go ahead, Louis. No, you can go, Brad. As I mentioned, we've put together a fairly robust and sourced budget impact model that customers can use and put their own data in. Whether it's a small volume center or a large volume center, we see there's benefits across the three areas of the value proposition, which is the direct cost offset, time savings, and then the avoidance complications from RV pacing complications. Really it's, the value proposition is relative to what they're doing today and what kind of outcomes that they've had today and how efficient they are. You know, these smaller centers may be less efficient. They don't do as many TAVRs. If you don't do that, you may also have more complications potentially on a percentage basis, and it only really takes one complication to cost the system, you know, anywhere from $30,000-$60,000. We see a value proposition for basically, you know, all size of hospitals, but our target from a commercialization standpoint has been those larger centers because we get the most efficiency from our field footprint in doing so. Okay, great. Last question. You mentioned in the mature centers, so 35%-50% of the cases. Is that because not all physicians are trained or are they selecting some patients for the SavvyWire and others for their other wires? On what basis are they selecting patients for SavvyWire, if that's the case? Brad, did you want to take this one or you want me to take it? No, certainly I can. I think when you look at it, that's the data that Louis mentioned. I would say it's really, it is variable by center. I think Louis was giving some averages there. I think the important thing is that we have some centers where it's the, you know, the dominant wire and it's their primary device that they would pull for every TAVR procedure. There are some exceptions then, you know, maybe when they look at what's their existing conduction abnormalities or specific patient anatomies, where they may want to use and choose a different wire, you know, in those one-off circumstances. By and large, what we've seen is it's the primary pull wire that could be used with any patient. As you mentioned on the physician level sometimes, and even the staff, it can take, you know, some time to make sure to get all physicians to that same level of comfort as well as each TAVR team. That's some of the ongoing, you know, training and education and best practice reinforcement that we do at each account. Okay, great. Thank you. Again, if you have a question, please press star then one. Our next question will come from Maxwell Carr with M Partners. You may now go ahead. Hi, gentlemen. Hope everyone's doing well. Lots of questions, so I'll try to keep mine brief. Noticing the inventory builds over the last few quarters, do you guys feel comfortable that you're able to execute on the full release without leaving any money on the table? Yeah, sure. I think, even, we were building this inventory and this was done on purpose in the context where we are seeing growing demand from our customers. You know, as I mentioned before, we are looking for another record quarter from a revenue standpoint in Q3. It was important for us to have all the raw material and the finished goods required to support such growth. This being said, you know, when you look to the rest of the year, I would say, most of the investment in inventory has been done. You could even see down the road some decrease in the inventory before the end of the year since we are seeing much more stable supply chain right now compared to what we had not so long ago. Perfect. In terms of the sales team, noticing, and you mentioned previously that you're looking for the cost associated with the sales team pretty much flat. Is that a result of a more effective team? If the team is more effective, do you see stock-based compensation increasing for those team members? You know, I won't go in detail on the way we compensate our sales team, but what I can mention in term of efficiency is that what we are seeing is that the revenue per territory manager will increase in the next quarters, which will help us to drive growth while maintaining similar sales and marketing expenses. Perfect. Lastly here, sort of, more of a philosophical question. You know, as we're seeing the proliferation of these weight loss drugs, Ozempic and, you know, other drugs, do you see the market for procedures opening up as, you know, morbidly obese patients are now able to have a TAVR procedure without any, you know, unforeseen complications during the procedure? Yeah. It's an interesting question because We could put more emphasis on this, but what I would say is that what we are seeing inside OpSens is that TAVR market is going to grow substantially. Brad was mentioning earlier today about the market extending from severe aortic stenosis to more moderate stenosis, younger patient. All those factors, we are seeing this as positive factors for the SavvyWire. This is the part of my response on SavvyWire. I would also even say that in general, what we are seeing in the medical industry is that there is more and more interest in having proper information, proper documentation to support decisions that are made. This is perfectly in line with OpSens' core competencies, which are, I mean, having a really incredible sensing technology capability to distribute information in real time to physician. We think this will help us to create value for shareholders down the road. Perfect. Thanks, Louis. Congrats on the great quarter. Thank you, Max. Our next question will be a follow-up from David Martin with Bloom Burton. You may now go ahead. Thanks for taking two quick follow-ups. What do you think is the ideal ultimate size of your sales force? Are you happy with where it is now? Do you expect to expand it, and what will be the triggers to expand it? I mean, it's a challenging question to answer, I would say. Right now, we still have a couple of positions that are open. We want to be sure to fill those position with people that are having the right expertise to succeed. But overall, I would say, we are comfortable with the existing team, and we think with that we can achieve the different strategic goals that we have. Obviously, down the road, at some point we may need to do another increase on the sales force, but I don't see this happening before the end of the fiscal year 2023, and most probably not also in the H1 of 2024. Okay. last question: You recently reported the 1,000 patients treated with SavvyWire. Do you have what that number was at the end of February, at the end of the quarter? I don't have that information, but, you know, I would prefer not to respond this because, we'll report our Q3 results with the full disclosure on the number of patients. I would say, yes, of course, there was part of those patients that were done in March. Okay. All right. Thank you. Thank you, David. This concludes the question and answer session. I would like to turn the conference back over to management for any closing remarks. Thank you. Thank you to all people that have been asking questions. Many thanks for again, our incredible team. We are seeing a great future for OpSens and looking forward to update you in future calls. Thank you and have a good day. The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.