Good morning. Thanks for joining us at the 23rd annual Needham Healthcare Conference for day 3. I'm Mike Matson, and I lead the MedTech Research Team here at Needham & Company. I'm pleased to introduce InspireMD. We have CEO Marvin Slosman and Chief Commercial Officer Shane Gleason. They're gonna give a presentation on InspireMD. There will likely be some time at the end for questions. If you do have any questions you would like to ask, you can submit them electronically through the Needham Conference website, or you can email them to me at mmatson@needhamco.com, and I'll do my best to fit them in. So with that, I'll turn it over to Marvin.
Thanks, Mike. Good morning, everyone. and thanks for sharing our story at InspireMD this morning. We're excited to be able to present at the Needham Conference as we gain a lot of traction in this carotid market. Our mission at InspireMD is to transform the carotid revascularization market by way of our novel stent platform, which has proven best-in-class clinical results compared to both open surgery and endarterectomy and first-generation stents. This morning, we're gonna walk you through our story and why we think this is an optimal time, for us as a company, but also for the carotid space in general. Our investment in this space, during a time in which carotid innovation lacked focus and remained dormant for well over 15 years, has now positioned us to lead this way forward.
The combination of our unmatched clinical results, real-world evidence with over 50,000 stent systems sold to date, combined with this recent change in reimbursement, which opens up the entirety of the carotid revascular market to a stent-first approach, has really positioned us to lead this way forward with this endovascular shift from open surgery. We also remain the only company supporting both CAS and TCAR delivery systems, further expanding our reach into the entirety of the physicians performing these procedures. So today, we'll share this story with you in detail, and we hope that there's great value in where we're headed as a company and our strategy in general.
I'd like to use this first slide just as a great example of our value proposition, which is built around this mesh covering we call MicroNet, which plays a critical role in stroke prevention by preventing plaque prolapse through these stent struts, which create a lot of post-procedural events and has been one of the key limiting factors to first-generation stent technology. So our investment in this platform was done, you know, anticipating a time when there was alignment with next-generation technology value, unmatched clinical evidence, and financial incentive through reimbursement for endovascular solutions. So that's the basis of our story. And Shane and I will get into the details now. We'll use this as a table of contents.
From the top left, you can see we really focus on our proprietary MicroNet mesh technology because it really has been the game changer in terms of preventing post-procedural strokes, by way of managing this plaque prolapse through the stent struts. We've studied our technology in over 1,850 patients, rigorously studied in trials in Europe. And we've got a deep pipeline of a roadmap here, including a T-CAR device, which we've previously announced. We've chosen as a company to really focus on an implant-first, stent-first approach and not to really battle one side of the aisle or the other in terms of whether this is delivered through transfemoral CAS or T-CAR. We've decided to have both solutions available so that really outcomes are driven by implant and stent performance.
How we deliver it there, we wanna be ubiquitous in, in the market. On the top right, we talk a lot about the CMS approval of standard risk and asymptomatic reimbursement. This really was a game changer for, for the carotid market and catalyzed, a stent-first approach, and we think will be the first step in a huge shift from surgery-first to, to a stent-first thinking. Our U.S. IDE trial advanced very quickly, 23 months of enrollment. We announced at VIVA last year, unmatched clinical results, which we'll talk about today as well. And we've announced that we're going to share our 1-year data at the upcoming LINC Conference at the end of May. The market potential is obviously significant here, and it's been very undervalued because of a surgery-first approach. And expanding our, commercial footprint into the U.S. market is the next, goal and objectives.
We'll talk about also a really transformable fundraising event that took place in May of last year, a total of $113 million potentially available to the company through a tranche approach, which has really allowed us to fund our way forward and fund our growth. So with that said, I'm gonna shift to the next slide and let Shane kinda walk you through the background of how this procedural landscape looks. Shane, can you take it from here?
Absolutely. Thanks, Marvin. And thanks again, Mike and Needham for the invitation. As Marvin said, it's not just an exciting time to talk about what we're working on at InspireMD, but it's an exciting time to talk about carotid intervention in general. And for any of you that have been following the cardiovascular space for the last 20 years would know it's been a long time since we've been able to say that about the carotid market. Something that we've seen across all other cardiovascular procedures is that predictably, as soon as there's an endovascular approach that has, that has outcomes on par with surgery and there's reimbursement in place, things move pretty quickly from, as Marvin described, from a surgery-first to an endo-first approach.
And you can see some of the other cardiovascular interventions performed here, whether we're talking about cerebral aneurysms, coronary disease, the movement from CABG to stents, aortic aneurysms, peripheral artery disease. We could add in stroke thrombectomy, aortic valve repair. Across all of these types of procedures, as soon as there's that endovascular approach available, things move quickly from that surgery, majority surgery, to a majority endo approach. And then off to the right, you see carotid artery disease as one of those last fields that still has that opportunity to make a shift where still today, the majority of procedures are done by open surgery versus endovascular.
So again, for those of you following this for the last 20 years, you'll remember 20 years ago, before Guidant got the first stent approved in 2004, they were followed quickly by Abbott before those two combined and the other big cardiovascular players, Boston Scientific, Johnson & Johnson, Medtronic, all got approvals before the year 2010. And they were all drawn by the same thing, that promise of this being the next big billion-dollar-plus segment of the cardiovascular space. And the math is pretty simple. There are already over 150,000 carotid interventions performed in the U.S. each year. Again, the majority of those today are surgery, but over 150,000 procedures being performed each and every year. And that's just kinda the tip of the iceberg.
You look at the untreated but diagnosed patients; there are close to 3 million of them worldwide. And then, of course, patients that have this condition but aren't yet diagnosed. So really an opportunity for exponential growth of the procedures of carotid interventions, as well as that shift that we now expect to see where it's roughly two-thirds surgery to something that we and the rest of the market forecast to be majority endovascular split between traditional transfemoral or transradial CAS approach and a TCAR approach, both of which involve placing a stent in the carotid artery. But that transition not just of the market growing, but also of the shift from surgery to that kinda 80-20 endovascular approach. And really, that's fueled, as I said, the market moves when solutions are available and reimbursement is in place.
What's really held this field back for the last 20 years is that CMS only covered a small portion of the patients that can be treated with endarterectomy. Only a small portion of those were able to be treated with stents until October of last year, at which point the details are on this slide. The short story here is that anyone in the United States that's a Medicare or Medicaid beneficiary that can get a carotid endarterectomy, all of those 150,000-plus patients each year are now eligible to get a carotid stent, whether it's a CAS or a TCAR procedure. We went from a very small portion of those patients to essentially 100% of those patients really overnight in October of last year. Timing isn't everything, but it's awfully important.
We're poised to enter the U.S. market at a really favorable time with that tailwind of reimbursement expanding.
I think I would only add to that, Shane, that we've moved actually from an exception basis of carotid stenting to now the narrative has become, is this a stentable lesion when physicians sit with patients? And so we think this is going to drive an easier approach to being able to address revascularization issues.
Yeah. That's a really good point, Marvin. Until now, coverage, one of the limiters has been high surgical risk patients. So we've always had to look first, is this patient high risk for surgery? If no, they get surgery. If yes, then with other considerations, they may be eligible for a stent. But that requirement from CMS went away. So it's really enabling physicians to look at what's best for the patient and really flip that conversation to, is this a stentable lesion? And if so, I'm probably going to do endovascular. The reason for that shift in all these other procedures is that all else being equal or close to equal, patients and providers tend to prefer less invasive.
So now that the high surgical risk requirement for CMS goes away, then that enables providers and patients to look first, okay, is this a stentable lesion? If so, proceed. If not, then consider the alternatives. So it really turns that conversation upside down that we've been forced to have these last 20 years.
Yeah. Great point. So so let's, let's take the next step here. When you have the best stent in the market and the best, implant approach, you play to your strengths. And that really has been our narrative from the beginning. CGuard really represents the best in class in terms of, outcomes as demonstrated and proven by a lot of clinical and real-world results. So our approach strategically as a company has been, rather than playing one side of the aisle or the other from a TCAR or CAS perspective, we wanna play with, with our stent-first approach and make sure that we address all the subspecialties, whether by way of a a CAS approach or TCAR. And that's why we've developed both systems in advance of those forward with next-generation technologies. We also are spending a lot of time and focus on the neuro community.
We know that during acute stroke, about 20%-30% of the time, the carotids are involved. This is a subset of the market where there's not been traditionally a lot of attention paid by traditional carotid companies. We believe that both the design of our CGuard stent with mesh and a low metal content, as well as our ability to perform in this environment, is fundamental to that three-pronged approach to how we're addressing the market. We feel really good about being able to capture the full value of the endovascular shift when it occurs. Just a couple of quick slides here for technology's sake. On the left-hand side, you can see what plaque prolapse looks like when you look down the barrel of the artery, clearly with the proximity of the carotid artery to the brain.
When these pieces of plaque break off, they end up in the brain and they cause strokes. So two-thirds of these strokes that are occurring are post-procedural after the safety of a neuroprotection system has been removed. And our mesh, you know, continues to provide that sustainable capability of keeping plaque where it belongs by way of the mesh against the artery, to keep things in place. We use about a 20-micron of mesh PET. This has been developed over the last 12 years, and we think optimizes both the design dimension and clinical outcomes. So we've been really pleased to have, I think, developed a much better system, which is performing in our clinical studies.
Shane, do you wanna take this one just by way of a little bit of background since you were with Abbott years ago, just to kinda walk through the different technologies and how pore size really impacts outcomes here?
Yeah. Absolutely. Thanks, Marvin. One thing that's, I think, always important to remember when we're talking about treating carotid artery disease. As Marvin said, the carotid arteries are the main arteries on either side of your neck that take blood to the brain. And the reason we stent carotids is different fundamentally than the reason we stent elsewhere in the body. If we're placing a coronary stent, a stent in a leg, stent elsewhere in the body, we tend to be treating occlusive disease. And the goal is to reestablish blood flow to the end organ and, reduce ischemia and, again, perfuse the end organ. That's not exactly why we treat carotid disease, where the concern is more of embolism than of occlusion. We're treating embolic disease and, trying to prevent that plaque from breaking off, as Marvin said, going upstream and causing a stroke.
So really, the whole purpose of that implant is to prevent embolization, to provide scaffolding, and to stabilize a plaque so that it can't protrude through the struts, break off, and cause a stroke. So when you just see this comparative side by side, it's very intuitive to anyone who performs these procedures that more scaffolding is better. There's evidence out there that closed cell stents perform better than open cell stents in terms of preventing stroke. And what we essentially have is a stent that has better scaffolding, a smaller pore size than any of the stents, open or closed cell, that are on the market, yet we do it without sacrificing the flexibility and the other characteristics of the implant because it's not all rigid metal.
So you can see CGuard in the upper left where we have what's essentially a flexible open cell Nitinol stent with that overlay of PET mesh that Marvin described. You can see it compare in comparison to three other stents approved in the U.S. or elsewhere. You can see the kind of comparison between the cell size, not just in the pictures, but in that the images of the circles there. Again, keeping in mind that the job of the implant is to prevent things from extruding through the stent struts, breaking off and causing a stroke, you can see the impact that smaller cell size would have.
Here, as the slide says, a picture's worth a thousand words, especially when you have a heavy, eccentric, bulky, ulcerated plaque like you see, with the arrows pointed to them having the ability not just to cover the plaque, exclude it, but also to be able to conform to the artery, is really important. And those are things that are, you know, quite unique to the CGuard platform.
Thanks, Shane. So let's shift gears to talk about unmet superior foundational data because at the end of the day, this is the method by which we've accomplished a lot of success outside of the U.S. And it's really the message that we're gonna bring to the U.S., which is outcomes-based approach and better patient care. So as you can see, CGuard has demonstrated somewhere around a 1% complication rate as compared to both conventional stents and open surgery at somewhere around 4%-5%. These are significant differences when it comes to clinical outcomes. And by way of proving this through 1,850 patients or so studied in nine clinical trials rigorously overseen and published, this is really how we've gone about, you know, establishing superiority.
Unmatched evidence really is the guideline that we're going to take forward in terms of why patients should demand better outcomes, and CGuard will provide those. As I said, we've really invested heavily into this work. This is a bit of a complicated slide, but it's a Carotid meta-analysis that was done on over 112 studies, about 68,000 patients, comparing both first and second-generation technologies. On the right-hand side, you can see that CGuard has demonstrated really best-in-class results both in this 30-day window of stroke prevention, but more importantly, studied out to 12 months where restenosis becomes a real factor in terms of next-generation technologies. We've actually studied CGuard out to five years through our PARADIGM and PARADIGM-Extend with 500 patients studied in that as well.
So I think on balance, without getting too deep into the weeds in terms of detailed statistics here, this is really the language that we take forward in terms of clinical outcomes. And it's been quite useful both on the podium as well as in real-world experience. Let me shift gears and talk a little bit about the PMA trial design and study. FDA approved a performance goal of about 11.6%. 315 patients were enrolled in 23 months in our study. We're thrilled about that. We had some of the top carotid performers, physicians that participated in this trial who were into the one-year follow-up at this point.
As I said, at VIVA in Leipzig last year in November, we presented data, which suggested, first time ever sub 1% complication rates in 30 days for death, stroke, and MI. We will be presenting at LINQ at the end of May our 1-year data. So we feel quite comfortable that those performance goals will not only be attained, but we're on par with our real-world experience at somewhere around 1% complication rates. Again, this is game-changing type of results, and this just adds to the level of evidence that CGuard has been able to provide. It also gives us great confidence as we go forward in this PMA effort for approval that some time around 1 year from now, we hope to have approval for our CGuard in the U.S.
We're in a PMA mode right now, and we'll be submitting the final module for that sometime in the August-September timeframe. So we feel very good about our confidence in the ability to get CGuard approved in the U.S. Shane has been spending a tremendous amount of time architecting a commercial plan so that we're really ready to hit the ground running, to take full advantage of the U.S. market. Any comments on that piece, Shane, just in terms of how you're looking at the absorption of both our T-CAR and CAS systems?
Yeah. I think the short version is that claims data is available. We know where the procedures are being performed. There's a 20-year history of carotid intervention in the U.S. So there are a lot of industry professionals that have a lot of experience in this space. We know where the procedures happen, and we have relationships with many, most of the providers, the physicians performing them. We're looking forward to be able to build out the commercial team. There's a lot of inbound enthusiasm for folks looking to join the team. You know, as Marvin said, we're keeping our eye on approval timelines so we can be poised and ready at approval and shortly thereafter to be able to take CGuard out to the market.
One of the things we'll talk about in terms of the financing last May—we'll end on that note—was the ability to drive commercial growth over this financing option so that we get about two full years of commercial growth in the U.S. on this tranche of funding so that we've got the capital in place to be able to go about taking market share and building our commercial footprint. So just let's shift gears here really quickly to talk about our TCAR device. We call it SwitchGuard. We are in the process of studying that right now. As I said in the beginning, our plan was always to have both a CAS system available for transfemoral access, but also a TCAR system as that's grown in popularity within the vascular surgery community.
We know that there's 2,600 or so trained TCAR physicians in the U.S., about 25,000 procedures being done currently. There's only one system approved and available in the market currently. We fully intend and expect to go after this market aggressively and look forward to a better device with certainly, a better stent system, providing those outcomes that we talked about. So as Shane's architecting this plan for U.S. launch, we're, again, going to balance how we approach both the CAS market and the TCAR market. Ultimately, it's about leading the end of vascular shift in general. If you look out over the roadmap, over the next couple of years, it's all about growth. It's approval timelines and processes.
2024 is a year where we've got our head down doing a lot of really hard work to make sure that we get these approvals in place and that we build the company in a robust fashion so that we're ready to take full advantage of this commercial growth. So we're looking forward to the next couple of years of approval of both our CAS system, our T-CAR system in the U.S., and a full commercial launch as well as a neuro focus as well. Spend a couple minutes here. We're really excited about having some of the best of the best supporting us on a multidisciplinary approach. These names are very familiar in the carotid space. We're really happy about having them on board as our strategic advisors as well as leaders.
One of the things that Shane just mentioned is it's one thing to complete a clinical trial. It's another thing to have the people that are completing that trial really excited about using the technology in real world. I think without exception, there's tremendous enthusiasm here for that approval process. Shane, you wanna spend a second about our worldview here and how we've gone about demonstrating both clinical utility and also in terms of our commercial bandwidth and how we bring that to the U.S.?
Yeah, absolutely. The one thing we've talked about it quite a bit in the last 25 minutes or so, but it's important to note that this is not like some products that are going through clinical trial that are otherwise unproven in the market. This is not a science fair project. CGuard's been in. We've sold over 50,000 units now in the US. That's an update to the slide here. Things are moving quickly. But again, we've sold over 50,000 units, close to 2,000 of those in the published peer-reviewed literature that Marvin described. And we already compete in over 30 countries. Now, we do that through distributors. So our goal to date has not been, let's maximize our spend to maximize revenue. It's been to compete wisely, work through distributors, and support the business.
But the big goal being, let's make sure we understand this product. Let's make sure that we can generate that best-in-class data to support when we do enter the US and some of those other important markets in blue there. We'll be entering the US through a direct sales model rather than through distributors. So, again, we're winning where we compete. The product itself is tested, and we've generated that data from this. But then when we get to the US, we'll be taking a direct sales approach.
Thanks, Shane. So, just to mention one member of our board of directors that I think is worth noting, Dr. Gary Roubin, did the first carotid intervention in the United States and has advocated an endovascular approach, a stenting approach to carotids for his entire career. And not only has he been a tremendous advocate and an investor in the company, but he joined our board a couple of years ago, which to us was just a huge proxy to the fact that we were headed in a good direction and strategically were making the right moves. So having Dr. Roubin, not only advocating for us but serving as a member of our board, has really created a tremendous amount of value. He was a very big participant in this NCD from CMS and getting approval. Obviously, we focus on our intellectual property portfolio.
This is not an easy technology to replicate, even if we had no patents of protection. But we do. And we continue to build that both with our T-CAR device as well as CAS system. CGuard has demonstrated over the years a lot of opportunity for us to build walls around this mesh platform. And so, we like the fact that we've well protected our investment here. And even though it's a complicated system, we're able to demonstrate that through good portfolio. Let me spend a couple of minutes just wrapping up here. In May of last year, we closed a transformational round of funding. As I mentioned, $113 million totally available.
42 came up front, and we have 4 tranches of about $18 million apiece based on milestones that we see in the near and medium term. This was put together by a PIPE structure that I thought was ambitious at the time. And we were really successful in being able to convince some of the best investors in the world mentioned here at the bottom, led by Marshall Wace and OrbiMed in particular. And again, I think this was a proxy to the fact that as a company, we were focused in the right direction at the right time with the right milestones. And so we were thrilled to be able to recapitalize about 80% of the company through these investors.
As we go forward for our our growth strategy, you know, we hope that this translates into significant value, for both the investment community as well as our our other investors. Just talk a little bit about our our cap table. It's a very clean cap structure. We're publicly traded, obviously. So when you consider the shares outstanding right now with pre-funded warrants, it's not a full a full picture, of what things will look like on a a fully diluted basis of about 93 million shares, if and when all of these warrants are exercised and and the tranches are completed. By the way, these are, warrants that expire 20 days following, following these milestones. So they will be executed as such.
We're coming up to the first one, at the end of May, as we mentioned, with disclosing our one-year data on our FDA trial. So that's all we had formally prepared. Shane, did I miss anything along the way that you wanted to add before we turn things over for maybe some questions or comments?
No, I think you nailed it.
All right. Thanks, guys. I do have a few questions. So I appreciate the overview on the reimbursement changes there, but I guess I'm just curious, you know, kind of what the history was and why, you know, stenting wasn't kind of covered earlier on. You know, was I guess what was the rationale for that for Medicare if you have a feel for that?
Shane?
Yeah. It's probably at least a couple chapters of a book could be written on the topic. But when the first systems got approved in, you know, literally 20 years ago, in 2004, it was an interesting time in peripheral intervention to where if you think of what was being done elsewhere in the body, there were biliary stents being used in arteries and veins. And where FDA did not have named vessel indications, CMS was covering those procedures. So you could put a biliary stent in a leg, and CMS would pay for it even though FDA had not approved it for that use. That was all changing at this time in the mid-2000s. And then when, you know, as I put it, we finally got stents that had arteries that were named after arteries.
We actually had PMA approvals for stents. CMS then covered those more cautiously. Some of it is proximity to the brain. Some of it is, there wasn't uniform support across all of the specialties involved. The surgery community, the neurology communities weren't fully on board with the interventional communities. So there wasn't this unified front of the physician societies going to CMS. They looked at it a couple of times. They reopened that NCD a few times. The last time they did in 2009, they still had this discrepancy of all high-risk patients are approved, but only a subset of subset of them were covered by CMS. Then things kind of went into hibernation, and 14 years passed before CMS took another look at it. Now, that gave time for the randomized trials to catch up.
The CREST study and three others totaling about 8,000 randomized patients were enrolled and published in that time. And then by the time they reopened the coverage decision, early last year, the evidence was kind of undeniable that there's at least parity between those two procedures even with first-generation technology and the recognition that next-generation technology, and improved patient selection just simply by giving physicians choices in how they treat patients could yield further improvements in the outcomes. So it took a long time to get here, but, you know, one of those 20-year overnight successes, right?
Yeah. Okay. Exactly. Okay. And then, you know, what's your sense of, you know, what are some of the larger companies that have had these stents? I understand, like, your argument that, you know, your stent is better and it does seem to be better. The data's better. The design's better, et cetera. But, I mean, do you think these bigger companies are gonna, you know, kind of come back in and try to, you know, reinvest in this business and refocus on it? Or have they just given up on it, you know, and kind of walked away?
I can take that one, Marvin. What do you think? You wanna take it?
You wanna grab that one?
Sure.
And I've got a comment on that as well. So why don't you take the first one? Now, then I'll fill you in there.
Well, I guess I'd say, writing out of my own autobiography here of the four big companies involved in carotid stenting, I've led marketing for one of them, and I've led sales for another. So I know a little bit about how they think. And really what happened was when CMS didn't change anything in 2009, companies shelved projects. It was the investment. The juice wasn't worth the squeeze. So when we enter the market with CGuard, all of the larger companies will be competing with stents that have been on the market for 15 years or longer. So they just really haven't invested in the innovation. But now that the market is looking like we all thought it was gonna look 20 years ago, so they all have decisions to make in terms of how they compete.
And what we've started to see from them is the quickest thing you can do is invest in sales or marketing. Invest in training. And that really helps us, helping develop the market, making sure physicians are trained to do the procedures. But then if you get into innovating and starting from, you know, starting from a flat-footed start to innovate and create a PMA product for a next-generation stent, those are things that take a lot of time. So I think that's the kind of decisions that are having to be made at the other companies is, okay, we can turn on the training machine. We can, you know, we can incentivize our sales force to go out and focus on these procedures. But giving them a new product to compete with CGuard takes a lot of time and effort and investment.
Yeah. I don't. I'd only add to that, Mike, that I think, you know, in the ecosystem of medical devices, there's only so many markets that are real opportunities to drive growth and do it through innovation. And I think the carotid space is, Shane has said, has been somewhat dormant for a long period of time. And as large companies look across their portfolios, they are obviously looking for organic growth and where they can drive change. And so this has become a priority for many of those that currently compete with first-generation technologies where they need better and others that haven't participated at all in this space that see it as a catalyst for their own growth.
So, you know, it's gone from sort of being a backseat idea to something that all are quite interested in and are watching this innovation and this change to an endovascular shift, which we're obviously advocating and will be driving.
Okay. Thanks. And then, I apologize if this was in the slides and I missed it, but, what sort of pricing are you expecting for your product or just the products generally in the market if you're not willing to disclose your own price?
I think the plan right now is, we obviously want to try to drive a premium for our products once we are approved in the US because we do have better outcomes. And with superior technology, we always wanna try to gain an edge on that. But at the same time, the carotid space in general is a lucrative space, from an ASP perspective. And, you know, it's obviously gonna be a game of pricing our products in a bandwidth that allows us to grow share aggressively but at the same time sort of meet the market expectations and demand. So remember, we have a, in the CAS market, a stent only. And in the T-CAR market, we're going to have a stent plus a neuroprotection system called SwitchGuard. So those economics are a bit different.
But I think the goal is to obviously take full advantage of premiums where possible. And as you know, it's a game of somewhat inconsistencies in terms of volume and hospital systems. And, you know, we will do our best to make sure that we're well positioned there. Shane, I didn't know if you had any other thoughts, but that's kind of our general feel.
Yeah. I guess I'd just add that, in the TCAR space, having a single competitor that's publicly traded, they're very transparent with their pricing. So we know exactly where the market pricing is for TCAR.
Yeah.
Similar for carotid stenting where instead of a neuroprotection system, as it's called there, you've got your embolic protection system and your sheaths and other accessories used there. So, we know where the market pricing is. And, you know, as Marvin said, we've got a premium technology. We'd like to, you know, get premium pricing. But we also have the flexibility of knowing that, you know, our ability to quickly compete for share where we're making our own product, we don't get it from someone else, that we've got the COGS flexibility that I'd say all options are on the table in terms of how we compete when we get to the market.
Okay. Got it. And then just finally on the, for your sales force when you start to build it out in the U.S., I guess, how concentrated is the customer base here? And, you know, how big of a sales force do you think you would need in the to cover the U.S.?
We've discussed those things publicly, right, Marvin?
Yeah. I no problem. You can.
Yeah. All right. Well, one thing that we see in all these cardiovascular procedures is if you get to around 60 territories, you have a fairly homogenous coverage of the map. You don't have reps doing a lot of overnight travel or a lot of flights within their territories. So we've got a path mapped out to getting to those 60 or so territories. Obviously, we complement that with sales leadership, with clinical case support, you know, therapy development, clinical specialist types. But, it's a benefit of having claims data is we kinda, you know, we can fish where the fish are. We know where things are happening. So you can focus, not driving around territories, looking for people that do procedures. You know where they are. But they are, you know, fairly distributed.
They're the, you know, the same kind of, you know, therapeutic deserts that we see in other cardiovascular spaces. But, it will be you can't say, "Oh, we're gonna cover these 10 markets and have the majority of the of the, you know, the majority of the cases.
Yeah. Mike, I think it's neat to assume that this is a book that's been written several times. And Shane and I have both written it. I think that, as he said, we're trying to optimize, being thoughtful about, our financial responsibility but at the same time keeping pace with growth. And there's been a lot of examples of it's an accordion effect, right? We if we can grow faster, we'll build faster. And, you know, the initial territory approach, I think, will serve us well in getting to some significant numbers.
Okay. Great. I think we're almost out of time. So we're gonna have to wrap up there. But thanks, guys.
Okay. Great. Thank you very much. We appreciate the opportunity. And, be in touch.
Thanks, Mike.