Good morning. Thanks for joining us again at the 24th Annual Needham Healthcare Conference. I'm Mike Matson, and I lead the MedTech and Diagnostics Equity Research team here. I'm pleased to introduce InspireMD. Presenting from InspireMD, we have Marvin Slosman, CEO, and Shane Gleason, Chief Commercial Officer. They're going to give a presentation on InspireMD, and then we'll open it for questions at the end. If you have 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. I'll do my best to fit them in. With that, I'll turn it over to Marvin and Shane.
Thanks, Mike. Good morning, everyone, and thanks for the opportunity to present the company this morning. Let me start off with the cover slide here, whereby we're saying InspireMD poised to revolutionize the carotid intervention market. Awfully bold statement, but I think this is a really remarkable time. Finally, after many years of dormancy in the carotid space, we're seeing the winds of change shift pretty dramatically. Our investment in this technology platform, I think, establishes an asset that we're incredibly proud of and we think can truly revolutionize the space. I'd like to draw your attention. First of all, Shane Gleason, our Chief Commercial Officer, is with me this morning.
The great context of having Shane on board is the fact that as we get closer to FDA approval, which we're still calling in the first half of this year, Shane has been architecting and developing a commercial plan for the company to really launch the product as effectively as possible. In context of his background, he launched the first carotid stent with Avid 20-some years ago, and I think can offer some real context and perspective as to how this market has shifted and migrated over the years. Really fortunate to have Shane on board and with us today. Let me draw your attention to this graphic because this really establishes the foundation of our value proposition. On the outside of this self-expanding stent, you can see a very fine mesh layer we call MicroNet.
It's 20 microns of PET, and this invention and innovation has really been the catalyst that we believe is going to enable this shift from open surgery to carotid stenting as a primary standard of care. Why is this important? We will explain it through the presentation today. Managing plaque prolapse through these stent struts and protecting the artery from post-procedural embolic reactions is really the game-changing opportunity for us as a company and, frankly, for the market in general. What you will hear is a background now over the next 30 minutes or so of why this mesh outer layer makes such a difference in terms of being able to enable this shift of improved clinical outcomes and changing standard of care. I wanted to just establish that as the key feature.
We've invested in this technology for the last 15+ years and are very proud of the progress that we've made, both in our OUS markets with over 60,000 stents sold, in addition to having studied this in rigorous trials of over 2,000 patients, including the FDA trial. Let's walk through the high-level enabling features of our table of contents and why it is such a remarkable time to be in the carotid business. As I said, our MicroNet mesh technology, Will explained, speaks for itself and has really been this game-changing platform. We have studied our technology in over 2,000 patients. We've sold over 60,000 stents globally. We have built a pipeline of innovation, including a TCAR device in addition to a CAS access technology, to really be able to capture the entirety of the market.
Up to this point, there have been companies that have played on one side of the aisle or the other. We decided with the best implant a while ago that we didn't want to limit our opportunity to address any access point, whether it's transfemoral or transcarotid, that ultimately the implant is what matters to the patient. We have developed these access platforms to capture the entirety of the market. The market potential is significant. We think it's close to $1 billion in the U.S. alone. Expanding our commercial footprint with our focus on the U.S. and approval of our PMA in this half of the year has been our primary and almost entire focus as we build on the results of our OUS market. The real enabling feature and driver behind this market shift was CMS' coverage expansion in October of 2023.
For almost 20 years, there was this anticipation that CMS would cover standard risk reimbursement, meaning a stent first approach to how revascularization occurred. That did not happen for a variety of reasons. There was a lot of disappointment over the years. In October 2023, that expanded coverage took place, and CMS enabled standard risk reimbursement, which has effectively opened the entirety of the 155,000 or so carotid interventions to a stent-first approach. We are beginning to see that shift and change, which Shane will explain to you in the next couple of slides. We think that shift will continue, and this will be a stent-driven market. For context, every other vascular bed has shifted from open surgery to an endovascular first. When endovascular solutions are available, patients, physicians, and others obviously prefer a less invasive approach to dealing with occlusion in whatever vascular bed.
Carotid disease did not shift for a variety of those reasons, including reimbursement. Frankly, first-generation stents that were invested in 20 years ago and available at that time really did not change the clinical outcome significantly enough to really shift that effort from a patient-first approach. We find ourselves in a market where we have best clinical outcomes combined with reimbursement and a general shift of momentum toward this stenting approach first, including the fact that Silk Road Medical had developed significantly this therapy called TCAR, which we are going to explain to you as well, which provided vascular surgeons that opportunity to do stenting in a more comfortable transcarotid environment. If you look across the market opportunity, as I said before, in the U.S., it is roughly 155,000 carotid interventions. If you translate that to dollars, it is somewhere around $900 million to $1 billion opportunity.
Globally, it's significantly more. Obviously, the U.S. market is the most lucrative, and reimbursement obviously fits that model quite well, which is how companies like Silk Road Medical built up to a $2 billion market cap, serving half the market with their TCAR procedure. As we've invested in this technology, our focus has and will remain U.S. approval. Unfortunately, it's early in the morning, and I'm sharing not the prettiest slides here, but this just gives you a sense of what shifting surgery first to an endovascular first approach looks like. Nobody wants open surgery. Everybody prefers stenting through the pipes where available. What we're really trying to accomplish, though, is preventing this plaque prolapse through the stent struts so that you have that residual protection that's available. The shift in the market that we talked about is occurring in front of us.
Maybe I'll ask Shane to jump in just to talk a little bit about the current market dynamics, how we see that shift over time, and why we're so enthusiastic about this change. Shane, you want to jump in?
Sure. Thank you, Marvin. Good morning, everyone. Actually, if you go to the next slide, Marvin, this shows what the market projection looks like. This is what it is based off of. As Marvin mentioned, there was a real transformative change in coverage from CMS in the fourth quarter of 2023, where since the first stent approval in 2004, coverage had been very restrictive for carotid stenting, where a small fraction of the patients who can get carotid endarterectomy could get a stent. Only high surgical risk patients and only symptomatic patients with high-grade stenosis. The majority of patients who receive an endarterectomy are asymptomatic. They are patients who have not yet had a stroke but have carotid disease. Again, the reason we do carotid stenting is to prevent stroke. It is typically not to treat stroke; it is to prevent it.
The majority of patients treated are intended to be treated before they have their first event. Until October of 2023, those patients were not eligible to receive a carotid stent if they were Medicare or Medicaid beneficiaries. With the expansion of TCAR that Marvin mentioned due to Silk Road's efforts, we can see going back three years, 70% of the carotid interventions performed in the U.S. were open surgery. Only 30% of the patients received a stent either through transfemoral, transradial, or transcarotid stenting. That has shifted over the last three years. We see some of the enabling time as TCAR coverage was expanded in 2022. As I mentioned, in late 2023, CAS, or transfemoral and transradial carotid stenting, as well as TCAR coverage, was expanded.
We see those lines converging where we see the number of Medicare claims for endarterectomy going down and being replaced by carotid stenting. What we see is those lines are very close to crossing and continuing on with stenting becoming the predominant procedure here and looking really like every other vascular intervention. Marvin showed on the pie chart slide that everywhere else, head to toe, as soon as there's a viable endovascular approach with reimbursement, things move to majority endovascular, minority surgery. You can see the carotid stenting as well on its way thanks to the expanded coverage. We think that will be further increased by introducing new technologies like ours.
Just shifting gears back to the science for a moment, the primary job of the carotid stent is to stabilize plaque, as we've talked about. When you have an open or closed-cell stent that's unprotected with mesh, what you find is that when the plaque gets pushed against the artery wall, you can see an OCT image here on the left-hand side. You see this plaque protruding through the stent strut in a high-volume blood flow environment with proximity to the brain. Post-procedural strokes, unfortunately, became problematic in this situation because you don't allow the plaque to remain where it belongs against the artery wall. Our mesh does the job that you can imagine it's intended to, which is to keep the plaque against the artery wall out of the lumen of the artery.
That really is what has enabled these clinical outcomes, this one feature. As we look across the landscape, we really focus our attention on the value of this implant. Patients walk around with the implant for the rest of their lives. The procedural safety of either a CAS transfemoral access procedure or a TCAR transcarotid procedure is all relatively safe, whether you're reversing flow in a TCAR procedure or you're adding a distal filter with a basket or a balloon for proximal protection. The procedure itself is relatively safe. The issue is once you remove all that gear, what you're left with is the implant. We like to think about this mesh as that residual protection. As I said, after 60,000 real-world experiences and studying this in 2,000 patients, we understand how this stent performs with this material with our MicroNet mesh.
The one thing that's unique about the carotid space is that it's multidisciplinary in terms of the physicians that perform. What you see here is a group of our KOLs that act as strategic advisors, all at the top of their game in terms of carotid intervention and capacity. What you see here is a group of people that are very different, a neurosurgeon, two interventional cardiologists, and a vascular surgeon. The point here is to be able to address the entirety of this market. I think the overwhelming response has been this market has been looking for a new asset. They're looking for a new technology, and they're all very enthusiastic about the CGuard with the MicroNet mesh.
I'm going to let Shane also jump into the evidence here a little bit because we performed what I consider to be a really remarkable PMA IDE trial with FDA to get us to a point of being very close to approval. Many times, these trials certainly go according to plan. In this particular case, we're thrilled by not just the way that the trial was done, but the enthusiasm of the operators that are looking forward to a better implant. Shane, would you mind just kind of walking through the high level and the results here? That'd be great.
Yeah, happy to. The CGuardians study is a carotid stenting trial performed with our CGuard stent. Fairly traditional in terms of the design of a carotid stenting trial, which makes it really easy to have an apples to apples comparison when we get to the next slide. 316 patients, 24 centers, the majority of them in the U.S. We had co-principal investigators, Dr. Metzger in the U.S. and Professor Musialek from Poland, two extremely well-regarded, highly experienced carotid interventionalists. When you perform these trials, you're treating high surgical risk patients, both symptomatic and asymptomatic patients who are either at risk of stroke or have had a stroke due to their carotid disease. If we go to the next slide, you can see what the results look like. Without getting into too much detail on the left, I'll just say that on the right, these are the approval trials.
These are the pivotal trials for all other carotid intervention tools in the market, all other carotid stenting trials. You see two things. One is a bit of a general downward trend, but you see the majority of those event rates, those 30-day event rates, hovering around that 5% mark. Until more recently, Silk Road had a 3.5%. You see us with less than 1%, really a different kind of number. What we're measuring here on this slide and the next, the standard endpoints for carotid intervention trials are through 30 days, a combination of death, stroke, and MI, myocardial infarction, heart attack. We go through one year looking at strokes that occur on the same side, ipsilateral stroke. Again, we see a number that's lower than any of the other previous trials. I think that's one of the exciting parts of it.
The other exciting part is the consistency with all of our prior data. Marvin mentioned earlier that we have over 2,000 patients that have been studied and presented. Here on the last slide, we mentioned over 1,300 patients that are in the published peer-reviewed literature out through 30 days. Here on this one, over 1,100 of those patients are in published peer-reviewed literature out through one year. We see remarkable consistency between our pivotal trial results and all of the previously published real-world data.
When we talk to physicians, this is something that really gets their attention, even more so than just our pivotal trial in isolation, because I think there's the perspective of, well, if you did a pivotal trial and carefully controlled it and wrapped it in bubble wrap and made sure to highly select your patients, you may be able to get good outcomes. What happens when that product is released into the wild and is actually used in real-world use? Conversely, if you just have real-world use, then there's the question of, well, does it have the rigor, the core lab, the independent adjudication that you would get from an FDA trial?
The combination of those two, all of our prior published data along with our now FDA trial here, the consistency of the two is what really stands out to the physician operators that we speak with. This slide that Marvin.
No, go ahead. Go ahead, Shane.
This slide that Marvin moved to is some more data. Again, a lot of numbers on here, so I'll speak at a high level. The authors of this Karman meta-analysis, they took at the time all of what they found to be the credible published papers in carotid intervention, carotid stenting. They found 112 papers that included over 68,000 patients. There's around 68,400 patients of all stent types. They did a meta-analysis. The columns on here, first thing they did was they compared first-generation stents, the ones that were launched back in the 2000s, with second-generation stents, the three dual-layer stents that have been studied since then. Those are called out on the right here. Their first conclusion was that second-generation stents, or SGS on this slide, performed better than first-generation stents. Their second conclusion was, that's true, but there's not a class effect.
Not all second-generation stents are created equal. The second from the right is a product that's not marketed, hasn't been launched anywhere in the world. From my understanding, we don't expect to see that. You can see the results were similar to those of first-generation stents anyways. When you get to CGuard, our product in green, and the one two over to the left, you'll see two dual-layer stents that both have similarly positive results at 30 days, low event rates. They're both dual-layer stents with good scaffolding, so it makes sense that they would do a good job of preventing strokes and events in the short- term.
When you look out to the one-year endpoint and you look at the bottom row, you can see a 0.73% number for CGuard and a 7.86% and 8% number, 10 times the rate of 12-month events with the other one. There are important differences in design that make a lot of sense. Really, the comments from the authors that second-generation stents perform better than first, there are important differences. The construction of CGuard results in both great short and long-term outcomes.
Thanks, Shane. I think, again, the thing that we're most proud of is the consistency and durability of the data when it comes to how many of our stents we've sold and put in patients. We've actually studied our stent out to five years with remarkably consistent results. This obviously forms the foundation of our go-to-market plan and gets the attention of the operators. It obviously will be an important discussion that they have with patients. Remember, up to this point, there's been a limited opportunity for physicians to discuss with patients, is this a stentable lesion that you have as opposed to our only real option is best medical therapy or surgery. Let's talk for a minute about our investment into the TCAR space.
Again, we wanted a universal approach to how physicians place stents, whether by TCAR, which is a therapy that appeals, obviously, to the vascular surgery community and the interventional community accessing transfemoral CAS. As a company, we strategically focused on this five plus years ago, excuse me, to build a system that was remarkably consistent to what Silk Road had developed and marketed over time. With the second-mover advantage, we always look for those opportunities to improve feature set and function. We are really proud of the fact that we are now studying our stent in a TCAR environment with the available neuroprotection system on the market and plan to study ours and have that cleared as well so that we capture the entirety of the market. You can see here just a quick graphic of the two devices themselves.
We will have our CGuard system in a short-shaft version or a TCAR-friendly version, if you will, available in the 2026 timeframe. I look forward to competing, obviously, for those 30,000 TCAR procedures that are in the market. I put this picture up because it is really kind of a remarkable, candid view of a meeting that Shane and I attended at the vascular surgery meeting a couple of years ago. The group that is assembled here with the names off to the left are really the top vascular, some of the top vascular surgeons that really put Silk Road Medical on the map and, most importantly, helped design and develop the TCAR therapy.
All of those individuals, without exception, were very enthusiastic about a better implant for us and the improved feature set of our TCAR device and gathered with us to talk openly and candidly about the changes that needed to be made and some of the improvements based on their experience over time. Without exceptions, the people that are in this room and on this list are not just enthusiastic, but will be participating in our trial. I think will really help drive the opportunity within the vascular surgery and TCAR community. I'm going to shift gears now here just to offer a quick comparison of what the tailwinds of carotid stenting have been. This gives you an example over time of a peer who built and developed this therapy.
Let me couch this by saying that building a therapy into the marketplace like TCAR is not a simple process. It's not inexpensive. Silk Road Medical trained over 3,000 vascular surgeons to do a procedure that they had never done. There's a heavy lift there related to the effort, the cost, and otherwise. We don't have that same issue. Our device is remarkably similar, and we plan to take full advantage of a matured market that's very comfortable and enthusiastic about doing TCAR procedures, but obviously looking for a better implant. In context of numbers of units sold, Silk Road Medical announced that they had sold over 100,000 systems, I believe, last year. We've sold over 60,000 in the market. Now, when you compare financials, we sell through distributors in our OUS markets, and it's a much less lucrative ASP business for us.
Just in terms of comparison, we like to think of the context of units sold. As we enter the U.S. market with very different ASPs and very different financials, we look for an accelerated growth opportunity on what we believe has been a real shift and change here. Shane, did you have any follow-up comments on these slides or otherwise? Okay.
I think you nailed it.
Good. As we look across the landscape, it's been an incredibly busy time for the company. We're shifting very rapidly from a strategically focused company, building tools and building features and addressing market opportunity to delivering and executing and measuring our results. 2025 is a big year for us. Obviously, we're looking for approval of our CAS system this half. A part of that is building our OUS operational and commercial expansion. We've moved our global headquarters here to Miami. We have signed an agreement to expand our production with a CMO that's based here in the United States. Shane has done a remarkable job of recruiting a group of commercial leaders and representatives that we think will be able to really enable a magnificent launch here as we get into the market and get approval.
In 2026, we look to be able to enter the TCAR market by way of our stent first we used with the current neuroprotection system that's available and approved in the market. Late in the year, hope to have the clearance on our full SwitchGuard neuroprotection system so that we're able to compete holistically on the TCAR opportunity. Really, the roadmap for our growth and our future is all about execution and capturing the enormity of this market expansion, which we're looking forward to. I'll let Shane spend a couple of minutes. I know we're on the clock here and have about five minutes left in the discussion, but I think it's important to do a really quick overview of how we're thinking about going to market. Shane, sorry to put you under the gun here on short timing, but I'll let you walk through these.
Just real quickly, as Marvin said, we've been able to attract a really, really strong team here. Carotid intervention, I mean, we're preventing stroke. We're treating patients who've had strokes. It is a highly specialized field. Of all the commercial professionals out there who have ever supported it over the last 20 years, a lot of the really good ones, this becomes their favorite procedure. Being a company that's focused on carotid intervention is something that can attract some of the best talent out there. We've been able to attract a really strong team. Everyone comes from a background in carotid stenting, TCAR, and/or neurovascular intervention. What this shows is essentially we have claims data, which we mentioned earlier, that's very granular.
We know where the procedures are being done, and we're going after the best talent in these markets to put, you could say, we're fishing where the fish are, and we're hiring really, really good fishermen and fisherwomen. Some additional detail here, not only do we know where the procedures are being done, we know in which hospitals, by which physician specialties, and we can plan our activity accordingly. This goes even another layer down of within hospitals seeing physicians and knowing when and where and how to target our business.
Just in lieu of time here, I think the message here is very clear, which is we're going to be very deliberate about where we go about focusing our representation, our go-to-market strategy. We obviously have different products entering the market at different timelines, but on balance, we're hiring a group of individuals that bring relationships and awareness and knowledge. We're taking both the discipline of the science here and the art of selling and combining those to hopefully make the biggest impact on our go-to-market strategy. Just really quickly here, this just gives you an overview of the globe. In the green is where we currently compete. Obviously, we're headed toward the United States here, and we've talked about the value of having established a foundation of high market share in OUS markets and the ability to really drive both our commercial as well as clinical programs.
I want to wrap up with a couple of quick slides here. Obviously, this was a transformational financing that we did in 2023. We decided to pivot to a pipe structure. We attracted the attention of six of the top fundamental investors in the marketplace. They felt very good about the direction of the company and invested in the company. We recapitalized about 80% of the company through this offering. It's a tranched program, $42 million upfront, about $17.9 million in each of the tranches. These were done in the form of pre-funded warrants. We've accomplished number one by the release of the data. Approval will garner number two. You can see going forward, once we approve our TCAR device, we'll get number three, and then our commercial sales for number four. These are not your typical warrants to perpetuity.
They expire 20 days after the milestone is achieved. We felt like this was a really good approach to how we raised capital. Each of these investors felt very strongly that they capitalized the company through commercialization. We did not want to run up to the starting line on approval and then have to refund the company flat-footed. This capital structure really worked well for us, which provides the opportunity to add the individuals that Shane just mentioned. We have got over 14 people that are ready to go building on our commercial momentum, which was the point here is to get a fast start out of the gate. Obviously, we are a publicly traded company. Just in terms of our cap table and warrant structure, on a fully diluted basis, we have about 100 million shares outstanding once each of these tranches triggers, and those shares are in the market.
That's what we had formally this morning. Happy to revisit any of the topics or take questions. Mike, how did we do? I'll put you on the spot.
That was great. It seems like a really interesting story. You seem to check all the boxes there, including having the financing in place and everything. I guess I do have a few questions. Just starting with the CGuard Prime approval. I assume it'd kind of be the, it said 2025 on the slide, I think, but I'm assuming that's kind of more like latter part of the year, correct?
Yeah. Let me walk you back through because it does get a little murky here. For our PMA, which is our first approval of the stent in the U.S., we're calling that in first half. Here within the next month or two, we still expect to have approval. That's for our.
First half.
Yeah, first half.
Okay.
For our transfemoral system. That is what we've been building toward. As we continue to study the TCAR options that are in our portfolio, we'll study those and look for mid-2026 for our TCAR indicated stent, and then late 2026, early 2027 launch for our full TCAR system called SwitchGuard. That is kind of how the progression works.
Okay. Got it. And then just the data, I mean, the data looks pretty good. I mean, do you see any sort of risk around the approval, the first one for CAS? What are you hearing about the situation at the FDA with the layoffs and everything? Is there any risk that could delay things?
Yeah, it's a great question, Mike. Let's go back a step. When we filed our PMA originally, we did it as a modular approach because we felt that that was a more efficient way of doing it. I think that played out nicely for us. We filed the PMA in September, I think September 16th of last year. We did our 100-day meeting with FDA. We've been in a very interactive approach with FDA. Let me go back to your original question. From a data perspective, I think we feel very confident that we've de-risked that part of it. As you know, there are so many things that go into getting a PMA approved. We've been very interactive with FDA, which is encouraging. Remember, CGuard was approved to use in the CREST-2 trial as the only unapproved stent in the U.S. market.
I think FDA is obviously very familiar with our technology, and we saw that as a real positive. Since that time, we've been interactive with FDA. We did a remote audit of our Tel Aviv facility. Are we concerned always because there's just dynamics in play that are out of our control, but we're still comfortable that the feedback that we've gotten from FDA will land this in the first half and don't have any indications that that will change? Things are always subject to that. It's very rare that companies get an approval at the 180-day mark. There's always things to be buttoned up. As a company that's still producing in Tel Aviv, there's aspects to that, but we're still comfortable calling first half.
Okay. Got it. Just on the CGuardians two trial, that's for the TCAR system, delivery system with the stent. Is that right?
That's correct.
2027 approval?
2026 approval. We're enrolling in that trial. FDA approved that trial for enrollment. It's using our CGuard in combination with the EnRoute neuroprotection system. We're studying 50 patients, and it will be filed as a supplement post-approval on our long-shaft CAS system. That's what we're enrolling now and working toward a first-half approval there for the short-shaft system to be used in a TCAR procedure or to be able to be used. Concurrent with that, CGuardians three is a 510(k) studying our SwitchGuard neuroprotection system along with our short-shaft stent to get 510(k) approval or clearance in this particular case for our entire TCAR neuroprotection kit and system.
Okay. Got it. Is there a pricing and/or margin differential between CAS and TCAR for you guys? I mean, do you have, is it better for you to sell one versus the other? I know you probably just want to provide whatever the customers want, but.
Yeah. Shane, you want to grab that one as we think about the pricing?
Yeah. Yeah. It's a good question, Mike. What we see is the market is split of the stents being put in. It's split pretty much dead on 50/50 between CAS and TCAR. We don't model that changing. One of the things we say frequently is we don't need to change anyone's politics or religion. If they prefer TCAR, we'll support that. If they prefer CAS, we'll support that. You did notice that in the TCAR procedure, by the time SwitchGuard is on the market, we'll have two products to sell in that case versus the one product to sell in the CAS case where we will just have the stent but not the neuroprotection system to sell.
You can see that associated with different market sizes here where in the gray bar, the TCAR, a higher revenue opportunity from those cases because there is both a stent and a neuroprotection system to sell versus just a stent in the CAS case.
Yeah. Okay. Got it. All right. Let me just make sure we do not have any questions from people. Yeah, I do not see any. I think we can wrap up there, but thanks, guys, for coming, and hopefully you had some good meetings.
Great. Thanks, Mike. We really appreciate the opportunity. Look forward to a good day.
Thanks so much.