Thank you. Good afternoon.
Oh, Marvin. I'll do a quick intro here.
Okay, great. Thanks, Mike.
Good afternoon. Thanks for joining us again at the 25th Annual Needham Healthcare Conference. I'm Mike Matson, and I lead the MedTech and Diagnostics Equity Research team at Needham & Company. I'm pleased to introduce InspireMD. Presenting from InspireMD today, we have CEO Marvin Slosman and CFO Michael Lawless. They're going to give a presentation on InspireMD, and then we should have some time at the end for questions. If you have any questions you'd like to ask, you can submit them electronically through the conference website, or feel free to email them to me at mmatson@needhamco.com. With that, I'll pass it over to Marvin.
Thanks, Mike, and good afternoon, everyone. I'm Marvin Slosman, CEO of InspireMD. Thanks for allowing us to present today. Looking forward to the opportunity to present the company. Let's start with the slide in front of us. It's a pretty bold statement, but I think we are truly poised to revolutionize the carotid intervention market and stroke prevention. What we like about using this slide initially is it really is the mechanism of action that is the innovation behind our ability to change the carotid space. What you're looking at is a self-expanded carotid stent, and what's unique is this simplistically sophisticated innovation, which is our mesh outer layer that sits on top of our stent device. Although it looks very simple, it is an incredible technology that allows us to prevent plaque from prolapsing through the stent struts when you do carotid stenting and carotid intervention.
Why that's important is because we're really treating embolic disease with stroke intervention with a carotid artery, as opposed to occlusive disease in the rest of the body. Because of the proximity of the carotid artery to the brain, we need to make sure that when we stent these arteries, the plaque does not prolapse through the stent struts. All of the first and second-generation stents that were introduced 20+ years ago failed in terms of their ability to prevent strokes at a level that we have established as a new standard of care. We're going to walk through the presentation. We'll go relatively quickly here.
Again, to reiterate the uniqueness of this MicroNet mesh protection, it really is the innovation that changed our company, and we think we are perfectly positioned at the right time when carotid intervention has become, for a number of different reasons, a very meaningful topic within the vascular community. This SmartFit technology in combination with the MicroNet mesh is really the innovation that we believe will allow us to change this space. Let's look across the landscape of the vascular beds of the body. Where there has been an endovascular alternative and standard of care, it has shifted open surgery to an endovascular-first point of view. Carotid artery disease is no different from that. There are a number of reasons why, for many years, endarterectomy, a surgical approach to carotid disease management, was always viewed as the standard of care.
We'll talk about the reasons for that and why, in today's market, that shift is accelerating very quickly to where we believe that carotid intervention will be dominated by a stent-first approach. There are a significant number of diagnosed and untreated patients annually. We are just at the beginning of what we believe to be a treatment technology and mechanism that will allow patients to be treated proactively, asymptomatically, and symptomatically, and all of the reasons that we believe are driving this innovation, both in technology as well as the CMS coverage decision that took place in October of 2023. There are really three legs to the stool here. This endovascular market shift really was catalyzed in October of 2023 by CMS coverage expansion that effectively put stenting on an equal level in terms of payment coverage to endarterectomy.
For 20-some odd years, it was attempted, and finally, in October of 2023, the CMS coverage expansion made stenting a reimbursed procedure that allowed it to become the standard of care for standard risk. The other landmark clinical evidence that was presented just last year was the CREST-2 study, which was a 10-year NIH study that validated that stenting as a mechanism for revascularization, in addition to medical therapy, was a superior technology and a superior approach. That's really, again, catalyzed a stent-first approach to the marketplace, and it's driving this CAGR response to building the entirety of the market. The second level of the stool here is obviously our platform built around our MicroNet mesh, which we talked about before, which really changes clinical outcomes. We'll talk about that a bit further into the slides.
Our organizational readiness: we have invested in this technology and marketplace for many years. We started our efforts in our OUS markets in about 30 markets outside the U.S. with CE Mark. We've studied over 2,000 patients. We have sold over 70,000 devices at this point. This is not a science project. What's unique about our strategy, in addition to our FDA approval back in July of 2025, is the fact that we invested in all the mechanisms that allowed stents to be delivered to the carotid arteries and all the physicians that stent the carotid arteries. We didn't choose one technique or another, or one approach or another. We weren't a CAS company, we weren't a TCAR company, we were an implant company.
At the end of the day, our strategy was to be ubiquitous in that market and make sure that our implant was effectively delivered and dominated the space. Again, as we talk about the entirety of the market, our implant sits in the middle. Transfemoral CAS is obviously our currently approved device. We're invested in TCAR. We have an ongoing study which has been completed and submitted to the FDA for approval of a TCAR indication with our CGuard Prime stent. Obviously, our focus on the neuro community with the tandem lesion EFS study continues to reiterate the fact that we are crossing all boundaries of physician interaction when it comes to carotid stenting and treating carotid disease and stroke prevention. Let's talk about these market trends.
We believe that we are at that tipping point where endarterectomy and stenting are crossing over, and we believe it will continue until this becomes a stent-first market. Up to this point, it was very much a 20/80 market dominated by surgery, and we think over the next several years, because of all these improved clinical outcomes, reimbursement, and otherwise, that market shift will continue to somewhere around 20%-30% surgery versus 70%-80% stenting. The size of the markets will grow significantly as well. U.S. market approval was a major catalyst for our company in being able to take advantage of the economics that the U.S. market drives for us. Again, endarterectomy is the standard of care, and has been for a while. That's shifting quickly where there is a stenting alternative.
Patients value that, physicians do, and this one-and-done approach to treating carotid disease is really taking a new view of the market. There are other technologies out there that are available. First- and second-generation technologies have either an open- or closed-cell approach to the design. None of them have a mesh outer layer that provides this sustainable protection to the brain, and that is really the unique feature of the size and the layer that we provide with mesh. As much as we appreciate some of these early versions of the technology, none have come close in terms of delivering the clinical outcomes that CGuard has. Let's talk about that for a minute.
In our C-GUARDIANS FDA trial, 316 patients at the 30-day endpoints, in comparison to other technologies and studies that have been done in the market, show that less than 1% with CGuard is truly a new bellwether for clinical outcomes. We're really proud of this in terms of real clinical outcomes and what it does for patients. At one year, considering ipsilateral stroke and follow-up, we still have the best and lowest complication rates when you consider other technologies on the market. What I find most remarkable, though, is the fact that in our FDA trial, the consistency of the results is truly astonishing when you compare that to the 1,300 or so patients that have been studied over the years outside of the U.S.
You can see a remarkable comparison in terms of outcomes in all of these studies combined, and the consistency of this with that FDA trial really drives this point home and gives us the foundation of our go-to-market strategy. We won't spend a lot of time here. This is about first- and second-generation stents, and you can see that CGuard really stands alone in terms of both its short- and long-term performance, which is, again, the foundation that we operate from, and which has gotten significant attention in the marketplace and from the physician community, because these are brand-new measures of success for patient outcomes. As we talked about, the CREST-2 outcomes highlight the benefit and value of stenting as opposed to just medical management alone.
I think this was, to a certain extent, a bit of a surprise when it was presented at the conference, at the VEITH conference last year. We are thrilled by this outcome in terms of the durability of early intervention and how that sustains itself over time. What you see here is a blown-up view of the fact that there were eight events that took place in this early intervention. What you can see here is that none of the eight took place on the table. They were all done post-procedurally. If you translate that into what this durable protection of our mesh provides to patients, it really reinforces the fact that after the procedure is done, however you do it, CAS, TCAR, whatever method, it is a safe procedure.
Once all of that gear is removed and patients are released, you want that durable protection, and that's exactly what the mesh provides. We have a TCAR strategy. As I said, we have an indication that we've submitted to the FDA for a short shaft version of our CGuard Prime, which has been submitted. The trial has been completed, and we're beginning our next trial of our SwitchGuard device, which is our version of the neuroprotection system. There's only one that's approved on the market, and we plan to have that approved in late 2027 and plan to compete for that neuroprotection system as well. We have a second-mover advantage here where we've integrated a lot of new features and functions into our device.
We talked about this before, but I have to reiterate again: the CMS coverage decision in October of 2023 really changed everything for carotid stenting and catalyzed the momentum of this shift from surgery to stenting. We really stand at a remarkable time to be able to take advantage of this monetary shift in reimbursement. Our roadmap and milestones are in front of us. Again, we have approval of our CAS device, which we got in July of last year. We continue to grow our commercial footprint with over 30 commercial professionals in the field. Our CGuard Prime TCAR approval is intended to be completed and done in the third quarter of this year. We've talked about that before. Our U.S. manufacturing ramp continues. We want to be ready for the growth in the overall stenting procedures that we anticipate.
In 2027, in the second half of 2027, we're looking at the SwitchGuard neuroprotection device and that approval. We've served many OUS markets up to this point and are thrilled to have our approval in the U.S. Let's talk a little bit about how we've capitalized the company. We're really fortunate to have recapitalized the company in May of 2023 with some outstanding fundamental investors that really believe in our strategy and our story. We raised $113 million in proceeds through a PIPE structure, followed up by another PIPE structure in July of 2025. That capital gets us well into 2027. It enabled us to get out of the gate post-approval with a team on the field, a commercial team on the field, and really allowed us to get into a go-to-market strategy and a playbook without having to wait post-approval in order to do so.
Our traction and momentum are really built around having the capital available to drive the next levels of growth for our company. Speaking of which, we look at our annualized growth into 2026, and we're thrilled by the fact that even though there are some normal barriers in front of us in terms of early adoption of this technology, VAC committees, contracts, and so forth, we believe that our pathway forward in terms of revenue growth is significant, both in 2026 and beyond. Of course, our goal as a company is to dominate this space and to lead carotid intervention and stroke prevention as well. Those are the formal slides I have for the moment. I'll turn this back over to Mike Lawless, our CFO, and I think Shane Gleason is on the line as well, for anything that I may have missed along the way.
Guys, if there's something you'd like to cover here, please do.
No, I think you covered it really well, Marvin. Why don't we let Mike offer some questions?
Yeah, sure. Our guests want to ask about the VAC committee process as you're entering new hospitals. What's your win rate there, and how long is the typical cycle from initial physician interest to actually stocking the shelves at the hospital?
Yeah, Mike, it's a great question. I think the obvious answer is, it depends, and I hate that answer for you.
Sure
It really does depend. There has been so much enthusiasm and momentum for this breakthrough technology. It has been 20 years since there's been any innovation at all in the carotid space, and given our success in the OUS markets and just the globalization of this subject, there was so much momentum for early commercialization. There's a very big difference between walking into a physician's office and them saying, "This is great technology. Let us know when you get it through the committees, and I'll be happy to give it a try," as opposed to, "Walk with me. We're going to purchasing now. I'm passionate about this, and I'm going to get this approved and submitted and on the shelf for my hospital." I think the majority of the interactions we've had with physicians are the latter, not the former.
I think our time through VAC committees and just in general, the enthusiasm is really terrific. I would say it's above expectations, and we're continuing to grind away at those early foundational contracts and stocking shelves and making sure, frankly, that these procedures go well in the early days. This is a new platform. There is a learning curve associated with it, and we just want to make sure that those user experiences are in line.
Yeah, I understand. I think you've talked about pricing it at a premium to the market. Has that been an obstacle at all in terms of getting into the hospitals and through the VAC committees?
No, I think we've selected a good landing, Mike. We believe that our technology is worthy of a premium in the marketplace for all those reasons that we've discussed. We haven't priced this out of the market either. What we want to try to avoid is that exception-only use in the case of really difficult situations or on an exception basis. I think we've picked a landing on our ASP that is a premium to market, but at the same time allows this to be the go-to stent and to be used as the primary technology. We've landed well with very little pushback, and we are selling at a premium currently in the market.
Okay. I think you've also talked about needing about 60 reps to cover the whole U.S. Where are you at right now, and how are you balancing the rep hiring versus trying to manage cash burn and OpEx?
Yeah, it's a great question. One of the things you'll realize about our company is we measure everything here. What we don't want to do is get ahead of ourselves. We have about 22 reps in the field right now, about 30 people in the commercial organization, including our clinical support organization. We think that's a great number for the indication we have right now, and we're able to get to these cases and provide that selling effort and selling support. We believe that this is a good spot for the time being until we get a TCAR indication, at which point we'll continue to advance the hiring. We think the magic number is somewhere around 45-60, still to be determined, but we're measuring everything from time to productivity to how quickly this adoption works.
What we want to be sensitive to is our capital and making sure that we're very prudent in how we put that to work. We're trying to get those time-to-productivity numbers as low as possible. If we see that the demand in the market requires us to hire more people, we've got a plethora of talent out there that wants to come to work for us, and we will turn those valves as necessary. What we don't want to do is to overspend in a market until the adoption shows us those significant results.
You mentioned that there's a lot of interest in sales positions. What is the typical background of these reps? Are they coming from other areas, like interventional cardiology, or more from neuro products?
Yeah, it's a great question, Mike. Without exception, every one of our sales representatives comes with a certain level of carotid experience, whether it be CAS experience or neuro background or TCAR. We want reps that understand how this game's played and, frankly, bring the relationships that marry that science and art together. Being able to drive this adoption is more than just having a great platform that's new and unique. It really is the trust and the relationships. I have to tell you, I've been in this business a long time and have never seen an assembly of such incredible commercial talent that are delivering every day. It's a combination of both CAS, TCAR, and in some cases, multiples of both. That's working out very well for us so far.
Okay, I think you said that your SwitchGuard neuroprotection system is going to be launched in 2027. How critical is it to have that full offering to compete with players like Silk Road? Can you win market share in the interim with the third-party protection system?
Yes, we can. Actually, this was sort of a two-pronged approach. It's interesting that you brought that up. Our intention from the beginning was to get an indication for a short-shaft TCAR-indicated version of our CGuard stent that we could compete with and that is compatible with the ENROUTE system, which is what the C-GUARDIANS II trial was all about. We completed enrollment and submitted that to the FDA and hope to have an approval of that indication in the third quarter of this year. That will be the first stent in the TCAR procedure. We will start enrolling, hopefully at the end of this month, into the SwitchGuard neuroprotection device, which will round out the second half of the TCAR procedure itself, in addition to a micropuncture kit and all of the other tools that go into TCAR, which will come about a year later.
So we're still calling the second half of '27. It depends on the enrollment of that trial, but that will be a 510 clearance. And we've got some really motivated vascular surgeons to help enrollment. But I think that two-pronged strategy, we're obviously going about the greatest opportunity for us, which is replacing a 20-year-old licensed stent with a much better technology with CGuard™. And we think that that adoption will then flow directly into the neuroprotection system.
Okay. I guess maybe talk about just the manufacturing side of things and your ability to kind of ramp up production, and then what the outlook for gross margins is as you do that.
Yeah. Thanks for that question. Up to this point, you know that the foundation of the company was founded in Israel, and we still have a large facility there with engineering and production. We began to look around at what we wanted to do in terms of expanding that scale. We contracted with a partner, Aptiqz, in Charlotte, North Carolina. We've been involved with them now for over one year, and by the end of 2026, we hope to have product produced and out the door there to supplement our production in Tel Aviv and keep pace with the scale that we believe we know is coming. We're trying to obviously diversify our production facility and so forth. We've established a base of operations here in Miami.
As a global company, we're now growing and expanding with all of those global requirements beyond just a startup company that was originally located in Tel Aviv. We certainly appreciate and value our colleagues and the work that's being done there, but we're scaling and growing to really meet global needs and expectations. It's a really great question and one we spend a lot of time on because we want that operational efficiency, and maybe Mike can talk a little bit about the margins we expect in U.S. market adoption.
Yeah, Mike, you ask a good question, and I think we expect the margins to be very comparable coming from the facility at Aptiqz versus our in-house manufacturing. In general, the margins in the U.S. are quite attractive, north of 70%. That compares very favorably to our international margins where we're selling through distributors, so we're selling at a lower price and a resulting lower margin. Over time, particularly after the introduction of the SwitchGuard product, we will see even higher margins on that product. That will also enhance our margin profile. Once we get to scale in the U.S., I should say, as we scale in the U.S., we're going to see increasingly higher margins as we continue to report our financial results as the U.S. business becomes a bigger percentage of the overall mix.
Okay, got it. I think you ended last year with about $54 million in cash. How does that compare to cash burn? I know you have this additional financing based on milestones. Maybe just walk through all that to ensure you have enough cash coming in to support the full commercialization efforts.
Sure. Marvin, should I take that or would you want to?
Yeah, go ahead, Mike. That's all right.
Okay. Yeah. Combining the cash we had on the balance sheet with the expectation for the next tranche to be exercised in the fall of 2026, we have runway, as Marvin mentioned earlier, into Q2 of 2027. Additionally, we would expect that last tranche to be exercised sometime in the second half of 2027, so roughly a year later. Taking all that into account with our forecasted ramp of our revenue, we believe we're going to need to raise another, say, $35 million-$40 million at some point during our progress. Certainly, we have ample cash on the balance sheet now to fund our growth, and we'll be opportunistic in the future as situations and opportunities present themselves.
Okay. All right. Well, that's it for my questions. I don't see any from the viewers, so I think we're going to have to wrap up there. Thanks, guys, I appreciate it. Hope you have some good meetings today.
Mike, thank you. Appreciate it. Thanks very much.
Thanks, Mike. We appreciate you. Thank you.