InspireMD, Inc. (NSPR) Earnings Call Transcript & Summary

I'm Stephanie Piazzola. I cover medical devices at BofA. Next up, we have a presentation from InspireMD. So I'll turn it over to Marvin Slosman, CEO; and Shane Gleason, CEO of InspireMD.

Stephanie, thanks. Good morning. We're working in real time here with the clock counting down. So we'll try to -- we didn't have the presentation queued up, but that's okay. So welcome to the story on InspireMD. I'm with Shane Gleason this morning, who's our Chief Commercial Officer. And it should go without saying, but our focus right now is really driven by our impending FDA approval and commercialization of this next-generation technology. Shane launched the first carotid stent just for context about 20 years ago with Abbott.

With that guy in the back row there, Richard [indiscernible].

Yes, yes. So I think we'll make this a -- fun session. I think it's safe to assume that Shane's probably forgotten more about carotid stenting than most of us have learned and really is the tip of the spear for launching this new exciting technology into the marketplace. So thanks for the attention this morning. I want to draw your attention to what's on the slide right now, which is a really unique inventive platform. And what's interesting about this implant -- it's a self-expanding carotid stent. It's the mesh outer layer that you see on the outside. It is the innovation that we believe is changing the way carotid revascularization is going to go forward in the future and strokes are prevented. It's been a long time since there's been any innovation at all in the carotid space, and we believe that we are perfectly positioned to -- take advantage of a lot of traction and momentum that's been built over the last few years. This gives you a little bit of a better graphic representation. What we're trying to do in carotid revascularization is to prevent plaque prolapsing through these stent struts and causing post-procedural strokes. So unlike opening up most of the areas of vasculature, which is dealing with occlusive disease, we're dealing with embolic disease here. And that's why this invention is so remarkable and I think is well positioned to change the way this marketplace goes forward. So in terms of table of content here, we've got this really unique mesh platform that we call MicroNet. We've got clinical data of over 2,000 patients studied, which is really the foundation of our story in general, and it's been the foundation for the company. We've just completed a remarkable FDA trial as well and a road map that covers both CAS and TCAR procedures, which is unique to our company. But the real factor that's catalyzed all of this reinvestment into the carotid space is CMS coverage expansion, which happened October of 2023 after many, many years of only reimbursing high-risk surgery patients, now all standard risk patients. So by definition, all patients with carotid disease are available to stenting procedures, which really opens up the entirety of the market, and I think it's driven a tremendous amount of enthusiasm and potential in shifting the standard of care. This is really the slide, I think, that drives you toward that, which is all things being equal, endovascular procedures always gravitate toward that standard of care, and that's been the case in all of the other vascular beds in the body with the exception of carotid. And we think that we're now in a position of being able to take advantage of this final shift to an endovascular first standard of care. It's about $1 billion market in the U.S., something just under $1 billion market in the U.S. And I think by way of investment by companies like Silk Road and others, you can see this trend is really going in a very positive direction. This is one of the few stories in MedTech that I think is lending itself to this next frontier of being able to drive significant growth. The slide here is really the one that I think everybody has been waiting for, which is the shift from open surgery to an endovascular first standard of care. We're using claims data here to validate all of these numbers. And I think as you can see here, this crossover shift looks to be at the end of this year and continues in a very positive direction. So we think it's the right time and the right place for the CGuard platform and we're poised to take full advantage of it. Just in terms of numbers in the market right now, the endovascular procedures are somewhere around 60,000. It's about 50-50, we think, between TCAR and CAS. And we see this trend growing, obviously, to a much more robust market in terms of financial opportunity in this market shift. I'm going to turn it over to Shane to talk a little bit about the platform and some of the data and why we believe that it is the right time in the right place, and we'll go there.

Thanks, Marvin. As Marvin said earlier, the reason we stent carotid is to stabilize plaque and prevent it from breaking off and causing strokes. So when you look at what the images on the left, that's a more traditional stent design where you can see this is an OCT image looking down the lumen of the stent, but you can see in the images on the left at about [indiscernible] here is pointing at plaque that's prolapsed through the stent struts, isn't held back by the structure of the stent and is prone to breaking off. And when you're treating arteries here, the only place it can go is north until it lodges itself somewhere and causes a large vessel occlusion stroke. So on the right, it shows what our stent looks like with that MicroNet mesh on the outside of the stent and preventing that plaque from collapsing through and embolizing causing stroke. So Marvin mentioned TCAR, he mentioned CAS. There are different ways to deliver carotid stent. We participate in both. And there's also a third served market where kind of the next frontier is stenting carotids during the time of a stroke thrombectomy. During the treatment of an active stroke, frequently, 20% to 30% of the time, it's carotid disease that caused that stroke to begin with. And the neuro interventionalists will encounter carotid disease on the way in to trying to reopen a vessel in the head and they're faced with a question of what to do with that lesion. Do they just push their way through? Do they treat it later or do they treat it now? And because of the properties of our stent with its low metal composition, but good scaffolding, the neuro community thinks that this is really well suited for stenting in that environment as well in that tandem stroke setting. So there are a lot of different specialties that treat carotid disease. We have a multidisciplinary board and I'm looking at Richard in the back. I think he knows all these guys from our past life together. But what you see here, not only are thought-leading physicians, but they're thought-leading physicians from different specialties. So Dr. Lyden is a vascular surgeon. We have 2 cardiologists, interventional cardiologists in the middle and Dr. Adnan Siddiqui is a neurosurgeon from Buffalo. And all of these specialties treat carotid disease. So to guide us, we really think it's important that we're listening to physicians from across the spectrum of physicians. So getting into this data that Marvin mentioned, the trial design is just like the ones that have been going on for 25 years back to our ARCHeR and Security trials back in the day. These were high surgical risk patients where the primary endpoints, you're looking at a 30-day composite endpoint of death, stroke and MI. So did they die, did they have any cause stroke or heart attack and then you follow same sided or ipsilateral stroke out through a year. And the next 2 slides are going to show bar charts, but essentially best-in-class, lowest primary endpoint, major adverse event rates of any clinical -- of any pivotal trial study in carotid intervention. So 0.95% at 30 days, 1.93% at 1 year. And if you're quick enough to read the bullets at the bottom, what's really remarkable about this, what really I think is more impressive for the physicians that we talk about this with is that this is a 316-patient pivotal trial. CGuard has had CE Mark since 2015. We've treated over 60,000 patients outside of the U.S., and there's a lot of published real-world evidence in peer-reviewed journals, over 1,000 patients out through 1 year that show remarkably consistent results with us. So sometimes you'll see a very well-controlled pivotal study that when you release that device out in the wild, it may not perform the same way. And sometimes you see that real-world evidence that held up to the scrutiny of an FDA trial, the results look different. What really impresses our physicians and excites us about launching this product is the consistency of that real-world data and our pivotal trial results, and this just shows more of that next level information. Getting into TCAR, keep rolling and hand it back...

Keep going.

Okay. So Silk Road, many people in the room are probably familiar with that acquisition that Boston Scientific completed. That is the traditional ways to insert a stent are through a transfemoral or transradial approach. TCAR is a -- surgical incision near the clavicle, near the collar bone and then reversing flow and stenting from the short distance. So the short version is that we have that approach, too. Back when Marvin showed the claims data and showed how it was 70% surgery 3 years ago. It's less than 60% surgery today, and those lines are converging. The stent line is a combination of CAS and TCAR. So the market is split about 50-50, and they are -- tend to be performed by different specialties. And our approach is we don't need to change anyone's mind. I say we don't need to change anyone's politics or religion. You like TCAR, great, so do we. Oh, you like CAS, awesome. We do too. And they are both ways of delivering a carotid stent. We feel like we have the evidence that we have the best implants, and we want to work with all the specialties, regardless of how they choose to deliver the set.

Great. Just a couple of follow-up slides here. The time line is aggressive, but I think it's achievable. We have FDA approval, we'll call it imminent. We've run a remarkable trial. We're in the final throes of submitting final details and data to FDA. So we're looking forward to having that shortly so that we can get this product, the CAS product in the market and followed up by our TCAR studies as well. So we will have a full complement of carotid interventions available over the next coming months and years. And so this is all about a growth strategy. That's why this guy is sitting next to me because it really becomes a revenue story very quickly. And if we do our work well, we'll be able to take advantage of both the momentum and also the establishment of therapies like TCAR as well, which we believe round out the market nicely. Ultimately, this is about getting the best implant in the patient regardless of how that implant is delivered and by what subspecialty. So that's been the goal for the company for a very long time, and I think we're in good shape in terms of following that strategy. As Jane said, we're serving a lot of OUS markets, developing a lot of clinical data, and a lot of support. All of those things form the foundation of where we're headed. And then in May 2023, we raised $113 million round of funding, all anchored by these investors that you're probably familiar with. And it's all a tranche-based approach. And so from a capital funding perspective, we feel like we're in very good shape to be able to deliver on our commercial launch plan, the whole intention here. It was not just to get us to FDA approval, but to get us through a commercial launch that really built that traction and momentum and value for the company. So we're looking forward to good days ahead. And we're listed under NSPR on the NASDAQ and trade accordingly. Our cap table is quite clean, and we obviously look for these value inflection points to drive the value of the company going forward. So a lot of good work ahead and the transition from the company being inventive-focused to more of a commercially viable growth story. That's all we had formally. Happy to take any questions. Made it with 2 minutes left. Thanks for the interest. It's a great time to be in carotid. I'm sure that some folks in the audience probably waited a long time to hear that story.

Yes. Just since we have another minute here, 20 years ago, all the big cardiovascular companies were getting into carotid intervention because it was the next $1 billion market. It was the next big thing in cardiovascular. So Guidant got the first approval, Abbott got the second and Abbott bought Guidant. And then Boston Scientific, Medtronic and Johnson & Johnson all got approvals. And unlike other therapies where as soon as there's an approved device with reimbursement, things tend to go less invasive. They go into first. Here, CMS didn't get the memo or didn't issue the memo, I guess, and coverage didn't expand along with the FDA approvals. And by the end of the 2000s, CMS have looked at it several times, chose not to expand coverage. And the big companies kind of put their pencils down and stopped working on next-generation products. So now with CMS expanding coverage just about 18 months ago, we're really entering the market at a really good time where we think it's poised to look like we all hoped it would look 20 years ago.

Thank you for the interest.

Yes. Thank you.