InspireMD at Bank of America 2025: Carotid Stent Innovation

On Wednesday, 14 May 2025, InspireMD (NASDAQ:NSPR) presented at the Bank of America 2025 Healthcare Conference, focusing on the upcoming FDA approval and commercialization of its CGuard carotid stent technology. The discussion highlighted both the potential market opportunity and the challenges in achieving widespread adoption. InspireMD is positioning itself to leverage CMS coverage expansion and significant funding to drive growth in the carotid revascularization market.

Key Takeaways

• InspireMD is set to launch its CGuard CAS product, with FDA approval expected soon.
• The company raised $113 million to support its commercial launch strategy.
• Expanded CMS coverage now includes standard-risk patients, broadening market potential.
• The CGuard stent, featuring a unique Micronet mesh, aims to reduce post-procedure strokes.
• InspireMD targets a $1 billion U.S. market, with plans for global expansion.

Financial Results

• The U.S. carotid revascularization market is estimated at just under $1 billion.
• InspireMD secured $113 million in May 2023 to fund its commercial launch.
• Funding is tranche-based, ensuring sustained support for market entry.

Operational Updates

• FDA approval for the CGuard CAS product is imminent, with final data submissions underway.
• InspireMD plans to launch the CAS product first, followed by TCAR studies.
• The company is building a comprehensive suite of carotid intervention solutions.

Future Outlook

• InspireMD anticipates a shift towards endovascular-first procedures in carotid revascularization.
• Expanded CMS coverage is expected to drive significant growth in the endovascular procedure market.
• The company aims to build momentum through a strategic commercial launch.

Q&A Highlights

• CMS coverage now includes standard-risk patients, previously limited to high-risk surgery patients.
• The endovascular procedure market is growing, with approximately 60,000 procedures annually.
• CGuard’s Micronet mesh design prevents plaque prolapse, reducing stroke risk.

InspireMD’s strategic focus on innovation and market expansion positions it well for future growth. For more detailed insights, please refer to the full transcript.

Full transcript - Bank of America 2025 Healthcare Conference:

Stephanie Piazzola, Medical Devices Analyst, BofA: 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 Slossman, CEO and Shane Gleason, CEO of InspireMD.

Marvin Slossman, CEO, 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 commercialization of this next generation technology. Shane launched the first carotid stent, just for context, about twenty years ago with Abbott.

Shane Gleason, Chief Commercial Officer, InspireMD: With that guy in the background there, Richard Fauci?

Marvin Slossman, CEO, InspireMD: 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, is 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 postprocedure 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 it’s well positioned to change the way this marketplace goes forward. So in terms of table of contents 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 crowded space is CMS coverage expansion, which happened October of twenty twenty Three. ’3. 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 has driven a tremendous amount of enthusiasm and potential in shifting this 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 carotids.

And we think that we’re now in a position of being able to take advantage of this final shift to endovascular first standard of care. It’s about $1,000,000,000 market in The U. S, something just under $1,000,000,000 market in The U. S. And I think by way of investment by companies like Silk Road and others, 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. This 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 fifty-fifty, 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 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 and the right place, and we’ll go Thanks,

Shane Gleason, Chief Commercial Officer, InspireMD: 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 if this is an OCT image looking down the lumen of the stent, but you can see in the images on the left at about 09:00, arrows pointing at plaque that’s prolapse through the stent struts. Is it held back by the 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 micro net mesh on the outside of the stent and preventing that plaque from from prolapsing through and embolizing causing stroke. So Marvin mentioned TCAR. He mentioned cast. There are different ways to deliver a carotid stents. 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 this treatment of an active stroke, frequently, twenty to thirty percent of the time, it’s carotid disease that caused that stroke to begin with. And the neurointerventionalist 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 multidisciplinary board that 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 doctor Lyden is a vascular surgeon. We have two cardiologists, interventional cardiologists in the middle and Doctor. Adnan Sadik, he’s 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, trial design is just like the ones that have been going on for twenty five 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 thirty day composite endpoint of death, stroke and MI. So did they die? Did they have any positive stroke or heart attack? And then you follow same sided or ipsilateral stroke out for a year.

And the next two slides are going to show both 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 zero point nine five percent at thirty days, one point nine three percent at one 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 to the physicians that we talked about this with is that this is a three sixteen 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 one 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 into the wild, it may not perform the same way. And sometimes you see that real world evidence that held up to the scrutiny of a FDA trial that 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 our pivotal trial results, and this just shows more of that next level information.

Getting into TCAR, keep rolling, hand it back.

Marvin Slossman, CEO, InspireMD: Yeah. No. Keep going.

Shane Gleason, Chief Commercial Officer, InspireMD: Okay. So Silc 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 collarbone, 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 seventy percent surgery three years ago, it’s less than sixty percent surgery today, and those lines are converging.

The stent line is a combination of CAS and TCAR. So the market is split about fifty-fifty, and they 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’re both ways of delivering a crowded 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 stent. Great.

Marvin Slossman, CEO, InspireMD: Just a couple of follow-up slides here. 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 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 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 $113,000,000 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 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 value in 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.

Maybe it was two minutes left. Thanks for the interest. It’s a great time to be in karate. I’m sure that some folks in the audience probably waited a long time to hear that story.

Shane Gleason, Chief Commercial Officer, InspireMD: Yes. Just as we have another minute here. Twenty years ago, all the big cardiovascular companies were getting into carotid intervention because it was the next billion dollar market. It was the next big thing in in cardiovascular. So Guiden got the first approval, Abbott got the second, then Abbott bought Guiden, and then Boston Scientific, Medtronic, and Johnson and 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 So now with CMS expanding coverage just about eighteen 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 twenty years ago.

Marvin Slossman, CEO, InspireMD: Thank you for the interest.

Shane Gleason, Chief Commercial Officer, InspireMD: Yeah. Thank you.

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