InspireMD at H.C. Wainwright: Revolutionizing Carotid Intervention

On Wednesday, 10 September 2025, InspireMD (NASDAQ:NSPR) presented at the H.C. Wainwright 27th Annual Global Investment Conference. CEO Marvin Slosman outlined the company’s strategic vision to transform the carotid intervention market with their newly FDA-approved CGuard™ Prime device. While InspireMD is poised for growth with strong financial backing, it faces challenges in navigating competitive pressures and market adoption.

Key Takeaways

• InspireMD aims to revolutionize the stagnant carotid intervention market with CGuard™ Prime.
• The company raised $153 million in 2023 to support commercialization efforts.
• InspireMD is targeting the $1 billion U.S. carotid intervention market.
• FDA approval for CGuard™ Prime was obtained nine weeks prior to the conference.
• InspireMD is developing a new TCAR device, SwitchGuard, expected by 2027.

Financial Results

• InspireMD has raised $113 million in a PIPE structure in May 2023, with an additional $40 million recently, ensuring strong capitalization for commercialization.
• The U.S. carotid intervention market is estimated to be a $1 billion total addressable market (TAM), presenting significant growth opportunities.

Operational Updates

• CGuard™ Prime, featuring MicroNet® technology, aims to prevent post-procedural strokes with sub-1% complication rates after 30 days.
• InspireMD is expanding its sales force to 60 professionals to cover the U.S. market effectively.
• The company is leveraging a claims database to target potential customers and enhance sales efficiency.

Future Outlook

• InspireMD anticipates that stenting procedures will constitute 50% of all carotid procedures by the end of 2025, with a projected increase to 80-85% in subsequent years.
• The company is focused on innovation, patent protection, and exploring acquisitions to enhance its product pipeline.
• InspireMD’s SwitchGuard device, designed for TCAR procedures, is expected to receive approval by 2027, with a TCAR-indicated stent anticipated by mid-2026.

Q&A Highlights

• InspireMD is focused on ensuring successful initial cases and overcoming challenges with VAC committees.
• The company is aware of competitive pressures, particularly from Boston Scientific’s acquisition of Silk Road Medical, but remains confident in its product’s superiority.
• Potential acquisitions are being considered to supplement InspireMD’s pipeline while maintaining focus on core carotid interventions.

Readers are encouraged to refer to the full transcript for more detailed insights into InspireMD’s strategic plans and market positioning.

Full transcript - H.C. Wainwright 27th Annual Global Investment Conference:

Arabella, Associate on the Equity Research Team, HC Wainwright: Everyone, and thank you for joining the HC Wainwright 27th Annual Global Investment Conference held on September 8th to 10th, 2025. My name is Arabella, and I’m an Associate on the Equity Research Team at HC Wainwright. We hope you have a productive day of one-on-one meetings, corporate presentations, and panels. With that said, it’s my pleasure to introduce InspireMD. InspireMD is a commercial-stage company using their proprietary MicroNet® technology for stroke prevention. From the company, we have Marvin Slosman, the CEO, and Michael Lawless, the CFO. The floor is yours.

Marvin Slosman, CEO, InspireMD: Thank you. Good morning. Good morning, everyone. I’m Marvin Slosman, CEO of InspireMD. I’m here with my CFO, Michael Lawless. Thank you for sharing this morning and some time with us. Let’s get started with the first slide here because I think it really reflects where we are as a company, which is we’re in a position of finally revolutionizing the carotid intervention market. That’s a big, bold statement to make. I think over the last 20 years, carotid intervention has been burdened with the fact that stenting technology, combined with lack of reimbursement and a domination of vascular surgeons doing these open surgery procedures, has remained dormant for the last 20 years for all of these reasons.

We find ourselves in a really unique position where all of these things have finally come together with a better technology platform that we’ve invested in for 15 years, combined with reimbursement from CMS, which took place in October of 2023. All of this is leading toward an endovascular-first shift in transition from open surgery to an endovascular-first point of view. What you’re seeing on this slide is important, and it’s important for a reason because in addition to the best-in-class clinical data, this is really a technology that’s built around mechanism of action. We put a 20-micron PET mesh sock overlaid on top of an open celled self-expanding carotid stent. Why is this important? What we’re trying to do is to prevent plaque from prolapsing through these stent struts. When you stent a carotid artery, the challenge that you have is being able to keep plaque where it belongs.

Because of the proximity of the carotid artery to the brain, any plaque that prolapses and breaks off causes post-procedural strokes. This is very much a mechanism of action that’s created the opportunity for best clinical outcomes by keeping the plaque exactly where it belongs. This is not a big AI story. It’s not robotics. It’s not genomics. This is the stent does and performs exactly as you would think that it does. We’ve invested in this technology for the last 15 years. We’ve sold over 65,000 devices outside the United States, and I’m really pleased to share that nine weeks ago, we finally got FDA approval for this device. We are really bringing this next-generation asset to the carotid intervention market. We’ve also, as a company, decided that we are going to invest both in the TCAR procedure and CAS procedure.

Both transfemoral and transcarotid application, first company to ever define that and do that. Our whole thesis here is that with the best stent and the best implant in the market, our goal is to get that implant where it belongs, whether it’s by vascular surgeons using a TCAR procedure or interventionalists using a CAS procedure. The goal is to get the implant to the patient. As I said, about nine weeks ago, we got approval for CGuard™ Prime in the U.S. We are off and running as a commercial company now. We’ve made this transition from a very strong R&D heritage with a lot of great results outside the U.S., but this is obviously the most robust market, and we’re really excited about finally having this approval. It gives us the opportunity to bring this technology into the market. This is a really busy slide.

We won’t spend a lot of time on it, but it’s kind of a table of contents that speaks to the micro mesh and the value of that. Our clinical data and outcomes are really what drive this story. Sub-1% complication rates after 30 days, best in class, best ever achieved in carotid intervention, especially when you’re dealing with strokes. It’s a really important data point. We’ve got a deep pipeline of technology, both CAS and TCAR. The CMS coverage expansion in October of 2023 really changed the entirety of the market, and it’s really changed our company because we’re able to now effectively address the full 160,000 procedures that are done annually, as opposed to a small subset of just high-risk patients to surgery. Really important for the overall market, but certainly for our company.

This is about a $1 billion market, TAM in the United States, and of course, globally, much larger than that. We’re obviously building on our OUS success. This slide is self-explanatory, but I think when there are less invasive opportunities, patients prefer that to have endovascular procedures done through the pipes, really important as opposed to open surgery. Carotid disease is really this last vascular bed to convert for all the reasons that we discussed, but we’re finally in a really advantageous position for all those reasons to do that. We’re looking at this migration happening pretty quickly. As I said, there’s about 155,000 procedures in the U.S. There are almost 3 million people globally that are diagnosed with high-grade carotid stenosis that are untreated at this point. The opportunity for growth is significant. What you see in this chart is a crossover between stenting and surgery.

By the end of 2025, it’ll be roughly 50-50, which is a really important trend. We think that in the next couple of years, this will move to somewhere around 80-85% stenting, and the balance of that being surgery. Up to this point, it’s been obviously the opposite of that. This is really encouraging data. I think this new technology platform that we’re bringing to the market is going to really facilitate that shift for all the reasons that we discussed. The economics are significant. Right now, there’s about 60,000 stenting procedures done in the U.S. of the total 160,000 or so that are out there. We think this conversion over the next several years is going to drive significant economic growth. The CAGR also built into this, I think, will be significant, still to be determined. Let’s get back to the mechanism of action for a minute.

What you see on the left-hand side here is looking down the barrel of the artery. This is what plaque looks like when it prolapses; it cheese grades through a stent strut. Obviously, with the proximity to the brain, you don’t want that, as Dr. Siddiqui would call it, that goober hanging out. That’s a medical term, by the way, hanging out into the artery. The mesh does exactly what you expect it to do. It keeps the plaque from prolapsing and keeps these post-procedural strokes from occurring. This is what’s changing clinical outcomes and clinical data. As I mentioned before, our focus is really around three legs of the stool: transcarotid access, TCAR access, and then we’re doing a study for tandem lesions. By definition, about 25% of the strokes that occur in the United States, 25% of them include the carotid artery.

A really important segment of our market. We’re investigating whether we’re going to go after a dedicated label for that. In the interim, the neurosurgery community really loves the idea of this extra protection that we have with the mesh. This is a multidisciplinary market for us. These are just examples of some of the thought leaders in the market that support us. You can see across the board: vascular surgeons, interventionalists, neurosurgeons. It’s a large segment of the market. We’re obviously focused on all these multidisciplinary groups. These are the folks, by the way, that really drove the CMS shift and reimbursement. They all came together to make carotid stenting a reimbursed procedure for all the reasons that benefit patients. We’re not going to spend a lot of time on the data except best in class is best in class.

Our PMA study was very efficient: 316 patients enrolled, 24 centers. We did it in 23 months. It’s one thing to say that we completed a very efficient trial with great outcomes, but the physicians that participated in this really are enthusiastic about using this technology now that it’s approved. It’s not about just conducting the trials; it’s about their enthusiasm for making this technology work in the marketplace. You can see by way of these charts, these are the past studies that were completed in carotid stenting. Obviously, in the green at the right, you can see at 30 days, less than 1% complication rates is best in class, best ever achieved. At one year, considering ipsilateral stroke, still below 2% complication rates. This is the kind of stuff that gets the attention, obviously, and builds our commercial strategy.

That, combined with just the physical properties of our stent and this mesh, have really resonated within the community. Even nine weeks out of the gate post-approval, we’re getting a tremendous amount of enthusiasm. What I love about this slide, it’s really an ugly one to read, but these are all the OUS studies that were done on CGuard™, and you can see a remarkable similarity in the outcomes with all of these other studies, even before the FDA trial. What’s great about this is the consistency in the numbers. What this says is that of the 65,000 stents that we’ve sold and the 2,000 or so patients that have been studied, there’s remarkable similarity in this. This is where consistency in the data really lines up. It’s not a select of 300 patients that were done in an FDA trial. This talks to durability.

We’ve studied this stent out for now five years. This is really a big foundational building block for the company. We have a TCAR device coming. It’s called SwitchGuard. It’s remarkably similar to the only other one that’s approved in the market. We’ve made some improvements. Second mover advantage gives you that opportunity to do so. We’re really thrilled about this being approved into the market sometime in 2027. We’ll have a TCAR-indicated stent mid-2026. We’ll be able to go compete for those 30,000 procedures that are out there. Lots of innovation here. We’ve tried to build next-generation technology along the way. In addition to getting the implant where it belongs, we’ve also tried to build tools on top of first-generation technologies that Silk Road Medical built into their initial platform. How are we going about selling and what’s our go-to-market strategy? It’s pretty straightforward.

Our OUS markets continue to be robust, but the real opportunity for us is in the U.S. market. As I said before, this is not a science project. This is a time-tested, proven technology. 65,000 devices sold. We’ve got more than double-digit share outside the U.S., but candidly speaking, the economics are not great. The U.S. market is the most robust from a reimbursement and economic perspective, and that’s why this is such a significant opportunity for the company to grow. Our early commercial traction is really built around getting the best sales professionals in the market as quickly as we can. These professionals come all from the vascular market, whether Silk Road Medical, Medtronic, Shockwave Medical, others. These are sales professionals that are used to developing markets and have access, and that’s the key. We’ve got over 20 people in the organization right now.

60 will be sort of the magic number of how we think about covering the U.S. along with clinical specialists, and they are being highly productive right out of the gate. We are targeting customers very clearly with a claims database. There’s no guesswork. Our reps are not driving around looking for blue hospital signs off the highway. We know exactly where every carotid procedure is done. We have relationships with those physicians. Quite candidly, the demand is coming to us. We participate in all the major conferences. Physicians are calling us faster than we’re calling them. I think demand creation for this product is going to be one of the least challenging of all the things that we need to perform and operate.

There’s been great demand out of the gate, and just nine weeks into it, it’s a lot of heavy lift when it comes to VAC committees and contracts. We have to go through those stages, but so far, really above expectations and thrilled with the response. We’re building a company that’s no longer an R&D shop. This is a commercial-focused company that’s coming into its own. We’re really focusing on significant branding opportunities. We had the chance to ring the bell at Nasdaq a couple of weeks ago. That was pretty fun. We are doing things to really create this opportunity that people will take notice of, the way Shockwave and Inari did and Silk Road. We are really thrilled to have that brand strategy in addition because, as you know, this is a momentum-building business. You look across the roadmap, the milestones that are in front of us.

Obviously, this approval is the biggest milestone that the company’s ever achieved. We have a pipeline full of other opportunities that we are building significantly, and it’s all about growth at this point. This is about establishing a leadership position in the carotid space and filling it with new products and new devices and capitalizing on that commercial growth and opportunity. We have really robust patents in this portfolio. In fact, we are able to extend some of the claims for three of our significant patents post-FDA approval. It is one of the opportunities that we are building on. The interesting thing about this technology is that even if we opened it up to the entirety of the market and said, "Build a mesh-covered carotid stent, we’ll give you the architectural plan," it’s a multi-year, multi, multimillion-dollar project.

We think when we talk about asset protection, it’s really built into the innovation as much as it is the patents, but significant. Let’s talk about the capital structure. In May of 2023, we raised $113 million in a PIPE structure. We are obviously a public company, but we did it through a PIPE structure with some of the top fundamental investors in the market. We have just reestablished another $40 million on top of that through a PIPE structure as well. We feel really great about the investment community that we have behind us. These names are significant. They are fundamental investors in the market. They have invested in us in the long view. Most importantly, they wanted to capitalize the company well after commercialization. They did not want us flat-footed on approval. They wanted to make sure that we took full advantage of the market opportunity.

We are really thrilled to have this syndicate put together and these people following us and supporting us. Obviously, capital raising in these environments that we are in right now is not easy, but I think this is a proxy to the value of the strategy and the execution that we are bringing along. It is great to have these folks supporting us and behind us from a capital perspective. Wow, four minutes under. That’s all I had formally.

: Progress.

Marvin Slosman, CEO, InspireMD: Thanks.

: I was just trying to think of our commercialization. What’s kind of the biggest growth gap you’re seeing? Particularly the sales team, do you think we can perform this as easily as we want to do?

Marvin Slosman, CEO, InspireMD: Yeah, I think the challenge is that when you got thoroughbreds kicking on the barn door, it’s hard to be patient in an environment that has so much demand creation. I think we’ve had to be very deliberate externally about getting through VAC committees properly, making sure that in the first cases that we do, they go really well. Our stent design is different. I’ll give you an example. Post-dilatation, when you balloon a stent at the end of the procedure, you really want that artery wall opposition to be good so that you don’t leave the stent hanging out. Open-celled stents, that was a very cautious tale because you didn’t want the plaque to prolapse by ballooning that stent too hard because you had nothing to protect it. We believe in aggressive post-dilatation because we have a protective layer.

That’s just one small example of being in the room with the physician and getting people comfortable in an uncomfortable environment because it’s different than what they’re used to. I think I would say that the biggest challenge is for us to be patient because when you have this kind of demand creation and this kind of input coming from the market, internally and operationally, we’ve also had to be very deliberate about how we get our ERP up and running properly and produce enough product and do those kinds of things. I know it sounds boring, but it’s the blocking and tackling. This is an execution-driven company now. I think it’s just been those kinds of growing pains of how you mature in a very robust environment. Good problems to have, candidly speaking.

You know, it’s not often we’ve waited the entirety of this company to get to a point where we’ve got this kind of opportunity. For patients, you know, we don’t lose sight of the fact that this is significant. A difference between a 5% stroke rate and a less than 1% stroke rate doesn’t seem to be a lot unless you happen to be in that 4%. Then it’s catastrophic. This is really, really an important, important moment for, yeah, for patients and the company. Yes, sir.

: Are there any competitors that you’re concerned about?

Marvin Slosman, CEO, InspireMD: We’re aware and always concerned about competitors. Right now, we’re competing with the acquisition of Silk Road Medical by Boston Scientific. We’re competing with primarily the large strategic companies. Breaking the bundle is a challenge, but we think that the efficiency and the discipline of being able to be a focused, targeted company like Inari did, like Shockwave Medical, like Silk Road Medical, gives us that ability to navigate without the complexity of a full bag of products. Candidly speaking, we’re aware, we’re always concerned, but we have the best product in the market, and we have, you know, that kind of demand from the physicians. Our competitors are significant from their size. The issue is that nobody invested in carotid stenting for 20 years. This was the next billion-dollar market 20 years ago. Because CMS pushed and pushed and pushed the reimbursement, everything got shelved. Innovation stopped.

We continued to innovate. We built a stent that is optimally suited for carotids, whether it was by just good luck or we happened to have some strategy behind it. We were able to progress the company to this point where we believe we’ve got the only standalone asset that.

: Do you have any data on early terminal development, be it labor of one or the other?

Marvin Slosman, CEO, InspireMD: Yeah, we’re going to run the company as if it’s never for sale because that’s the right way to do it. We’ve built our capital structure around time to productivity and time to profitability. For us to acquire things, yeah, we’re looking at a few things along the way. Candidly speaking, five and a half years ago when I joined the company, what we needed to do was focus on what we had. There were a lot of people, a lot of great ideas. You can imagine you walk into an engineering environment. What about this indication and that and this? No, let’s do this. This is the holy grail for carotids. Let’s get it right and let’s develop our TCAR product. We’re always looking at areas that we could potentially supplement with some pipeline.

There are other indications and uses for mesh, but we needed to get this one right and be very disciplined about the capital that we had to get us to this point. Lots of interesting things, flow diversion, iliacs, other things. There’s ample opportunity. Just got to keep people focused. Yeah. Anything else? Yeah, thank you. Thanks for the opportunity. We’re excited about where we are.

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