InspireMD at 24th Annual Needham: Strategic Moves in Healthcare

On Wednesday, April 9, 2025, InspireMD (NASDAQ: NSPR) presented at the 24th Annual Needham Virtual Healthcare Conference. The company showcased its innovative carotid intervention technology, emphasizing its potential to transform the market. While InspireMD is poised for growth with strategic initiatives, it faces competitive challenges and execution risks in the US market.

Key Takeaways

• InspireMD's CGuard stent, featuring Micronet mesh technology, aims to revolutionize carotid interventions by preventing plaque prolapse.
• The US market opportunity is estimated at nearly $1 billion, bolstered by expanded CMS coverage for carotid stenting.
• A major financing round in 2023 recapitalized 80% of InspireMD, providing a financial foundation for commercialization.
• InspireMD plans to enter the TCAR market by 2026, competing with Silk Road Medical.
• The company relocated its global headquarters to Miami and expanded US production capabilities to support market entry.

Financial Results

• Transformational financing in 2023 included $42 million upfront, with additional tranches of $17.9 million linked to key milestones.
• The financing structure ensures InspireMD is well-capitalized for commercialization, avoiding funding gaps.
• Approximately 100 million shares are outstanding on a fully diluted basis once all tranches are triggered.

Operational Updates

• InspireMD moved its global headquarters to Miami and expanded production with a US-based contract manufacturing organization.
• The commercial team comprises experienced leaders in carotid stenting, TCAR, and neurovascular intervention.
• The company expects FDA approval for its CGuard stent in the first half of the year and aims for a full US launch soon after.

Future Outlook

• InspireMD is focused on gaining FDA approval and launching the CGuard stent in the US market.
• The company plans to enter the TCAR market in 2026, with a comprehensive product lineup, including the Switchgard neuroprotection system.
• InspireMD's strategy emphasizes disciplined execution and data-driven commercial efforts to capture a significant market share.

Q&A Highlights

• The CGuard Prime stent is expected to receive approval in the first half of the year.
• InspireMD expressed confidence in its clinical data, which supports its market strategy.
• The company conducted a remote audit of its Tel Aviv facility to ensure compliance.
• The TCAR market is split 50/50 between CAS and TCAR procedures, with TCAR offering higher revenue opportunities.

For more detailed insights, please refer to the full conference call transcript below.

Full transcript - 24th Annual Needham Virtual Healthcare Conference:

Mike Matson, Lead of Med Tech and Diagnostics Equity Research Team, Needham: Good morning. Thanks for joining us again at the twenty fourth Annual Needham Healthcare Conference. I'm Mike Matson, and I lead the med tech and diagnostics equity research team here. I'm pleased to introduce InspireMD. Presenting from InspireMD, we have Martin Slossman, CEO, and Shane Gleason, chief commercial officer.

They're gonna 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 conference Needham sorry, Needham conference website, or you can email them to me at mmads@theNeedhamco.com. I'll do my best to fit them in. So with that, I'll turn it around, Marvin and Jean.

Martin Slossman, CEO, InspireMD: Thanks, Mike. Good morning, everyone, and and thanks for the opportunity to present the company this morning. Let me 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 the winds of change shift pretty dramatically.

And our investment in this technology platform, I think, establishes an asset that we're incredibly proud of and we think can truly revolutionize the, 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 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. But in context of his background, he launched the first carotid stent with Avid twenty some years ago, and I think can can offer some real context and perspective as to how this market has shifted and migrated over the years. So 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 is going to enable this shift, from open surgery to carotid stenting as a primary standard of care. Why is this important? We'll explain it through the presentation today.

But managing plaque prolapse through these stent struts and protecting the artery from post procedural embolic reactions is really the game changing, opportunity for for us as a company and, frankly, for the market in general. So what you'll hear is is a background now over the the next thirty minutes or so of why this mesh outer layer makes such a difference in terms of of being able to enable this shift of improved, clinical outcomes and changing standard of care. So I wanted to just establish that as, as the key feature we've invested in this technology for the last fifteen plus years and are very proud of, 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. So let's walk through the, the high level, enabling features of our table of contents and why it is such a remarkable time to be in the crowded business. As I said, our Micronet mesh technology will explain, speaks for itself and has really been this 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 wanna limit our opportunity to, address any access point, whether it's transfemoral or transcarotid, that ultimately the implant is what matters to the patient.

And so we've developed these access platforms to, to capture the entirety of the market. The market potential is significant. We think it's close to a billion dollars in The US alone, expanding our commercial footprint with our focus on The US and approval of our PMA in this half of of of the year has been our primary and almost entire focus as we build on the results of our OUS market. But the real enabling feature and driver behind this market shift was CMS' coverage expansion in October of twenty twenty three. For almost twenty years, there was this anticipation that CMS would cover standard risk reimbursement, meaning a stent first approach to how revascularization occurred, and that didn't happen for a variety of reasons.

So there was a lot of disappointment over the years. In October 23, that expanded coverage took place and CMS enabled standard risk reimbursement, which has effectively opened the entirety of the 55,000 or so carotid interventions to a stent first approach. And we're beginning to see that shift and change, which Shane will explain to you in the next couple of slides. We think that that that shift will continue, and this will be a a stent driven market. For context, every other vascular bed has shifted from open surgery to an endovascular first.

When 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 didn't shift for a variety of those reasons, reimbursement. But frankly, first generation stents that were invested in twenty years ago and have been available at that time really did not change the the clinical outcome significantly enough to really shift that effort from a a patient first approach. And so we find ourselves in a market where we've got best clinical outcomes combined with reimbursement and a general shift of of momentum toward this stenting approach first, including the fact that Silk Road Medical had developed significantly this therapy called TCAR, which we're going to explain to you as well, which provided vascular surgeons that opportunity to do stenting in a more comfortable transcarotid environment. So if you look across the the market opportunity, as I said before, in The US, it's roughly a 55,000 carotid interventions.

If you translate that to dollars, it's somewhere around 900,000,000 to a billion dollar opportunity. Globally, it's, it's significantly more. But, obviously, The US market is the most lucrative, and, reimbursement, obviously fits, fits that model quite well, which is how companies like Silk Road Medical built up to a $2,000,000,000 market cap serving half the market with their TCAR procedure. So as we've invested in this technology, our focus has and will remain US approval. So, unfortunately, it's early in the morning, and I'm sharing not the prettiest slides here, but just 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, is preventing this plaque prolapse through the stent struts so that you have that residual protection that's available. In the shift in the market that we talked about, is occurring in front of us. Maybe I'll, I'll ask Shane to jump in just to talk a little bit about the current market dynamics, how we should see that shift over time, and, why we're so enthusiastic about about this change.

So Shane, you wanna jump in?

Shane Gleason, Chief Commercial Officer, InspireMD: Sure. Thank you, Marvin, and, good morning, everyone. Actually, if you go to the next slide, Marvin, this shows what the market projection looks like. This is what it's based off of. So as Marvin mentioned, there was a real transformative, change in coverage from CMS in the fourth quarter of twenty twenty three, where since the first stent approval in 02/2004, coverage had been very restrictive for carotid stenting where a small 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. So the majority of patients who receive an endarterectomy are asymptomatic, they're patients who have not yet had a stroke but have, but have crowded disease. Again, the reason we do crowded stenting is to prevent stroke, it's typically not to treat stroke, it's to prevent it. So the majority of patients treated are intended to be treated before they have their first event, but until October of twenty twenty three, those patients were not eligible to receive a carotid stent if they are Medicare or Medicaid beneficiaries. So, with the expansion of TCAR that Marvin mentioned due to Silk Road's efforts, we can see going back three years, seventy percent of the carotid interventions performed in The US were open surgery.

Only thirty percent of the patients received a stent either through, transfemoral, transradial, or transcorted stenting. But that has shifted over the last three years. We see the, some of the some of the enabling times TCAR coverage was expand was expanded in 2022. And then as I mentioned in late twenty twenty three, CAS or transfemoral and transradial carotid stenting, as well as TCAR coverage was expanded. And now we see those lines converging where we see the number of Medicare claims, for endarterectomy going down and being replaced by carotid stenting.

And what we see is those lines are very close to crossing and continuing on, with stenting becoming the 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, and you can see the crowded stenting as well on its way. Thanks to the expanded coverage, and, we think that will be, that will be further increased by introducing new top new technologies like ours.

Martin Slossman, CEO, InspireMD: So just shifting gears back to the science for a moment. The the primary job of the carotid stent is to stabilize plaque as we've talked about. So when 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. And so post procedural strokes, unfortunately, became, problematic in in this situation because you 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. And that really is what, has enabled these clinical outcomes, this this one feature. So as we 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 cast 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 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. So we like to think about this mesh as that residual protection. And 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 Microsoft 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 advisers, all at the top of their game in terms of of carotid intervention and and capacity. But what you see here is a group of people that are very different, a neuro neurosurgeon, two interventional cardiologists, and a vascular surgeon. The point here is to be able to address the entirety of this market. And I think the overwhelming response has been, this market has been looking for a new asset. They're looking for technology, and they're all very enthusiastic about, about the CGuard with the Micronet, mesh.

So I'm gonna 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. And and many times these trials certainly go according to plan. And in this particular case, we're we're thrilled by not just the way that the trial was was done, but the enthusiasm of the operators that are looking forward to to a better implant. So, Shane, would you mind just kinda walking through the the high level and and the results here? That'd be great.

Shane Gleason, Chief Commercial Officer, InspireMD: Happy to. So the CGuardian study is a 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 and apples comparison when we get to the next slide. 316 patients, 24 centers, the majority of them in The US. We had co principal investigators, doctor Metzger, in The US and professor Musialik from Poland, Two extremely, well regarded, highly experienced carotid interventionalists.

And 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. So if we go to the next slide, you can see what the results look like. And 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. And you see two things, one is a bit of a general downward trend, but you see the majority of those event rates, those thirty day event rates, hovering around that five percent mark.

Until more recently, Silk Road had a three and a half, and then you see us with less than one percent, really a different kind of number. What we're measuring here, on this slide and the next, the standard endpoints for crowded intervention trials are through thirty days, a combination of death, stroke and MI, myocardial infarction heart attack. So, and then we go through one year looking at strokes that occur on the same side, ipsilateral stroke. And again, we see a number that's lower than any any of the other previous trials. And I think that's one of the exciting parts of it.

But 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 thirty days. And here on this one, over 1,100 of those patients are in published peer reviewed literature out through one year, and we see remarkable consistency between our pivotal trial results and all of the previously published real world data. And 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, but what happens when that product is released into the wild and is actually used in in real world use? Conversely, if you just have real world use, then there's a question of, well, does it have the rigor, the core lab, the independent independent adjudication that you would get from a from a FDA trial? So the combination of those two, all of our prior, published data along with our now FDA trial here, the the consistency of the two is what really, stands out to, the physician operators that we speak with. Yeah. So this slide that mar

Martin Slossman, CEO, InspireMD: No. Go ahead. Go ahead, Shane.

Shane Gleason, Chief Commercial Officer, InspireMD: So this slide that Marvin that Marvin moved to is, some more data. And again, a lot of numbers on here, I'll speak at a high level. But the authors of this Carmen 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 a 12 papers that included over sixty eight thousand patients, it's around sixty eight thousand four hundred patients of all stent types, and they did a meta analysis. And the columns on here, first thing they did was they compared first generation stents, the ones that were launched back in the February, with second generation stents, the three, dual layer stents that have been studied since then, and those are are called out on the right here.

Their first conclusion was that second generation stents or s g s 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. And the the second from the right is a product that's not marketed, hasn't been launched anywhere in the world. And, from my understanding, we don't expect to see that.

You can see the the results were similar to those of first generation stents anyways. But when you get to, CGuard, our product in green, and the one two over to the left, you'll see, two two layer stents, dual air stents that both have similarly positive results at thirty days, low event rates. They're both dual air stents with good scaffolding, so it makes sense that they would do a good job of preventing, strokes and events in the short term. But when you look out to the one year end point and you look at the the bottom row, you can see a point seven three percent number for CGuard and a seven point eight six, an eight percent number, you know, 10 times the rate of twelve month events with the other one. And there are important differences in design that have that make a lot of sense.

But really the the comments from the authors that second second generation stents perform better than first, there are important differences, and the construction of CGuard results in both great short and long term outcomes.

Martin Slossman, CEO, InspireMD: Thanks, Shane. So I I think, again, the the thing that we're most proud of is 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 of our our go to market plan and and gets the attention of, of the operators and, obviously, will be an important discussion that they have with patients. Remember, up to this point, there's been a 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. So let's talk for a minute about our investment in the into the TCAR space. Again, we we wanted a universal approach to how physicians place stents whether by TCAR, which which is a therapy that appeals obviously to the vascular surgery community and the interventional community accessing transfemoral cast. And so 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. But with the second mover advantage, we always look for those opportunities to improve feature set and function.

And we're really proud of the fact that we're we're 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 a TCAR, friendly version, if you will, available in the 26 time frame and, look forward to competing, obviously, for those 30,000 TCAR procedures that are that are in the market. I put this picture up because it's it's really kind of a remarkable candid candid view of a meeting that Shane and I attended at the vascular surgery meeting a couple of years ago. The group that's assembled here with the names off to the left are really the the top vascular some of the top vascular surgeons that really put Silk Road Medical on the map and and most importantly, design and develop the TCAR therapy.

All of those individuals, without exception, were very enthusiastic about a better implant for us in the improved feature set of our TCAR device and gathered with us to to to talk openly and candidly about the changes that needed to be made and some of the improvements based on their experience over time. And without exceptions, the people that are in this room and on this list are not just enthusiastic, but will be participating in our trial, and I think will really help drive drive the opportunity within the vascular surgery and and TCAR community. I'm gonna shift gears now here just to to offer a a quick comparison of what the tailwinds of carotid stenting have been. This gives you an example over time of of a peer who who built and developed this therapy. Let me couch this by saying that building a therapy into the marketplace like TCAR is 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, 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 a hundred thousand 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. But just in terms of of comparison, we'd like to think of the context of units sold. So as we enter The US 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 in in change here.

Shane, did you have any follow-up comments on on these slides or otherwise? K.

Shane Gleason, Chief Commercial Officer, InspireMD: I think you nailed it.

Martin Slossman, CEO, InspireMD: Good. So as we 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. Twenty twenty five is a big year for us. Obviously, we're looking for approval of our cast system, this half.

And, 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. And Shane has done a remarkable job of recruiting a group of of commercial leaders and and representatives that we think will be able to really enable, a magnificent loss launch here as we as we get into the market and get approval. In 2026, we we look to be able to enter the TCAR market by way of our stent first.

We used with the, the current neuroprotection system that's available and approved in the market. And then late in the year, hope to have the clearance on our full Switchgard neuroprotection system so that we're able to to compete holistically on on the TCAR opportunity. So really the road map for our growth and our future is all about execution and capturing the enormity of of this market expansion, which we're we're looking forward to. I'll let Shane spend a couple of minutes. I know we're on on the clock here and have about five minutes left in the discussion, but I think it's important to do a a really quick overview of how we're thinking about going to market.

So, Shane, sorry to put you under the gun here on short timing, but I'll let you walk through these.

Shane Gleason, Chief Commercial Officer, InspireMD: No. Just real quickly, it's as Marvin said, we've been able to attract a really, 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 and of all the the commercial professionals out there who have ever supported it over the last twenty years, a lot of the really good ones, this becomes their favorite procedure.

So being a company that's focused on carotid intervention is something that can attract some of the best talent out there. So we've been able to attract a really strong team. Everyone comes from a background in carotid stenting, TCAR and or neurovascular intervention. And, 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 you could say we're we're fishing where the fish are and we're hiring, really, really good fishermen and fisher women.

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. And this goes even another layer down of within hospitals, seeing physicians, and knowing when and where and how to target our business.

Martin Slossman, CEO, InspireMD: So just in lieu of time here, I think the message here is very clear, which is we're we're gonna 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. So we're taking both the, the discipline of the science here and the art of, of selling and combining those to to hopefully, make the biggest impact on our our go to market strategy. Just really quickly here, this just gives you an overview of of the globe, and 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 O US markets and the ability to to really drive, both our commercial as well as clinical programs.

I wanna wrap up with a couple of quick quick slides here. Obviously, this was a transformational financing that that we did in 2023. We decided to to pivot to a pipe structure. We attracted the attention of six of the of the top fundamental investors in the marketplace. They felt very good about the direction of the company and invested in the company, and we we recapitalized about 80% of the company through this offering.

It's a tranche program, $42,000,000 upfront, about 17,900,000.0 in each of the tranches. These were done in the form of prefunded warrants. We've, we've accomplished number one by the release of the data. Approval will will garner number two, and then you can see going forward once we approve our our TCAR device, we'll get number three, and then our commercial sales, for number four. So these are not your typical warrants to perpetuity.

They expire twenty days after, the milestone is achieved. We felt like this was a a a really good approach to how we raised capital. Each of these investors felt very strongly that they capitalized the company through commercialization. We didn't wanna run up to the the starting line, on approval and then have to refund the company flat footed. So, this capital structure really worked well for us, which, provides the opportunity for to to add the individuals that Shane just mentioned.

We've got, you know, over 14 people that are ready to go, building on our commercial momentum, which was the the point here is to get a a fast start out of the gate. Obviously, we're a publicly traded company. Just in terms of of our our cap table and warrant structure, on a fully diluted basis. We have about a hundred million shares outstanding once each of these tranches triggers and those those shares are in the market. So that's that's what we had formally this morning.

Happy to to revisit any of the topics or take questions. Mike, how did we do? I'll put you on the spot.

Mike Matson, Lead of Med Tech and Diagnostics Equity Research Team, Needham: That was great. It seems like a really interesting story. You you seem to check all the boxes there, including the you know, having the financing in place and everything. So I guess, you know, I do have a few questions. So, you know, just starting with the the CGuard Prime approval.

So do you I assume it kind of be this it said 2025 on the slide, I think, but I'm assuming that's kind of more, like, latter part of the year. Correct? Or

Martin Slossman, CEO, InspireMD: Yeah. Let me let me walk you back through because it it does get a a little, murky here. So for our PMA, which is our our first approval of the stent in The US, we're calling that in first half. So here in within the next month or two, we we still expect to have approval. That's for our

Mike Matson, Lead of Med Tech and Diagnostics Equity Research Team, Needham: First half.

Martin Slossman, CEO, InspireMD: Yeah. First half.

Shane Gleason, Chief Commercial Officer, InspireMD: Okay.

Martin Slossman, CEO, InspireMD: For our our transfemoral system. And so that's that's what we've been building toward. And then as we continue to study the TCAR options that are in our portfolio, we'll study those and and look for mid twenty six for our TCAR indicated stent and then late twenty six, early '20 '7 launch for our full our full TCAR system called Switchgard. So that's kind of how the the progression works.

Mike Matson, Lead of Med Tech and Diagnostics Equity Research Team, Needham: Okay. Got it. And then just the the data, I mean, the data looks pretty good. So, I mean, is there do you see any sort of risk around the approval, the the, you know, the first one for CAS? And, you know, what about what are you hearing, you know, about the situation at the FDA with the layoffs and everything?

Is there any risk that could delay things?

Martin Slossman, CEO, InspireMD: Yeah. It's a great it's a great question, Mike. So let's let's go back a step one. 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.

So I think that played out nicely for us. We filed the PMA in September, I think September sixteenth of last year. We did our hundred day meeting with FDA. We've been in a very interactive approach with FDA. So let me go back to your original question.

From a data perspective, I think we feel very confident that we've derisked that part of it. But as you know, there's so many things that go into to getting a PMA approved, but we've been very interactive with FDA, which which is encouraging. Remember, CGuard, was approved to use in the CREST two trial as the only unapproved stent, in The US market. And I think FDA is obviously very familiar with our technology, and we we saw that as a real positive. But, 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, 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 that will change. But, you know, things are always subject to to that. It's very rare that companies get an approval at the hundred and eighty day mark. There's always things to be buttoned up.

And, you know, as a company that's still producing in in Tel Aviv, there's there's aspects to that, but we're we're still comfortable calling first half.

Mike Matson, Lead of Med Tech and Diagnostics Equity Research Team, Needham: Okay. Got it. And then just on the so the CGuardians two trial, that's for the TCAR system delivery system with the stent. Is that correct?

Martin Slossman, CEO, InspireMD: That's correct.

Mike Matson, Lead of Med Tech and Diagnostics Equity Research Team, Needham: 27 approval.

Martin Slossman, CEO, InspireMD: We're twenty twenty, 20 six approval. So 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, a a supplement filed as a supplement post approval on our long shaft cast system.

So that's what we're enrolling now and working toward a first half, approval there for the, the the short shaft system to be used in in a TCAR procedure or to be able to be used. And then concurrent with that, CGuardians three is a five ten k studying our Switchgard neuroprotection system along with our short shaft stent to get five ten k approval or clearance in this particular case for our for our entire TCAR neuroprotection kit and system.

Mike Matson, Lead of Med Tech and Diagnostics Equity Research Team, Needham: Okay. Got it. And then just is there a pricing and or margin differential between CES 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 wanna provide whatever the customers want.

But

Martin Slossman, CEO, InspireMD: Yeah. Shane, you wanna you wanna grab that one as we think about the

Shane Gleason, Chief Commercial Officer, InspireMD: the pricing? Yeah. It's a good question, Mike. So what we see is the market is split of the stents being put in. It's split it's split pretty much dead on fifty fifty between CAS and TCAR, and, we don't we don't model that changing.

So, you know, 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 you did notice that in the TCAR procedure, by the time Switchgard is on the market, we'll have two products to sell in that case, versus, the one product, to sell in the in the cast case where we will just have the stent, but not the neuroprotection system to sell. So 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's both a stent and a neuroprotection system to sell versus just a stent in the cast case.

Mike Matson, Lead of Med Tech and Diagnostics Equity Research Team, Needham: Yeah. Okay. Got it. Alright. Let me just make sure we don't have any questions from people.

Yeah. I don't see any. So I think we can wrap up there, but, thanks guys for coming and hopefully had some good meetings.

Martin Slossman, CEO, InspireMD: Great. Thanks, Mike. We really appreciate the opportunity. Look forward to a good day.

Shane Gleason, Chief Commercial Officer, InspireMD: Thanks so much.

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