Good afternoon, everyone, and welcome to the H.C. Wainwright 28th Annual Global Investment Conference. I'm Dr. Katherine Degen. I'll be your moderator for this session. We're pleased to welcome Marvin Slosman, CEO of InspireMD. Thank you for being here. Thank you for having me. Thanks for everybody for joining us today. I'm Marvin Slosman, CEO of InspireMD. What we're going to talk about today is really revolutionizing the carotid intervention market and stroke prevention. What you're not going to hear about today is therapeutics and biopharma and AI and a lot of other topics. You're going to hear about mechanism of action. In so doing, we have designed and developed over the last 15 years a self-expanding carotid stent. What's special about this stent technology and what's changing outcomes for patients is we have a 20-micron mesh outer layer that is attached to the outside of our self-expanding stent. You have a view of this on the screen, and it has revolutionized and changed outcomes for patients by way of protecting the brain from prolapsing during the carotid procedure itself. When you stent a carotid artery, it's very different than stenting a coronary artery in the fact that you're dealing with occlusive disease, and that plaque that prolapses into the stent strut following the stenting procedure causes a lot of post-procedural strokes. This small but very elegant invention over the years has really changed outcomes for patients and really changed the entirety of the carotid intervention market. This is the value proposition of our company and one that we're significantly leveraging. We've sold over 75,000 stents globally. This is not a science project. We have evidence that really, I think, demonstrates these best outcomes, and we're really excited about being able to enter the U.S. market. There's two ways of approaching the delivery system of a carotid stent. One is through a transfemoral approach, and the other is through a TCAR approach. Very early on, we decided that we didn't want to compete in one or the other market. We wanted to, as having the best implant, we wanted to make sure that we had the full access to all the delivery systems, including the protection system that's used in TCAR. Right now, the standard of care is endarterectomy. It's open surgery, and stenting has been around for 20+ years. But with these first-generation open and closed cell stents, the issue was this plaque prolapsing through the stent struts and causing a lot of post-procedural strokes. This mesh outer layer that we invented and designed was specifically created to prevent that from happening. What you can see here is just an OCT image on the left there that shows what plaque looks like when it protrudes through the stent strut. We want to eliminate that because obviously in a high-velocity blood flow environment with the carotid, the next bus stop north is the brain. There is a lot of post-procedural events that happen, and you can see an example of the stents, the first and second-generation stents above, where you see the opening is significant as compared to the mesh outer layer on the right-hand side of ours. The entire vascular market is foundationally adopting less invasive endovascular solutions when available. Carotids really remain the last area of this vascular segment to adopt that, mainly because reimbursement was not in place for what we call standard risk for patients. Patients only had one option, which was open surgery. TCAR was developed by a company called Silk Road Medical, and that got the vascular surgeons on board with stenting by way of the TCAR procedure. In October of 2023, CMS finally approved standard risk reimbursement for stenting. It really has changed the landscape of the carotid environment and pushes everything toward this endovascular first approach. We are taking full advantage of that right now. This is a $1 billion market in the U.S., and that adoption is continuing to grow faster and faster. We have three trials that we have, two that we have completed, one that is underway right now. Those trials have demonstrated best outcomes ever seen in the carotid space. You can see this as a comparison against some of the competitors that have been out there. Sub 1% complication rates in carotid stenting is really unheard of in this market. The adoption of this technology, both through the trial environment but also in our real-world experience, has really opened up an opportunity for us to meet with physicians and them to convey to patients that this really is game-changing technology. Both in one year and two year, we still are able to demonstrate the lowest outcomes. When we decided to address the TCAR market, we wanted to go after the existing market, which is now a part of Boston Scientific. They have the only TCAR device approved in the market. Our first shot on goal for that was to develop an indication for our TCAR implant and using that with the neuroprotection system from Boston Scientific. We completed our trial of 50 patients, zero adverse events. The trial went remarkably well. We are really excited about the opportunity, and we believe the prospect for having that approval in the next couple of months. That will open up the entirety of the TCAR market, which is about 45,000 procedures. One of the things that I am really pleased about is the fact that our FDA trial had such tremendous outcomes, and the evidence was compelling. When you compare that against all the other studies that we have done with this stent globally in real-world environments and physician-initiated studies, you can see that the outcomes are remarkably similar. This was not sort of a well-managed trial. This is really how this implant performs, and I think that is really what has gotten the attention of the market. CREST-2 is an NIH study, 10 years in duration, which demonstrated, as it was reported out last year, there was a lot of anticipation as to comparing in a randomized environment, medical therapy alone versus stenting and medical therapy. Many people thought that medical therapy would supersede the value of stenting because it is an invasive procedure. What it demonstrated was that stenting showed real superiority against medical management alone. These are the tailwinds that have been created for a stent-first approach, and we are really pleased by the fact that we believe we have got the only real asset available in the market to take advantage of this growing momentum. We have invested a lot in both the CAS side of our business as well as TCAR. We know that that is a 45,000 procedure environment right now that we are going after. Silk Road Medical generated about $200 million in revenue when they sold their company to Boston Scientific for $1.3 billion. We are both addressing the TCAR market with these new tools as well as the CAS market because we want the implant to really drive the decisions from physicians. This gets into the weeds in terms of the details on our product development, which is not really relevant. The relevance here is that we have got a second-mover advantage. Silk Road Medical had a monopoly for several years, and Boston Scientific has the only approved device in the marketplace. But we are going to aggressively attack this market because we have better technology with a better implant. We think about the market in terms of treating the lesion and allow the physicians and patients to determine how the implant is gotten there, whether it is done transfemorally or in a transcarotid method. But at the end of the day, when you have the best implant with best outcomes, we ultimately want the patient to get that treatment. If you look backwards, we had FDA approval for our CAS device in June of 2025, and you can see our trajectory of revenue growth over that period of time when it was approved in the market. In May of 2026, we were not pleased with the delivery system that we had put into the market with our CAS system. We only used it about 40 times in the FDA trial, and when you have the best implant in the market, your delivery system really needs to reflect that. We had friction building up in the catheter. We knew what the issue was, and we decided to do a voluntary recall in order to improve that and fix that so that we did not frustrate what was a market that really demanded and was looking forward to this new implant. When we stepped away from the market briefly, we are off the market right now, still approved, but off the market to improve the delivery system. What we are showing here is the fact that the market absorption and the demand for this product really was significant, and that is what we will come back to. The majority of the procedures are still done by vascular surgeons. Our next approval will be our TCAR indication, which we think will come in early November. We are really pleased about the fact that this is a very mature market. The vascular surgeons own the majority of the carotid interventions. We think that our ability to absorb market share and take advantage of this very stable market that is really looking for a better implant will be significant for the company and will be able to get out of the gate and grow significantly. Right now we have 12 field representatives on the ground. We use Acuity claims data to be very specific about where we go to sell. We know where all the carotid procedures are. These professional representatives come to the company with a lot of experience in this space. The whole idea is to drive productivity out of our sales organization and continue to scale and grow that organization as we continue to build revenue. We are going to do it in a very productive mindset. Productivity is going to drive our next hiring and how we utilize the capital that is available. There is a tremendous market available to us of about 80,000 procedures, so there is a lot of growth opportunity. Globally, we are in 35 markets right now. This has been CE marked for 10 years. We have sold over 75,000 devices. We have clearly differentiated this technology as best in class in terms of outcomes. We have significant market share in these areas, although the economics outside the U.S. are not as compelling as the U.S. market. So our margins are obviously less. We sell through distributors, but our OUS presence over the last 10 years has established a foundation of data that we really work from and have leveraged significantly in our U.S. market launch. We have very detailed patents around this, as you can imagine. If we open source this technology, putting mesh on a self-expanding carotid stent is not an easy business. We believe that right now this is the only asset in this market and obviously a lot of strategic interest as we grow a high margin business in a very significant top-line market with a lot of companies that are building peripheral franchises. Carotids has become the podium discussion in almost every area of vascular medicine. We funded the company significantly over the last several years. We did a transformational funding event in May of 2023 of about $113 million, followed by another pipe of 40. We have a line of sight to what we believe is cash flow break even at a revenue number that we also think is achievable. We are in the process of contemplating how we raise that final quantum of capital. As you can see on the right-hand side of the page, there are significant investors that have supported us and continue to support us in our quest to really lead this market. The CMS coverage decision back in October of 2023 really changed the entire landscape of carotid stenting. If we had this discussion five years ago, I would tell you that there was a number of things that needed to come together, including vascular surgeons' willingness to stent, CMS' willingness to reimburse. All of these things were creating a lot of headwind, which is why there was very little investment over the last 20 years into this technology platform. We happen to be at the right place at the right time, and we are really looking forward to taking full advantage. I sort of equate this to we're in a flip phone environment right now and we have the only iPhone, and it's really our opportunity now to execute on being able to dominate the space. We're thrilled about that. Obviously, what our KOLs think matters. We sell across many boundaries of physician specialties, including neurosurgery, interventional cardiology, vascular surgery, and so we've done a really good job of creating this demand, and there's a lot of physicians that are really looking forward to finally having the product back in the market. I'll take a few questions if there are any. It's like a familiar face in the back of the room.
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