Shane Gleason, InspireMD - Integrated Embolic Prevention System (EPS) | LSI USA '24

Shane Gleason  0:00  
Shane. My name is Shane Gleason, Chief Commercial Officer for Inspire. MD, like to thank the organizers for the invitation of this great meeting, and thank all of you for choosing to spend your afternoon in this meeting room rather than out there enjoying that view in that weather. I wouldn't like to say it's a really exciting time to talk about the opportunity in front of us at Inspire MD, and more generally speaking, it's an exciting time to talk about crowded stenting in general. And many of you in the room know that it's been a very long time since we've been able to say that about the crowded stenting market. Those of you that know, some of you may remember in 2004 when the first crowded stent system was approved for guidance. A year later, Abbott followed before those two combined, and then in the following couple of years, Boston Scientific Cordis and Medtronic all followed suit, and we're all attracted by the same thing, and that is that crowded stenting 20 years ago, was going to be the next big billion dollar plus opportunity in the cardiovascular space. The math here is pretty simple, and that is that there every year, there are over 150,000 crowded interventions performed in the US already, primarily carotid endarterectomy, the surgical removal of plaque, but also crowded stenting, either through traditional percutaneous means or through tcar, which is a crowded stent placed through an incision in the crowded artery. So 150,000 plus procedures happening every year in the US. You look worldwide, that's north of 400,000 procedures. And that's just the tip of the iceberg. If you look at diagnosed but untreated, high grade crowded stenosis, nearly 3 million of those patients, and obviously, many, many more who are not diagnosed but are suffering from this condition. So huge market opportunity and the promise being what we have grown to see in every other cardiovascular space, where it's somewhat predictable the way it works. As soon as there's a reliable endovascular approach to a cardiovascular treatment, things move very quickly, from surgery first to endo first, almost being equal, patients and providers tend to prefer less invasive. So you can see this really from head down to down to foot, whether it's cerebral aneurysms or you could add stroke thrombectomy here, the aortic arch, the heart structural, heart legs, everywhere, there are viable endovascular options. The pendulum has swung from surgery first to endovascular first, except for this lonely green pie chart over on the far right, which is carotid stenting. So what's happened here? Why are we still talking about it being the next big, billion dollar plus opportunity in future tense, when we're saying this all 20 years ago, and many of you know others may have guessed, but it's all been based on reimbursement. So these are the drivers that we're really excited about in our business. And if I start in the upper right side of this slide, when FDA approved the first crowded stenting systems in the 2000s the systems were all approved for high surgical risk patients, well, symptomatic and asymptomatic patients. So that wasn't that restrictive. That's about two thirds of patients qualify as high surgical risk. But CMS took a more cautious approach and did not cover all those patients. So starting in the 2000s re looked at as recently as 2009 the coverage that was in place was not just restricted high surgical risk patients, but only symptomatic patients, and only symptomatic patients with very high grade stenosis. So literally, a fraction of a fraction of a fraction of the patients that can get carotid endarterectomy could get a carotid stent that was looked at a few times by CMS in the 2000s as recently as 2009 and they stood, they stood put. Didn't change and 14 years passed. For 14 years, we've been living under the environment of the same old coverage, and that all changed last year. So as you can imagine, coverage was real. The coverage the NCD discussion was reopened the beginning of the year. There were two very, I'll say, spirited, open comment periods during that time, and in October, five months ago, CMS decided to basically level the playing field. It simply put any patient in the US, that's a that's a Medicare beneficiary, that can get an endarterectomy, can also get a stent, whether that's a percutaneously placed, you know, transformer stent, or tcar. So the playing field is now level, and we've gone from that fraction of a fraction of a fraction to the whole pie for the opportunity for crowded stenting. So now is the time that we all predicted 20 years ago, and at inspiremd, we stand poised to enter the market at this really good time. So as you can see on the slide, we're predicting FDA, PMA approval in the first half of next year. That is for our seaguard stent that I'll spend a little bit of time talking about. So this is not a science fair project. This is not an experimental product. It's had CE mark Since 2015 and we sold over 50,000 seaguard stents worldwide. Over 1800 50 of those patients have been enrolled in clinical trial. Nine clinical trials. They're in the published, peer reviewed literature, with best in class results. We have a deep pipeline of other clinical programs and supporting products that we're working on, and all of this is funded by transformative financing that we announced in May of last year, where we are a publicly traded company, but through a pipe process, we raised with milestone based tranches up to $114 million in in funding to finance all this. So this is what our product looks like. What differentiates it is it's a fairly traditional open celled nitinol stent, but it's covered by a woven pet mesh. So the reason we stent carotids is different than the reason we spent elsewhere in the elsewhere in the body. We tend to treat occlusive disease, where the job of the stent is to reestablish blood flow, perfuse the end organ, and, again, optimize blood flow. That's not why we stent carotids and carotids, we're dealing with embolic disease, and our goal is to stabilize a plaque to prevent stroke from occurring. So scaffolding really is the name of the game. Here are some Oct images. You can see a stent with and without the Micronet mesh on the stent. And you don't need to be an OCT expert to know that if you were the patient or the practitioner, you would prefer the images on the right versus the ones on the left, where you see that plaque protruding into the lumen at nine o'clock on the left there. These are comparative cell sizes versus the other stents that are out there. Again, scaffolding is the name of the game here, and as this slide says, A picture says 1000 words when you're dealing with this embolic nature. So we've kept the stent at the center of our focus, whether it's through our trans femoral trial, which has been completed, our tcar program, which we're initiating now, or even for use during acute stroke. So I've mentioned our data. This is how we look. It's this is a comparison of all of our published data compared to results from the crest trial, and you can really see an order of magnitude difference in the type of outcomes that we receive. We've enrolled our pivotal trial. 30 day results were presented in November, and in short, these are the lowest major adverse event rates at 30 days that have ever been presented in a crowded trial. So the words go with the music, the features and benefits that you see in this next generation device have been shown time and again in our clinical results. I've mentioned our tcar program, where Silk Road has developed a procedure trained over 2500 operators now in the US, our goal is not to go out and take someone who likes to do tcar and convince them to come for the groin or vice versa, however you want to deliver your carotid stent. We're the ones that are going to deliver that next generation product. Here are milestones. 2024 is a year of execution. We're planning for filing and building towards a US approval next year, when we plan to launch scale and then scale and launch in other markets going forward. I'll end with this slide. I mentioned it earlier, but we did do this transformative financing, which part of the value is we raised a bunch of money to fund us for the next several years, and the other part is very high quality investors that are not just sources of funding, but also provide a lot of good insight and direction for us as an organization. So thanks for the time. Thanks for spending your time here this afternoon. Enjoy the rest of the meeting. You.