John Simpson Presents Simpson Interventions at LSI USA '23

Transcription

But thank you very much for the opportunity to talk I just heard the the discussion about OCD and ultrasound and a combined setting. Fascinating. Definitely like that. I'm going to talk about ocgt optical coherence tomography, it's a laser based system for imaging, or reason. And our use of OCD is a little bit different than was just previously discussed. We use Oct T to guide an intervention. And so probably we're very early compared to some of the other companies that have been presenting. But just to kind of give you an overview, we're here to to raise money, I know this probably sharks, you may be really surprised that we're raising $5 million, we have $10 million $12 million in the project. So far, we have as close to Series A, you can read the slide. But we did that the $5 million were raised to now be used to complete our first and main studies in in in Paraguay. We're about halfway through that analysis thus far. So we're, but we believe that $5 million will get us to the completion of that. So that'll that'll close out a series B financing for US Series C, then we'll we'll be required to get full FDA approval for the product. Within that it'll be a 20 to $25 million funding effort, which will come at some later date. So I'm actually just going to show one video clip. But I'll tell you in advance, since I have I have a laser, the laser may maybe it will work. It's hard to kind of do the presentation without a pointer or something to tell you kind of what's going on. So I'm gonna describe it first. So you kind of know what will you'll be seeing. Once I start the video, I'm afraid that the laser pointer is not going to be particularly helpful. But we continue to can discuss this, but the video is going to be of a patient that we treated in in South America. First, there'll be a short video on the device, which has an OCT dmg and system on it a series of guide guide wire that can be exited out the end of the catheter and then can be exited out the side. And for the individual credit cardiologists the key element for crossing chronic total occlusions, which is what this device is designed to do, is to be able to exit off the side of a catheter with a guide wire. So the concept is that the catheter frequently Nikos sub intimal space, or they're kind of used to say that, like a car stuck in the mud, and that car needs to get back down into the main road, the way to get back onto the main road is to get a guide wire back onto the main road. So you can get the car out of the mud, let's say probably a terrible analogy, but it's the sort of best I could do this hour. And so we'll show you how we use this guidewire mechanism to go from this vegetable space back into the so called quote true lumen. And the true lumen is the target. And then the patients would then have chronic total occlusions. And this is the my patient population that I should have alluded to first, that's the patient population we're dealing with. And these are patients who have a complaint about coronary artery and in that blockage in time in terms of trying to cross the blockage. The catheter has ended up in the quote suboptimal space, they end up in the mud. So it's really a common problem when you're trying to cross a chronic total occlusion. And then once you once you get buried, you have to get back on track and our device gets you back on track today. But the device called the acolyte had to digress just a little bit, we actually want to call it the sidekick. I have sort of a West Texas background, if you will, because it kicks the the guide where I like the cowboy references being kicks the guy brought to the side of the catheter side kickass makes a lot of sense. I think you can all see that I can tell that everybody understands it. But sidekick was trademarked. So we changed the name to acolyte, which is the French term for sidekick. So I know that you think we're very sophisticated in how we've done our analysis and our naming processes. The acolyte is really the device that allows us to aim a guide wire into the true lumen and get us out of the surmountable space or the trouble space so we'll start the video and see how well the the how well this works. So I can go if that works, they're fine that way you can see oh, yeah, that's good. Ah, oh, that preface and then I It's okay. Okay, so this shows the acolyte catheter down here has a laser based Octa directed system has a guide wire that used when the catheters position Send this the O CT image that we produce. And the nd we have an algorithm to tell us where this particular guidewire is going to be executed when it goes out into the true lumen. So all of this is computer generated. And the guideway that we're going to use to do all of this is positioned here inside the the catheter. So this is the OCT image of the catheter. This the OCT image of kin chins finger that Candice here. And so the catheter and these are the controls that go into the catheter. So the goal is going to be to get this, put this into a patient and and see what we see right now we're just showing that on the on the bench, we're showing that the guard was being pulled back. And this may seem like something kind of trivial, but then when the guard wears pull back the guard where I was here to disappears. When it's really advanced, it comes out the side of the catheter directed where these red lines the guardrails are. So that's the direction and trajectory the guide wire, when you turn it over to the side, you can see that the red lines go over to the side. And I'm sorry, that was a. Okay, so now that this is the vessel that's completed, blocked off, so it's the left anterior descending coronary artery, which is a big vessel in this patient, and it's closed off right there. So it's an LED chronic total occlusion is called. So we need to get across that with our catheter with a guide wire and you can just try and guide wires first. And this is probably more clinically directed that maybe some of you might be truly interested in. But unless you understand something about this, then the rest of it just makes so much sense. So now we're trying to get across this chronic total occlusion with guard wires. And this is the big dilemma that we've had we talked about, we heard about poking hope early on a previous presentation. So this is poking holes in the coronary arteries with guide wires. And we've done that for years. And unfortunately, booking hoping without imaging isn't a very, has not been a rewarding experience. You can see this in the angiogram now of looking at this space, the fluoroscopy. And the angiography tells you nothing about what's really going on inside the artery. So once we connect up the the acolyte, the French version of the sidekick to imaging, they will get to see we'll get to compare this to this the O CT image, do they just come in right off with this catheter, and it's it's inside there, it just tells you everything. So we're going to aim these red lines at the true lumen at the track that we want to get into this is normal artery up here, you would never want to point the red lines at the normal area. So the safety profile of this particular device is really kind of the key element for us. So this is called the adventitia. This iMedia then this is the peri vascular structure, lipid, I'm sorry, fat that sits around the artery. If you were to aim a guidewire out in this direction, you think you had the risk of perforating the artery, right. So if you aimed a system down in the opposite direction, so this is the so called pulsating true lumen down here. And so that's the target, we're stuck in the mud up here, we want to get back down here into the crack paths. So we possession positions, I'm sorry, the red lines, which is the angle for the guide was going to come out, we positioned the red lines over the the trilemma and then we advanced the guide where so here's the guide where it's going to be advanced, it'll be advanced into the true lemon. And you can see fluoroscopically That there's very little information for a scapula that tells you where to aim or direct anything. And now then when the guide rest advanced in this direction, then that is the guide where I have been invested into the trilemma. So this is a big event because there are 350,000 400,000 patients in the US. You see the guy who was in the trilemma, this whole area is going to be ballooned and stunted, which is the common practice this shows the guidewire going across the the tissue plane that's going to go into the true lumen over here in this penetration. So in talking to Bram sarcoma at the FDA, he said, I'm glad it kind of works. But I have a guy that really works. But he said, I'm really much to the safety profile, because we can aim away from trouble. This is trouble. And this is where you want to aim you see the guide where I go into this area of here that we're trying to aim at. So the safety profile is really, really dramatically improved. I asked Brad, I said, Does this constitute an approval? He said, No, not really, but I thought it was worth asking. No brand for a while. So now then here's the RDF it's been ballooned and stunted. Just to show you this, so this patient was headed to bypass surgery with absolute certainty. If this procedure had not worked, so we want to convert all of the patients currently they're being referred to bypass surgery. You know, three or 4000 Almost all Let them not really all but almost all of them for chronic total occlusions. Because because the doctors do not have a very effective tool for treating these and they're reluctant to treat the total occlusions, they send the patient to surgery, they find out oh, gee, I don't want to do that. So if we had a tool, which we believe this to be the tool that can make it really safe to approach and we call this an antegrade, crossing crossing from a forward direction, there are things called retrograde crossings where you go down another artery and come back up, and it takes a really, really long time. This Fernanda gray crossing, we worked for 45 minutes in this patient trying to traditional approach and successfully and with and we, with this particular guide, why it took us seven minutes to get it into the into the true limit. Back on Track, out of the mud, if you want to trouble I'm gonna have to change the analogy that doesn't sound not very fair. But But the bottom line is that we have, we believe a way to make all of the doctors in the interventions that are are interested in treating chronic total occlusion where we can give them the tool that will really make a difference for them. Because give them the confidence that they can, you know, get a better outcome for, for treating the CTO. And in a way give them the confidence just to try right now a lot of the interventional cardiologists actually did not try because they they're experienced and I haven't had the same experience. You just you poke and you hope and we heard that term used already broke it up in the spinal canal. That's a terrible place to poke and hook. And that tell you another really bad place to poke and hope is in the coronary arteries, poke it with the guard wires and trying to hope that you go to get into the true lumen get in the right spot, get out of the wrong place is unfavorable. If you have a way to let's say house, what's the right term, maybe just lean things in your favor as Dan Fisher cardiologists, then imaging has the chest to do with Octa reason we'd like go CT is because it's so small, it's laser based system is optical fiber. And we can combine that with a guide where if we added ultrasound to it in this particular setting in this category gets a little bit large for us. And to get it into we I'm really impressed with the previous discussions about the combination of the catheters, I think that's that could be potentially exciting. But frustrating. Now we need small because it's in the coronary arteries in the sublingual space in the coronary arteries. And this is like for French catheters is one point What was that 1.3 millimeters. So that has worked out worked out well for us. And so we think that that could be something that would drive further adoption in in physicians that want to treat CTOs but are nervous about doing it. And this will give them the chance to get a really good outcome. So thank you very much.