Mike Rosenthal, Endovascular Engineering - Clot Removal Technology | LSI USA '24

Mike Rosenthal  0:04  
My name is Mike Rosenthal. I'm, as we said CEO of Endovascular Engineering, and I'm excited to tell you what we've been working on up in Menlo Park to treat venous thromboembolism. So we're working on mechanical devices, minimally invasive devices to treat this need. And there's a lot of smart people out there doing it. I see some of them, some of them in the audience. This is a big problem and it's split up into two main categories deep vein thrombosis and pulmonary embolism. Deep vein thrombosis is a condition where clots form and the deep veins typically within the legs, pulmonary embolism, we were typically those clots release and move into the lungs and arteries within lungs. Now, massive occlusions within lungs can cause serious and significant problems, right? This is something where you have to deal with in a matter of hours, sometimes minutes, where you have more time and DVT. We do have devices. In both categories. We have a platform technology, we have a 510 K clearance in DVT. But pulmonary embolism is where I'd really like to focus today. So in both cases, it's a massive problem, right. And this has been talked about a few times 1.5 million patients each year in the US suffer from a PE or DVT 50% of the PE population 900,000 patients in that population actually have concomitant P and DVT. So a platform that can treat both would be hugely valuable. One in four patients die from a pulmonary embolism without warning and other patients that come in and actually diagnosed in the massive and sub massive categories 12 to 15 fold to 50% of those patients actually passed away. So massive markets, we wouldn't be up here if we didn't have a B in our market. We've got three B's in these markets. But looking specifically at each there are huge markets, but they're they're not penetrated, right? So you've got massive companies that are working on these things, but they're not approachable technologies currently unapproachable or they're becoming irrelevant, particularly in the pulmonary embolism area would like to folks 12% penetrated companies like the Boston Scientific Inari Penumbra and a few of us that are chasing that area, there are huge opportunities there. Most of the technologies are fall into two categories mechanical thrombectomy and CDT catheter directed from a license. These are the invasive categories minimally invasive devices, the rest still drug management. So where the growth is happening now, Jay Giri who's a leader in this field, both from a science and from a clinician standpoint, is come out and said like many others, it's the way to go. Drugs are no longer the way to go, it's time to go with catheter based interventions. Now, if you look at the catheter based interventions that are driving the growth in this market to 20% CAGR approximately 2324 25. But what's contributing to this growth, mechanical thrombectomy to mechanical devices. Now, there's a lot of people working on catheter directed thrombolysis, as well. And there's a role for that we're focused on the mechanical side, and catheter based technologies. So what are the needs, if you look at the mechanical thrombectomy space, there are nuances for sure, different ways to approach it. But fundamentally, the big devices that are used out there are tubes with suction. So you've got big tubes, and you have small tubes. But they have trade offs. And you have to consider those when you use them. And the physicians are using safety, efficacy and ease of use navigation to the lesion to the clot in the lungs, you have to go from the legs up through the heart strained heart and into into the lungs and the complex anatomy with the lungs big devices will be great. At the second one, there'll be terrible with the first one, a small device used to for effective clot removal, you get a lot of clogging. And then you're going to have to interchange that device significantly. It's a complicated procedure. And I came out of the r&d world. So I know we make a lot of cool devices, but sometimes you forget to focus on what's going on in the cath lab as a whole. This is an important moment in these procedures. Having capital equipment that's complicated or having ancillary devices that are feeding in is always a challenge. And we've tried to create a system that's very simple. So you mentioned simple technologies. We've seen them. I'm hoping you guys can get your head around this one as well. So helo platform, this is what we're developing up in Menlo Park. And we have already taken it all the way into the clinical trials. And I'll show you more about that. This enables small bore navigation with large blood clot removal go in small become big. It's a dual action technology. So we are using the advantage of aspiration. But we also have a system that agitates the clot and helps him move down a small board device. We have clinical data that's far beyond any of the next generation technologies that are out there. This will be a video. I hope it plays showing you small profile, but large core technology comes into the system. The bottom are really access systems and I'll walk through mainly the catheter itself on the front end. There's a 15 French device on the outer sheath, a curve that allows for macro adjustment, and then the inner side is the aspiration device and catheter system that has a funnel that expands to 24 French on the back end is very accessible ergonomics system that's fully in the physicians hands used to operate the front system back connection to a suction pump standard off the shelf, nothing special. And then the agitator in the middle, which we'll look at more specifically, that can be introduced and removed without removing the device from its target area. Macro adjustments in the with the handle adjusting the outside to get to right and left long. And then manipulation of a controller on the back end to get you more precise adjustment within the within the anatomy. Depression of the button slight the back gives you aspiration control full depression gives you activation of the agitator, where then you're disrupting the clot, which enables it again to move down to smaller. So I'll let that play on the on the what is the left side, which is showing you again, the navigation benefits, really the most important thing and looking on the right side here, this is the navigation through the heart and up into the complex anatomy. I mean its anatomy in the lungs is something that physicians who have been looking at fluoroscopy for a very long time have to learn is a challenging environment to work within. So if you're crossing over the heart as well with a large device, then you're going to have strain on that device on the on the heart right and this target is already strained. It's pumping against high pressures. It's deteriorating risk of cardiac arrest, you need a device that can sit in there sitting there safely, or else you're removing devices and large devices to get the heart back to where it needs to be is that the device works to remove clot navigates the Legion using a standard dilator and guidewire technique, open up the funnel, advanced the funnel after introducing the agitator into the system to the clot, engage the clot by slight depression in the proximal handle to engage a clot with suction. And then for depression within the handle kicks on the agitator and manipulates the clot down the device is a very specific interaction in terms of how they adjust to agitator spins, and how the funnel interacts with the cloth. Simple technology. But as an engineer, there's definitely a nuance. This is a quick video showing how it actually happens at full speed. So yes, animation benchtop model, but we have much to show you in terms of where we've been in the clinic as well. So what we've shown in clinic is this is a single pass procedure never have to move the devices in and out, typically less than 30 minutes 55 minute average, which is huge. This is the example of a first case for a physician. On the left side you see a lung that's not well perfused clots in the proximal end. And on the right side you see along and now it's fully perfused at 28 minutes with our device, it's credible pace in less than 30 minutes. And then you're able to assess progress here, which I didn't talk about previously with the ability to manage local In contrast, injection and pressure monitoring on the back end. So I lost the bet on the Space Invaders symbology there, but it is there in golf trial is is our trial that we've been running, there's a feasibility phase at a pivotal phase, we have 25 subjects that have been enrolled already, that's far ahead of what anybody else has done in eight sites. So 11 users in eight sites and 25 subjects. In that safety study, we proved safety and efficacy, there's absolutely in line with what we're going to need in our pivotal trial. It's proven that our patient outcomes today are safe and effective. And we de risk the technology, the procedure, and also the pivotal phase execution and we're transitioning to the pivotal phase can't do anything without great doctors. I like to play one on TV as an engineer. But if you don't get someone in to the room that's going to tell you what you're doing wrong and what you're doing right then then you're in trouble. And these are the right physicians to have clinical physicians scientists both on the DVT and the PE side. Also an amazing team, each with over 25 years of experience in this space. I hate to even put up this slide because there's a huge number of people back home that are making a huge difference. And just as qualified as anybody on this slide here to where are we? We are ahead like I said of the other technologies that are coming along. A lot of very smart people are respectful where people we're doing, we've been able to execute in a timeline that very proud of as we go through both our first inhuman in the US feasibility phase and our interim reporting to get approval for our pivotal trial. We're now enrolling our pivotal trial a great pace. So what have we been able to accomplish? In our series seethrough series as

Speaker 1  9:32  
I mentioned, we've obviously expanded our IP portfolio I mentioned the I Ian goal feasibility enrollment and reporting. We also have a 510 K clearance and DVT and I'd love to talk to people more about our experience clinically there and we're headed into our pivotal enrollment with first patient enrolled only days ago as we go into our series B raise significant raise here when I would love to talk to anybody about their interest in this primary goals or to get through our engulf pivotal phase enrollment, get through the 510 K submission and clearance for P E and engage some pretty critical platform improvements that we're excited to talk about in the near future to really enable differentiated device to hit the market. Thank you very much already over time