Thomas Douthitt, Caeli Vascular - Catheter-Based Multi-Modal Technology Platform | LSI USA '24

Thomas Douthitt  0:00  
Tom, all right, thank you. And I want to thank everybody who's attending, given this is afternoon session on the last day of of the conference. So appreciate it. I'm sure all of our presenters do. My name's Tom Douthitt. I'm the CEO of Kaylee vascular. Kaylee has developed a transformational, truly transformational, thrombectomy system. I know it's a very crowded market, and I'm looking forward to sharing what we have to offer a little bit about the company. We're a C corporation. At the preclinical stage, we've raised 3.3 5 million in equity financing and another 2.1 in NIH grants, we have a post money valuation of 16.5 so the catheter that we've developed, or the system that we've developed, is called spectrum. Spectrum is a multimodal, modular system for removal of venous obstructions from acute through chronic. And that's an important point. Getting all the way across that entire continuum, we're seeking $15 million in series a financing. So contrary to a lot of other companies, we are focused on deep vein thrombosis. DVT. It's a large opportunity. 750,000 people in the US experience DVTs each year. 500,000 acute, another 250,000 chronic. It's a large opportunity, $4 billion opportunity, and fully a billion to a billion and a half of that is in the chronic segment, which is virtually untapped. So why DVT and not pulmonary embolism? Well, the core reason for that is that greater than 50% of pulmonary embolisms originate with inadequately treated DVTs. So our view is, can we go after the beginning of the problem and not wait for a PE to occur associated with high mortality rates, and so we focus on that. So starting point really would be, well, how is DVT treated? Now, virtually 100% of patients will go on anticoagulation therapy that would be Eliquis or Xarelto. And then the thing to keep in mind with anticoagulants is that they're going to stabilize the clot, but they're going to do nothing to reduce or eliminate the clot. So it's a good thing to be on if you have one, but it's, it's it's not going to get at the at the core of the problem in terms of removal, there are, that's what endovascular systems are for. FDA classifies endovascular systems along three different categories, catheter directed, thrombolysis, aspiration and then mechanical removal, or some combination thereof. But you know, I mentioned, 100% of patients go on anticoagulation. Fully 85% of those patients, that's the only thing that they're on. And so there's a reason why 15% of patients, only 15% of patients, receive endovascular care, and that's because there are limitations with the with the procedures, and they center around three general areas, safety and efficacy. Embolization occurs in nearly 50% of cases, bleeding when, even with catheter directed thrombolysis, delivering it at the site of the clot, the effect of a thrombolytic is systemic, so you have the risk of bleeding and the risk of intracranial hemorrhage, and then blood loss during aspiration. Rapid registry pointed to the fact that 25% of these patients require transfusions because they're aspirating healthy blood along with the clot itself. And then there's technology limitations. All the products that are on the market today are designed to treat acute disease, and as I pointed out on the previous slide, there's a third of these patients each year that suffer chronic disease. So that's you know, as the clot ages, a lot of these systems require capital equipment that's expensive. And actually the most important thing in terms of healthcare economics is really the fact that the device utilization rates are extremely high, 1.8 to three. So when you're using that many devices per procedure, you've taken a well reimbursed money winning procedure and turned it into a money loser, and it's a big reason why the Barnes Jewish healthcare system is one of our investors. So let me introduce you to what we've done with the spectrum system, and I'll point out two key factors that target some of the limitations that I previously described. First is that this system is a dual balloon system, so I'll play a video that shows all this, and that dual balloon system actually gets at treating many of the issues that I highlighted before. The second is that we have a modular system, so we call our macerators the clot fragment. Component of the system, we can provide different modules or different macerators to address specific morphologies of disease, and that's unique. So I'll start the video here. We start with internal jugular access and take the catheter down to through the vena cava or into the iliacs. The first thing that we'll do is inflate the proximal balloon. This prevents embolization from the get go. We'll advance the guide wire and the distal catheter, and then inflate a distal balloon. And now we've isolated the treatment zone. Now we can introduce a a the macerator. And in this case, I'm showing an acute version of it. The macerator is equipped with infusion ports that can allow infusion of saline contrast, or in this case, what we're showing is a thrombolytic that thrombolytic is contained within those two balloons. When you're ready, when the physician is ready, they can begin to rotate and translate the macerator back and forth to fragment the clot. And when satisfied, they can and during that process, they can inject contrast to gage progress. And when satisfied, they can aspirate the debris. At this point, then you retract the macerator, deflate the balloons, and take the system out. So what does this do for you? There's key advantages on the same parameters that I highlighted before, from a safety and efficacy standpoint, the balloon, the dual balloon system, helps prevent embolization. It contains the thrombolytics within that treatment zone, and so both the dose, the dose, dosage is minimized. The effect is localized. It limits blood loss during aspiration, because we infuse saline while we're aspirating, and so you end up aspirating saline and clot, and not healthy blood and clot. And really what we're excited about is we're able to treat the entire continuum of disease. This really opens up that chronic market and be able and we're able to provide different macerators for different degrees of chronicity. There's no capital equipment, and we believe that by doing this all in a single system, that we can significantly reduce device utilization rates and improve margins to the healthcare institution. We have a very straightforward regulatory path, 510, K, no. Clinical trial is required prior to approval or to authorization. We have a very experienced leadership team between Stacy rich and myself. All of us have 30 plus years of experience across multiple startup companies. Rich and I actually have been fortunate to work together for four of these companies, and we've taken our last three to successful exit. We're supplemented by a great scientific advisory board. This is really a who's who of the industry. All these groups are almost all of these people work with the different competitors on the market. They are helping us with our product development, and they're committed to sponsoring our clinical trials upon commercialization. So again, we're raising a Series A of $15 million we have strong financial support across five different investors. We have a, I think, a very powerful platform, an experienced team in place and strong IP, as I mentioned, regulatory pathway that's very favorable upon closing of series. A, what we will do is complete the development of the spectrum system, submit that and gain approval from FDA, and then initiate commercialization and post market studies. I know I kind of drove through all that in a hurry. I feel like I'm talking really fast. But if the if there's interest in this, this is a huge market that we're going after. If there's interest, I'm happy to answer questions after this. Thank you very much. Applause.