Thomas Looby, Conavi - Minimally Invasive Image-Guidance Technologies | LSI USA '24

Thomas Looby  0:04  
Tom, hi everybody. My name is Tom Looby. I'm the CEO of Conavi Medical. We're going to start our discussion about the coronary intervention landscape, where 4 million coronary interventions are done each year around the globe. All of them are guided by angiography, which shows the flow of blood or the lack of flow of blood, as the case may be. And over the last few years, two different modalities have been developed, individually, Ibis or intravascular ultrasound and Oct optical coherence tomography to go into the vessel to give better detail about how to conduct the case. They account for about $700 million annually in catheter sales. But if all of these interventions were guided by imaging, the value of that marketplace would be about $4 billion in the coronary space. So why has it been so low? Well, because it takes some time to develop markets. There are big companies out there like Boston Scientific and Abbott and Philips who have funded a lot of clinical trials. I'm showing you a slide that is the result of a meta analysis that was published in August of last year that summarized 20 randomized controlled trials over 12,000 patients, and all of these designs were with one of the modalities against angiography by itself or the other modality. But what you can see are striking outcomes that are pretty well powered. In addition to this, there's very favorable healthcare economics surrounding this. So we think that with this development in the marketplace for the last 10 years, now is the time to take on imaging. We know that clinical evidence is the foundation. Guidelines are warming. Physicians are already being trained in their medical school programs to have an imaging first strategy, and we're already starting to see a warming in the coronary space for the use of imaging as well. So these are the two modalities that cannabi Medical has brought together in a single catheter. Ibis is the most familiar, most commonly used in the industry, about 70% of the time if imaging is used, ivis is the one. It offers greater depth of penetration and no contrast is required to make the image. Oct is less commonly used as limited depth of penetration, but it has 10 times the resolution that ivis provides, and for that, you need to have contrast so they have different strengths and weaknesses. In the pre intervention run, you may rely on Ibis more than Oct because it gives you a sense of how large that vessel is. You can get a sense for where calcium is going to show up, but Oct is useful to measure the calcium thickness to infer different strategies within the case. In the post intervention run it kind of flips. There's a tendency to use Oct more to kind of show the good result that they achieved. But in reintervention cases, Ibis would certainly also be necessary, and hopefully you're getting the sense that it's not so practical to have two different systems in the surgical suite, two different catheters being used, and that is why we really bring the best of both worlds, right? So our solution is novice site, hybrid system. We're the first and only commercial system that combines both of these imaging modalities into a single catheter. If you look at the image on the right hand side, there is an ultrasonic transducer with a pinhole out of which an OCT laser beam extends. They rotate at the same speed and they address the same tissue at the same time, and that's ultra important, as you can see in the coming slides. So essentially, we bring the strengths of both into phase, whether it's a pre intervention run, a mid run or a post intervention run. So our value proposition is versatility. Versatility without compromise. We create economic value. You the hospitals only have to buy and maintain one system instead of two. We make interpretations easier because you can't read what you can't see. And if you look at the black and white image on the screen here, you'll see a big white circle. That's because the sound wave from the ultrasound bounces off of a structure and bounces back, and it has shadowing on the other side of it, where you can't really determine what's going on. Doctors still think that they have all the data that they need, but when they see our images, they realize they're missing a lot if they rely only on the Ibis image. Also, there's more complex disease being presented around the globe, and if you can, you don't know what you're going to get into within a case, so it's best to have on board both ibis and Oct. One thing I wanted to point out is this paragraph at the bottom of the screen, I'm sure point up here instead of down here at my monitor. So we did not have anything to do with this particular study, but one that was published in February of last year sort of anticipates the marketing or the launch of a product like. Ours the use of multi modality imaging, so ivis and Oct combined in the same catheter could further optimize those results we saw a few slides ago. So there are probably three beachhead applications that make the most sense for hybrid imaging. The first one is with coronary calcium, which presents in about 30% of the cases. For ibis, you can quickly detect the size of the vessel. You can size your stent, but it cannot determine the overall severity of the calcium that's presented. For that, we would glance to the right, and we would see what the OCT has to say. And not only can you determine where that calcium is, you can actually measure it, and that would maybe infer the use of a shockwave device to break open the calcium before stenting over the lesion. Another application would be in instant restenosis. 10% of these procedures come back for a redo. And same thing ibis, you can accurately assess and size the native artery, but it's more challenged to determine the mechanism of failure, you just have to glance at the OCT to see the mechanism of failure. You can tell lepidic plaque from fibrotic plaque. You can see the stents where they're expanded properly or not, and the third area would be in chronic total occlusions, where the vessel is completely closed off. And the strategy in this particular case is not to use the OCT side, because you don't want to use contrast and put more fluid into the vessel, thus maybe propagating a dissection you would do the Ibis run First, break open the calcium, break open the blockage and then use Oct later on in the case. So those are just three areas that we think are beachhead areas where hybrid imaging is the most advantage. So we're cleared in the coronary space today, but we're going to launch in the peripheral area for all of the reasons that I just showed you, for the power that Oct brings alongside of Ibis today, Ibis tends to dominate in the space, but we think that those, those advantages for detecting dissection, recoil and thrombus are going to be important. And for a small company, we're looking for the most leverage from our sales force. I just heard the panel earlier talking about focus, but this allows us to train users in the coronary space, and 40% of them also operate in peripherals. So it gives us a good bang for our commercial buck there, and it also allows us to then participate in a much larger market opportunity. We've launched generation one, we're in the process of rolling out generation two to five hospitals in the US, and then up to 20 we are in development right now for novisite 3.0 and I just want to quickly show you some images there. Anybody who's used to reading ivis images can see that the black and white image on the left hand side is much clearer than the ones that I showed you before. So we're going to high definition ivis and improving our depth of penetration on the OCT side as well. We compared it with Boston and Abbott, and we think that if you see the current novice site product and focus in on the stent structures that you can see in white novicy, 3.0 is much clearer, and we think it's actually pushing, if not, maybe exceeding what Boston is showing. These are all on the same test phantoms. We have a razor and razor blade model. Our cost of goods are going to be the same as the single modality player. So we have all the range of motion to place capital or sell capital, and certainly we have all the flexibility, or we'll have all the flexibility for pricing the catheters as well. We just announced on Monday that we are going to do a reverse takeover of a public company. The shell is going to contribute about five to $8 million we're going to do a concurrent financing between 15 and 20 and with that cash in the bank, we hope to achieve the following milestones, launching the next generation product, building up revenue, trending to high catheter margins, and expanding into the peripheral marketplace. If we do all that well, we think that we're a good acquisition target Ibis. The main players are Phillips and Boston and Oct it's Abbott. The potential targets out there for, you know, acquirable companies. There's really only two in imaging right now, and we're the only ones that offer hybrid imaging. And I think, I hope, I demonstrated the importance of hybrid imaging. We have surrounded ourselves with a good board. One of my board members is here. We've surrounded ourselves with good development partners. We've got development partners from innovate here as well, and I think we're off to the races. If you want to talk about cannabidi medical, please see me after the presentation. Thank you. Applause.