Tom Looby Presents Conavi Medical at LSI Europe '23

Its flagship product is the Novasight Hybrid system, a unique coronary imaging system that combines co-registered ultrasound (IVUS) and optics (OCT).
Tom Looby
Tom Looby
CEO, Conavi Medical


Thomas Looby  0:05  
Hi, everybody, my name is Tom Looby. I'm with Conavi Medical. I'll give you a couple of minutes to read our. Nobody's gonna read it. Okay. So I want to tell you about the experience team that is being deployed to focus on a large and growing market opportunity. We have a differentiated technology that combines intravascular imaging and ultrasound and OCT in the same catheter with one pullback. It's protected by core IP, and we're in the middle of a pilot clinical adoption phase. In the US, Canada, we also have clearances in China and in Japan. angiography is used to guide over 4 million coronary interventions each year. As we all know the x rays can see in a two dimensional space, the flow of blood or the lack thereof, and it's guided therapy for decades. OCT, or optical coherence tomography and Ibis intravascular ultrasound have been developed to go and look inside of the vessel, but they exist only in one form or the other until we have come along and they have not been combined into a catheter in a co registered fashion. There's a substantial market opportunity just for the disposable components alone, we value the market, over $4 billion in the coronary space. Today imaging accounts for only about $700 million within that so there's room to grow is an octa each have unique advantages. Ibis is used to look deeper within the vessel, and you're able to see the lumen wall and and size stents more easily on the ultrasound side. OCT brings 10 times the resolution that Ivus does. And yet it requires contrast to be used, which can sometimes be problematic in this patient cohort. So our solution brings IVUS and OCT into the same catheter. If you look at the image on the right, you'll see at the tip of the catheter and ultrasound transducer with a pinhole that has an OCT laser beam shooting through it, they are mechanically locked, they rotate at the same speed. And they address the same tissue at the very same time. And we're the only ones in the world that can say that. We are packaging this into a cart based system very similar to this standalone IVUS are OCT players. And we're pricing our catheters right around the same price as the standalone catheters. As I said, we're cleared in the US, Canada, Japan and China. And we've got core patents that protect the core part of the technology. So this is a bit of an oversimplification. But in two parts, we got to have pre intervention runs to determine what's going on inside the vessel. And we have post intervention runs. In the pre intervention run IVIS, this tends to be favored, because we need to know how big that vessel wall is, we can roughly detect if there's calcium, or the presence of other lesions and whatnot. But, but OCT certainly does have a role to play as I'll show you in the next couple of slides. In the post intervention phase OCT tends to dominate, you can determine whether the stent has been expanded properly and is seated properly. And in 2023, we're having a bit of a heyday with regard to clinical evidence, large companies that own either IVUS or own either OCT have conducted multi year multi centered random prospective studies. And the meta analysis that was recently published last week shows for 20 Different randomized control studies, you see a 46% reduction in cardiac death 29% reduction in re intervention 20% reduction in target vessel MI and a 52% reduction in stent thrombosis. So that is particularly compelling, especially since the last time we saw all this evidence in the marketplace. It accounted for a doubling in uptake in the United States market. So what we do is we address the unmet need that now a lot of hospitals who are seeing this evidence to rushing out to buy OCT and or IVUS systems in the way we're pricing it, we want to basically remove that problem from from their minds and provide them the best of both worlds for the same price. So we think we can produce significant economic value for the hospitals. We know that we can make interpretations easier. Many people who are used to reading Ibis images but are not not familiar with OCT, they quickly can look to the side and determine what's really going on in the vessel. So the marketplace has has started to change right? At angiography guiding therapy for a while. We had o CT and Ibis has standalone modalities, you know finding their way. Now the evidence is such that the experts are saying now's the time to adopt imaging. Well, this is the last sentence of a paper released in February that basically says, At the end of this curve, the company that could be advantaged as the one that brings ibis and Octa into the same product, thus, the use of multi modality intravascular imaging. So that's what we're doing in the coronary space, a couple of three quick pictures, more than 30% of PCI is present with calcified arteries. IVUS does a good job of showing the vessels wall, the size of the stent suggested. And OCT is used to assess, you know, the severity of the calcium and so on. The same thing for instant restenosis. IVUS does the same sort of thing. But in order to accurately assess the mechanism of the stent failure, we need to look at the OCT side of the picture. And then finally CTOs, CTO is where you have a chronically, you know, closed off vessel, you're not going to want to use OCT because you have to have contrast that could further propagate dissections. And, and that's dangerous. So you would rely on IVUS at first until you broke up that calcium, and then you could go and image with OCT to determine how good of a job you have done. In addition to the coronary application, the very same product we will get a clearance for in the next 12 months for peripheral applications, IVUS also dominates in this space, but the benefits that we just showed for OCT are very relevant in that space, specifically, and below the knee applications. There's favorable reimbursement, and 40% of doctors crossover between peripheral and in coronary applications. So Conavi is, in terms of our market development, we went to five top hospitals in '22, 2022, we will expand that footprint to about 15 to 20. Really focusing on going wide and deep within each of these hospitals. Meanwhile, we have started to develop Novasite 3.0, which will have sharper imaging on the ultrasound better. That's a workflow and ease of use characteristics in order for broad market adoption. And we will launch that into the marketplace in 2025. It's a razor razor blade model and our costs for the console. And the catheters are similar to what our bigger competitors would experience with their standalone modalities, it doesn't cost that much to combine the two. So at volume, we think we've got a very competitive device where we can price it where the single modality players are pricing their products, but give them so much more than what they have experienced thus far, we are in the middle of a $30 million raise, we've closed on 12 and a half, we're looking for the rest the 17 and a half to finish. To finish it. We've set the pre money valuation at 50 million, senior preferred shares with an 8% dividend. And we would be very interested in engaging any of you in conversations about where we can find some of that capital. As this evidence has developed, you know, it certainly does point to imaging being important. And we think that the combination of ultrasound and optical imaging can maybe even be preferred. So if you're an IVUS player and want to take on OC t, we are a standalone entity that could be a good acquisition target. And if you're an OCT company, we have Ivus and we bring along the familiarity of the OCT as well. So we think that this makes a very good acquisition target for the company. we surrounded ourselves with really great folks on the board. We've recruited a lot of great talent to the management team. We now have well over 125 years of medical device device experience at the senior team. And, you know, we're taking great science and technology and bringing it into the market. Thank you very much

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