Thomas Looby Presents Conavi Medical at LSI USA '23

Transcription

Thomas Looby  0:04  

Hi everyone, my name is Tom Looby. I'm the CEO of Konavi Medical. I want to tell you about our company. We've got a very experienced team. Starting with our board of directors and management team. We're part of a large and growing market opportunity. We have a differentiated technology. We are commercial stage with 510K in the US, Health Canada and Japan, with a clearance in China brewing as well. And we've got core IP surrounding the fundamental technology. So we've surrounded ourselves with people with a lot of experience. Here's a snapshot of our board. Brian Courtney helped to found the company taking the technology out of Sunnybrook Hospital in Toronto, Canada. Aaron's our chairman, both experience at AIG capital, but also some stints as an operator at profound medical Nova DAC. You can see Bob Mitchell's pedigree, and Cameron's in the back of the room somewhere, you may have seen his presentation earlier this week. So a lot of good guides for our company with a lot of experience finding some exits as well. Today, we're all about PCI, we're over 4 million coronary angioplasty and stenting. stenting procedures are done annually. We know that angiography shows blood flow or the lack thereof. And that has guided a lot of procedures over the years. And ibis and Octa have been developed in the space to help augment that picture with a view inside of the vessel. And that is accounted for 600,000 procedures within that 4 million. So they each come with their own advantages. For iOS, you don't have to use contrast, there's greater operation operator comfort, it has the ability to see with greater depth, so you can get a sense of the vessel size in Octa provides 10 times greater resolution allowing more of the characteristics of what that lesion can look like inside the vessel. But it does not have that depth of field that Ibis has. So advantages of both. But they've been around for a while, and they only account for about 600,000 procedures out of that 4 million. And the question is, why should we get excited about that now. And there's a growing body of evidence, both in outcomes and cost effectiveness, that are now directing the way to greater uptake of these underlying modalities, both ultrasound and optical imaging. In this particular slide, we talk about a 50% reduction of adverse cardiac events, if you were to use only one of the modalities that we've got in our catheter, ibis, so instead of 10.7, people having an adverse event, five years post, that will drop five point, so 5.1 people, so that's a massive improvement. With an aging population, people are getting older, and heart disease is now becoming more complex. So we think that PCI is of the complex variety account for about 40% of the procedures. And this study has shown that the mortality rate drops from 17% to only 10%. If you were to use only one of the modalities that our product has within it Ibis in this case, as well. So in addition to those outcomes, and there's a in the last four weeks, we've actually seen almost weekly, more evidence hitting and we expect to see more evidence on ICT hitting in 2023 as well. This particular slide speaks to the cost effectiveness ratio. So in this case, using angio guided piece US versus using angio guided piece us with ultrasound, the incremental cost effectiveness is 12,730 for each additional life year gained if you have a complex PCI that drops to $8,200. So what does that mean? It means it's well within that sweet spot sweet spot for the quality adjusted life years. And in comparison with diabetes treatments and drug eluting stents, it's indicating that this is going to be very exciting that the cost effectiveness for doing these procedures using imaging is going to pay off as well. So but these these modalities have trade offs. Yeah, when asked a number of doctors were given a particular situation that you can see listed in the left hand column and they're saying, what would I want to have on board doing this PCI, some would say I want o CT for acute coronary syndrome for an example, okay, where Ivus is favored for other for other situations. But the fact of the matter is, is that when you get into the procedure, you're going to see a host of situations. And it may be that the one that you chose OCT or Ibis is not the one most suitable for conducting the rest of the case. So what we really do is we combined both of those imaging modalities into one catheter. We are the first and only commercially intravascular imaging system that combines co registered IVs and o CT. So what is CO registered mean? You You can see in the picture there, there's a small, ultrasonic transducer, and we've got a little pinhole through it that shoots out a laser beam. These are mechanically locked, they rotate at the same rate, they address the same tissue at the same time. And we're the only ones in the world that have that it's patented. We are cleared, as I said, in the US, Canada and Japan with with China, on the way as well. And so our value proposition is we're going to give the physicians both modalities. With no trade offs, we're going to make the interpretations easier. So if you are used to seeing a ultrasound, but maybe have some sort of question about what you're seeing there, you glance over to the other side of the image, and you can confirm deny change your strategy. We also think that we can help to streamline hospital processes. With this growing body of evidence, there are now key opinion leaders who are pounding on the podium saying you need to be doing imaging in your hospital now. So now a lot of hospitals are being faced with do I install IVs? Do I install OCT? Or do I get the canabis system and I have the best of both worlds at the same price as what the single modality devices would cost. I'll show you three quick cases. On the left hand side, we have IVs. On the right hand side, we have OCT or optical. And in this particular case, you can on the left hand side, you can see the vessel pretty well and doctors can size stents with the information that they're provided. But what you can't see, unless you look over at the OC T side is that you've got a dissection in that vessel. And so that would change the strategy. Once you get in to that case, all three of these cases were done at New York Presbyterian. This second case at 12 o'clock on the on the left hand side, the physicians could get a sense that there's calcium, but it's only when you look at the right hand side that you can see the nature of that calcium. And that would also change how the case is being conducted. In this particular case, it may suggest the use of a debulking device where you would not get that information if you just resided on the ultrasound side of the image. In this particular case, again, the left hand side ibis, which is used maybe two to one in favor over OCT, you get a good sense of how big that vessel is, you can't really determine that there's thrombus in that vessel until you look over at the OC T side. So there are strengths and weaknesses of the punch line is their strength and weaknesses of the underlying modalities. Ibis has got some strengths, but some weaknesses Octa does, we bring them together into one. And one of our key opinion leaders, Dr. Prasad at New York Presbyterian says she can have her cake and eat it too, and allows her to capitalize on both the strengths of the underlying systems. And the punchline of the last sentence, and a paper that was released just last month says not only should you be using imaging, but the use of multimodality imaging, or those that combine ultrasound and an optical in the same system, as an example, could further optimize lesion assessment and PCI optimization. And as we read a lot of these papers, we know that that's a sentence that is about as strong as you're going to get when they release data. We think that the marketplace for coronary procedures for just a consumable alone is about $3 billion. Right now, the serve market is only 660. But with these outcomes data with the ICERs that are hitting with products like ours that kind of increase the confidence of the interpretation that physicians have, we think that we can help to build that 660 well into that 3 billion opportunity. And this is coronary alone. We are also looking at the peripheral market with the same exact product, we think it's a relatively straightforward process to get it cleared. And because it also has favored reimbursement on top of a DRG, it could be a good way to help us get additional traction within the marketplace. So it since 2021, we've really bolstered our management team, in addition to the board that I presented earlier, we have just hired a gentleman with 25 years of experience at Boston Scientific and other places to run r&d for us. 40 year guy running operations for us, and a 2025 year vet of this marketplace developing the commercial space. So we're really kind of surrounding ourselves with experience. And we've used that in some investment that we achieved in 2021 to go to five US sites. Besides New York Presbyterian we're at Montefiore Mount Sinai, Cleveland Clinic, Emory healthcare, and we'll expand that footprint in the next two years to go to 20 sites. We'll probably cap it there because we want to go deep into these sites. And meanwhile, we're developing our next generation product that we call Nova site 3.0 will enhance the imaging we'll refine the workflow And most importantly, for the business aspect of it, we'll create some gross margins. And that disposable that we don't currently have today, we'll launch that at the end of 24 into 25. And from there, we'll expand that footprint in the US and then go to other regions around the globe, as well. So we'll we'll have some revenue in 23 and 24, from the catheter sales in the US from our partner in China. And then after that release, and this is just showing the coronary procedures, we think that we can grow quite, you know, aggressively and 25 through 27. And with that volume will have the gross margins that we want to see on the disposable unit. We've raised 50 and equity for 4 million in government loans. 16 and a half in other places, non dilutive sources. We're in the market right now for raising 30. And if you'd like to talk to me or my CFO about that, that would be great. So thank you for your attention.