John Engels, Corvivo Cardiovascular - Regenerative Medtech Company | LSI USA ‘24

John Engels  0:03  
Corvivo heals the heart. Our products will help hundreds of 1000s of people with severe damage or dysfunction in their heart to regenerate using regenerative medicine principles, you see a picture of a child on the beginning of our deck because our approach to tricuspid valve was first invented by pediatric surgeons trying to help young kids born with congenital birth anomalies. And now there are 70 of these in the literature. And those results have been fantastic. So here's a quick summary of our company. We're focused on one of the bigger markets that there is in medical device, the structural heart market, and our subset of that focus is the $2 billion market. Our lead product is a regenerative tricuspid valve. So this will be the first surgical tricuspid valve and it will be the first truly regenerative heart valve. We have good leadership we have Kol is with us, we have a great patent landscape over 150 patents now. And we have three milestones for our Series A and that's why I'm here got two institutional funds who have committed these three milestones are, let's get our pivotal study finished and tricuspid valve was submitted to the FDA. And we've already achieved the third, which is a really significant reimbursement milestone. A quick bit about my co founder, he's a cardiac surgeon, one of the best inventors in cardiac cardiovascular technologies. He's an expert on ECM EMS, a bit about me, my last company is a company called axogen. So oxygen was five products that were regenerative in nature, we took those five products into the plastic and orthopedic worlds. And we changed how people do nerve repair, we built that company and today it's 170 million in sales. And at my exit 17 years after I founded it, we had a $2 billion market cap, we're going to do it again, with core vivo, we're going to start as I said, with the tricuspid valve. So we have our tricuspid valve and pivotal study. And it will be both an approval for pediatric and adult. And we'll also work on other valve applications. So we'll start in the tricuspid first, and that's all we need to get you your exit. We also have an approved product called the core patch epicardial repair product. And I won't go into details of that. But it's really key to our strategy, about how we'll market our valve. So let's talk about the valve. So here you see the valve is placed in an open surgical procedure you see on the right side of the screen there. It's a cylinder This is an ECM cylinder that regenerates. So over time that regenerates it over more time, it recapitulates the form and function of your native valve. And this is the video of that, if we could cue that. So this video will show you basically we're going to zoom in on the right side of the heart. And basically you're going to see it implanted there, it's suited at the annulus at the top into the papillary muscles. And when you come off pump, basically it's working right away and you can measure its function. Over time, we're showing you the process of it regenerating, and over more time, it recapitulates the form and function. So a famous cardiologist asked me how did you get those? Those coordinate there? And I said, Well, that's the body right? So the ECM itself, cell by cell basically creates those coordinates. So how do we know this works? We have a ton of clinical data. So we start with the ECM itself, the extracellular matrix, 6 million applications of this in the human body. I used it in nerve repair for three of oxygens products. And now we've focused in on cardiovascular hundreds of 1000s of cardiovascular applications. We've done a ton of preclinical work with it. It's been in two EF s is in our in our pivotal. Why do we care about tricuspid valve? There's 1.8 million people with tricuspid valve problems in the United States alone. What's on known about this is a good half of them are under the age of 45. So these are motivated people everybody's most motivated to heal the heart, right. But this is a group of people who maybe three procedures, each one of them could be very, very serious for them. Governor Schwarzenegger has had three heart valve procedures. I've asked him to be an advisor to us. I think in many ways he tells the story. Each time the team has declared his surgery a success. But if he's had three of them, that's the problem in itself, right? We want to heal the problem and not push the problem down the road. So we're focused on a human humanitarian device approval in this valve right. So we'll get access to 150 million or so in revenue with our initial approval of this valve. This humanitarian device approval is a special category There's never been a surgical tricuspid valve, we will be the first. And we may be the only. So what we're doing is displacing 1970s technology that's worked very effectively for many people. But its initial goal was to work for a certain number of years, right? You, you take bovine pericardium glutaraldehyde, cross fix it. That's what makes it more durable. But that also means it's likely to calcify and stenosis, right. And that's sometimes the problem with the bio prosthetic valve. There's been a lot of work to try to improve that technology. I was just at the heart valve society. And it's still a problem today. So what are we doing? We're using an extracellular matrix that regenerates and revascularize is, after many months with this in your, in your heart, you have your heart pack. So here's some of the statistics on the failure rates. And younger people seem to calcify quicker. So here's how we position ourselves. We are a native valve, essentially, right? We reflect the native physiology of the heart. And if we give you your normal heart tissue back, the question is, what is the longevity of your native tissue. So that's really the prospect here. So if you have us compared to others in the tricuspid space, basically, others are going after this transcatheter delivered valve. And that's a beautiful delivery system, we want to basically first work on the valve itself, make the optimal valve, and then next we'll work on how we deliver it, we're going to deliver it surgically, we're going to deliver it eventually through a catheter. Until that happens, we have this surgical market to ourselves, we're likely to be the only surgical valve ever approved and tricuspid, that will leave us quite a nice patient population. If you think about the 1.8 million people that have tricuspid valve problems, many, many of those will not be able to be treated by a transcatheter therapy. Okay, and so some of the rule outs you see on this page, primarily, what we'll be focused on is congenital primary damage revision cases, and the rule outs for transcatheter. Currently, transcatheter will be focused on patients who have are too frail for surgery, or are not responding to optimal medical therapy. Right. So the bigger challenge is actually marketing on that side right now. So we will we will be the players in the surgical space. I mentioned, we have quite a bit of patents protecting basically the valve material, how we deliver it, and, and the different shapes and sizes and valves that we might go after. There's quite a few, many of us know of good examples of exits in this space. So most people talk about regulatory exits for their valve approval, and our valve approval is is coming, right? So, but I like to think of something a little different. And my company oxygen, right? We built the regenerative medicine, nerve repair market. And I would like to be the company that you think of later as building the regenerative structural heart market. So we'll be we'll be exit ready in just a few months was our pivotal data rolls out. But I'd like you as investors to think of how we might do this as let's go and commercialize these technologies and build a regenerative future for the heart valve. So that's us. In summary, again, our series is focused on three milestones are pivotal study, submitting that to the FDA, and our reimbursement since we've already checked off the reimbursement bucket, we're going to add to animal models for our transcatheter delivered valve. So happy to take questions and thanks for your time.