Paul G. Mead Presents CorFlow at LSI USA ‘23

Transcription

Paul Mead  0:05  

So hello everybody. My name is Paul Mead. I'm the CEO of CorFlow. This was a company that was founded by two renowned interventional cardiologist, one who is Martin Rothman, who's in the room here with us today, based on what they saw over decades in their own clinical practice, whereas heart attack treatment outcomes were not what they should have been a bit of a mystery, which we're going to explain here today. So CorFlow has developed the world's first platform able to diagnose and potentially treat microvascular obstruction known as envio, in real time during PCI in a cath lab. Now this image on the left hand side, you see the date 1963, roughly when MBO was discovered, which says a lot that, here I am standing on the stage changing, the world's first able to potentially address this decades long problem. Let's take a walk back in history of the treatment pathways for acute myocardial infarction. There's a beautiful series of innovations here that lead to reduction in mortality. So all told, in in hospital mortality, there was a 95% reduction in relative risk, because of some of these innovations, but when you zoom in, it's not quite as positive as it looks. And it turns out over the last roughly 20 years, things start to plateau. Whereas in this day and age, the last available data still greater than 20%, are showing up with heart failure or worse, cardiac major events in a year, and 10% are dead. Researchers ask why. So you zoom in, again, what's causing these very high unacceptable event rates. And to the shock of many, the number one reason on the list was the one that no one had heard of microvascular obstruction, ahead of these Hallmark indexes, ejection fraction, ischemia size, hypertension, were many of the careers in this room, industries were built on solving. No, it was envio most important factor. So we go a bit further. Timmy, if you're not familiar with that, is a degree of flow after reperfusion of the main arteries, correlation emerges, not exactly what you might think, though, get to that in a moment. So three years later, we're now only in 2017. Researchers go back and look on a more binary if you have MBO or not. Or if measured by echo microvascular dysfunction. how devastating is it? The answer is very, absolutely devastating. Without any question, the number one driver of mortality in these patients, still no solution to diagnose it in a STEMI situation accurately, still no solution to treat it accurately. Why isn't this headline news? I'll let you answer that yourself. But it should have been if this doesn't scream unmet need, I don't know what does. So back what I mentioned about the Timmy flow and the relationship of getting those arteries open as fast as you can, when researchers saw the last set of data, you might think, well, let's just get them all open faster, not so fast. This is that same timescale roughly the same 100 years, you notice the introduction of primary PCI means getting those arteries open as fast as you can create something known as reperfusion injury. Long story short, reperfusion injury causes more MBO on top of the MBO that you may have already had. So scroll to the bottom, what is the future asking for, you need to treat the reperfusion injury, you need to treat that original ischemic injury and you need to do it fast. It's not just heart attack patients. These technologies in the left hand side are probably a $2 billion industry, imaging, almost all of them are only looking at the major arteries. One exception there is our NGO, which is also looking at the microvasculature. But still, across all of these huge randomized clinical trials, roughly 1/3 of patients are back in a year with angina evidence is pointing that's also caused by microvasculature. This is the average STEMI patient. By that I mean more than half led before after marked in the book as successful. Not so fast. It three days Black Death MBO there it is six months, you have ischemia turned into dead tissue, you're in a heart failure situation. I don't know if this patient is still alive, but I would challenge in the future. Would an interventional cardiologist call this successful in five to 10 years from now? I'm going to argue now. So it was laid out in 2022. What would the holy grail solution be to solve all of this which looks Like a conundrum, five step process. Number one, can you identify those patients at risk, so you know who to treat. Number two, do this all fast. Number three, do it fast and treat the reperfusion injury which I just explained. Number four, first do no harm, don't add risk don't add complication on top of what you're already doing, basically fit into the PCI. And of course, you need to prove it like every technology here, it CorFlow is the only technology the first and only you can potentially hit all of these with a single system. How big of a market are we talking about? roughly a million patients a year if you just look at the acute patients. And if you talk to experts, that's just scratching the surface. microvasculature can also affect all angina patients, widespread use also outside of cardio use cases, the total addressable market, we estimate just in those acute cases, though, is about $4 billion, which is very significant. So how does it work, you see our console in the center, which is a very complicated on the back end. But on the user side for the interventional cardiology cardiologist is very simple. So there's an occlusion balloon that you see on the left hand side of the screen. occlusion is made saline goes through that occlusion balloon back pressure is then measured in a stepwise process to give you an indication of what's happening in your microvasculature. If it tells you that you should treat, same catheter, same control deliver a therapeutic agent, deep into the microvasculature, slightly more technical look, you see here, this stepwise increase in pressure. That's never exceeding your native pressure, which is important both on the diagnostic side and on the right hand side on the treatment side for safety reasons. But there's some deeper science behind why this is actually getting more drug in tissue with this proprietary patented method. And you can see the time that this takes roughly 1.5 minutes for your diagnostic for the therapy. In our study, we're doing three one minute cycles. So all in you could diagnose, you can treat under 15 minutes with our next generation system. I'm happy to say that our clinical data from our first in human study about 50 patients is under embargo, because we were just accepted as a late breaking clinical trial at PCR in May. But you can see here on the screen, roughly 90% sensitivity, specificity accuracy and area under the curve, which would be phenomenal and a breakthrough in and of itself. On the therapy side, which is also studying our first inhuman data. This example patient greater than 20 20%, his in this case, 24% improvement in their LV EF which we need more data to prove this in a larger trial, but is remarkable for our pilot experience. The 10 second value proposition to the interventional cardiologist, accurately rapidly treat or diagnose your MBO fit into the PCI fluc workflow you already have and deliver a drug when you need it, where you need it. There's more to it, we'll have aI connectivity, when regulatory allow it will constantly lead learning so that we can refine the the diagnostic parameters behind this. And we asked physicians two years ago before any data before telling them who we are or who's involved. Do they believe they could change clinical outcomes with this? Overwhelmingly, the answer was yes, short term and long term. I imagine after PCR, after we published the data, the scores are going to be a lot higher. So what I leave you with here, I don't go through all the five T's you can find it in an executive summary, you can contact me, but I will say that we're raising 20 million in a series B round, which is just kicking off now that takes us to early commercialization in the US and the EU. And my last comment would be I encourage you as investors invest in the space and the unmet need, not just in my company because the patients need it. I believe that's why we're all here. Thank you very much.