Rafael J. Veraza Presents Vascular Perfusion Solution at LSI Europe '23

Transcription

Rafael J. Veraza  0:05  
Hi, thank you. We are excited to be here and present our technology. In not many areas of medicine, you have the special case where you have two patients, right you have the donor that is giving life. And the Recipient that is, like we just heard, right that they're waiting for an organ, they have organ failure. So in the aspect in the history of organ transplant, last 50 years, there have been a couple of companies have done really good innovation. The advent of of immunosuppression has helped. But the fact is that in the last 50 years, there's still people dying, waiting for an organ. So in the United States, about 15,000 deceased organ donors were available in 2022. And only a very small fraction of those available organs for transplant were used. In hearts, about only 30% of available hearts are used the majority that can be transplanted due to logistics, due to the complexity of taking the heart from a center in Texas to Oregon or the distance it's a limitation for preserving the Oregon. And there's about 100,000 patients waiting for a lifesaving Oregon, like we heard from SynCardia. There's patients waiting for an Oregon and the limited resources in Oregon, are, are there and we are we think we have a solution for that. So what we developed, it's a hypothermic preservation device. Very simple, as simple as the cooler. The standard of care has been an ice just the same way you basically keep your fish after you go fishing. That's exactly how they've been preserving hearts for the last 50 years. So while we develop this a portable, easy to use and accessible, and we be able to demonstrate with preclinical data to extend cardiac viability longer than the standard of care. We don't need blood or red blood cells. We use a commercially available perfuse that is currently used for kidney preservation. Kidney pumps have been around for at least 30 years. You can take a kidney, put it in a pump and leave it there for 24 hours. Why can you do that for hearts. And we have FDA breakthrough device designation which allows us to work closely with the FDA we get responses within a week when we submit it, we already had two pre sub meetings with them. And we have strong IP to protect our technology. So in this chart, it gives you an idea of what the current market is the majority of hearts are preserving the standard of care, like I said, cooler, you put a heart nice, and you only have about four hours to transport the heart. That limits the amount of hearts are placed in different areas of the country. There are three companies that are trying to address this, this need and they're doing a really good job. paragonix is a company that has a static preservation device. They're capturing about 30% of the market. However, they're limited by time. There's TransMedics, which is a publicly traded company, they're doing really well. However, they have limited indication of us they keep the heart beating at normal thermic temperatures. With blood. It's a complex device. It's about a $200,000 per device, $75,000 per cartridge. And then there's a great company called Exivo they're Swedish they have a hypothermic auctioneer profusion system similar to us, however more complex, they use a proprietary perfusate with cocaine, they need red blood cells. And the pricing of the device is going to be about $200,000, $30000 per cartridge. Where we see we can create a difference is we have a very simple solution, we use off the shelf perfusate solution, we keep the heart cold, being perfused during transport. And what we're trying to do is extend that time, our preclinical data and our clinical trials will show that we can extend the preservation of hearts up to eight hours. That means double the amount the standard of care. This is our preclinical data. This is the heart that was placed in our Encore device perfused during 24 hours, and then placed in another system that rewarms the heart and and beats we can evaluate cardiac function. So as you can see this a heart was placed for 24 hours per survey in preservation and when looked at left ventricular contractility. On the left side of the screen, you'll see another heart that was preserved in the cooler standard of care for hours. And what happens with most hearts than the standard of care, they need a lot of medication to keep beating you need to pace them, which means that it's much more cost for the patient and we'll show you some transplant data we've done in animals. This is a case that we did orthotopic heart transplant in Texas at the Texas Heart Institute where we compare standard of care about five hours. There are there are complications sometimes in surgery where the time goes beyond the four hours versus six hours of preservation. And the first market aspect that we look like is we preserve the heart replaced and the transplant and then we do we monitor the animal for six hours for Cardiac viability The first thing we noticed that we had less bypass time, that meaning less bypass time better cardiac function. Overall, when you do when you do a transplant, you look at ionotropic support how many drugs you need to keep the heart beating in a healthy state. Overall, we had a significant reduction of ionotropic support and by suppressed support, the heart needed to be paced, we had higher cardiac output, higher cardiac index mean heart rate was normal and mean arterial pressure kept higher at normal levels with minimal drug intervention. We also preserve human hearts, human hearts are donated sometimes for research or hearts that can't reach a patient in time they give it to us for research, all this data will be going to the FDA and the same thing, the same results, we see we have higher contractility, minimum gained weight. So what do we provide to patients and providers? Like I said, about 65% of hearts are no use, we think that we're at a device, we can target that part of the market and start using those hearts in our device. What does that mean for patients shorter waitlist, they can have access to organs that are viable, but currently that technology they can use them. And only that if you preserve the heart in a better shape, you can reduce primary graft dysfunction in about 50% of cases of heart transplants, you get primary graft dysfunction, which in turn increases the cost of the transplant to almost twice. So it's a very simple technology if you can keep the heart viable in a better condition. Overall, you impact providers, patients and payers, of course. So where are we focusing, our focus is very simple. In the United States, we have 35 centers, transplant centers that can be our customers and 57 organ procurement organizations that coordinate all the organ transplant in the United States. We think that we can improve outcomes again, by preserving the heart better, we can increase organ utilisation rates. And that's exactly how transplants, transplant centers make money. And we have a very clear pathway for reimbursement through the OPOs and the transplant centers, we can expand that to the existing market that is not being used. And not only that, we can think that with our device, we can have global expansion. And the fact that our device is so simple compared to the competition, is we can have pretty high and healthy margins. So what is the current market in the United States, it's currently about $165 million market currently with the number of transplants conducted about 4000 transplants in the US, the entire organ preservation market is about $2 billion. And we've seen a transplantation happening and there's actually companies spending a lot of money on single transplant, they're going to need machines to be able to keep those hearts and transport them they won't, they won't be able to have the pigs in the operating room, they're still going to have on the machine to be able to transport them. So where are we? We have done a lot of preclinical work for about last last two years, we've been communicating with the FDA, we're just about to close our seed round for $2 million to complete our GLP study at Texas Heart Institute. The FDA already gave us the green light for this study. And we're currently raising our series A. We need about 12 million to do an early feasibility clinical trial. And we're looking at options of starting at first inhuman in Spain, Chile and the United States. And that's a 12 million to get us through a device that is from the preclinical to a clinical device. And then after that we'll do our pivotal clinical trials in PMA class three device but our breakthrough device designation allows us to communicate quicker and get better responses from the FDA. We also have non diluted funding from DARPA and ARPA H conducting pipeline development on better preservation solutions using our machine. So, we that we have developed a very simple technology that uses commercially available perfuse aid, you calculate the heart, you place it in the device, you fill the device with solution, like again with a commercially available solution. Lower the heart into the device, you close it the head of the device has all the pumps oxygenation and connects to an electronic component and to an oxygen line to be able to provide the oxygen through the system. We use passive cooling an oxygen tank and electronics and then the case there will be transported and the idea is to keep it very small to be able to be transported by only one person still five people that other devices use. So with that, thank you very much