Manny Villafaña Presents Medical 21 at LSI USA ‘23

Transcription

Manny Villafana  0:05  

Good morning, I, I thought that it would be best, rather than going over all the technology that we've been doing, just to bring up all our friends and attendees up to date to what we're doing at Medical 21. Obviously, you know, we open knowing that we've been working on the development of an artificial artery to be used in bypass surgery, eliminating the need to harvest vessels from the arms, the legs, the chest, etc. We've reached a point where now develop this done a enormous amount of animal work, and we have begun doing patients with our device. I want to leave a lot of time, so that you can ask any questions. I mean, because if you try to do explain this technology in nine minutes, you're going to come up short no matter what you do. First of all, let's take a look at what we have accomplished. In the animal work where we've been able to show long term results, via angiograms, showing the what we can do with this graph. I still remember clearly when our friend Billy Cohn said to me, Manny, the best graph I've ever seen only lasted three days. So when I was showing him, angiograms that 20 days, 14 20 days, he got so excited that he actually left the nice warm climate of Huston, Texas, to come up to Minneapolis, which by the way, the other morning was about nine degrees, when we got on a plane to come to the warm climate of California. But let's take a look at this, here is an angiogram of our graph at 170 days. And in my opinion, the finest angio I've ever seen have a graph. In fact, I mean, you remember showing it to some of our clinicians, and they said Manny, I've never seen one better than that either. Then we took that same animal. And we went to 270 days, and we saw no change. It was beautiful, which helped to explain the fact that our graph, when we make it, put into the body, eventually it will become a totally endothelial alized. Graph, by the patient's own cells. And our art materials, our polymers that are in our graph will have disappeared. So now we have in that patient, his or her own cells, maintaining a graph, we further blew the doctor away when we came back, and again showed him that same animal, but now at 370 days, and in other words, over a year now. And that's what we had been seeing performances of our graph over a year. Now with that information with that was our go ahead to do some human work. We began doing some work on compassionate patients, please understand what a compassionate patient is. It's an individual, in which the doctor will call us up and say Manny, we got this guy on the table, that if we don't do something, he's never gonna get off the table. Those are the types. I mean, we identify them ahead of time, et cetera. And they approach us and say, can we use the graph? We go through a series of steps with the FDA, with the IRB of the hospital getting their permission as well. And of course, the physician himself must have a another physician agreeing with the choice. We have the patient self allowing us to perform that and we do that and we did our first control patient that is our compassionate patient that also had a control that is would have a vein typically when we do a bypass, we use a saphenous vein. In this picture we're looking at now we did a quadruple bypass. And there was a vein involved, although we were not too happy with it the size of the vein etcetera, we are a little bit nervous about it. Okay? But by the rules of a compassionate patient, if the patient has a vein, you gotta use it because that is the standard of care. So we use the vein and I don't know if I have a pointer on this. Can we point? No, we cannot point can we go back please to the slide, go back out. I don't know how to go back. Okay, back, back. We're not gonna go back. Let's go back guys. How do we go back? There we go. Thank you very much. So the main vein, you can see it right in front, a thick vein was our control, it was connected to the right coronary, a very long coronary, what we sometimes call a hemispheric taking care of a large part of the heart. And 30 days is how unfortunately, the vein failed. Closing off the right coronary, the patient had arrhythmias and unfortunately, passed away. We immediately did an autopsy. And within two hours, we examine the patient, the vein was clogged up, while our two arteries that you can see right below, were were wide open. It was in a way showing that we had excelled and met the requirements of being able to create arteries that could work in the heart. We are proceeding with the continuation of the compassionate use of our product while we wait for the approvals of our two submissions one submission for an early feasibility trial with the FDA. And simultaneously we are filing with the Swiss medica to secure CE mark permission to begin CE mark trials in Switzerland. Again, let me remind you of the size of this market. It's enormous. It's been the holy grail for quite some time with people trying to develop an artificial graph for bypass surgery. Allow for the financial guys that are here looking at this. If we show the three biggest products that are used in patients for coronary or I should say for the heart, we're talking about pacemakers, heart valves, stents. And as you can see, we're a bigger than probably all those three combined as far as the market. I want to thank you. I told you, we'd be short, and trying to leave some time here for any questions. Any questions? All right, thank you very much.