Manny Villafana Presents Medical 21 at LSI Europe '23

The company is developing an artificial artery to eliminate the harvesting of vessels from the patient during bypass CABG surgery.
Manny Manny Villafaña
Manny Manny Villafaña
Founder, Chairman & CEO, Medical 21



Manny Villafana  0:05  
I've been up here a few times. And I thank Scott and his group for inviting us again to bring you up to date on the work that we have been doing at at Medical 21. For some of you who may not know who I am, we figured that if one more time was show this slide, which as you can see, demonstrates the work that we have done in the past, we developed the first lithium powered pacemaker, which is the standard of the world today. We started CPI and eventually, Boston Scientific took us out at $27 billion. The next thing that we did was to develop a heart valve, the St. Jude heart valve, which became the most common prosthesis used in the world. And Abbott recently acquired a company for about 30 billion. After I done, St. Jude, a few people came to me about 15 years later and said, Manny, we want you back in the heart valve business. Before I've done that been there, why are we gonna do that? Well, for a variety of reasons, they asked me if we could improve on the St. Jude valve, which we did. And Medtronic came and took us out early and paid about 400 million, I suppose in today's dollars, about a billion dollars. Ironically, Medtronic came to me later on with an idea of working with a nitinol wire support system for bypass surgery. We formed a company called Kips Bay medical. But while we were doing some financing for that company, the great recession came and knocked us out. And we had to close that. Because we weren't able to complete a financing that we were doing with a major, major, major finance firm in New York. But we'll talk about that night and our support system as we go along. For some of you again, that don't know me, I've been globally I've been recognized globally, as the living legend and medicine Ward received from the World Society of cardiothoracic surgeons, um, the master entrepreneur of our country, in the business Hall of Fame, as well as a science and technology Hall of Fame of Minnesota, and recipients of an honorary doctorate degree from the University of Iowa. So what are we doing? We have a concept, can we eliminate the harvesting of vessels from taking harvesting vessel from the patient's legs and arms and breasts, if we can develop our own coronary bypass graph, which is shown here. By doing that, we hope to eliminate the standard procedures that are done every single day. And approximately 100,000 to a million patients per year, of which we either fillet a leg and try to take up the saphenous veins in about 28%, I'm sorry, 23% of the patients, we also have to take out the radial arteries out of the arm. And then in about 95% of the patients. That is virtually every patient, we're also taking vessels off the mammaries and putting him on the heart. The most common ways are, as mentioned showing here the harvesting of vessels by filleting it or by using endoscopic harvesting. The endoscopic harvesting will probably eliminate some of the scarring but still creates the pain and infection rates and still require the very highly skilled individuals to do that. Otherwise, we end up with vessels that have been torn and result in a reduced patency rate. Let's get rid of this. So what we have done is we have developed using tissue regeneration methods of developing a artificial coronary artery, small diameter, which once implanted begins to disappear and begin to regenerate new cells within the graph. That will create a endothelial alized graph but will still continue to be formed by a nitinol structure around it. Obviously, people have been trying to do this for the last 50 years. But we got It is showing some of the long term angiograms that we have done on over 120 or so animals. As you can see on the left hand side, in my opinion, this is the best angio I've ever seen in my life. And I've been around angios for a long, long time, guys. All right, that was at 170 days, when you take a look at it at 270 days is virtually unchanged, which is telling us that the polymers that we use are no longer within the grafts they had been absorbed by the body and replaced by endothelial cells. If that's not enough, we have this particular animal, we continued it until we recently euthanize the animal, and that 547 days, so over a year and a half, that animal was perfect, the graph was perfect. And so going. This shows the view from every possible angle, taking a look at that graph. Now, here's an example of one of our animals that we euthanize a basically a year, then we open up the graph and a graph was gone, all the polymer was gone. And what you see in the middle here, if I can point this at very small little dot here, right down the middle, is you have totally endothelial cells, we still have the nitinol wire around the structure, maintaining the graph. Now, if we take a look at this, and a lot of people say Manny bypass surgery, there is no market for anything. In cardiac surgery, many of the major players strategics, do not play in that area. And I started to study that I said, I can understand that, well, here's what happens. When we go and take out a saphenous vein, or radial artery or any of these vessels from the body, there is no value, there's nothing to sell, there's nothing, it's just taking it out and putting on the heart. But all of a sudden, when you take now instead of pulling it out of the body, and we pull it out of a package, we have an artificial device. Alright, career outside the body, which has a value. And when you begin to multiply the fact that you are doing over two to that half to three and a half million grafts per year, and you multiply it by a possible price somewhere between $3,500 $5,000 per graph, you end up with a market that is larger than the three biggest products that we have in medical technology. That is pacemakers, heart valve and coronary stents combined. So what's next? We're doing our first clinical trials. Okay. We hope that before the end of the quarter that we will have five centers, starting with two centers in Zurich, one in Bern, one in Busan and the other one in Lugano, Switzerland, doing a study of approximately 125 patients to secure our CE mark. All right, so let's talk about the financing. Okay. We've been fortunate to be able to finance this through private placements of our shares. We are presently doing a $10 million private financing so that we can finance this, we are open to all suggestions of how to get this $10 million. We're doing private. We're looking at possible ventures and even possible strategic interests that we have seen. During the finance I'm sorry, during the clinical trial, we've already received indication from a couple of the larger investment firm and said Manny, you've done seven IPOs. Can we do another one? And I said, sure there's a bird you know, there's a bear live in the woods. Sure we can do that. So we're looking at that, possibly of doing an IPO during this study. Guys, thank you so much again for allowing me to present our stories. Thank you

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