Manny Villafaña, Medical 21 - Revolutionizing Heart Bypass Surgery | LSI Europe '22

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


Manny Villafana  0:02  

Thank you very much. It's always a pleasure to be at these LSI meetings and the first one in Europe. It's a real honor to be here. I thought that first before we begin, just give you a quick overview of who I am. For some of you who may not know my background, I've been developing medical products for for about 45-50 years. And I first started a little company called CPI in which we developed the first lithium powered pacemakers. Interesting enough, we have pacemakers that are still running over 40 years that are still running. Next, we developed a little heart valve called the St. Jude heart valve, which went on to become the most commonly used prosthesis in the world. In both of those cases, financially, we did quite well, selling the first company for $27 billion to Boston Scientific, and relatively recently, Abbott bought out St. Jude for about $30,000,000,000. 16 years later, however, we, we went on to further develop the idea of a by Leafly valve and we developed the ATS valve and made some significant improvements. Even over the St. Jude Val Medtronic recognized that early on and acquired us for about 400 million, I suppose in today's dollars, over a billion dollars. Then Medtronic approached me in developing a product using a new nitinol wire in which we try to improve the outcomes of saphenous veins and bypass surgery. And we'll talk about that we had to close down that company strictly because of financial situation because we were doing it in the middle of the Great Recession. For some of you who want to know a little bit more on the left hand side, we talked about the fact that I've been known as a living legend and medicine board I've received from the World Society of cardiac thoracic surgery, while also been the master entrepreneur of our country of USA, been in the business Hall of Fame, the Science Hall of Fame, and I'm a recipient of a honoree of Dr. Award from the University of Iowa. Okay, so let's get down to what we're trying to do. Heart disease, the number one, the number one killer, not COVID, not cancer and things like that still, it's heart disease patient comes in, Doc, I have chest pains, what am I going to do? They do an image of the patient and determined that in this particular case, he has a blockage in the on the ILD the Widowmaker. He has some from some plaque buildup, they bring in a balloon to open that up, and then leave behind the stent. And that patient now has received a stent and many times will receive maybe multiple stents in a procedure. However, two days later, two weeks later, two years later, several years later, he's back in with the same pain. doctor looks at him again, it says Charley, you continue to eat all that garbage. And I see you're still smoking and I see you doing all the bad things I was telling you not to do. Because now you have blockages and then several places. And by the way, that stent that we put in, is closed down. So we're going to have to do some bypass surgery. In this particular case, we see that on the on the right coronary, which is we have to connect a vein on that and that and do a bypass there. And then of course, as I mentioned, you clogged up the, the sentry from before so we're going to take the left internal mammary, bring it down and bypass that. So we now have a double bypass. But how do we get these vessels up Believe it or not, these are some of the things that typically are done but first of all, the harvesting of a vessel out of a leg is done in a typical method used in in the UK most of outside the US. We take we basically fillet a leg and pull out a saphenous vein, not a pleasant sight And furthermore, in about 23% of the patients, we also do take out the radial artery. And that's not a very nice thing to do. In many cases, particularly in the US, we also use a method called endoscopic harvesting, which requires us to pass a rods and do cautery and variety of different things, to try to pull out a very sensitive vessel to be used to, to make graphs. Now, as we take a look at this, how often has this been done Manny? I said, Well, we estimated between 800,000, and a million patients are done per year. And the average patient gets between three and four graphs. Mathematically, that's 3.5. And we ended up with about two and a half to three and a half million graphs are done this way, every single year. Okay, so our concept is wait a minute. Why do we have to do that? Why can't we develop a method by which we can eliminate the harvesting of vessels? Why can't we develop an artificial artery, small diameter graph? All right, so that we can, you know, cut it any way we want it surgeon friendly, long shelf life, and we can do bypass surgery without the harvesting of vessels. And that's what we've done. using synthetic materials, synthetic polymers, we built a graph, so that we can put it in the body. And within somewhere around nine months to maybe 18 months, that graph disappears. It is absorbed by the body all the polymers and about the only thing that's left behind is a scaffolding that we make out of nitinol wire. So that it is replaced the the polymers are replaced by the very endothelial cells of the patient. So that patient now ends up with a graph totally designed by, by he or she. And the only thing that remains from us is the nitinol wire. So that that graph, that vessel is stronger than any vessel in your body. We've done a tremendous amount of animal work, we started in 2017, we have somewhere about 95, to over 100 animals, in which we shown that it can be done. These are a couple of examples of how it looks on an angiogram. A lot of patients, not patients, but doctors have said to me Manny, why you show me the same thing three different times. These are three actually different graphs. What we're trying to show is that we can repeat what we're doing. These are three different sheep had been implanted in excess of 45 days. Here's an example of a graph that's over 180 days. Now to do this, we have a tremendous team involved with us. Starting in the lower left hand corner there with Dr. Lyle Joyce, who used to be the chief of cardiac surgery at the Mayo Clinic. In the upper right hand side. There is Dr. David Joyce, his son, also used to be at the Mayo Clinic and both of those gentlemen are now in Wisconsin, at the Medical College of Wisconsin, in their heart center. They both have been very instrumental in helping us develop this. We have other teams of individuals and advisors to help us do this project. Later on, you'll be able to at any time during the meeting, you can catch up with Dr. David choices with us. One of our partners is the Mayo Clinic and we were very pleased and proud of the fact that they were willing and able to join us in the development of this. Alright, so from an investment point of view, and we've been talking to investors today last night, and these are things that you should consider. First of all, we're talking about a very big market. Secondly, we've now read each milestone is a one year and animals. So that's usually the typical go ahead for human implants. And I'm pleased to tell you that we hope in either November or December this year, in other words, about a couple of months, we should be doing our first humans. Obviously, what we're trying to do is by nope, by not harvesting vessels, we just give a better quality of life for the patient. You know, people say many Come on, can we make any money on this? I said, Well, if you're hanging out with me, some of our earlier projects, like for example, when we did CPR, and you gave me $10,000, today be worth about 90 $95 million. Not a bad return. Okay, if you did St. Jude, you know, again, that the initial investment would be about 16,500. And that would now be worth about $92 million. So we know how to handle these projects, and make them into a profitable situation. Obviously, there's no assurance of that, because it's not an easy thing to do what we tried to do it, we have the experience. And that leads me to the fact that we are presently doing a reggae financing for $40 million. It's in process, you can go to our website, read the material, and if you're interested, you're going to invest that way. Or otherwise just grab me somewhere in the hallway. And we can talk but I have to read this disclaimer, I have to show it to you. Anyway, in case I thank you for your time and interest. Any questions? Questions. Okay, thank you very much.



LSI Europe ‘24 is filling fast. Secure your spot today to join Medtech and Healthtech leaders.

September 16-20, 2024 The Ritz-Carlton - Sintra, Portugal Register arrow