Omar M. Khateeb Interviews Manny Villafaña, Founder, Chairman, & CEO of Medical 21, Inc.

Omar M. Khateeb  0:00  
Hey everyone. My name is Omar Kazim, and welcome back to the state of medtech. We are live from LSI, USA, 2024 I'm so excited because I'm joined by somebody who has a remarkable story, but more importantly, a very well respected name in the industry, and one of the nicest men that I know, Manny vilfa. And Manny, thank you so much for joining us today. How are you? 

Manny Villafana  0:20  
Pleasure, Omar.

Omar M. Khateeb  0:20  
you know, I appreciate it, because earlier, you're telling me that you're gonna bring out the best in me, and you're bringing out the best in me

Manny Villafana  0:27  
today. But the good news, we're getting it done good.

Omar M. Khateeb  0:30  
So, you know, Manny, a lot of people in our industry know, know of you know your story. But I want to start from the beginning. Who? Who is Manny villafana?

Manny Villafana  0:39  
Well, okay, then I think we have to start in the South Bronx. I was born and raised in the South Bronx, in an area called Mount Haven. And what's interesting is that the New York Times, which is probably the most prominent newspaper of the world, on the front page of The New York Times, they did a story about my street where I was born and raised, which was east 130/9 Street, and the story dealt with the fact that the neighborhood was the poorest congressional district of our country. Was filled with crime, prostitution, drugs, whatever have it, and they named the story life at the bottom. Now, what does that mean for me? Well, it happens that there was in my family zero education, my father, who was born in in in Puerto Rico. My mother, was born in Puerto Rico, had no education. My father did not know how to read or write and was signed with the proverbial X. My mother had a third grade, not third year, third grade, Spanish education, a little little bit about reading and but it was in Spanish that was no help to me. I had three brothers, all of whom did not even graduate from grammar school because it was a prevalence, a very high prevalence of alcohol in our family. They were alcoholics before they even were old enough to graduate from Grammar School. They left. All them left. That is to say my father and my three brothers were gone from the family by the time I was seven years old, and so it was just mom and I doing our thing in the South Bronx. My mother was a seamstress. Tried to make a little bit of pennies. I had no money, but fortunately, I had a neighborhood boy across the street that introduced me to a boys club, Kip spade boys club. And I asked him, Where do you go on Saturdays? And he says, Well, we go down to a boys club. And he introduced me, and I started to be at that club a lot, because it takes the kid off the street, away from the drugs, away from the crimes, away from the gangs, okay, and fortunately, through them, I had a few opportunities. The first opportunity was that at the age of nine, I was working full time, eight hours a day, I'm sorry, seven hours a day, hanging up coats for kids and taking care of the gym equipment and stuff like that. That was my first job at 40 cents an hour. Later on, through them, I met someone who was able to get me even a better job, and as a result, I ended up working, of all things, working in a company that was making equipment for the ballistic early warning systems during the Cold War, but I had A little bit of education next door was a Catholic parish school, a grammar school called St Luke's school. Graduated from there and then went to Carnell Hayes High School, which still, in my opinion, probably the best high school in the country. I was able to get a decent education there very proud of it and but never had a chance to go to college, because there was no such thing as a, you know, a education system to, you know, funding for colleges and stuff like that. So. So I never had the chance to go to college. I worked my way through. I learn, I read, and I'm self educated on various things. As I went forward, I finally ended up working at a company called picker X ray, which had an international division called picker International, in which we acted as an export agent for small developing medical companies. And one of those small medical company was a teeny weeny company that had no profits, less than $1 million in sales, and that company was called Medtronic. And Medtronic was noted for developing implantable pacemakers. Pacemakers, they were put in your body to stimulate the heart in case your heart rate was going too low. I worked for picker. Finally, one day, the President of Medtronic and the Vice President of Sales for Medtronic came out to New York to hire me, to pull me out of picker and to come work directly for Medtronic, which I did in 1967 it's interesting that when I arrived in Minneapolis with the headquarters of Medtronic on March 8, 1967 the temperature was 15 below zero with a wind chill of 43 below zero. And I said to myself, where did I go wrong, dear Lord, that I'm here on this day anyway, that's my early beginning. As far as, how did I get into the medical device industry?

Omar M. Khateeb  6:46  
Amazing, and it's amazing also to hear that, you know, Medtronic, who's, I think, as of today, their market caps like, I think 120 $5 billion some point, was making less than a million, almost bankrupt in your career. There's a point where Manny goes from an employee to becoming an entrepreneur. What made you do that?

Manny Villafana  7:07  
Well, during my early years at Medtronic, I convinced them that we should open up a facility in South America. Because South America, Latin America, was really the biggest market for pacemakers. What are you talking about? Manny, they have no money. What are you talking about? I said, Well, it turns out that there is a bug, believe it. It looks like a little cockroach that causes a disease in children called Chagas disease, which manifests itself by young men and women falling down around the age of 1718, 1920, years old, falling down because they developed heart block. And the heart block started when a when they were little babies, and a bug looked like a cockroach would would bite them on the cheek and on the eyelids and cause a parasite to go into the body, which would then bore a hole in the myocardium of the heart and disturbed the conduction system of the heart and caused heart block. But it didn't manifest itself until another 1520, years after the child was bitten. So the child was never treated. It was there was nothing to be done until the child manifested the heart block by boom, the heart rate going so far down that they fall on the floor, go unconscious, and sometimes even die. And no one in the USA knew about this thing. And so when I started to talk about it at Medtronic Manny, you're crazy, I said, No, no, I've been told I'm crazy a lot of times, but not this time. Chagas disease. He was very prevalent. I convinced him, and I opened up a facility for Medtronic in Buenos Aires, Argentina. Now, during that time we were that is, Medtronic was making pacemakers that were big and bulky, about the size of a hockey puck, and it would then, but they would last only about 12 to 18 months. At that time, pacing was so new that I was actually going into the or into the operating room and teaching doctors how to implant it, how to take a catheter, put it down a vessel high, you know, or maybe putting a sewing onto the epicardium of the heart, a lead so that you can pace. I was in the or teaching all the time, but they were failing all the time too, so much so that at times, we were having actual pacemakers fail before we even put them into the box. Body. It was pretty, pretty bad. So as a result, after my tenure down in South America for two years after, when I came back, I said to the people at Medtronic, we got we got to do something about that. We got to make a better pacemaker. Simultaneously, there was a gentleman who had invented the very first successful implantable pacemaker, a guy named Bill Greatbatch who we ran into each other. We knew each other, and he started talking about some work that he was doing on a new power supply called lithium power. And we know lithium today to operate cars and things like that, and flashlights and all that. But at that time, there was nothing. It was just lithium. It was a high density battery, et cetera, et cetera. I said, What are you going to do with it? He says, Well, I'm going to tomorrow morning, I'm meeting with Medtronic to see if I can get him to change from the old Mercury zinc batteries to a lithium battery. I said, Okay, fine. And he went his way, and I went my way. In the meantime, a couple of months later, I was meeting with some people, and they said, how would you what would you do to compete against Medtronic? I said, Well, I would go and make a lithium pacemaker, blah, blah, blah, et cetera. And in fact, the idea was so good that I went back to Bill, and I said, Bill, whatever happened to that idea? He says, I went to Medtronic, and they said it can't be done. And I said to him, do you believe it can be done? He says, yes. So I said to him, and I'm leaving out a few chapters of the story. I said to him, here's the deal, if you promise never to make a pacemaker, I promise never to make a battery. Not that I knew how to make a battery, but I said that to him, and I will be your first customer, and you will be my first supplier, without any paperwork, without any lawyers or anything. We shook hands. He left to start a company called Wilson, great batch limited, which is a multi billion dollar company making batteries. And I went off and started a little pacemaker company called CPI, which stood for cardiac pacemakers, Inc. CPI became CPI guide, and eventually was bought out by Boston Scientific for $27.2 billion and that's how we started pacemakers. Okay? I was sued by Medtronic, but we eventually won that handsomely, and so that's how I got started in making a product,

Omar M. Khateeb  12:50  
not about not a bad first, first company, not not not a bad one. I got to ask you, hearing your story about how you grew up and the difficulties you went through. Why is it you ended up where you were at Medtronic and starting CPI versus any other route? What? What made you take a different route? Well,

Manny Villafana  13:13  
if you follow my career, I always go the opposite direction, because going down the same direction as everybody else is going to end up at the same destination as everybody else, which is usually a failure, or usually something that is so. So when we started CPI, there were seven manufacturers of pacemakers, all were making the same basic pacemaker, the same power source, having the same results of about 12 to 18 months. Okay, you had to go do totally something different. In fact, at one point, Bill Greatbatch calls me up and said, you know, Manny, I think you should, you should first make a standard Mercury pacemaker, because I don't know if I can supply the battery that I thought I could supply you and I and I said, Bill, everybody's going that direction. I am not going to go to that direction. Waste time. How am I going to compete against seven other manufacturers without something other than the name of the company? Okay, so we stuck and we worked it out with the lithium even though his reduced battery capacity was still good enough to power one of our pacemakers for 50 years. 5o Okay, and I just do those things that way. When we started our next company, which was St Jude, I don't know if you want to go into that right now, but when we started St Jude again, every single doctor was begging us, we got to make a better valve. All valves were failing terribly. They were made out of rubber or metal, plastic, some forms of just the introduction of some pyrolytic. Carbon and but they would all would fail tremendously. And we said we're going a different way. We're not going to use rubber, we're not going to use metal, we're going to make a valve out of glass. What are you crazy? Manny, yeah, glass. What happens if I hit it accidentally? It breaks really? Yeah. You can break it with your pinky. You could break it with your with your needle. If you scratch it with a needle, you can't implant it because it would cause a thrombus formation there. It was really, really difficult to the point that there was actually an article written in a medical journal that said, Open quotation marks, it will never work. Exclamation point, closed, quotation marks dashed, the St Jude Bell, the medically written paper, saying, ain't going to work, but we got it to work and became the most commonly used prosthesis of the world, the standard of the world. And eventually that company was sold for $30 billion in today's dollars, another $50 billion not bad, not bad. Not bad. Why?

Omar M. Khateeb  16:05  
You know, after your first success, which was CPI, then guided, yeah, having such a success like that, most people decide to sort of sit back on their laurels, enjoy it. Oh, what? What about it made you say, I'm ready to do the next thing? No,

Manny Villafana  16:19  
you don't. You don't do that. People think that you okay, we've done that now. Now what are we going to do? It doesn't it doesn't really happen that way, but it does happen that when you're doing something and, and, and I'm the kind of guy I don't get my jollies watching a company go from from 100 employees to 500 employees to 5000 employees, and watching that grow. That doesn't turn me on. What turns me on is, there's a challenge. Can we solve that challenge? Can we, can we finance it properly? Can we make it grow? Can we put a team and do it? And can now, once it's doing it up and running, I'm finished. You know, I leave okay and and go on to another challenge. Okay, when we were doing CPI, two doctors came to me and said, Manny, you know how bad valves are. And I didn't, and I knew nothing about heart valves. And they said they told me, in fact, one had a little metal prototype that Daddy got me interested in, and, and, and he said, Man, why don't you make a valve? And I said, what do you what do you mean? I said, Well, yeah, here's, here's a little prototype. Maybe we can make a valve at CPI. We're pretty busy at CPI. In fact, when I talked to the guys and said that one of our doctors, Dr Nikolov, wants us to make a heart valve, that one of the guys just turned around, I said, What are you kidding me? We are so busy. We are open 24 hours a day, seven days a week, the lights never go out. We don't even have enough time to go to the bathroom. So I said, Well, guys, I've done my thing here. Okay, you guys can run the company and which you did it went, went to the moon and bounced off the moon and went to Mars. Okay, but I'm going to try this. I didn't know anything about heart valve. So the doctor, Dr Nikolov, went to his own personal library, took a book off the shelf, and it says, From the Library of Dr Nikolov, and he gave me the book, he signed and everything. Gave me the book, he said, Read. And the name of the book was heart valves. A whole thick volume on the work that had been done on heart valves. I brought in a couple of guys that I knew, and we went and bought two more of those books, and the three of us just sat down and looked on how we're going to try to solve this problem. We brought in not an engineer. We brought in a Gadgeteer, for lack of a better word. Who was a Gadgeteer working on cars, antique cars. I had antique cars as well, too. So we had a little fun, and together, we solved the problem, my totally different way of making a heart valve. In fact, he got the idea from a carburetor in a car, one of the cars, and it worked, and we pursued it. We chose to go with an exotic material at that time called pyrolytic carbon, which is a form of glass. And we worked, and we worked, and we put it in animals, and it was working fine. And at the very, very first human implant, which was the third of October of 1977 there was Dr Nick often planting it into a lady Helen heinkenen, 75 Five year old woman, and she lived 11 years with that valve. She died of cancer, and that valve, that was the beginning, and it took off like unbelievable. Okay, financially, that that project was probably one of the most successful financial projects that Wall Street has ever seen. Case in point, if you took a million dollars and you put it on the IPO of a little company called Tesla, okay, and you held that stock until it reached a high, you would have a return of $450 million on your million dollar investment, and you would be dancing all day long, twice on Sunday, your own dancing, because that's a hell of a return. But if you did the same thing when we did St Jude and you put a million dollars on the IPO of St Jude, and you held it only for the time that you've held your Tesla, you would have between 1.2 and $2.0 billion so we're talking about a company who's outperformed Tesla by six or seven times. Think about that. Not bad, not bad at all. That's why, when I say, when you come to my our booth, and we start saying, We're doing another St Jude, because what we're doing is creating a new product, which I have all the same major steps, except the first step. When we did St Jude, the first step was, we decided to do a heart valve. The first step at medical 21 is, we're trying to do an artificial graph. Okay, that's the only difference. But you still have to form a team. You still have to finance it, you still have to fill build facilities. You still have to do your your your research and development, your animal work, your clinical trials and all, etc, etc, etc, and and we find that many of our doctors are the same doctors, the doctors who praise us for doing the St Jude valve and doing the ATS file later on, the same doctors, the same Manning, when? When can we get this graph? So that's what we're doing.

Omar M. Khateeb  22:27  
That's fantastic. You know, you shared a lot of amazing success stories, and it's and it's one after the other. I'm wondering, during that time there, there were times that you probably went through some very difficult times you had to make very difficult decisions. I want to go decisions. I want to go, you know, back to CPI, because that was your very first company, being a young CEO, young entrepreneur. What were some of the more difficult decisions that you had to make, and how did that change you?

Manny Villafana  22:52  
I know it's hard to imagine this, but CPI was a cakewalk. Okay, oh yeah. If you, if you think about this, this will blow you away. We open the doors on the second of February 1972 we had the first human implant, okay, put into a human being on November 29 of the same year. That's

Omar M. Khateeb  23:17  
nine months. That's unheard of, right? Of course,

Manny Villafana  23:21  
unheard of. Everything went very, very well, and our biggest challenge probably was the fact that we were doing this while Medtronic was suing us, claiming that we had taken something, which later on, we showed them that we had done nothing, okay, but that was the only real challenge. But we kept doing it, we were able to raise capital. Actually, it became very easy when Medtronic sued us, because they said, well, Manny, we thought you had something. Now that Medtronic is suing you, we know you got something so that validated. It validated, okay, that that also was a home run financially, in fact, even better than St Jude, if you could imagine that, okay, the return to an investor at at CPI was even better than the story I told you about St Jude,

Omar M. Khateeb  24:23  
so everything was good. So as you said, it was

Manny Villafana  24:26  
a cakewalk. Yeah, it was.

Omar M. Khateeb  24:28  
Do you feel that because of that, because your first try, it was so easy, everything that momentum and confidence carried over to St Jude, even though you were tackling a very difficult issue. Things that people wrote, they said, it can never be done. It just kind of, you know, went off, you like, serve water on a duck's back. And he said, Well, you

Manny Villafana  24:46  
know, part, there was a little hidden agenda in my head. What was that? Which I've never discussed before. This is the first time I told you,

Omar M. Khateeb  24:54  
you're going to bring out the best, right? There you go, all right. And there's a little hidden

Manny Villafana  24:58  
secret, you. When, when I started seeing Jude, there was within me a little hidden thing. I wanted to do it again, to prove that I could do it again. You know, you did CPI. Was it because of you? Was it because of anything else. Was it because of this or that? You never really had a degree of confidence. But let's go and do St Jude where we had nothing staring us in the face, no new ideas, and you just had to study vows and see how bad they were and create something around that. And that's what we did with the with the St Jude out and there again, we opened the doors on the Fourth of July, 1976 Okay, and and we did our first human implant on the third of October 1977 so about 15 months later, again, Again, a very fast track record, but we did it. And in fact, during the processing of everything, somebody used the word legend, legend. And mannyville founded a legend, and we all started to laugh, because I'd never seen that. And was in a it was in an actual document. Obviously, it was in the proof. You know, one of my lawyer friends were saying, and Manny the legend wrote that down, and, and we kind of laughed and everything. And of course, in the final document, the word legend was not in there, because it was a serious document. It was a it was a prospectus, okay, but we kid around. But after that time, everybody used that word legend. In fact, at one point, the the World Society of cardiothoracic surgeons gave me the living legend of medicine award.

Omar M. Khateeb  26:51  
That's what year was that? 2006 That's amazing. Yeah, what you mentioned that you the hidden secret is that you wanted to do it again. You wanted to do that. Was it because you were trying to prove something? Why? Why do you why did you feel like you wanted to do it again? What was driving that

Manny Villafana  27:09  
look, if you did something and you hit a home run, right, you got up at a bat and you swung the bat and happened to be the first pitch, and then went out of here, right? Wouldn't you want to try to do that again. Absolutely, absolutely, I tell you, I might bring the best out on you. Okay, of course, you want to do it again. You don't want anybody. When I was lucky, he was lucky. I wanted to do it again. And I did do it again, okay, all right, and this one was even more recognized than the first one. Why? Because it was much harder. No one. There had been at that time, at least 50 valves that had been tried. There was at least six or seven major manufacturers of valves, all struggling, trying to make and they would clog up tissue. Bells would fail at five years. I even remember going to Mass General Hospital and talking to the chief of cardiac surgery and saying to him, right in his room, you are practicing bad medicine, because they were, they were implanting tissue valves at that time. And he got up, and there was several doctors there. He got up, grabbed me by the arm. He said, Let me walk you out. Not only did he walk me out of the room, he walked down a long, long hallway at Mass General Hospital, where all the patients are walking back and forth and long, long hallway to the front door. And the front door of Mass General is at the top of a long staircase, and we and he walked me right outside. And I thought for sure he was going to push me down those stairs. He didn't, of course, and but the moral of the story was that about a year later, he was implanting the St Jude Valley. It's amazing,

Omar M. Khateeb  28:59  
during those those years that St Jude was started cardiac surgery, I feel that was one of the most exciting areas. You had Debakey Cooley battling it out. And, I mean, it was so famous that even, I think life of Time magazine had a cover story on it. You know, two surgeons battling at the heart, right, right. What was it like to be pioneering such a difficult area and dealing with probably the most, let's just be be frank, difficult surgeons, because these were these people. These were people who were doing the most difficult type of surgeries at the time, pioneering. And of course, you're dealing with a lot of big egos. How did you manage that? How important was it to find the right surgeons who got the vision? Well,

Manny Villafana  29:43  
it's interesting. You will always hear stories about Dr so and so competing with Dr so and so. You always have that those are personalities. Okay, it'd be like you and me. Okay, you're good looking. I'm better looking. Okay, something like that. But at the end of the day. Okay, both of them want to do the best that they know how to do for their patients, I have the greatest respect of for example, those two gentlemen, Debakey and then Cooley, okay, you know, we became friends. I knew them personally and things like that, but they all wanted to do the best. Okay? There's another doctrine in life, and that's a guy named Christian Barnard who did the first heart transplant, okay? And he wrote a book called Second Life, and there's a chapter, a whole chapter, in that book, devoted on his effort to try to make a heart valve. And the last sentence of that chapter says, The hardest thing a man can do is to try to create a heart valve. Why is that? Why it's so hard you put anything in the body. Body wants to reject. It wants to dissolve. It wants to beat it up. And you're going to try something to say, oh, move over. We're going to take out that organ that keeps you alive, namely your heart valve. We're going to throw it away. We're going to put in this artificial thing, okay? And it's going to have to take 40 million beats per year. It has to go tremendous pressure during your normal lifetime. It's going to open and close several billion times. How do you do that? And it doesn't change. So it was very difficult. However, when we approached them and they saw the benefit, they became our biggest proponent. A perfect example was I was walking down the hallway in this meeting's medical Congress with Dr Chris Maloney, out of Tucson, Arizona. And we were in, I believe, Phoenix at the time, and and we had just started doing a few implants, and he was one of the original guys doing the implant. And he saw immediately, before you get out of the or you see the difference with a good valve versus the old bad valves. And so we're walking down the hallway. He's done maybe 1015, valves we have in a whole world, maybe a couple of 100 valves, maybe 300 valves in a whole world. And we're walking down the hallway, and another doctor comes our direction, and he says to the doctor, hey, I want you to introduce you to Manny vilfana. He's the guy that's done the the St Jude Val and and. And the doctor says, yeah, yeah. I heard about how many, how many do you have in? And Chris Maloney said, Yeah, between two and 3000 implants. And I'm going to look that up. Have you have your guy come and talk to me? Okay, fine. And we continue walking down the hall, down the aisle there, and I said to Chris, we don't have that. I mean, we have maybe 200 300,000 planet. He says, That's what I said, between two and 3000 Okay, the guys would help me. They really, really would. I mean, I had a meeting at a temperature of 35 below zero, and a little dinky motel, and doctors came from all over the world to listen to the very first things of what we were doing with the St Jude valve. Okay? And they were they would get up and I'll help you do that. I'll help you prove that, for example, we never had a single mitral valve implanted. We only had aortic valves in planet because those were a little bit easier than the mitral and one doctor said, Well, what's your results with the mitral position? We haven't done that yet. Why? Well, we're just kind of going a little bit slow to see how things are going with the aortic he said, I'll do that study for you, I'll do my next 35 valves. Were your valve in the mitral position? He did, he did. He did it, no ands ifs or buts about it. And about a year later, he reported on his 35 and they were all fine and good, but they were helping us do it. They needed that valve, and a lot of people helped us with the St Jude valve. And again, it was a case that we were having difficulty making enough of them. Now, a funny thing to happen, we did our first human implant on the third of October, 1977 however, this valve that's made out of pyrolytic carbon, which is a compressed glass, was very fragile to handle, and when we started to make the valve, they would break. Okay. So, October 3, 1977 so. So in October, November, December, January and February, in those five months, we could not make the vowel enough of them, because it would break in the month of February of 1978 we made 100 rings, but when we tried to put the leaflets into the Val 97 out of 100 rings broke. Right? So I'm laying in bed in March, almost crying because we know we're going to have to close down the company can't make the product. We've tried everything. My engineers going crazy, and it's snowing to beat the bandit. This is Minnesota in March. Phone rings at three o'clock in the morning. Ring, ring, hello, Manny. Manny. Manny. It's Peter. Peter. It's three o'clock in the morning. Yeah, yeah. I know. I know, I know, but I just had a dream. I know how to solve the problem. This is one of my engineers have been saying to me, yeah, we're going to solve this problem. Don't worry about it, man, we'll solve it. We'll solve it. And here we are, five months later, unable to make just a few valves, and we needed 1000s of valves. Okay? And I said, Peter, it's snowing. It's cold. Go back to bed. And he said, No, no, Manny, I'll meet you at the office at five o'clock. And I said, You'll be lucky if I'm there at nine o'clock to the big snowstorm. I said, All right, so we hang up the phone. Sure enough, nine o'clock comes, I pull in and it's snowing, and he's at the door, takes my jacket off and hangs it up for me. He says, Come on. Come on, come on, come on. We're going into the lab. So we go into the lab, and there on the lab, there are 13 rings to make the valves. He says, Yeah, sit down. I said, Wait a minute. I'm the president of the company. I don't think I'm going to be making valves for the rest of my life. Okay, all right. He said, No, I want you to do I said, Why don't you grab one of the production gals, you know, they have these glasses, so then when the bow breaks, it doesn't hit their eyes. And, you know, oh no, no, no, no, there's no there's no glasses, not we're going to do it. And I said, Why am I going to do it? He said, Well, I figured if a Puerto Rican kid could do it, anybody can do it. So after I kick him in a few places, I sit down, and I proceeded to make 13 vowels, all of them worked. And at which time I said, Come over here. Tell me what to dream. And he told me what happened. And I said, Okay, we're going to make a special room with only a manufacturing young lady, the small hands that will do this, and a supervisor. And we're never going to patent that procedure. We'll keep it as a trade secret, and we never patent how to be able to get the ring so that we can stick in the leaflets and stuff like that. That was the end, and from then on, we went to the moon. What was the dream? Though? No, I can't tell you that. Oh, you can't tell us that. I would have to cut your tongue and do a few other things to you. Okay, so we'll move on away from

Omar M. Khateeb  37:52  
the and St Jude ended up exiting for about a little little north of 30 billion

Manny Villafana  37:56  
to right. $30 billion to Abbott, fantastic. And today's dollars 45 to 50 billion, yeah, what? You know,

Omar M. Khateeb  38:07  
not a lot of people are in those kind of rooms that you end up negotiating a deal like that. What? What's that process like? You've done it multiple times in your career when you're when you're negotiating with the strategic What is

Manny Villafana  38:18  
that like? What are some first and foremost is that you, when you build a company, you build a company, surround yourself with the very best that you can get. Okay, sitting here is shade, okay, all right, you'll have to ask him, okay, when, when somebody comes along and tries to buy medical 21 which I'm sure it will be. I may be already fishing or not playing golf, but doing some other things. And he will bring in his talents to negotiate that. I was calling in a couple of them just to ask him, What do you think about the company and all that, because we, you know, we want to buy it and stuff like that. And I, and I basically will tell them what I think, okay, and, and, but it's nothing different than you're going to buy a car, you're going to negotiate, you know, and being Puerto Rican, but just living with your mom. Your mom taught you how to negotiate, okay, like there's other stories, but again, we don't have that much time okay, and it's just something that you do, and there's nothing a secret to it. I mean, right now we talk to our potential investors that, unlike other companies, where they will wait for you to have 30, $50 million in sales before they will approach you. I sincerely feel that on this company, medical 21 strategics will approach us earlier. Why do. Because it's such a big, big market, we're working on a product right now which is the single biggest product ever developed to be implanted in the human body. And all the key players, the medtronics of the world, the St Jude, the Bostons, the Edwards, all these kinds of company, this would fit into them, and this would be bigger than their top three products combined. A Medtronic, for example, makes pacemakers. They make hard valves, they make sense. They make defibrillators all that, right, take that all, put it all together, and this product is bigger than that. Okay, so you mean to tell me they're going to just wait around till we hit 30 to $50 million when three other companies are looking at that same thing? No, I think somebody's going to come in a little bit earlier than normal. This. This is my, my thinking. I mean, I can't guarantee and this is with the artificial graft correct. We're making an artificial graph.

Omar M. Khateeb  40:59  
Do you feel that this is in some ways similar to the challenges that you faced at St Jude's, which, which is doing an artificial valve, never been done. Very difficult to do, right? Do you feel like it's, it's, it's somehow similar to that?

Manny Villafana  41:13  
Very, very similar to that, but, but a much larger market? Yeah, much like not

Omar M. Khateeb  41:17  
everybody gets a valve these days, but the graphs, I mean, right, my father had one. I mean, why? Yeah, when we started

Manny Villafana  41:23  
St Jude, the world market for for heart valves was 65,000 vowels per year of all kinds of valves, tissue and mechanical. Okay, this project, the market is about two and a half to three and a half million graphs per year. So we're talking about a market 50 times larger. Okay. Now the degree of difficulty of making it okay again is we started with new materials, doing St Jude, and on this graph, we're trying new materials, and it's been very challenging. We've been at this for seven years. We put seven years of work. We have done a lot, a lot, a lot of animals, okay? And it's just now that when we are ready to go into humans. And part of the reason that we're here at the LSI meeting is that we're meeting with potential investors as we're trying to do a raise of about 10 million to do the clinical trial in Switzerland to get started. Okay, we're doing that right now. Okay. Is it difficult? They've both been very, very difficult. Okay, now, in the same way 4050, 100 different companies are trying to make a better valve, the same thing here. People for the last 60 years, maybe 50, 100 at least 100 companies have tried to make a product that would work, and no one has ever been able to do that the same degree of difficulty. But the market is, like I said, at least 50 times larger, and there are no competitors, okay? I mean, there are three or four companies trying to do okay. But is there anybody walking around with a graph? No, okay.

Omar M. Khateeb  43:15  
I want to before you jump into medical tour. I do have to ask one, one question. You know, aside from CPI St Jude, there is a handful of other companies you had started successfully that we haven't mentioned. When you kind of look back at at your career, the sex, the success is all there, right? And leaves a lot of clues. I'm also wondering, what were some of the more painful and difficult lessons that you learned? Because, you know when, when you go into medical 21 you're taking all that experience, all those lessons, and tackling a very difficult problem with a massive market. So if you look back in your history, is there certain moments you know, whether it's mentors or people you work with, that you know you learned a very painful lesson that changed, changed the way you act as a leader, change the way you operate as an entrepreneur. Does anything stand out? Okay,

Manny Villafana  44:03  
let's go back to the beginning of time. Okay, all right, in the book of Genesis, okay, when you go back to cardiac surgery, there was a gentleman that came up with an idea. His name was Professor C Walton lulahi. He was going to do the first open heart surgery, and he had this idea, and he spoke to his group, and he, of course, went to his boss and said, This is what I would like to do, and this is the animal work I've done, and et cetera, et cetera. And the boss said, by all means, go ahead. It's written on a little piece of paper, which is in a museum. You can read this little piece of paper says, by all Walt, by all means, go ahead. Okay. He he described what he was going to do to a group of surgeons, of which one surgeon got. Up, left and went to see the judge and looked for to get a cert to get a warrant for his arrest. And he went to the judge, and he says, this crazy guy wants to do this thing which doesn't have 100% chance of mortality, it has a 200% chance of mortality. Of course. The judge says, How does that happen? And he begins to describe what C Walton wants to do. Now, mind you, no one has done this, okay, all right. And so he proceeded to do an operation in which, in reality, without we don't have time to describe the entire operation, but in reality, if something went wrong, the child, which was a baby, would die, and the parent would die. Okay, so that's a 200% chance of mortality. Now history. It went well, and that was the beginning. But in the meeting with him, talking to him, he described what I now call the the creed of the entrepreneur, and that is this, the greatest hazard in life is an individual who does not want to take risk, because if you don't take risks, nothing will happen. You'll do nothing, and you are nothing. And that is the creed. And in fact, when I give lectures on entrepreneurship, that's my last slide that I throw up on the screen. So everybody leaves that room going, Hey, if you want to play this game, you better be able to take risks. Do not be one that's risk averse. Risk averse is for something else, not to put your family, your life, your income, your everything on the line. You know, one of the greatest things I always talk about entrepreneurs is the guy comes home and he says to his wife, or or the wife comes home and says to the spouse, whatever. But the entrepreneur says, I am going to do this. I'm going to conquer the world. I got this great idea. I'm going to conquer the world. I'm leaving my job. I'm going to be an entrepreneur. Comes Home and the wife says, You're doing what? Yeah, I'm going to do all this. And this is you realize the company is going to stop paying you, you're not an employee anymore, okay? And I'm sorry, who's going to pay the mortgage? Who's going to put food on the table, who's going to educate our children? And by the way, I forgot to tell you I'm pregnant. Okay, that is the first step that you have to encounter when you think that you want to conquer the world and be an entrepreneur, et cetera. Okay, another slide that I show is basically a slide in which I ask the audience, guys, I want you to open up your shirts, and gals, open up your blouses. First of all, I get a lot of attention when I say that. It's a good it's a good line, right. Good line, right. And what I do is I throw a slide on the screen, and there's a guy opening up his shirt, and it has a big red s, okay. And I said, Now take a look. If you don't have a red s. Forget about becoming an entrepreneur in the medical device area. Why? Because, unlike other industries, where you first go and you develop the greatest thing since sliced bread, okay, but now you get started, because now you didn't have the regulatory aspects of this, you gotta be Superman to be able to do all of this. You gotta be a superwoman. You gotta have the red s, okay. And those are all the things you know when they say, Well, what do you think about this? Or how do you think this is a different ball game? This is a totally different ball game, and starts with taking risk. Well, what are you going to do when you get down there? I don't know. We'll work on it when we get down there. OK, there's no answers. Ok, we learned shade and the group working on this graph, and we tried, and I remember having dinner with him after we had done the first animal and it was working, we were, you know, we were smiling that it went from ear to ear to ear and all the way to the back. We were smiling. But within 24 hours, that animal died. Okay, and so that was iteration number one. Put it aside, and we tried another thing fail, another one fail, you know? And they failed, maybe 30 days, 10 days, reality. When we got to iteration number 11, all of my guys were kind of looking at me, kind of cross side, and said, Manny, this ain't looking good, you. Manny, what are we going to do that kind of stuff? And I turned around to them, and I said, I want to tell you a little story. When we were doing St Jude, one day going to St Jude, I happened to go back to the machine shop. Mind you, you're working with hard material, so you always work in a machine shop, cutting it, and all that sort of stuff. And there was a guy named Charlie Hosley who was my machinist, and he was adjusting the machines, okay, but he was crying. Tears were coming down his cheeks. I said, Charlie, what's wrong? And he said, Manny, Manny, this is the 26th adjusting of this machine. Says 26 iterations of the St Jude valve and still not working. 26 Well, of course, that story ended in maybe the 27th 28th 29th I don't remember iteration finally working, but when I'm telling the story to my guys at their at 11, got a way to go, guys. And sure enough, around iteration number 13, we thought we had it. In fact, we had a meeting with our advisors, our Surgeon advisors, and one of the surgeons kind of looked like this. He said, well, not just yet, okay. And immediately, without hesitation, I said, Okay, guys, we're on to 14, and we made the changes that we felt that we had to do, and that's what we are now implanting in humans. We're going to be implanting that model because we solve what we thought are all the necessary problems. How do you know you got all we don't know if we have all the problems. The new layer of unknowns comes. What you do the humans people say, do you know if this is going to happen? You know if this No, an entrepreneur does not have all the answer. He or she is seeking those answers, and we will seek those when we're doing our humans. Now, what we can say to the doctor is, this is the angiogram with our device in the animal. This is a long term study in the animals. And then the final risk is from two people. Finally is from the doctor who says, I a surgeon of this institution, but willing to take that risk. And Charlie, what do you think? Think we should go for it. And Charlie says, of course, let's go for it. Those are the two final risk takers, okay? And then we hope to find the answers, okay? And hopefully those are good answers. If they're not back to the drawing boards or go home,

Omar M. Khateeb  52:57  
I love it, and I have to ask you going and sort of pioneering into space with an art artificial glass, with medical 21 your entire career sounds like looking at the hardest, most complex problems and seeing the roads that people have gone, gone gone down, the risk they take and say, Okay, we're gonna go down a completely different road that we don't know what's down that road, but the risks there are worth taking, because the payoff is going to be somewhere down there versus going down the same road. Do you feel like that's the same thing with medical 21 of this artificial graft?

Manny Villafana  53:33  
No, we are. You know, if I studied everything that has been tried before, and I we study the basics. Okay? If I put 10 engine engineers and we say we're going to make a graph, the first thing everybody's going to say, Well, number one, we're going to have biomecha, biocompatible material. Okay, fine. And let's face it, there are lots and lots of materials that are biocompatible. We put a lot of things in the human body, all right, you know, pacemakers and valves and stuff like that with different materials and stuff like that. So that's but the next thing everybody seems to say, we want to have a very strong graph. It's got to handle high pressures of the heart, and it's got to handle the 40 million times a year pounding. So everybody goes in those two things. And then there's other things that you know, compliant and you know, and, and ease of suturing and a variety of different things, okay, but the two biggest one was biocompatibility and strength, and, and, and when you study that, everybody has failed, so why am I going to go down the same thing? Okay? All right. So instead of our making our graph strong, like everybody else, we went the opposite direction. Remember, I told you, I don't go the same, because everybody feel that. Why am I going to go to that room? I'm going to go this far. In fact, if we were going to name the company, medical 180 you know what 180 means? Mm, hmm, okay. Means you're going the opposite direction. But there wasn't enough people that knew what 180 was, so we just named it medical 21 talking about that the materials that we're using now are 21st century material, not the material that been tried in the past, which was in the 20th century. So that's how simple explanation. Okay, so we try different things. We go down different materials. We're looking for different answers. You're doing what everybody else does, including our regulators. Unfortunately, they look at the past. Well, what about this and what about that? Yeah, yeah, yeah, that was a problem back there. We're going a different direction. Okay, you got to live with what we're trying to do, and we try to prove it as much as we possibly can in the animal, which has been the standard. Okay? If there was another way of being able to prove it, we would be using a different method, but we used the sheep model. Okay? We started out with pigs, but pigs grow too big on you can't throw 1000 pound pig on the table, you know. So we go, we stick with sheep, and then works fine, okay? And we've been doing that. And when we show that we have angiograms longer than anything that's ever been done before an animal, wow, let's go.

Omar M. Khateeb  56:19  
I want to wrap up, specifically just talking about medical 21 the amount you guys have raised, which you're looking to do and everything, is that? Okay? Sure. So with medical 21 you're going after a massive market, right? Yes, right. Because, with graphs, as you mentioned before, not everybody needs a pacemaker. Not everybody needs a valve. But especially given the fact that, let's face it, in the 21st century, if we're going to talk about the 21st century, you know, in honor of medical 21 people are living longer than ever before, right? And part of that, you have an explosion of longevity medicine people living well into their 90s, hundreds, etc, right? And the human body is not used to that. And so, of course, as we get older, even if you're you got, you have no like, comorbidities, you don't have a family history, everything you're going to need, things as you get older. And so a graft is going to be something that a lot of people are going to need, right? You know, something that might be as known as you know, as you get older, maybe you know a lot of people, they just take aspirin, right? So knowing that, right, what were the first steps when you came to creating the artificial graph from medical 21 what makes it what makes the graph different than what we've seen before?

Manny Villafana  57:27  
People, as I said before, were trying to make graphs very strong and this and that, because they were just thinking, Well, you know, it's got to be strong. We went the opposite direction. We make our graph very weak.

Omar M. Khateeb  57:40  
You said it was so weak, you make it weak,

Manny Villafana  57:43  
weak, W, E, A, K, okay, very weak. Okay, by making the walls extremely thin. But when it makes the walls extremely thin, the graph all of a sudden becomes permeable or porous. Okay, that allows nutrients from the outside to go in, in your veins of your legs or in any vessel of your body. The walls of that vessel is thin because nutrients have to go in. That's called vasobasorum, to use a very technical word. Took me years to learn how to spell it, okay, and that's what we want. We want that nutrients that come from the outset. So we make it very weak. Of course, some guy comes along, he said, Manny, hell of a great idea, except for one basic problem, as soon as you saw it onto the heart, it'll blow up in your face because it can't handle the pressure that the heart creates. That's why everybody makes it strong. And you're coming along and making it very weak. And like an artery, right? Yeah, you're making it more like a vein, yeah? No, making even less than a vein, even less of it, yeah, which is going to blow up in your face. Yeah, exactly, exactly. But we had a technology called nitinol. It's a wire. We have that technology, and what we do is we make, we use the the wire technology, the nitinol technology, to make a scaffold, make it a form of a tube, okay? And then we put in polymers that now make that into a graph. But the polymers, the way we do it, help generate, help force the creation, regeneration of tissue within the graph. We call that angiogenesis, okay? And so that after the graph is implanted, your own tissue, your own endothelial cells begin to grow within the graph, and the polymers are absorbed by the body, so that the end of maybe a year and a half, two years,

Omar M. Khateeb  59:44  
breath is gone. It's dissolved by the body,

Manny Villafana  59:48  
except, except for the night in the wire that says, But now you're left with a vessel that is stronger than any vessel in your body, because

Omar M. Khateeb  59:57  
it has this night in all reinforcement. The majority of it, essentially, is you have that angiogenic, angiogenesis that happens with the cells. Yeah. And so how long, over what period of time does it take for that to have, you said,

Manny Villafana  1:00:09  
about a year, year and a half, about a year to two years.

Omar M. Khateeb  1:00:12  
So at that point, the problem with previous, you know, like, not just valves, but grass and everything, is that you have always this issue of rejection by the body, right? There's you, you remove that issue, yeah, and it sounds like, based on the the pressure issues, because the body essentially grows into and becomes angiogenic. The body has a sort of a magical way of figuring out this is the sort of strength that that vessel needs based on the pressures, etc. So you kind of solve,

Manny Villafana  1:00:38  
we make them, we make it, like into an artery. Okay, your strongest vessels are the arteries. So we make an artery.

Would you say, you know what's fascinating about that? Would you say fascinating? It is fascinating. Pulling out the best of you,

Omar M. Khateeb  1:00:52  
it sounds that, rather than saying we're going to find every way to engineer this, etc, etc, the best engineer of all time is the human body. So you're essentially providing the scaffold, the bridge, for the human body to use and use its own materials, its own intuitive engineering, to develop the best graph of all time. You go, not bad, not bad. Not bad at all.

Manny Villafana  1:01:20  
That's what we're doing. How

Omar M. Khateeb  1:01:22  
much have you all raised today, to date, so

Manny Villafana  1:01:25  
far? Well, for the company, from the beginning, we're in a neighborhood of about 17 to 20 million that we have raised, okay, and over a seven year period of time, you know, we're very, very cheap. We don't spend money. Okay, now that we're preparing for a clinical trial in Switzerland, we're raising ten million right now. Okay? We do private individuals, families, private placement, plain vanilla, stock, no, prefers No, nothing, just like they've done all my other companies. We're doing nothing different, as I said at the beginning. We're doing the exact same way as we did St Jude, okay, and, and I don't know why I say St Jude, it could be CPI as well, because CPI was even a greater success than St Jude. That's hard to imagine.

Omar M. Khateeb  1:02:19  
Why. You know, in in doing this raise, especially given your track record, your history, you can, you can race through a variety of different avenues. Why is it that you're specifically focusing just on, like, family offices, private investors and no preferred stock and everything, educate the our audience? Because not everybody knows why. Okay,

Manny Villafana  1:02:38  
the I think the way I do this is simple. Everybody knows if they if they have some extra money, they go down to their broker and they say, I want to buy 100 shares in general, motors, Tesla, us, steel, whatever you want. Okay, all right, and they hope that the performance of the company will cause that stock, the value of that stock, to go up. That's a normal, publicly held thing, and they want to have the ability that, I think it's not going to go up any further. So I'm going to sell or, gee, I just found out that my wife is pregnant. I need the money for the baby. Okay? So we pull it out all right. Now we try to run our company like a public company, but we can. We're still private, right? So we sell plain common stock. Right now, we're selling shares at $5 a share, and by the way, on this film, this is not a solicitation, okay, I don't get any trouble. It's just trying to explain how we try to run our company. We run it as close to a public company as possible. You buy shares, common stocks, like everybody else. Okay, now, how do you raise the value? What happens is that, as we have special events, and if there's a very key event that's really big, I want to raise the value of that stock. Well, the only way I can do that is I split the stock. So now, Charlie, who put in $50,000 and you got 10,000 shares at five bucks. Now I said, Charlie, you get twice too many shares. Okay, all right. Now you got, you know, 20,000 shares, okay, but still $5 okay? And we keep the $5 as long as we can until our next event. Like, for example, one of the events that happened to our company was when the Mayo Clinic, which is recognized as probably the number one hospital in the world, with the top of surgeons, et cetera, et cetera. And they approached us. I didn't approach them. They approached us and said, We want to be involved with this. This is too important. And I said, Yeah, sure. You want to be involved. Yeah, of course. I wouldn't say no to you. What do you want to do? Well, how about if we send some surgeons over to your lab and help you in your lab. That. Okay, so the then current chief of cardiac surgery, professor, Dr Creston Elio, okay, Juan Creston Elio, came to our labs and tried to participate in our animal trials. Okay, and then, by the way, do you need any money? Oh, I said the bear lived in the woods. Of course, I need some money. So they put some money into it. And then finally, we want to do the clinical trial. Well, yeah, you sure you want to, yeah, well, sign the paper. And they actually signed a contract with us that they will do the clinical trial for us here in the United States. What else would I want, right? Okay, now that's a big event, so what I did is I split the stock to again, allow our earlier shareholders to benefit growth, okay? And that's how we do that. That's

Omar M. Khateeb  1:05:58  
what I love about that again, for a lot of the audience who's new to the world of investing and venture everything. What's nice about that is that a lot of times when you're raising money, the early investors end up getting diluted, diluted into we don't do that. And you doing the opposite, which is you're taking care of those early because, because those people put up their hard earned money right early on, before there was any any traction, before even they knew there was gonna it was gonna work. You got it. And so you reward those people. Yep, fantastic. In raising this 10 million, you're gonna do that clinical trial in Switzerland. What I love about my show is that sometimes people make predictions on the show that come true. So let's imagine all things go the way that you see that they're going to go you raise the 10 million. What happens in Switzerland? If you can give us sort of an outlook for the next five or 10 years with medical 21 and when it comes true, I'll clip this out and say, Hey, Manny said it on my show at 25

Manny Villafana  1:06:52  
okay, well, we are trying to raise 10 million to help finance the trial, because in the trial, you have additional expenses coming up. The cost of following some of these patients, the cost of the hospitals, cost of travel, you know, going, I can't find a subway that goes from Minneapolis to Switzerland, so I have to take a plane and, you know, and all that sort of stuff. And so we have extra expenses. So it becomes costly gathering the data, etc, so that's why you need that extra money. All right, we the study that we hoping to be able to do is calls for 118 patients. Now I don't put down 118 patient because everybody's going to ask you, where did you come up with that number? I was just gonna ask, right? Okay, so instead, we say 125 patients, okay, you know, plus or minus a few, okay? And, and then, the last time we did a study like that, it took us nine months. We're because times are what they are today. We're saying that in about a couple of years, we should be able to get a CE mark. Now, the CE mark allows us to virtually go to every country in Europe, and there's a lot of countries outside of Europe that will accept the CE mark as good enough. Okay. Now the market is so big that one day, I said to our guys, when can we build 1000 of these grass per day? And he kind of, what are you talking about? Bill O'Connell, I said, guys don't get excited, but 1000 grass per day is only 10% of the market. That is nothing in my standards. My standard is always 20% or we don't do it, okay. But anyway, I looked at it in a different way. I said, if we took Europe, when we got to see Mark, and we took Europe, and we have no other implants, nothing, in fact, just Western Europe. So nothing in Russia, nothing in Lithuania or any other country Romania. Nothing in Canada, nothing in the US, nothing anywhere else except Western Europe. And we got eight to 10% of the Western European market. You're talking about $400 million in sales. Do you want to do all the valuations of what that would mean in value of a company? It's multi billion dollars. Not bad for just getting the CE mark. And before you even come to the US market, right? Okay, that's how big this is. And then only recently, the guys said, Manny, we have other platforms with this device. We can use it in peripheral, renal, pediatric, a variety of different things. The numbers I talk about is only the cardia. Okay, so the numbers are staggering. So I don't care about where we get approvals, just let me get let me just get started. Because no matter where we start, it's big numbers,

Omar M. Khateeb  1:09:58  
absolutely and especially. As we mentioned before, that. You know, people are living longer as you live longer the body. Body was never designed to last that long, yeah. And so certain things like even, I mean, I'm just thinking off the top of my head, like things like varicose veins, instead of collapsing the vein, maybe you, you just replace it. Yeah, right. So in wrapping up and again, Manny, I want to, I want to thank you for spending some time with us and sharing, sharing all these, all these stories. I'm very excited for medical 21 will be following along. And what's, what's the, what's the website for medical 21 medical 20 one.com Easy enough. So I'll make sure our listeners go check that out. In wrapping up, I want to kind of wrap up, you know, being at LSI, what I, what I love about this conference, you know, Scott, Scott Patel and his team do such a wonderful job, because they bring the best of our industry together, from the investor side, the innovators, etc. Right when you look at the current med tech entrepreneur today, I'm sure there's many things that you you know are happy about, other things where you're like, you know, you guys could be doing better in these areas. What's something that you see today with your average medtech entrepreneur that you wish you could give them advice on?

Manny Villafana  1:11:02  
That's a good question. I see a lot of the entrepreneurs here truly dedicated to what they want to do. Okay? And that's good if you don't believe in what you're doing, go home. Okay, simple as that. And they are very, very dedicated to what they're doing. I think one of the things that keeps hitting me right in the forehead is the cost time of the regulatory avenues that you have to take these days. And so you have to take that into consideration. The simplest of products can cost you a lot of money. I remember one of our advisors said, you don't realize Manny that today a brand new drug eluting stent, which we have hundreds of them. But if somebody comes up with another one, all right, it's going to cost about 500 million to a billion dollars just to carry that all the way through the FDA regulation. That's a staggering amount of money. Okay? We are trying, for example, through some of the work that shade is doing. My wife is helping out as well, of going to the VA and other avenues where you can do some studies that may be not circumvent the FDA. That's not what we're trying to do, but can get started earlier through some of the things like that. That's one thing you have to learn. To consider that there is a lot of potentially non dilutive money available through the NIH, through the VA, and through things like that, and we are doing the paperwork, although the truth of the matter is that maybe there's a 30 40% chance that you will succeed, but you got to take a risk. I mean, if you think about anything that we're doing, we're working with far less than 30% success rates. Okay, I don't know what else I can tell you. I think I see everybody trying they come to these meetings to learn how they're going to finance now this meeting, this LSI meeting, was initially started by Scott because he saw a lot of young entrepreneurs going through the standard VC venture capital route and ending up with very little, if anything, of their former company of their company, and it says, got to be a better way. And of course, that's true. There's got to be a better way. And just the mere fact that they're here, they're trying to find out how to do this. They come