Manny Villafana - Medical 21, Studio Interview | LSI Europe '22


Manny Villafana

Manny Villafana

CEO, Medical 21
Read Biography
CEO, Manny Villafana and Medical 21 are developing an artificial artery to eliminate the harvesting of vessels from the patient during bypass CABG surgery.


Nick Talamantes  0:00  

Manny, thank you for joining us at our inaugural event here in LSI. Europe. Tell us a little bit about what you've been doing.


Manny Villafana  0:07  

Well, Nick, it's great to be here, I just wrote a little note that Scott, wishing him well on on this inaugural event, continuing our work, and we've been doing for the past 50 years trying to develop a variety of implantable devices, things that never been done before. And the work that we're presently doing is in the field of developing an artificial coronary artery. And the way we are doing it is to create a device that we can implant in the body. And then with a period of time, somewhere around nine months to a year, the product disappears, it's absorbed into the body, and leaving behind an artificial, I should say, naturally developed artery for the heart, it's incredible. And we're hoping to begin our first human studies in November, December of this year, keeping our fingers crossed and praying a lot.


Nick Talamantes  1:10  

That's exciting. We're looking forward to hearing how that goes. And in the next coming months here now,


Manny Villafana  1:16  

you know, we're excited, we're excited, we're nervous, and all of the above.


Nick Talamantes  1:21  

So what makes what you're doing so important?


Manny Villafana  1:25  

Well, if you consider the fact that the most one of the most common operations in the world is coronary bypass surgery, when you realize that, between two and a half and three and a half million grafts are implanted, but taken out of the legs, off your arms off your breasts, and we're trying to totally eliminate that, by creating an artificial graph, it's important, we feel that we can reduce pain, scarring, time, injury, get better results. It is very, very important. We feel that in our country alone, the United States alone, we will be saving four to $8 billion in costs per year, we feel that we will be helping worldwide million patients per year. And I think that as a result of quality of life of a patient will be better. And who knows, we might even be able to extend the life of the patient because he or she will have less trauma to their body, since we will no longer be harvesting vessels from from the body.


Nick Talamantes  2:46  

And it's my understanding that grafts are not just used in the heart, but in other parts of the body too. So is that the future looking beyond


Manny Villafana  2:55  

That's the future, I can't even look that far ahead. Because what we're tackling right now is so big. That I if I if I look beyond it, I'll get scared, and I don't want to get scared or exciting. We'll just take care of the heart right now for until we can prove that it works. And then once that happens, sure, we'll have staff members that will continue to work so that we can use this device throughout the body.


Nick Talamantes  3:24  

What's my understanding? You've recently received a commit a financial commitment recently. Do you want to talk a bit about that?


Manny Villafana  3:30  

Yeah, the you know, it's interesting, we were trying to raise a neighborhood of about $40 million. We're doing presently a, a RegA financing. That was with the help of, of Scott Pantel and his group. And in addition to that, we have had, we found a private individual who wants to be part of this and is committed $20 million over a period of time. So that help us secure that, you know, help us secure the financing that we need to complete this project. We continue to look we're doing this Reg A financing so that the average individual both accredited and non accredited investors can participate.


Nick Talamantes  4:19  

So I can invest today if I wanted to.


Manny Villafana  4:22  

We will take your money. Okay. We'll put you up. Okay.


Nick Talamantes  4:27  

Is there anything else you want to share with us with what you're doing right now?


Manny Villafana  4:30  

Well, I think that people have to understand that we are constantly trying to see what areas of the medical part of the you know, particularly cardiac related, where we can contribute we over the years you may know that we have developed the first Long live pacemaker and we started a company called CPI which became Gaiden, which is now owned by Boston Scientific. We started developed the first by I left with valves, which became the standard of the world, the most commonly used valve in the world is the St. Jude valve that we developed about 50 years ago now. Then we develop other valves, and we have developed a variety of products. Fortunately, we've been able to finance those things. We've done seven IPOs, initial public offerings. And we would be be doing that, again, however, we have tackled a project that took it's taken us a long, long time, namely the development of this graph over six years now. And we still have no revenue. So it's difficult to do an IPO. But Scott and his people have suggested, and we have begun this Reg A financing. But we will continue to take a look at a variety of different things. And as you said, once we start this in the coronary area, we can use this graph, we hope in peripheral areas and paediatric, a lot of different places in the body. And that's the contributions we'd like to make.


Nick Talamantes  6:13  

So you mentioned earlier when we were talking, before we got set up that other companies have tried to build an artificial graft and implanted in the body. What are you guys doing differently? That's going to make this a success? Well,


Manny Villafana  6:27  

the, it's true, I mean, I got a great kick out of people's hat. Manny, how risky is this? And I said, Well, you know, in the last 50 years, a variety of companies, a variety of hospitals and health care centers, have tried to develop an artificial graph, we're trying to eliminate this harvest thing of vessels out of your legs and arms. And no one has been able to do in the Medtronics of the world, a large companies that might one of my old companies, St. Jude also tried to develop this, it's very risky. And in fact, in the same 50 years that we put them in the moon, but we still have not been able to develop an artificial coronary artery, we have taken a different approach. And apparently, that approach is working, we're using different materials. But we're also taking a different approach and how we are implanting this device. And as I mentioned before, it will be a device that will be implanted, then our materials will be absorbed by the body leaving behind a method by which a naturally formed artery will take place of our artificial artery.


Nick Talamantes  7:42  

What makes you keep doing what you're doing?


Manny Villafana  7:46  

You know, that question was asked of me by a young finance person who had just gotten his MBA from Harvard. And he said to me, Manny, why don't you continue to do these things? Why aren't you playing golf? And I said, Well, I was in Spain one day, visiting with some surgeons, and they were talking about a heart transplant. And I said, Gee, I never seen a heart transplant. Any chance I could attend? And they said, Are you going to be here this weekend? I said, Yes, I not leaving Madrid till Monday. Well, then we'll we'll do one this weekend for you. And I said, How do you know you're going to be able to do one, and the doctor went over to the window and he open up the window, and we were looking at a little plaza and Madrid, and everybody was driving around little mopeds, and little scooters and things like that, and no one was wearing a helmet. And he looked at me and he said, on the weekend, it's even worse than this. He says, we will have a heart transplant this weekend. I said, okay, sure enough that evening, or maybe the following evening, they call me in the middle of the night and Manny come on down. So went to the hospital went in, went to the ground up and then at the head of the table, I was watching them take out an old heart, but just as they were ready to take it out. An individual came in with a simple, cooler igloo, a simple Coca Cola, cooler a nice carrier. And he opened it up in in a simple Ziploc bag. There was a heart with a couple of labels on it and things like that. And, and there was a little table they took up to the heart, they put it on the table, okay? And the check the numbers everything checked in and said okay, let's proceed. And they started to take out the old heart. They took out the old heart, they put it on the table, and what what was amazing was that when they put it on the table, it was still beating, start to slow down, but it was still beating. In the meantime, then they took the new heart and they were implanting it. And, and I was watching the old heart, and it was still beating, but slowing down. And then, at a moment, when the new heart was positioned and put in the proper place, they started to release clamps so that the blood would be going into the new heart. And as I was watching, all of a sudden, the new heart started to beat. But at that very moment, and I mean, the very same moment, the old heart stopped. And I said, it was like life had gone from the old heart to the new heart. And I turned around to the young man, the young MBA, and I said, when golfing is as exciting as that, maybe I'll take up playing golf. And I don't think I'll find that. I think what we do is so exciting. You know, as good lords, let's my brain still work and keep me in good health, we'll be doing fine.


Nick Talamantes  11:18  

It's incredible what you're doing. And you're right. It's exciting to see what how med tech is changing people's lives. Is there anything else you want to share with us before we let you get on with the day?


Manny Villafana  11:31  

Yeah. Last time we had an opportunity to talk to some of the finance people that are at this meeting. And they of course, are a major, major player, a major contributor to what we are trying to accomplish without the financing. Lot of this thing of these things would not happen. But again, I kind of emphasize that we all are taking risk every day. Next month, or I should say in November of this year, we will be asking some doctors to actually put a lot of risk on the table by asking through implant for the very first time one of our graphs on a patient. He will be taking risks, the patient will be taking risks to the hospital, a lot of you will be taking risks. And I'm trying to say to the finance people that I realize you you are required to investigate or do do do the due diligence on the reviewing companies. But please, have a little less adversity to risk take some risks. You will be helping a lot of patience a lot of new companies and and believe me at the end of the day, you'll be doing better than the present method of narrowing the possibility of getting venture capital, broaden that base so that we couldn't have more companies doing the things like we're doing.


Nick Talamantes  13:04  

That's incredible. I want to thank you so much for doing our first interview here in Europe. I couldn't have asked for a better person to start talking to conference. 


Manny Villafana  13:14  

Thank you, Nick, and thank you to the entire staff of LSI for letting us the entrepreneurs sell on half of the story.


Nick Talamantes  13:23  

It's amazing work that you guys are doing, you know you're you're changing health care.


Manny Villafana  13:27  

Okay. Thank you. Thank you very much.


Nick Talamantes  13:30  

Thank you


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