Stem Cells, Exosomes & the Future of Recovery ft. Seth Berge I Coffeez with Joe Shalaby

0:00My passion is so many people still think stem cell therapy is unattainable. Yeah, it's not cheap. I thought it was unattainable. Yeah, people think it's unattainable. They think they have to go somewhere else. And even if, you know, they might hear some ad that says you need to go to Panama. They're like, well, I'm not spending 50 grand to go to Panama. Welcome to another episode of Coffees. Thanks for coming on today's show, Seth. Good to be here. All right, cool. So I'd like to start the show off. Seth, a guy like you, very, very fit guy in the health and wellness space. What's your morning routine?

0:26Morning routine. Boy, I am not at this point, I've not got myself to get up at 4 a.m. and do the cold plunges. So I'm not going to give you a really good answer here. I like to stay up a little bit late, watch some TV, wind down. So I'm not really getting up until 7, 7.30 probably. So I know that's not going to play very well in the super health and wellness space. But I also like to be there when my kids get ready for school. So I have a 13-year-old and a 9-year-old. The 13-year-old's up at about 7, gets ready for school, and the 9-year-old comes down about 8. So I'm kind of checking emails, getting ready for the day.

0:56and then when they go to school, then I really start working. When do you hit the gym and do all the other stuff? So I am different. I don't like this, but because I can't get myself to get up at 4 or 5 in the morning, which would require going to bed super early, most of the time I don't get to the gym until after 5.30, sometimes after 6.30 because it's just hard for me to take an hour, hour and a half in the middle of the day with everything I have going on. So usually when I'm done working, then I can just go to the gym and kind of focus on the gym and not be as distracted. The days I try to get up in the morning and do it, You know, at like nine or even at one or two, it's just I find I get calls and emails and texts.

1:30I don't get a good workout in. So I'm saving it for later in the day. Usually you get thrown off there. You get thrown off. Yeah. Nice. So let me ask you, I mean, like right now, the health and wellness space is, I would argue, one of the most emerging, if not one of the most dominant businesses. You hear the health and med spa business just exploding. What is it that drew you to specifically the stem cell space? Now, you didn't get into the normal health and wellness labs, you know, they got going on. Yeah, so I've always been a sports guy. I grew up loving team sports. My dad instilled a love of basketball, baseball, football to me.

2:10So my heroes growing up were always pro athletes, you know, 80s, 90s kids. So pro wrestlers, you know, the guys with the big bodies and, you know, the freak athletes. So I've always, as a kid, everybody wants to be an action figure, right? So I certainly was not naturally built that way, but I did play a lot of sports growing up. I played baseball, basketball, all the way through high school, played Division III basketball, baseball. But even then, I was by no means a biohacker. So I'm a serial entrepreneur too. So about eight and a half years ago, a former business partner of mine went to a marketing conference in Florida where there was a speaker.

2:47He was a medical guy, but also a marketer. and he was basically selling a stem cell business in a box. And really, nobody hardly knew anything about what a stem cell was. I think maybe people had heard about it from the early 2000s and the controversy with the George W. Bush years where they're talking about embryonic stem cell research, which was kind of a taboo subject. And then maybe people heard about Kobe Bryant going over to Germany and getting some crazy new stem cell procedure. But that's about the extent that I knew of stem cells. But he brought it back to me as a business opportunity.

3:17And so I first looked at it from the business opportunity, not even necessarily the health and wellness space. So I kind of tell people there isn't some great hero origin story necessarily for my beginning in this space, but I've done a lot of different things, a lot of different industries. And without a doubt, I'm really glad or blessed that I kind of fell into the space because it is what I'm passionate about. I've done financial planning. I've done home improvement stuff before that. All that was just a business, but this is, this is actually fun and rewarding, you know, getting to see lives change.

3:49And, you know, I've got more dialed into my own fitness and health, of course, since being into this space. So I'm super happy and fortunate that I did get into it. So it was presented back when, I mean, now, I mean, if it was presented to you as a business opportunity eight and a half years ago, I'm surprised that we don't see many districts. I mean, you're one of the biggest distributors in America of stem cells. Like I'm surprised this isn't just, you know, a rampant business. It's getting there. So it might seem like to somebody who isn't in the industry, you know, you don't hear about it that much, of course.

4:23So I'm in the industry. There's been a huge uptick in med spas and places that are offering regenerative therapies like stem cells and exosomes. Even in the last couple of years, it's really, really gone up. But it is still, Well, people still tell me, and I have to remind myself that we are still in the early stages, and there's exponential growth to be had. And I just say that's kind of funny because I've been in it for eight and a half years. I've seen it go from basically nothing to what it is now. I think it's about a$10 billion industry. And within a year or two, at least by 2030, expect it to be a$40 to$50 billion industry, if not more.

4:58Wow. So it is, yeah. I like it when people tell me that because it reminds me that, hey, you're still in the ground floor. still in the infancy and you know again fortunate enough that i've been in it for a little while so i've been able to get my i've got really anchored in in this world it's kind of a small world so yeah you know it's a big role but it's a it's a you don't see a lot of you don't see any of the big biohackers talking about simpsons gary brecca's not talking about it or brian johnson maybe he's doing some of it or yeah yeah maybe not publicly but um i can tell you some stories about gary Brecca and some of his most famous clients, he uses stem cells and exosomes.

5:36They've been a little bit controversial in the past. So I think Gary Brecca just doesn't like to talk about it as much. But if you talk to some of Gary Brecca's clients, they'll tell you that they've been doing exosome and stem cell treatments with Gary Brecca. So he actually does have, he has a stem cell line as well. Yeah, he does. I distribute to this group. Yeah. I've been trying to get him as my client, but not yet. Maybe after the show. Yeah, yeah. Who do you know? Yeah. Okay, cool. When did this vision for Regenerative Revival first come, Neil? Yeah, so originally when I got into the space, we're going way back here, but my previous, I've been about 20, I've been in business for myself since I was in my early 20s.

6:21And I've always done one-to-many type of sales, so dinner seminars. So I started in the home improvement business. We'd drop direct mail. We'd invite a bunch of homeowners in the area that fit our demographic, feed them dinner, a steak dinner, present what we were selling. And the whole idea was to get them interested in a one-on-one meeting. So I've been doing that model since I was 23 years old for home improvement. I went on to walk-in bathtubs using that same model. Then I went to financial planning using that same model. So the reason the stem cell thing intrigued me when my former business partner went there is he said, hey, I think that we can plug in the stem cell business using our dinner seminar one-to-many approach.

7:04So that's really what we did. So we at first hired doctors to do these educational talks and tried to send them to the doctor's clinic. So we were kind of overseeing everything. And the first three weeks out, these doctors did the seminar. They knew all the science behind stem cells, but they couldn't communicate it. So we went three weeks with zero sales. We stuck like 40 grand into marketing and we got nothing. And me and my business partner were like, we don't know that much of the science of stem cells, but we do know how to explain things to people at a level that can resonate. Because really what we're presenting with regenerative therapy, stem cell therapy, whatever you want to call it, is we're presenting a solution to a problem.

7:45These people have a problem. That problem is they're in pain. It's chronic. And the options that they've been given so far haven't been working. So meaning somebody might, say you're a 60-year-old pickleball player, and you've got an old knee injury, and you've been doing cortisone shots. They only last for a couple of weeks. There's a lot of side effects. You've got chronic pain in that knee, and you've been told the only thing that you can do by your traditional orthopedic doctor is get a knee replacement. So it's kind of like pain management, pain manage, and then surgery. Well, nobody really wants to get an artificial knee or a hip or things like that.

8:19There's a lot of downsides to having hardware in your body. So what we're presenting is a solution, an alternative to the problem. So by doing the dinner seminars and explaining, hitting on all the points, it's not just how do stem cells talk to each other. Nobody really cares about the bio. I shouldn't say nobody. But the average consumer doesn't really care that much about the deep biology that goes on with the body and the products. They want to know, what's it going to do for me? So what we decided was, the problem isn't the science, it's communicating the science. So we just took over doing the dinner seminars ourselves.

8:56And we did like$175 ,000 of business off of one meeting. And that's kind of where we took off. We said, OK, we need to be able to communicate the story. The results are there. The products are there. The science is there. We just need to be able to tell the story better. So we took that vision, and then we just started expanding it. And the other thing that we've done, that I've done, we've since, I'm not working with this guy anymore, what we've decided to do is the only barrier for a lot of people to get this treatment is they don't know where to go. So these dinner seminars, which are educational, solve the problem of explaining the solution.

9:31and then what we decided instead of having brick and mortar clinics in every city all across America we just started hiring nurse practitioners getting them certified to do stem cell therapies and they're mobile so we can do we can treat patients in any part of the country and we can send a nurse practitioner directly to their home so that was the vision that I had about eight eight and a half years ago when we got into it is how can we take some of the overhead away too because stem cell therapy is expensive and part of the reasons it's so expensive the products cost a lot of money, but there's a lot of overhead in running a brick and mortar clinic.

10:03So I thought, well, if the only service we're doing doesn't require like a surgery room, because we're talking about injections and IV pushes, there's no reason to spend hundreds of thousands of dollars in startup costs in every territory when we can be mobile, have our nurse practitioners and our doctors be concierge white glove style. And that's really where it's grown to today. Now I I have almost 100 nurse practitioners, doctors, and I'm in all 50 states, and we can send our medical team directly to somebody anywhere in the country virtually to get the treatment done. So that's a long answer to your short question, but that was kind of always the vision.

10:39It just takes a little while to get all 50 states, to get enough providers to be able to cover the whole country, but that's pretty much where we're at now. That's fantastic. And now you're able to go direct consumer in the comfort of their own home. what have been some of the biggest challenges that you've faced building a stem cell empire yeah so obviously what one of the it's hiring is always tough there's plenty of nurse practitioners out there but you got to find them that are willing to travel go on the road we pay them very well but you still have to be able to find ones that are independent enough to just be gone all day or sometimes it's two or three days and they're going house they're remember They're making house calls too.

11:20So it's always a challenge finding enough providers to take care of the patients. That's probably a normal business challenge. This world of regenerative therapy, there are regulatory challenges. So that's probably without, I don't think. I mean, yeah, hyper-regulated. Yeah, it is hyper-regulated. So you have to be very, very careful. I've seen a lot of people in this space say the wrong things, try to cut corners, try to fly under the radar, do things maybe not on the up and up. And I've seen a lot of people get in trouble because they're making unfounded claims. So the biggest challenge, even to this day, is running a medical company, a regenerative therapy company, because these products are not FDA approved, right?

12:02Because the FDA stands for Food and Drug Administration. Stem cell products, regenerative products, another term for that is biologics. They are not a drug. They're not food. So they're regulated somewhat by the FDA. It just means it's a gray area. So you have to be very, very careful. So who regulates stem cells? It's not the FDA. Well, the FDA regulates the labs. They regulate the process of how we collect the tissue. They regulate how we can, you know, we're not even allowed to manipulate the umbilical core tissue. So there's tons of regulation. The FTC along with the FDA regulates the marketing side.

12:39It's really the marketing side that you have to be careful of. So you can't say things like, we guarantee that this stem cell therapy will completely eliminate your osteoarthritis. Even though it's done that for the vast majority of people that have used it, if you make that claim, now you're, according to the FDA, you're making a claim as if it were a drug. And let's say, well, since it's not a drug, you can't make that claim. And if you're claiming it, it's acting like a drug. Even if it's a drug, though, you can't. Well, if a drug has been FDA approved for a specific indication, So you take a drug that gets approved for osteoarthritis.

13:15They can say this drug is for your osteoarthritis specifically because it's been approved. It's done that$800 million process. Yeah, but they can't say it's going to heal. No, but they can say it's specifically designed for your osteoarthritis. We're not even really supposed to say this will treat your osteoarthritis. We have to say things like this can address the symptoms of your osteoarthritis. A lot of it is almost like wink, wink. It's like look it up on your own. You'll see what it's done. Here's thousands of testimonials. I would just say see what ChatGPT says. Yes, go to ChatGPT. And see what StemCells is doing for millions of people.

13:54So it's walking a tightrope, making sure that you're staying out of the bullseye of the regulators. And I've grown a lot. People know who I am in the industry. I'm sure the FDA knows who I am, who my companies are, and I've never had any trouble because we try to make sure we're doing everything on the up and up. Like we go above and beyond when we educate people to let them know everything. You know, we're not trying to tell people like this is your insurance not going to cover stem cell therapy. It's just not going to. So we're very upfront about that. Which is crazy. You know, they'd rather cover a$50 ,000 surgery.

14:30Yeah, man, we could talk. How much time do we have? Yeah, there's all sorts of, you know, there's big pharma is very powerful in this country. So they've probably been the biggest inhibitor of getting more access to this type of treatment. And they've been really fighting it tooth and nail for over 20 years. And they're still fighting it. If they had their way, they would have the government shut down this whole industry. And they've spent hundreds and hundreds and hundreds of millions of dollars lobbying to keep this a little bit more in the gray. because the last thing they want is for people to get better quickly.

15:06Yeah, they don't want you healed. No, they don't want you healed. A patient cured is a customer lost. And I don't think that's – I always be very careful with this. I know hundreds and hundreds of doctors, medical professionals. I think the vast majority of them are doing the best they can. But if you talk to any one of them, even younger doctors, they learn nothing about regenerative medicine in med school. They've spent very little time on nutrition or prevention. They're practicing medicine. There's a reason we say practice medicine. Oh, man, it's sad because all they know is just to basically feed people poison and then fix them later.

15:40Yeah, what's that saying? If you're a hammer, everything looks like a nail or something like that. It's like if you're an orthopedic surgeon, you get paid big bucks to do knee replacements. I've had so many people, like customers, potential customers that are this close to getting the stem cell therapy for their knee, and they're like, I just got to talk to my orthopedic doctor first. It's like, well, what do you think the guy who makes a living off of giving you a knee replacement is going to tell you when you say you're going to do this experimental thing? It's like, good luck with that. He's not going to sign off.

16:07Are they still calling stem cells experimental? They are technically experimental. Technically, they are. It's not an FDA. Again, it's not an FDA-approved drug. But neither is any supplement you take. So if you take a multivitamin, you look at the bottle, or even vitamin D. I always ask you, what does it say about the FDA? It says these statements have not been evaluated by the FDA. It doesn't mean that the FDA looked at them and said they're no good. But if it's not food or a drug, it's outside of their jurisdiction. So that's really where the biologics industry, the stem cell exosome industry, it's not FDA approved.

16:45So doctors are able to use it at their own discretion. So what do you think the future is of stem cells? And when you collaborate this new variable AI, Like, what does that world of AI and stem cells look like? Well, I don't know exactly about AI on the medical side yet. I know AI has obviously changed the way we market, the way we can, you know, narrow down our demographics. I do know what I think is going to happen, what I think in the very short term anyway, I'm seeing it, is it's kind of this current administration is far more stem cell peptide natural healing. They're a lot more for that.

17:24so that's partly why you're seeing more and more people getting into the space. So I think that's a good thing, generally speaking. Yeah, well, you've got RFK. RFK even tweeted, he said, stem cells, peptides, leave them alone, let people have access to them. So obviously I'm not political, but that's a good thing in my opinion. But what I'm seeing is there's going to be less action by the FDA trying to – they're not going to try to shut down anything. They're going to try to probably start making sure that the people that are in the business are doing it correctly. So I think there's going to be a lot more rules and regulations, but not in a bad way.

18:00I think they're going to be put in place to make sure that the consumer is not being taken advantage of. There's going to be more compliance regulations. But if you're doing it the right way like we are, we always have been, I welcome that because there are some nefarious players that just jump in and see a money grab and they start saying, oh, stem cells will cure anything. Just, you know, oh, you've got a bad knee and a shoulder. We'll do an IV and everything will be better. You're going to be back to 20 years old. There needs to be some regulation in the healthcare space. So what I'm seeing is there's going to be some more uniformity where there's going to – because it's kind of now Wild West.

18:35But I think what's coming is there's going to be some more specific rules in place that if you follow them, great. If you don't, hopefully it just gets the bad actors out. I mean, that seems like there's going to be a lot of competition then. Yep. Definitely. Competition is healthy. For me, which brings to the other side of it, so we're talking about my direct-to-consumer model, which is great. We'll educate you. We'll send a nurse practitioner. So you love the competition because you're going to feed the competition. Yeah, so the other thing I'm in, Precision Biologics, is my wholesale company.

19:09So a few years ago, I got together with some of the big players in the industry, and we said, we're tired of buying these products and making some distributor rich. So we just got into the manufacturing side. So we're actually buying the raw materials from, we have contracts with hospitals. So the raw materials being birthing tissue. So that birthing tissue, after it's been screened at the hospital, the core, the placenta, the amniotic fluid, the tissue, all that, that gets sent to third party, which the FDA oversees. It gets screened for sterility. So then we purchase tons of raw material from these third party labs that have cleaned it, cleared it and then we purchase millions of dollars worth at a time and then we have cut we have a we have deals with manufacturers that take those cords and make the products for us to our specifications so what we what we pride ourselves at on the wholesale side is nobody has more stem cell and umbilical cord dense or exosome rich products than we have so we actually get to make them the way we want the way the marketplace wants them and because we do such volume we we have a very, very good affordable business model.

20:14What are exosomes? So the crowd. Yeah. So exosomes are like stem cells. So stem cells actually naturally secrete stem exosomes. So if you're getting a, a product from the umbilical core tissue, like what we have, there's going to be some exosomes that are naturally secreted. Exosomes are like, so think about if, if, if you're building a house, the stem cells are like the workers, they're going to be doing the work. The exosomes are going to be sending the messages to the workers of what they need to do. Or maybe it's like the exosomes are like the blueprint. So if you can get stem cells and exosomes working together, that's going to be your best bet.

20:50So all of our stem cell products that we sell have naturally occurring exosomes in them. But we also have a line of exosome only products where we're actually taking out in the lab, not me, but the manufacturers are actually able to extract just the exosome. So it's just pure exosomes so like what you got today was a stem cell product 80 million live stem cells plus 180 billion exosomes we put them together and the the exosomes are going to kind of tell the the stem cells what to do so it's i feel great yeah there was no recovery time and they're like yeah you just went through a procedure i'm like that was a procedure yeah yeah like yeah it doesn't even feel like a procedure yeah so stem cells and exosomes i mean i don't think we want to get i don't know how scientific we how scientific we want to get but there's different applications for both.

21:37But it's all derived from the placental birthing tissue, the cord, the placenta, all that. Now, building in the health space often comes with a lot of skepticism and hyperregulation, as we discussed. What are some of the early hurdles you had to overcome to build that momentum that you have right now? Yeah. Obviously, when people are spending thousands of dollars, some people are more skeptical than others. So that's why we love the dinner seminars. We love one-on-ones to educate. But one of the hurdles is, like I said earlier, if somebody goes and asks their traditional doctor who makes their house payment, their car payment by doing traditional medicine, doing cortisone shots and knee surgeries, it's pretty hard to get them on your side regarding something new like stem cell therapy.

22:26So there's general skepticism and each person's different. So that's always a little bit hard to get around. We talked about the regulation side. That's always walking a tightrope, but we've got that. Is it mostly young doctors that you work with now? All across the board. The common denominator for the doctors we work with is they're almost all going to be independent. So it's very hard to sell into some hospital because there's so much bureaucracy, there's so many decision makers trying to get a board to agree on doing a non-FTA approved procedure at a hospital that's worth hundreds of millions of dollars, that's pretty tough.

23:05So the doctors we work with are usually private practice. So somebody might own an interventional pain clinic. And I just signed one up yesterday. It's like, they came to me because they've had so many patients come to them asking, hey, do you guys do stem cells? Do you guys do these cellular therapies? I'm like, no, we don't. And they finally had enough people ask them about it that I don't know how they got my info but they're like hey we've had enough people ask about it. It seems like this is something we should be doing. But again that's an independent practice. Yeah, you're not going to get Hogue Hospital No, it's tough.

23:40The future, you asked me what do I see happening? That could be the future. Certainly, certainly. There will probably be some product that does get an FDA approval in this space and that will probably change the game. I wish they just offered it to all those with torn meniscuses. They should. The Achilles is torn this or that. They should. If actual patient outcomes was the most important thing, they would do that. There's a couple countries in the EU. It changes now, but there's several countries in the EU that before they will pay for a knee replacement or a surgery, they require you to try some form of regenerative therapy first, and the insurance covers that.

24:15That just makes so much more sense. It does. It makes too much sense, and that's the problem. That's the problem. Yeah, I mean, what if it did? And then you saved yourself a surgery and then not having to destroy your knee from it. I mean, I've probably helped facilitate 1 ,400, 1 ,500 of these treatment packages. And one of the most common things we hear three months, six months, nine months, a year later is, I'm out of pain, almost completely out of pain, and surgery is now off the table. That's many people's end goal is to avoid that surgery. Now, let me ask you this. What's the world of cellular repair headed to in the next five years?