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From Pioneering PDGF to Regenerating Under-Eye Tissue with Dr. Samuel Lynch · Skin Anarchy

• 0:00
  SPEAKER_01: Hey guys, welcome back to another episode of Skin Anarchy.
• 0:02
  SPEAKER_01: This is very, very special because, you know, we talk a lot about regenerative medicine on the show.
• 0:07
  SPEAKER_01: And I think the world of aesthetics is really going towards understanding what regenerative medicine actually means and how it's applied.
• 0:13
  SPEAKER_01: And so our guest today, I mean, it is such an honor to host someone like this who has really pioneered this field before anyone was talking about growth factors or understanding what you know PDGF even was.
• 0:23
  SPEAKER_01: I mean, he was the one doing the research, doing the work.
• 0:26
  SPEAKER_01: And so without further ado, please welcome Dr.
• 0:28
  SPEAKER_01: Samuel Lynch, who showed uh what PDGF, the dried growth factor, actually does in a healing wound and that growth factors work as a team.
• 0:36
  SPEAKER_01: He then turned that discovery into medicine, inventing FDA-approved PDGF therapies for dental and bone regeneration.
• 0:43
  SPEAKER_01: Uh recombinant PDGF products, as many of you know, have now treated more than five million patients.
• 0:47
  SPEAKER_01: So Dr.
• 0:48
  SPEAKER_01: Lynch, welcome.
• 0:48
  SPEAKER_00: It's truly, Ecta.
• 0:51
  SPEAKER_00: It's a pleasure to be here.
• 0:52
  SPEAKER_00: Really excited to have an opportunity to talk with you about a topic that I obviously love, which is regenerative aesthetics and regenerative medicine.
• 1:00
  SPEAKER_01: No, it's it's such an opportunity for us and such a privilege to have you on the show because this word gets thrown around a lot, Dr.
• 1:05
  SPEAKER_01: Lynch.
• 1:06
  SPEAKER_01: I'm sure you've seen in the longevity space and the aesthetic space, a lot of people are talking about regenerative medicine and aesthetics, but we don't really get to dive in, you know, and we don't get to understand like what is the true meaning and like what are the major discoveries that have really propelled this field forward.
• 1:19
  SPEAKER_01: So without me ranting too much, I'd love to kind of walk down memory lane with you.
• 1:22
  SPEAKER_01: If you can kind of walk us back to your initial work, you know, in the 80s and the 1987 experiment.
• 1:27
  SPEAKER_01: Talk to us about what is PDGF and when did you realize that this was something worth looking into?
• 1:32
  SPEAKER_00: Thank you for asking that question.
• 1:34
  SPEAKER_00: It's a again, it's a trip down memory lane for me, but it has been such an honor to work in this whole field of regenerative medicine, really most of my career for 35 years.
• 1:44
  SPEAKER_00: I like to say, you know, I was involved in regenerative medicine before regenerative medicine wasn't even known as a buzzword, right?
• 1:51
  SPEAKER_00: And helped really to pioneer the field.
• 1:54
  SPEAKER_00: So going way back to those early experiments, you know, we had a sense that there was something really important in platelets that could help the body regenerate itself and heal itself.
• 2:08
  SPEAKER_00: And we kind of had that sense because, right, one of the first responders when you have an injury, any injury, whether it's an accidental injury or, you know, a microneedling or laser surgical procedure, right?
• 2:21
  SPEAKER_00: One of the first things that happens, you have a blood clot.
• 2:23
  SPEAKER_00: And we said, Well, what's in a blood clot, right?
• 2:25
  SPEAKER_00: Platelets and fibrin and so forth.
• 2:26
  SPEAKER_00: But platelets certainly played, we knew played a key role.
• 2:30
  SPEAKER_00: And so we said, well, maybe there's something in platelets that tells the body there's an injury.
• 2:36
  SPEAKER_00: I like to say I spent my whole career trying to answer really two very simple questions.
• 2:41
  SPEAKER_00: One, how does a body know that it's been injured?
• 2:45
  SPEAKER_00: Like, think about that.
• 2:46
  SPEAKER_00: Like, how in the world does the body know it's been injured?
• 2:49
  SPEAKER_00: And two, how does it go about stimulating the healing process?
• 2:54
  SPEAKER_00: So I started with the platelets, and and we happened to be in a building.
• 2:59
  SPEAKER_00: My lab was in a building with the American Red Cross.
• 3:02
  SPEAKER_00: So, what does the Red Cross do?
• 3:03
  SPEAKER_00: It collects blood, right?
• 3:05
  SPEAKER_00: But it also collects platelets.
• 3:07
  SPEAKER_00: So we would get these bucket full of outdated platelets from the American Red Cross.
• 3:14
  SPEAKER_00: We would have like rows of these buckets of outdated platelets lined up, and then we would start activating them, kind of lysing them open, and to try to find out what's inside them and what would make cells and tissue grow.
• 3:29
  SPEAKER_00: And I will simplify uh probably over a decade of my life like saying we eventually found platelet derived growth factor.
• 3:40
  SPEAKER_00: It wasn't a very imaginative, we you know, we helped name it, it wasn't a very imaginative name, right?
• 3:44
  SPEAKER_00: We took a bunch of platelets, we got this protein out of them.
• 3:47
  SPEAKER_00: So we call it platelet derived growth factor.
• 3:49
  SPEAKER_00: It's to the point.
• 3:51
  SPEAKER_00: Right.
• 3:52
  SPEAKER_00: But that's how we that's how we got started.
• 3:54
  SPEAKER_00: And um, and then, you know, like many biotech, you know, pharmaceuticals today, we were able to find the amino acids, the sequence of the protein, right?
• 4:04
  SPEAKER_00: The building blocks of the protein.
• 4:06
  SPEAKER_00: Based on that, we were able to find the gene in the human chromosome that is responsible for making PDGF.
• 4:13
  SPEAKER_00: And then we were able to put that gene into, in our case, we use yeast cells.
• 4:18
  SPEAKER_00: And then the yeast cells, the amazing thing is the yeast cells, now when you grow them up like you're brewing beer, they make one human protein and only one.
• 4:29
  SPEAKER_00: And in our case, it's human platelet-derived growth factor, human PDGF.
• 4:33
  SPEAKER_00: And that was sort of the beginning.
• 4:34
  SPEAKER_00: That was another decade in my life.
• 4:36
  SPEAKER_00: So now we're past the first two decades of all my my work.
• 4:39
  SPEAKER_00: It was very exciting and continues to be very exciting because PDGF remains the only growth factor to have ever gotten FDA approval for tissue regeneration.
• 4:50
  SPEAKER_01: Wow.
• 4:51
  SPEAKER_01: Yeah.
• 4:51
  SPEAKER_01: I mean, that's the that's what's really, really groundbreaking here is that, you know, we like we hear the word growth factor a lot.
• 4:58
  SPEAKER_01: You know, we hear about growth factors, and obviously we learn about them for those of you in medicine, and we learn about the potential of growth factors.
• 5:04
  SPEAKER_01: But this one specifically, I mean, I would love for you to kind of dive in, if you don't mind, like maybe the theory side of this, right?
• 5:09
  SPEAKER_01: Like, what do you think it was about this specific one that that made it stick for an entire industry, for the medical community?
• 5:16
  SPEAKER_01: Like, what was it here that you think was really like, okay, we get it, and we're gonna get behind this?
• 5:21
  SPEAKER_00: Well, it turns out that PDGF is the most potent growth factor for tissue regeneration.
• 5:29
  SPEAKER_00: And not only is it the most potent one, but it is the most balanced one.
• 5:34
  SPEAKER_00: So there are some other types of growth factors that, you know, just stimulate collagen, just stimulate a bunch of type one collagen, but they might decrease the natural hyuronic acid in your skin, which obviously is not a good thing, right?
• 5:48
  SPEAKER_00: But PDGF will increase types one, three, and six collagen, elastin, and your natural hyuronic acid.
• 5:57
  SPEAKER_00: So it gives you a really nice, balanced rejuvenative and regenerative response in your skin.
• 6:04
  SPEAKER_00: So that's why I think that it, you know, has been so wildly successful in aesthetic medicine, is because of that.
• 6:14
  SPEAKER_00: The other unique aspect of PDGF, and you know, I don't know how technical or scientific we we should get into here, but it stimulates a lot of different kinds of cells.
• 6:24
  SPEAKER_00: So it'll stimulate not only, you know, the extracellular matrix components like collagen, elastin, and natural HA in your skin, but it'll also stimulate more blood growth to your skin, what a term we call angiogenesis, just means a lot more blood and blood vessel growth into your skin.
• 6:41
  SPEAKER_00: And that's really, really important because for the cells in your skin to be able to function properly, correctly, optimally, they need a good blood supply.
• 6:52
  SPEAKER_00: They need a lot of oxygen and nutrients and so forth, right?
• 6:56
  SPEAKER_00: So PDGF enhances that aspect of your skin as well.
• 7:01
  SPEAKER_01: I mean, that's huge because I mean, you took this molecule through FDA approval in dental and orthopedic medicine, right?
• 7:07
  SPEAKER_01: Long before aesthetics.
• 7:09
  SPEAKER_01: So, like I think I would love for you to speak on that because we rarely get to, I think in aesthetic medicine it becomes so siloed that we forget about like the full understanding of medicine when it comes to this type of like result, right?
• 7:22
  SPEAKER_01: So what what did that those components like what can they really teach us about the way it works in aesthetics?
• 7:27
  SPEAKER_01: Like, you know, those fields of medicine.
• 7:29
  SPEAKER_00: Yes.
• 7:30
  SPEAKER_00: So you're right.
• 7:31
  SPEAKER_00: People tend to put like aesthetic medicine or orthopedics or dental and in silos, but that's not the way the body works, right?
• 7:40
  SPEAKER_00: So again, go back to thinking about an injury.
• 7:42
  SPEAKER_00: If you have an injury, whether it's again microneedling or plastic surgery, something in the skin or the face, or whether or not it's a broken bone in your foot, right?
• 7:52
  SPEAKER_00: Or anywhere in between, right?
• 7:54
  SPEAKER_00: What is the first thing that happens?
• 7:56
  SPEAKER_00: You have a blood clot, you have release of the platelet-derived growth factor from the platelets, the PDGF from the platelets naturally.
• 8:03
  SPEAKER_00: So we all, everybody in the world has PDGF.
• 8:07
  SPEAKER_00: You know, fun little fact every mammal in the world has PDGF.
• 8:13
  SPEAKER_00: That's how important it is to our very survival, right?
• 8:18
  SPEAKER_00: So as I look at it, right, you shouldn't put aesthetic medicine into a silo, or you shouldn't put dental surgery or orthopedic surgery into a silo because the healing process in all of those has this common, fundamentally important starting point, which is the blood clot, which is the release of PDGF naturally.
• 8:39
  SPEAKER_00: And PGF, therefore, naturally has been proven to stimulate, you know, not only again the regeneration, rejuvenation, the healing of skin, but of your dental tissues around your teeth and also orthopedic injuries in your bone, because again, what happens when you have a broken bone?
• 8:56
  SPEAKER_00: Yeah.
• 8:56
  SPEAKER_00: You have a blood clot.
• 8:57
  SPEAKER_00: So PDGF is naturally released there.
• 9:00
  SPEAKER_00: So all we're doing is augmenting or enhancing your natural regenerative and rejuvenant process that you have, but that you tend to lose as you get older.
• 9:13
  SPEAKER_00: We're just taking that natural healing and regenerative response and taking it from maybe what it's like when you're 50 down to what it's like when you're 18.
• 9:22
  SPEAKER_00: That's that's phenomenal.
• 9:24
  SPEAKER_01: I mean, that's really where I think that's what we all think about when we think about the potential of this field, you know, and where it can take us is this like true kind of like resetting of our body's ability to do what it does best, you know, which is like regrow itself and fix itself and heal itself.
• 9:40
  SPEAKER_01: And I would love to for you to kind of, I mean, if you don't mind, do a deep dive into PDGF BB specifically, because I know there's different isoforms, right?
• 9:47
  SPEAKER_01: And I think for our listeners, like for the clinicians out there, understanding that differentiation, understanding like why BB is just more effective in the long run, I'd love for you to kind of dive into that.
• 9:57
  SPEAKER_00: Sure.
• 9:58
  SPEAKER_00: So it turns out that there are two different types of receptors for PDGF.
• 10:04
  SPEAKER_00: In PDGF, there's PDGF AA, there's PDGF B B, there's PDGF AB, which is a mixture, right?
• 10:10
  SPEAKER_00: And then there's D and D.
• 10:12
  SPEAKER_00: PDGF B B is the only type, the only isoform of PDGF that binds to both types of receptors.
• 10:21
  SPEAKER_00: So all cells that have receptors, either one of these kinds of receptors, will be stimulated by PDGF B B.
• 10:29
  SPEAKER_00: And that gives you this holistic response, right?
• 10:33
  SPEAKER_00: Whereas if you use PDGF AA or even AB, it's only going to stimulate one type of receptor or another, right?
• 10:42
  SPEAKER_00: And the same with C and D.
• 10:43
  SPEAKER_00: So PDGF BB, the magic behind that is that is the only type of PDGF that stimulates both isoforms of receptors in your body.
• 10:53
  SPEAKER_01: That's really interesting.
• 10:54
  SPEAKER_01: Yeah, because I mean, I think that's the this type of like critical analysis of like what we're using.
• 11:00
  SPEAKER_01: I think we don't really get into that.
• 11:02
  SPEAKER_01: You know, I I look at aesthetic medicine and we have so many like categories now of treatments, you know, but it's like an understanding like why does certain, like why do certain treatments work better than others?
• 11:12
  SPEAKER_01: For example, like I'll give you a scenario, like right now when I'm looking into the field, I see, I'm I'm sure you see this all too.
• 11:17
  SPEAKER_01: We have so many therapies, like exosomes, their secret homes, you know, growth factors and is an entire category.
• 11:23
  SPEAKER_01: Why do you think this type of understanding really matters in a world that's getting cluttered, I think, every day with so much newness?
• 11:30
  SPEAKER_01: I mean, you know, like from a molecular medicine point of view, like why do you think we'd really have to hone in now more than ever?
• 11:36
  SPEAKER_00: Yeah, because I think we have to hone in now more than ever because there is so much confusion, especially in the aesthetic field, as you say, with exosomes and secretomes and PDRNs and they also, well, we have growth factors, we have growth factors, growth factors.
• 11:50
  SPEAKER_00: But the fact is that if you actually measure the amount of growth factors that are in each of those other different types of products, it's absolutely minuscule, right?
• 12:02
  SPEAKER_00: And it really, based on what we've seen, it's really subtherapeutic.
• 12:06
  SPEAKER_00: So, yes, if you test those in the laboratory on a laboratory bench and use very sophisticated, you know, antibody techniques to try to detect them, you can detect growth factors in some of these other types of products.
• 12:20
  SPEAKER_00: But that's really, really to detect a growth factor on a laboratory bench using specific monoclonal antibodies is a night and day difference from using it therapeutically to get a therapeutic benefit in a person.
• 12:34
  SPEAKER_00: And I think we have to really understand and appreciate and go to the next level deep and say, well, how much growth factor, which exactly growth factors is it?
• 12:43
  SPEAKER_00: And how much of that growth factor is found?
• 12:46
  SPEAKER_00: And is it reproducible?
• 12:48
  SPEAKER_00: Because so many of the products that you hear talking about growth factors, right?
• 12:53
  SPEAKER_00: They're kind of naturally derived from different types of cells or from plants or from different people.
• 13:02
  SPEAKER_00: But, you know, those are all variable sources.
• 13:05
  SPEAKER_00: And for FDA approval, it's a medicine, right?
• 13:08
  SPEAKER_00: So, like any other medicine, if you go take insulin, right, you don't want an insulin that, hey, is really potent one time and well, not so potent the next time, right?
• 13:17
  SPEAKER_00: Yeah, exactly.
• 13:18
  SPEAKER_00: That would not be conducive to health.
• 13:21
  SPEAKER_00: So you want that consistency of a medicine.
• 13:24
  SPEAKER_00: And really the main way you can get that is using these biotechnology type of techniques to produce that exact protein that you want in the exact concentration that you want, in the exact purity that you want, in the exact formulation that you want.
• 13:40
  SPEAKER_00: That's what differentiates pure PDGF from a lot of these other products and things that say we have growth factors.
• 13:48
  SPEAKER_01: Yeah.
• 13:48
  SPEAKER_01: No, that's, I mean, that's absolutely huge.
• 13:50
  SPEAKER_01: And I think that's an ongoing debate now.
• 13:52
  SPEAKER_01: You know, a lot of the conversations I've seen that are going on are talking about, for example, like I brought up secretome, you know, a lot of people are talking about, well, you need everything, but it's like there's no quantification, there's no measurement we're using right now, you know, for these other products.
• 14:05
  SPEAKER_01: Like you said, like there's no like precise delivery of them.
• 14:09
  SPEAKER_01: So, you know, that really makes you also wonder about that interaction component as well.
• 14:13
  SPEAKER_01: I know that on some of your early work, you didn't just show, you know, the value of PDGF, you also showed the value of the synergy that it has with other growth factors.
• 14:20
  SPEAKER_01: And I would love for you to speak on that in terms of like, what do we need to understand as scientists and doctors about how these molecules work together, how these proteins work together to create the regenerative profile and the effects that we're looking for?
• 14:33
  SPEAKER_00: Great question.
• 14:33
  SPEAKER_00: So, I mean, there is no such one thing, you know, as just a magic bullet, right?
• 14:38
  SPEAKER_00: It all has to work in harmony.
• 14:40
  SPEAKER_00: And that's why I feel like PDGF works so well is again, it works in harmony.
• 14:44
  SPEAKER_00: It gives you this balanced regenerative response.
• 14:48
  SPEAKER_00: And one of the things that, you know, we noticed early on was PDGF in particular will what we call upregulate or increase the natural production of some of these other growth factors.
• 15:01
  SPEAKER_00: So it doesn't just increase the production of collagens and elastins and HA, which is hugely critically important to the regenerative response, but it it will, as being the body's wound healing catalyst, you know, it has evolved to also kind of stimulate the production, the local production of a lot of the other growth factors and cytokines.
• 15:24
  SPEAKER_00: You know, it helps and it also helps modulate the inflammatory response.
• 15:29
  SPEAKER_00: It's not that it totally gets rid of the inflammatory response, but it gets you through that inflammatory phase much quicker so you can get onto the reparative phase.
• 15:39
  SPEAKER_00: And you know, that's how wound healing works, right?
• 15:41
  SPEAKER_00: You first have an inflammatory phase, then you go to the reparative phase, and then you go to the remodeling phase.
• 15:46
  SPEAKER_00: It's important to have a little bit of the inflammatory phase, but you want to get through that quickly so that you can get onto the reparative phase of healing.
• 15:54
  SPEAKER_00: And that's what PDGF helps you do.
• 15:56
  SPEAKER_00: Clinically, the importance of that is that your downtime is greatly reduced.
• 16:02
  SPEAKER_00: So your redness, your swelling, your pain, the heat, and so forth after a laser treatment or a microneeling treatment is significantly reduced by the application of topical application of the PDGF.
• 16:17
  SPEAKER_01: Yeah, that's the I think that that was my next question for you was like, what do you think the real like?
• 16:22
  SPEAKER_01: I know we're using, you know, PDGF like post-procedure, during procedures.
• 16:26
  SPEAKER_01: Like, do you think that's the most optimal way to use this specifically?
• 16:30
  SPEAKER_01: Or do you think growth factors can work topically and intact skin as well?
• 16:34
  SPEAKER_01: Because there's so many like serums on the market, for example, right?
• 16:37
  SPEAKER_01: That are like claiming, like, hey, put this on, you know, you're not getting any microneedling done, anything, and then you can go and see benefits of like true like regenerative aesthetics.
• 16:44
  SPEAKER_01: Do you think that's true or that's not how it works?
• 16:46
  SPEAKER_00: I think it's for the most part unproven.
• 16:49
  SPEAKER_00: Yeah.
• 16:50
  SPEAKER_00: Maybe it's true, but we need a lot more studies to really demonstrate if there's a substantive lasting effect of just applying some of these topical serums and things onto the skin.
• 17:03
  SPEAKER_00: I mean, people who are listening to this, right?
• 17:06
  SPEAKER_00: I mean, some people may say, Oh, I I'm a total believer in this topical serum on in-text skin.
• 17:13
  SPEAKER_00: And hey, if that's the case, that's great.
• 17:15
  SPEAKER_00: And if they feel like they can even get a 24-hour, 48-hour sort of glow, okay.
• 17:20
  SPEAKER_00: Yeah, that's great.
• 17:21
  SPEAKER_00: But to get the longer lasting true tissue regeneration, right now I feel like you need to do something to disrupt the surface of the skin, whether it's microneedling, chemical peels, lasers, something to allow more of the growth factors to really penetrate the epidermis.
• 17:40
  SPEAKER_01: Yeah, no, that makes that makes sense.
• 17:42
  SPEAKER_01: And I asked you that just to have it, you know, clarified for our listeners, because I know we we hear a lot, you know, the word growth factor is really thrown out a lot.
• 17:49
  SPEAKER_01: And I I think it's just important for us to understand that there is a real place that regarded medicine in aesthetics, like that's there's a way that it's practiced that's going to show you results rather than all of the marketing and stuff that we see a lot of.
• 18:03
  SPEAKER_00: Couldn't agree for it.
• 18:04
  SPEAKER_01: Um, I want to move on to the phase to be uh trial.
• 18:06
  SPEAKER_01: This is so exciting.
• 18:08
  SPEAKER_01: I mean, it's so exciting to see your work, you know, move forward and and this is a huge, huge opportunity for aesthetics.
• 18:13
  SPEAKER_01: I mean, can you talk to us about it?
• 18:15
  SPEAKER_01: I mean, tell us about the the study and the trial and what you're trying to accomplish here so our listeners can understand.
• 18:21
  SPEAKER_00: Yes.
• 18:21
  SPEAKER_00: Yeah.
• 18:22
  SPEAKER_00: So, you know, my whole career has again been working with the FDA, doing clinical trials, all the way from the preclinical to the phase one, phase two, phase three, and ultimately FDA approval.
• 18:33
  SPEAKER_00: That's what I've done my whole career.
• 18:34
  SPEAKER_00: And we all know how time consuming and expensive that can be.
• 18:37
  SPEAKER_00: But I think that's the right way to do it.
• 18:40
  SPEAKER_00: And so we're pursuing that same path here in aesthetic medicine as as well.
• 18:46
  SPEAKER_00: So we are super excited.
• 18:48
  SPEAKER_00: And for your listeners who don't know yet, because it's very new, we have just received IND approval from the US FDA for injection of pure PDGF for treatment of infraorbital hollowing under I injections.
• 19:05
  SPEAKER_00: And again, first pure growth factor to reach this phase 2B clinical trial phase with FDA approval to proceed forward into this trial.
• 19:16
  SPEAKER_00: So, to be clear, right, it's just for the clinical trial.
• 19:20
  SPEAKER_00: For phase 2B, we'll have up to 75 patients enrolled in the trial.
• 19:25
  SPEAKER_00: It'll be a prospective randomized control dosing study.
• 19:29
  SPEAKER_00: And we're super excited about it.
• 19:31
  SPEAKER_00: Um, we're super excited that the FDA allowed us to go straight into a phase two B.
• 19:36
  SPEAKER_00: The reason for that is, of course, as we've talked about, the other FDA approvals, which are for implantation or injection of PDGF into the skin or bone, or topical onto diabetic foot ulcers.
• 19:49
  SPEAKER_00: But ECTA, I think a super important point that your audience needs to appreciate, understand, is when you go through all those other FDA trials for those other indications, the FDA doesn't just make you test your product, right, in those indications.
• 20:05
  SPEAKER_00: So let's take diabetic foot ulcers for an example, right?
• 20:08
  SPEAKER_00: They don't just make you test a product in a diabetic foot ulcer.
• 20:13
  SPEAKER_00: They, FDA understands that, hey, that product might get used on the face or for orthopedic applications.
• 20:20
  SPEAKER_00: Hey, it might get injected.
• 20:21
  SPEAKER_00: Some of it might go into the bloodstream.
• 20:23
  SPEAKER_00: So we already, throughout this whole development process over the last two decades, had to do subcutaneous injections into the skin, intradermal injections, intramuscular injections, intraperitoneal injections, and intravenous injections in case somebody accidentally injected it into the bloodstream.
• 20:44
  SPEAKER_00: Most people don't understand and appreciate that.
• 20:46
  SPEAKER_00: They're like, oh, well, that indication is just in the foot.
• 20:49
  SPEAKER_00: That has nothing to do, you know, with the skin, right?
• 20:52
  SPEAKER_00: You know, that topical application with the skin and the face or whatever.
• 20:55
  SPEAKER_00: But they don't understand the rigorous nature of product development and how we have had to test pure recommodent PDGF in all these different routes of administration.
• 21:06
  SPEAKER_00: So what we had to do for this indication, the under-eye indication, is to what we call cross-references to reference all those previous safety studies that had to be done, right, for all these different injections into different parts of the skin and show that that was that was safe and talk to FDA about exactly the face, the skin and the face and how we've worked in that area specifically as well.
• 21:34
  SPEAKER_00: But it was gratifying that the safety of this molecule has been established beyond any other growth factor, period, right?
• 21:43
  SPEAKER_00: So be able to go into those late stage clinical trials was pretty amazing.
• 21:48
  SPEAKER_01: No, this is huge.
• 21:49
  SPEAKER_01: I mean, it's absolutely I love that you said that.
• 21:51
  SPEAKER_01: Thank you for clarifying that because that is something that I it really drives me up the wall, you know, because there's a lot of people who will take like, I don't know, like a study, like, you know, when you go through a trial.
• 22:00
  SPEAKER_01: Like this is something that everyone needs to understand, you know, is that you have to really do the due diligence, like in all ways.
• 22:06
  SPEAKER_01: And I think many times discoveries do get kind of buried, you know, or like they get overlooked because people are like, oh, well, it's only been done like you were saying, like in a foot alt or in one specific environment.
• 22:16
  SPEAKER_01: And that's where there's a lot of misunderstanding in aesthetics.
• 22:19
  SPEAKER_01: I've definitely seen that.
• 22:20
  SPEAKER_01: And I think it's interesting because from when I look at it from the regenerative medicine lens, that's also like again tying in that principle of like, well, you need to understand what's happening with all of the tissues because we don't know, like in my, and this is my understanding, I mean you're the expert here, but we don't know enough about the signaling yet in regenerative medicine where we can say, like, this is exactly what's going on.
• 22:40
  SPEAKER_01: This is the only signaling that's happening.
• 22:42
  SPEAKER_01: Like we have to understand the broader view to then start connecting those dots, you know.
• 22:46
  SPEAKER_01: And I feel like a trial like this, that's laying the groundwork for that kind of science, you know, and that kind of discovery approach.
• 22:52
  SPEAKER_01: So it's absolutely huge.
• 22:53
  SPEAKER_00: Yeah, it is.
• 22:54
  SPEAKER_00: I couldn't agree more.
• 22:55
  SPEAKER_00: And again, you know, PDGF's unique in that it attracts your stem cells.
• 23:00
  SPEAKER_00: But then those stem cells do, I mean, they do different things.
• 23:04
  SPEAKER_00: If they're your body's own stem cells, right?
• 23:06
  SPEAKER_00: We're not implanting any stem cells, but we're just kind of supercharging your body's own stem cells.
• 23:12
  SPEAKER_00: But then once they go into different environments, those stem cells read different molecular clues from the local environment.
• 23:20
  SPEAKER_00: I think that's what you're saying is yeah, I may have a bunch of stem cells here and they could go one way or the other.
• 23:26
  SPEAKER_00: And they take their cues, their signals from the local environment.
• 23:31
  SPEAKER_00: So it's a really exciting time, I think, to be in regenerative aesthetics or regenerative medicine.
• 23:37
  SPEAKER_01: Absolutely.
• 23:37
  SPEAKER_01: Now, I want to just ask you, because we are looking at under-eye hollowing.
• 23:41
  SPEAKER_01: That is in itself like a huge, huge area that we haven't had a lot of like innovation in this, you know, in this and in solving this problem.
• 23:49
  SPEAKER_01: Why do you think it's such a hard field in aesthetics to target, like the under-eye area and the hollowing specifically?
• 23:55
  SPEAKER_00: Well, look, I mean, that we do have, you know, some fillers, right?
• 23:58
  SPEAKER_00: HA hyuronic acid fillers, right, that are often used for infraorbital hollowing under eyes, right?
• 24:04
  SPEAKER_00: But our belief, and this is our perspective, is that most patients would rather have their own tissue regenerated than to have some sort of filler injected, right?
• 24:16
  SPEAKER_00: You want to have your own tissue there like it was when you were 18 or 20, instead of having a filler that might migrate, you know, around or dissolve or resorb or create other problems or vascular occlusions.
• 24:30
  SPEAKER_00: And I think it's particularly to your question about the challenges of under-eye, that's a really has been a very challenging area for clinicians to treat effectively, even with, you know, these fillers.
• 24:43
  SPEAKER_00: And so a lot of clinicians are looking for a solution because they don't feel like the filler's really meeting the needs that they need.
• 24:52
  SPEAKER_00: The PRP and PRF hasn't really worked very well under eye either.
• 24:56
  SPEAKER_00: So we get a tremendous amount of unintended, off-label, whatever term you want to use, use of PDGF already in the under-eye.
• 25:06
  SPEAKER_00: And it's not something we can promote or advocate at all, but it's the reality.
• 25:11
  SPEAKER_00: Why?
• 25:12
  SPEAKER_00: Because it is one of the few things that really seem to provide a great benefit for most patients.
• 25:20
  SPEAKER_00: And so we were hearing that and trying to be a responsible company.
• 25:25
  SPEAKER_00: You know, we want to say, okay, and again, it's been my whole history throughout my career, is let's do the trials, right?
• 25:31
  SPEAKER_00: Okay, let's generate the data.
• 25:33
  SPEAKER_00: We'll do the randomized controlled clinical trials with FDA to try to really prove out what people seem to be experiencing in their clinics.
• 25:44
  SPEAKER_01: No, I mean, it's really, really fascinating because for the under-eye, especially, I mean, there's a lot of like like the therapies I've seen, there's it it becomes very confusing.
• 25:52
  SPEAKER_01: Like, is it are you actually fixing the problem or are is it the swelling that's happening or the filling?
• 25:58
  SPEAKER_01: You know, like we sometimes you can't really differentiate that, right?
• 26:01
  SPEAKER_01: Like as in just the clinic setting.
• 26:03
  SPEAKER_01: And I'd love for you to actually talk about that in terms of like, how are you guys measuring the true regenerative potential for the under-eye area versus you know, something like just swelling that happens and starts filling in those areas, you know, in that space.
• 26:14
  SPEAKER_01: Yeah.
• 26:15
  SPEAKER_00: Well, first of all, we're we're looking at, you know, the effects after treatment, whether it's control or which is just saline injected under eye or or the PDGF over a period of, I think it's six months altogether.
• 26:29
  SPEAKER_00: So, you know, any just if it's just swelling, you know, it's gonna be gone, you know, long before that.
• 26:35
  SPEAKER_00: But we're using a variety of what's called validated uh assessment tools.
• 26:40
  SPEAKER_00: So can field imaging, right?
• 26:43
  SPEAKER_00: Standardized photographs and image analysis, as well as patient validated patient rater tools and investigator clinician uh validated clinician rater tools.
• 26:55
  SPEAKER_00: And so we're we're really trying to get a complete assessment of not only physically, but how does the patient feel about the results and do that over time well past what might be expected from any transient swelling?
• 27:10
  SPEAKER_01: That's interesting.
• 27:11
  SPEAKER_01: And I know there's a hollowing score that you're looking at 12 weeks.
• 27:14
  SPEAKER_01: What is that score?
• 27:15
  SPEAKER_01: Like what was used to determine that score?
• 27:17
  SPEAKER_00: Again, what a lot of people don't appreciate is that there are a lot of different assessment tools or scores, but there are very few that have been fully validated in the eyes of the FDA.
• 27:28
  SPEAKER_00: So the image analysis hollowing score that we're using is one of the validated assessment tools in the eyes of the FDA, meaning that that tool has been proven to reliably and reproducibly assess the filling in of the hollowing areas, hollow, you know, under eyes and specifically under eyes.
• 27:53
  SPEAKER_01: I'm really excited about this, honestly.
• 27:54
  SPEAKER_01: This is gonna be huge, you know, for for the aesthetic field because there's a lot of, I know a lot of patients are there's so many concerns for that specifically.
• 28:02
  SPEAKER_01: I can't tell you how many eye creams I get in PR.
• 28:06
  SPEAKER_01: You know, I'm just always looking at eye creams like that specific sector.
• 28:09
  SPEAKER_01: I'm like, guys, we gotta stop this, you know, like we gotta start figuring out what is actually going to help the under-eye area.
• 28:14
  SPEAKER_01: And so this is incredibly exciting, you know, to see this work.
• 28:17
  SPEAKER_00: Well, the under eye is again a complicated area in that it's you know, loss of tissue, but then also the crepiness of the skin on the surface and so forth.
• 28:26
  SPEAKER_00: So you get the hollowing and the crepiness of the skin.
• 28:29
  SPEAKER_00: And so it's it's a multifactorial sort of problem that you're trying to address.
• 28:34
  SPEAKER_00: And just, as you say, just adding creams to the surface is is not going to affect what's happening underneath the skin.
• 28:41
  SPEAKER_01: Not at all.
• 28:41
  SPEAKER_01: And I want to actually, you know, for all of our practitioners that might be listening in, you know, regenerative aesthetics is a very, very new field.
• 28:48
  SPEAKER_01: Like I mean, in the sense of like the way it's evolving, the way it's coming out, and and we're starting to practice.
• 28:53
  SPEAKER_01: I'd love for you to kind of tell us, like, you know, any advice you have, like in terms of what questions should younger practitioners maybe start asking companies or like, you know, these new products that are coming to market about what should I know as a doctor?
• 29:05
  SPEAKER_01: What should I know about how to use this in practice and like, you know, the potential of this um in the future?
• 29:10
  SPEAKER_01: Any advice that you have?
• 29:12
  SPEAKER_00: Well, physicians, right, have the ability to use approved medicines off label.
• 29:19
  SPEAKER_00: And honestly, that is where a lot of our learning start.
• 29:24
  SPEAKER_00: But it's really important, and you know, we've gotten some criticism for this in the past, but we've been working towards getting this under eye study started with FDA.
• 29:34
  SPEAKER_00: And we all know FDA is not the quickest uh agency in the in the world, right?
• 29:38
  SPEAKER_00: No offense to them, but it just takes time.
• 29:41
  SPEAKER_00: And I think asking, hey, this cosmetic product, if it's used for anything other than topical applications, right?
• 29:50
  SPEAKER_00: What is the FDA status?
• 29:52
  SPEAKER_00: Is it has it ever gotten approved, you know, for anything?
• 29:55
  SPEAKER_00: Because as I was talking about earlier, at least if it's gotten FDA approval for something, then you know that it's been rigorously tested for both safety and efficacy.
• 30:05
  SPEAKER_00: But if it's never gotten an FDA approval for anything, and not to pick on exosomes or PDRNs or any other products, but you know, those have never gotten FDA approval for anything, right?
• 30:17
  SPEAKER_00: And so you just don't know really as thoroughly as you want to know, other than maybe topical onto in-tech skin.
• 30:25
  SPEAKER_00: But beyond that, you know, I I you just don't know what your what the full history, you know, might be or the full implications of what you're might, what you're doing, you know, might be down the road.
• 30:36
  SPEAKER_00: And so that to me, I I still, and again, coming from my history, think that getting the FDA approval is really important and that really gives you that sort of stamp of approval to say, yeah, this medicine, this treatment has been really well studied, not only in the indication for which it's approved, but probably more than likely for indications and applications well beyond that.
• 31:00
  SPEAKER_01: Absolutely.
• 31:01
  SPEAKER_01: That's wonderful advice, Dr.
• 31:02
  SPEAKER_01: Lynch.
• 31:02
  SPEAKER_01: And I just one last question to round out the interview.
• 31:05
  SPEAKER_01: I mean, regenerative medicine is such a promising field of medicine.
• 31:09
  SPEAKER_01: And I just wonder, I mean, in your view and looking at it at large, where do you think we're headed in the next 10 years, the next 20 years?
• 31:15
  SPEAKER_01: Do you think we're gonna completely reverse aging or where do you think we're headed?
• 31:19
  SPEAKER_00: I'm not sure about completely reversing aging in the next 10 years.
• 31:23
  SPEAKER_00: I hope so.
• 31:23
  SPEAKER_00: It would be awesome.
• 31:24
  SPEAKER_00: I would great.
• 31:25
  SPEAKER_00: But no, I mean, I think in all seriousness, I think we will continue to make advances.
• 31:30
  SPEAKER_00: You know, we've been talking for a decade, maybe closer to two decades, about regenerating organs, obviously the skin being one organ, but other types of organs that are now in short supply, you know, that we have to transplant and so forth.
• 31:45
  SPEAKER_00: And that would be my holy grail, right?
• 31:47
  SPEAKER_00: That's where I would like to see us get to.
• 31:51
  SPEAKER_00: There's we're a long ways from that.
• 31:53
  SPEAKER_00: I don't think it'll happen in the next decade, but I think we will get incremental steps.
• 31:57
  SPEAKER_00: She do you know that diabetic foot ulcers are still today the leading cause of amputation in the United States of America?
• 32:06
  SPEAKER_00: Isn't that crazy?
• 32:07
  SPEAKER_00: Yeah.
• 32:08
  SPEAKER_00: It's crazy that a wound that we can't get to heal is still the leading cause of amputation in America.
• 32:14
  SPEAKER_00: Like we have got to change that.
• 32:16
  SPEAKER_00: And I think we can change that in the next decade.
• 32:20
  SPEAKER_00: Like we can figure out how to heal those wounds better than we are right now.
• 32:24
  SPEAKER_00: And the same with bed sores and you know, pressure injuries and that kind of thing.
• 32:28
  SPEAKER_00: I think those kinds of specific skin wounds, I think we will get to much better treatments over the next decade.
• 32:37
  SPEAKER_00: Whether we get to anti-aging or you know, regenerating organs and that kind of thing, maybe we'll make some incremental progress along the way.
• 32:46
  SPEAKER_00: But you know, that's probably gonna take probably longer than a decade.
• 32:49
  SPEAKER_00: But think how far we've come in the last decade or two.
• 32:52
  SPEAKER_00: Yeah, medicine overall, right?
• 32:54
  SPEAKER_00: We made huge advances in in medicine in general over the last decade or two.
• 32:58
  SPEAKER_00: So maybe regenerative medicine will really take off.
• 33:02
  SPEAKER_01: Absolutely.
• 33:02
  SPEAKER_01: No, this is so exciting.
• 33:04
  SPEAKER_01: Your work is so phenomenal.
• 33:05
  SPEAKER_01: It's so exciting to see and and watch, you know, this happen because I think for young scientists, for young practitioners, it's really, really inspiring to see like medicine evolve like this.
• 33:15
  SPEAKER_01: For so long, we've been studying the textbooks that tell us like there's nothing, you know, there's nothing you can do and just accept it for what it is.
• 33:21
  SPEAKER_01: But this is really, really exciting.
• 33:23
  SPEAKER_01: So I thank you for your time and for your knowledge.
• 33:25
  SPEAKER_01: It's been wonderful.
• 33:26
  SPEAKER_00: Well, thank you, Ecta.
• 33:27
  SPEAKER_00: It's it has been wonderful.
• 33:28
  SPEAKER_00: I've enjoyed it very much.
• 33:30
  SPEAKER_00: Thank you.