Advancing Wound Care: Conference Insights and Surprising Data from Innovative Gel Treatments

[00:00:09] We are back to Health Unlocked: The Power of Salutogenesis with Jasen Petersen. Jasen Petersen, how are you? Not too bad. I'm muting my phone here because I always forget. Yeah. There we go. So yeah, I guess today's episode is going to be a little different and we are going to talk about that you went to this conference and I guess that's what we want to talk about. What was your experience there and there's a cool stuff that you want to share from there.

[00:00:38] And then of course, also give us a little bit. We'll also talk about a few other things you have planned in coming days. So let's start with, I guess, plain and simple, what conference you went. Give us a little overview so people know the stage is set and then we go into conversation. Okay. So last week I went to the SAWC, that is the Symposium of Advanced Wound Care, a conference in North Carolina. It was in Charlotte.

[00:01:06] And I got to present a poster while I was there. I think I showed that to you. Now, when I say I got to present it, it was a late breaking poster. So I didn't actually get to get up in front of lots of people and present it formally. I was more on the informal presentations where it was actually a really big room, much bigger than I had seen before, but maybe poster sessions are growing.

[00:01:32] But so it's basically a room within the convention center, a large room within the convention center that has posters all over it. And then for some of the time, all the presenters just have to stand there by their poster and then people wander around and look at posters and ask you questions and all sorts of stuff.

[00:01:51] So it was really interesting. It was the first. So I've, I've actually been involved in developing the data that gets presented more when I was in urology and looking at laser lithotripsy and that kind of stuff. But I was never the author before. So this was a different experience for me. Yeah. Interesting. Can you talk about what was that specifically poster wise? What exactly you were presenting? And also, how did you ended up actually getting to present? Talk about that too.

[00:02:22] Well, yeah. So actually I'll give you a little presentation on the poster. I'm going to have to read the title. Okay. So the title was real world outcomes of topical ionic co-factor delivery in chronic wounds, refractory to standard of care and equal 71. So what the N equals 71, that just means that the cohort was 71 total cases. And in truth, that's all the cases that we have documented.

[00:02:48] The mean age was 53.9 years old. I think a little bit more than 66% of them were diabetics. Well, here, I've got the data here. 76.8% had documented vascular disease. 57.2%. The severity was grade three or four.

[00:03:16] They've got a grading system to grade wounds based on their severity. And it goes from one to four. The entire cohort, or I guess not the entire, but almost the entire cohort had failed multiple prior standard of care interventions, or at least I said standard of care. Some of them could have been advanced as well. Advanced care, that is. And many of these wounds were headed towards amputation. We've talked about a bunch of the individual ones in the past here.

[00:03:44] But so here were the outcomes, right? So 82.6% mean wound volume reduction. What that means is if you were to look at the volume of a wound, you know, so height, width, and then depth into it, we replaced, or the use of the ion gel. That's the ionic cofactor matrix.

[00:04:14] It replaced a little bit more than 80% of the wound volume in 32.7 days. And they used just about two of the little tubes. So just over 20 grams. Just about 50% had confirmed wound closure. That was 35 of the 71 patients.

[00:04:42] And then another 13 or about 18% were suspected closure at the last visit. And about 25 or 18, about 25% of the people had partial healing at the last visit. And for 7% of them are 5%. We didn't really have enough data to draw much of a conclusion one way or the other, except for the fact that it was responding,

[00:05:11] which is already pretty amazing since all of these cases were non-responding. And there were zero adverse events, zero toxicity, and zero microbial resistance. Let's see, the wound types, there were diabetic foot ulcers, 22 of those, pressure ulcers, 17 of those, diabetic foot infections, 14 of those, just other general wound infections, which included MRSA. There were six of those.

[00:05:40] There was one burn and 11 other types of injuries. And I believe there was actually one death before closure, but that person actually died in a car crash, so it was completely unrelated. And so that's it. That's what I presented. And just so you can understand, that data is not normal.

[00:06:08] And so I guess one of the problems with the data is there is potentially survivor bias built into that. And survivor bias means, you know, I've got this great new drug and, you know, there are a hundred people that I give it to and, you know, it's trying to save their life from some specific disease. And 10 of them come back to me and say, oh my gosh, that worked great. And then the other 90. And if I only report the 10 that came back,

[00:06:38] well, I'm actually reporting the ones that it worked on. And I'm ignoring all the ones that it didn't work on. And so that's, that's actually, I mean, I know that that's a, one of the problems with our data, but that it's more because of how we've collected the data. Most of this data came from wheat free wound clinics. We've talked about how on the conservative side,

[00:07:06] where it actually makes the efficacy look worse for us is they don't, you know, once it gets close to being a closing the wound, they don't come back. And so we never get to see the end. But what, what we need to do is find some way to show that this actually is the expected resolution.

[00:07:30] And it's not, you know, all of the early cases that we had aren't kind of cherry picking themselves, if you will. So to try and resolve that to some extent, that's why we presented all of the data we had, every single one that we had, including the, what was it? The five that had insufficient data. And something actually that I just found out today,

[00:07:54] one of the doctors that is using this in Mexico. Well, let me put it this way. Somewhere between around 15 to 17 people within that cohort actually could be, so that subset could be a prospective study, still an observational study. So it's not looking at a control. It's not looking at comparison to anything else,

[00:08:23] but that's probably okay because it's still on wounds that weren't healing. So, you know, in truth there, the control is whatever else they tried, everything else that they tried. But so he has been collecting or has a release and the patients that come to see him, if they want to try this, they have to sign this saying, yep, I'm good to try. Now, they don't need an ethical committee approval or anything in Mexico

[00:08:53] because it's already an approved product being used for what it's approved for. So there's no ethics concerns there. But the fact that he has them sign something and then they start applying the gel and tracking it, that makes it a prospective study. And then there's no survivor bias. There might be a little bit because I think a handful, maybe three or so patients ended up not coming back for follow-up.

[00:09:19] But three out of 17 is actually pretty darn good. So here's actually, I apologize. I'm just talking a lot. Should I stop and let you ask more questions? Yeah, yeah, yeah. I want to ask, I guess this data is obviously like, first of all, great strategy, right? Instead of talking about everything else, show data, right? That's amazing. Well, how you, however you came up with that idea, that's brilliant because that's good. But I want to know the reaction.

[00:09:46] What was, like, because this data is kind of unheard, unseen of. So what is the reactions you got from, especially from the clinical community there? What was that like? To be honest, they don't believe it. They don't believe it. Right. So, okay. So on Friday, I actually sat through a wound innovation or innovation in wound healing something long. It was the entire day.

[00:10:15] It was kind of a whole cohort of people sitting down and hearing from doctors, from the FDA, from different regulators, from actually, they even had patients up there. So really putting all sorts of things together. And one of the things that really stuck with me, they were talking about how to put together clinical trials. And they were saying,

[00:10:41] look, we all know that there's no one product that can work across the entire life cycle of the wound. Okay. And they separate that into kind of the early wound where, you know, or the early portion of the life cycle where you would want to use topical antimicrobials. And then the middle portion where you're trying to get the wound to actually repair. And then the late portion where you're kind of cleaning it up and so on and so forth.

[00:11:10] And so kind of an aside here, they are, I mean, that is the CDR healing cycle. They don't recognize it as such. And they don't have very good definitions between the different stages. They just kind of put it as this continuum. And they know that, well, there's this early time, this middle time and this late time, but they haven't really identified that very well, or at least not in all the conversations that I heard from them.

[00:11:39] But remember, from their point of view, they're thinking of cratogenic drugs. And so I'm going to start talking about the CDR stages now instead of the wound life cycle. The cells are trying to do different things at different times. Sure. Cratogenic drug forces specific behavior, but the problem is the cells need different behavior at those different times. So again, from their perspective,

[00:12:07] a single drug cannot work across the entire life cycle because the cell needs to do different things. And the drug can only force one thing. I mean, right? The same drug can't force three separate things under three separate conditions. Now, you know, I'm not talking about adverse events, but... But which they're right, right? Because that's what they use. Yeah, they're right. Based on their experience, they actually are stating the right thing, right? Yes. So you agree? And so... Yeah, no, I agree.

[00:12:37] And so they went so far as to say, we should be setting up trials where you don't have to just test your product. And the guy actually used this as an example. He said, okay, so imagine the trial is set up like this. You use some topical antimicrobial early on. Then you use your product to get the tissue to heal. And then you finish with another product at the late stage.

[00:13:07] And that really hit home for me that, yeah, a cratogenic drug. This is part of the reason why wound healing is so hard. First of all, they haven't really separated those healing stages. Dr. Navio has with a CDR 1, 2, and 3. But when you get into wound healing, I mean, it's clear as day if you already know this. But if you're just looking at it from a wound healing perspective, they kind of blend together, and you don't have a real clear,

[00:13:36] this is when we want to use this drug versus that drug versus that drug. The CDR actually identifies that really well. That would actually help significantly. But this is so ingrained that they... I mean, they know that nothing can work across the entire wound cycle. Because there's no one thing that could cause or that could force

[00:14:05] three different types of or multiple different types of cellular behavior. Again, that's not how eyeball works. And so I understand why they don't believe our data. Because when I heard that, I went, I mean, for this entire cohort, that's pretty much all that was used for the entire life cycle was this one product. That's it. I mean, you know, some doctors still did debridement. Other doctors still might have used,

[00:14:35] you know, some of the fancier bandages, but probably not a lot. Because this was a free clinic or different free clinics and or free hospitals, public hospitals down in Mexico. So they're not using too much of the super fancy things. But then this also explains why so little works with wound healing. Yeah. Oh, and actually, I do want to tell you about there was in that wound innovation, there was a competition on the best wound healing products.

[00:15:04] There were, I think there were some 20, I think it was 22 total competitors. And they had four finalists that presented their product there. And one of them was a wound healing gel. And, you know, how all of these people talked about these things is, we know that most of this stuff doesn't work, but ours really does. And they all said that. And they all were trying to do little different things. This wound healing gel, by the way, was,

[00:15:34] they were basically combining hydrogel, which really just is, it is antimicrobial itself. So it keeps from becoming a breeding ground for bacteria. They were adding into it the ECM extracellular matrix from basically a scaffolding product from a genetically modified pig. And so the way that I've always seen these scaffolding products before, I think I might have explained it to you,

[00:16:02] but basically imagine they're taking the pig skin, and then they wash it with acid, and all the pig parts come out, leaving behind this extracellular matrix. And then that, they can lay over the wound, and it causes, I mean, it gives this scaffolding, that's why I've called such, especially when you're forcing cellular regrowth, well, now it's got kind of a scaffolding to keep it a little bit more ordered and structured.

[00:16:32] But so what they were doing is they were taking the ECM, and I guess chopping it up, and then mixing it into the hydrogel. And one of the questions they got was, so they didn't win, by the way, one of the questions that they got, but they, but they were one of the top four finalists. I really wish that I had known about this and applied. Yeah. But so one of the questions that they got was, is this scalable? And the answer was, oh yeah, we can,

[00:17:00] we can a thousand products out of one pig. And I realized that, holy crap, they're not, they're not like, you know, growing this pig skin and stuff in a, in a Petri dish. They actually have a pig farm with genetically modified pigs. And yeah, that, I don't know. That does not seem scalable to me, but, but this is, you know, kind of, this is like the state of the art. Yeah. But, but that, that was really interesting. In case you're interested,

[00:17:30] the winner was a product. It was actually looking at, um, a way to measure and track compression pressures for compression therapies. I didn't know this, but apparently they're up to 80% of the time. They either have too much pressure or not enough. And it's really hard to know exactly what the pressure is and what the pressure that you want is. So they won first place. And then the second place was, uh,

[00:17:58] actually using laser diodes. I thought it was really funny. They called them quantum well devices. And I went, you just need a laser laser diode. Um, but I guess quantum well device sounds cooler. Yeah. Yeah. Any, any conversation with any clinician? It was like, yeah, this is really sounds amazing. Any positive side where they were like mind blown or something and then wanted to have something to do with it? No, not, uh,

[00:18:28] not as much as I would have liked. Um, but I also was really trying to find out a lot more about the, the industry. I did have a long conversation with a doctor from the WCCC or you triple C that's the, uh, wound care. Oh gosh. I don't know what the other two C's are. Something consortium maybe. But, um,

[00:18:54] he actually talked to me long enough that he started to understand a little bit, but he also kind of said, you know, look, I kind of don't care how it works. If it works, that's, uh, you know, that's what I really care about. And he said, you know, if, if you're right and, and all of your data continues to hold up, then this is amazing. He's also the one who told me that up to 90% of, uh,

[00:19:24] patients get rejected from clinical trials specifically for wound healing. Basically. And he, and he started, he was assuming that I was doing the same thing. And he said, look, I understand, you know, exclude people from your testing that are, you know, gonna are likely not to heal. I understand that, you know? And, you know, so he went through this whole process and I was like, huh, wait a minute. So you're, you're telling me that for wound healing devices or products,

[00:19:53] specifically like diabetics, you're going to exclude diabetics because they're unlikely to, to heal. Well, I was like, well, isn't that like, this didn't make any sense to me. And I had to come back and say, yeah, no, I didn't exclude anyone on purpose. Yeah. And he, he came back and said, well, I mean, okay, yeah, this is a retrospective study, an observational study. So it's, it's not the same as a prospective with the, you know, controls. And,

[00:20:22] you know, because when I say to you, yes, all of these things were refractory to standard of care, you say, okay, well, what care did they use? I don't necessarily know. Okay. So obviously that's a hole. Yeah. But I know that they were trying to, to heal the wound and couldn't, and they gave up. Um, uh, so he, he came back and he said, you know, if, if anyone ever ran a test or a study or a clinical trial where they just

[00:20:52] accepted everybody, now, obviously there are going to be some people that you have to reject based on, you know, the, the wound is so bad that they should be in an emergency room, not in your trial or something along those lines. And so there are some reasons that are always going to drop somebody out. But if the intent was to accept as many people as you possibly could, he said, yeah, that, that would be amazing. And his expectation is that the data wouldn't be nearly as good. But again, remember,

[00:21:23] Oh, actually maybe I should explain it this way. So there is, I got to look at the name because I forget. Okay. So there's that something called the Kaplan Meyer analysis. And it's built for, so it's a, it's a process of, or a method for answering how long until a specific event happens when not everyone finishes your study. And so it's built for exactly this kind of situation where some patients drop

[00:21:52] out and then some are still healing at the last visit. And, you know, others have like a short observation window. The KM analysis handles all of that, honestly. And so I, I didn't do this for the poster, but I've, I ran that for our data set. And I think it showed a median time to closure of 34 days. So what that means is that for any, any patient within that data,

[00:22:22] they had a 50% chance, 50% probability of the wound fully closing at 34 days. Remember that was, that data potentially has, you know, so there, whatever, there were 71 total patients, right? But did we, or, you know,

[00:22:48] did the doctors actually try the gel on a hundred people? And, you know, 29 of them just never came back or, you know, a thousand people and a whole ton never came back. We don't know, but remember there's, there's a stub data set in there. Yeah. I'm still verifying this, but I believe that the one that came out of the IMS hospital, and it's, I don't know. I think I had a total of 13 of the cases. What?

[00:23:16] I think it's up to 17 now. In any case that might be prospective and doesn't have any dropouts. I ran the same analysis on those, on just those 13 that I had available. And the mean wound healing was 30 days. So pretty darn close. What that means is the data is probably pretty good. And also what's it, you know, the difference between 30 days and 34 days. Well, the,

[00:23:46] the IMS cohort didn't have really large wounds. And so really what you'd want to do is you'd probably want to define wound sizes, you know, small, medium, and large, and then separate those with your KM analysis. Because obviously besides all of the other variables that are bundled into that analysis is going to be, one of them is going to be the initial size of the wound. Obviously the larger it is, the larger it's going to take to, to heal regardless of everything else. So in any case,

[00:24:17] that's, that's really exciting to be able to see that. Yeah. And, I guess out of the conference, what's the biggest takeaway for you to where you want to take it next from there? Well, the biggest thing I learned is that truly everything in wound healing kind of sucks. I mean, you know, and, and the, the things that people are using are expensive and weird. Like with the, the,

[00:24:45] the genetically modified pig parts within the hydrogel. I was kidding. What is that? It's pink, a pig farms. That's what it is. Yeah. And you can't even like, you know, sell the rest of the pig because it's genetically modified. I'm not sure that people would want to be eating that. So yeah, I'm not, I'm not sure how that's going to work, but the, at least for,

[00:25:13] for ionic Alliance foundation, probably what we really need to do is figure out how we can fund a study that is prospective. And, uh, I've actually, I would, I would still have it be a kind of a, a Kaplan-Meier first study, still have it be observational. So not, I guess, as strong as a placebo controlled study or anything like that, but that's going to get a lot more expensive, you know,

[00:25:44] the double blinded and all that kind of stuff that will get a lot more, a lot more expensive. And, uh, but figuring out a way to actually fund this, right? So remember, before we started this process, we had a whole lot of anecdotal data. And we had to make the decision, okay, we've got enough money to develop this into a product that we can go get real data,

[00:26:13] not the gameable data for bench trials and all sorts of stuff. So real data, real clinical data in Mexico, or we could go the route of just continuing to collect the data to where we could then attract somebody for funding, you know, being a nonprofit and wanting to actually help people. We decided that, you know, we've got something that is really safe. We believe that it can work really well. But remember at the time,

[00:26:44] uh, we didn't know how well it was going to work for wounds. We knew it was an incredible antimicrobial. That's what it got approved for. So we knew it was going to be really good at that. And we figured, well, if we can help people sooner rather than later, why don't we do that? And then we can figure out the funding later. Turns out the wound healing ended up being better than anyone had ever seen. So the point where it's hard to believe the data and then the assumption really has to be, well, since I know that nothing can actually do this,

[00:27:13] there must be a significant amount of survivor bias in all of this data. We don't believe so, but I can't prove to you that there's not. Except maybe with the data that were the subset that is a potentially a prospective portion. But so now we're kind of stuck in a situation of, we really need to run this type of a study so that anyone will believe the data and investors will believe it's known and so forth.

[00:27:41] And we need that to attract either doctors for using it or an investor to invest in it so that we can bring it to market and get it to lots of people. But there's a chicken and egg problem there. We need funding to run the study. We need the study to get the funding. And we're already past the point of where you would normally get the early funding because we've already got a product approved in Mexico.

[00:28:11] So we're kind of in this weird limbo. And that's, I guess that's what I have to figure out. And that's where I want to see if D-Sci can, decentralized science can fill that hole. And if it can, that would be awesome. Yeah. Okay. Yeah. I mean, on that news, remember we talked about that, the wound care company I was showing you that I know from that was here in Pittsburgh. And they had, they were using the fish,

[00:28:41] fish, I guess, fish sales. And in that thing, they got, they had the similar, like, of course, it's wound care. Anything you do, you need a lot of funding to really bring the product. You have to just cross all these studies. Right. And this is the same thing I saw with them, but I saw that they got into yesterday. They announced, I guess they're calling it a collaboration right now with Cardinal, Cardinal health. And they,

[00:29:10] of course, have their health side, but they also have ecosystem of, especially on the wound care side. And so they are trying to, I guess, fund their, under their umbrella and see how that can work. And so I, that's not a typical venture arm. I don't think that's a typical venture capital kind of collaboration. This is more like,

[00:29:36] more like this product can help and become so much valuable and Cardinal health understand that. So they are, so they have built this, their wound care, whatever they have built in, they're trying to help accelerate with whatever needs to run those, I guess, research development that's going to happen. So I can, what's your thought on that kind of partner? Like somebody like, well, that would be great. The problem is that costs money, right? So they're getting paid for,

[00:30:06] for doing all of that work. Um, who is, and who is the, the, the, the, uh, did you say Cardinal medical? Cardinal health. Oh, Cardinal health. Yeah. So they would be getting paid for running the clinical trials. Wow. And, you know, and that's actually, I, uh, I heard lots of discussions with hospital groups walking up to, you know, different vendors saying, Hey, we, you know,

[00:30:32] we can run all of your clinical trials and yeah, that's, that's actually a big deal to, to hospitals. That's, uh, that's how they can make a bunch of money. The problem is I'm a nonprofit without a lot of money. And so I need to find a partner that will be willing to look at the data we've got, realize that this is an approved product in Mexico.

[00:30:58] Remember bringing it to the U S especially with an IRB or the internal review board is fairly easy. Bringing it to the U S as a class one device and not claiming that it's antimicrobial is also pretty easy. Mm-hmm. You know, so having someone who could look at this and say, looks like this actually will help my patients a lot. I'll go ahead and run a study for you.

[00:31:24] Now I would expect them to do a real small pilot to prove to themselves that, yeah, this is real. Um, and then after that, okay, do you want to, do you want to actually do something that will really help people or do you want to make money? And the, to be honest, even if we can't pay them upfront, I would be more than willing to enter into a partnership with someone where we can pay them afterwards. But again,

[00:31:53] for them to ever accept that they would have to have seen it work. And that's, that's the situation that we're getting into in Mexico. Now, lots of the doctors are actually seeing it work. And remember, almost all of the, the use in Mexico is really just word of mouth. Yeah. Yeah. Yeah. And then is there nobody based on, because this is also real market data, right? Again, I go back to this, like, are there,

[00:32:21] the ecosystem does not exist in Mexico to support this to further along the line? Like, okay, you know, even capital wise to, well, so no, it does. And actually we, so they say in April, but who knows when we'll actually get it. We should be getting another 30 cases from Dr. Cardenas in the, he's the IMS hospital system. Now his data is, you know, it's tough. It's all observational. And cause it's a, it's a free hospital system. So, you know, he doesn't have much time.

[00:32:50] We're not paying him. So he can't, can't assign staff to this. He's collecting the data that he can collect in the time that he's got. And, you know, if they sign this piece of paper that says, yes, I'll be part of this, he slaps the stuff on them. And hopefully he sees them again. There's another private hospital that is also running things. Now, the data that we get out of that should be much stronger. And that should be basically just much stronger perspective data there.

[00:33:18] They have a little bit more time and a little bit more money to do this. So yes, it does exist. One of the concerns that we might run into is that everyone in the U S is just going to say that came out of Mexico. So I don't really believe it. Even though it's a real data, but it's kind of everywhere. They might not be using the multi thousand dollar per application things.

[00:33:45] And I doubt like hyperbaric oxygen probably isn't used very often in Mexico. I, I suspect that Regranix isn't used very often. Remember Regranix was the drug, the tissue growth factor drug because it was, I mean, it's, I don't know, a couple grand per, you know, a little 15 gram too. Um, and they just, they don't have the money to be able to do that. So really, uh,

[00:34:15] and you can argue that, well, that was our mistake from the get go. We chose to help people first. Yeah. And to prove this second. And that's not the way that you're supposed to do it. And that's why it's now somewhat difficult for us. And even if we've got this thing that, you know, is really the output is too good to believe, but you know, from,

[00:34:44] from our perspective, we've seen it over and over and over again. Oh, and by the way, so the, I've been kind of personally tracking everything that I have been involved with. Yeah. Now, obviously that's not, that's not a formalized study, but it's, it's, uh, one of the ways that I can deal with this survivor bias issue kind of personally. Right. So, you know,

[00:35:10] when I've seen it on every case of psoriasis or eczema that I've ever put it on myself, my family, friends, and, uh, and remember I gave it to, you know, one lady that I didn't know, the results were amazing. Um, same thing with the, like, you know, pink eye, I understand that's not a wound, but, um, it for, uh, you know, uh, well, I guess all five of us, my entire family, it took, uh, what's pink.

[00:35:39] I normally take seven, seven to 10 or 14 days to get through normally. And we all got through it in, uh, you know, two to three days and I never got it. Now you could argue, well, my entire family is, is genetically very close to me. So maybe we were super responders, you know, except for my wife. Um, you know, but at least I've got some way to, for myself, be able to say,

[00:36:05] I've seen incredible effects pretty much every single time that I have been directly involved in somebody getting this. Yeah. So I can say with confidence for myself, this works incredibly well. Yeah. I understand that if I'm asking you to invest, you might not like that, but I guess that's, that's where we're at. Uh, you know, we chose to try and help people first. Yeah.

[00:36:34] Rather than, you know, set up a company to that could be, you know, a billion dollar company. And, uh, and now we're trying to figure out how to continue moving forward without going broke. Yeah. Yeah. All right. Okay. I guess, you know, that's been the kind of, that's what we are kind of fighting in healthcare, right? That, that, that layer in is the, unfortunately,

[00:37:02] the story that too much of a control is on the pharma side or insurance side. And it's like everybody else is just, uh, trying to work for them. That's how it feels. That's how it feels. So even, even, uh, you know, talk about cost in, in the U S actually. So just recently, the reimbursement allowable, I think,

[00:37:28] was it in Medicaid or Medicare for wounds has dropped significantly on a, on a per, uh, area basis. And I might be misquoting some of this. I, I won't, I won't, uh, quote any numbers here, but that is perhaps going to make some of the really expensive products. They're not just going to lower their prices. They're just going to pull them off the market. Um, so that might end up being a really big opportunity for us, but also remember,

[00:37:58] uh, you don't, I don't know, with, with insurance, it's, you don't just like, um, create a price. It's not, it's not like normal market, uh, dynamics. Actually, here's a good example. Another question that the, the pig hydrogel people got was, okay, let's assume this works really well. Is this going to be priced to the point where people can't afford it? And his response was, well,

[00:38:26] that's not the way that that's not the way pricing works. It's going to be priced based off of whatever, you know, insurance is. And it's, you know, it's a couple hundred dollars per, uh, centimeter squared or something like that, you know? And so he's like, you know, so in the end it'll all be about, you know, a couple thousand dollars. Um, but, uh, you know, so even if our product can be significantly less expensive, so like in Mexico, that's great, right?

[00:38:54] It's actually affordable enough so that it can be used in Mexico. And it's better than these, you know, thousands of dollars, uh, you know, the competition that's thousands of dollars, but in the U S it's going to be priced at what reimbursement is. Anyways, now, not necessarily to us as the manufacturer, but the price that the end users see. And that's, so I agree with, you know, the whole insurance thing,

[00:39:24] all of this is a little bit frustrated. The good news is, I guess, you know, the government looked at this and said, yeah, we're done paying so much for all this stuff. We're going to reduce the, the reimbursement dramatically. Yeah. Which is now most of the industry, what's happening is they're complaining, Oh, well that's just going to make care away, you know, nowhere near as good. Right. Because now it doesn't make sense for, you know, us to develop these super fancy,

[00:39:52] whatever pig part treatments. And, you know, so hopefully we'll be able to step into that hole and really, um, end up treating people better than they were ever being treated before. For, for dramatically less money. Yeah. That's, uh, yeah, that's where we are. I guess before we conclude this conversation, so what's next coming up for you, I guess, uh,

[00:40:18] you're going also to American Diabetes Association conference. Yeah. So the ADA accepted, um, a poster as well. And basically in that one, what's that one or it's different. It's the same that you presented there or? No, no, no. It's, it's a, it's not the same poster. I mean, it's, it's similar. Sure. But, uh, it's a subset of just the patients who are diabetic and,

[00:40:45] or the original abstract that I submitted was just the diabetic foot ulcer and diabetic foot infection. And then, you know, if I, if I can get the information back from Dr. Cardenas and show a subset that was a prospective, that would actually be great because then, then you can't say that there's a survivor bias built into that, right? I could extract that out and show that, look, the data is actually pretty darn close to this subset,

[00:41:13] which has no survivor bias and the entire thing. So we don't actually think there's much survivor bias in this. And then on top of that, the, the KM analysis, basically what that allows you to do is take the data when you've got it. And really it's just, you know, whatever your event is. And for us, that's wound closure. So how close to wound closure have you gotten? What percentage? And the time, that's it. It's all you really need.

[00:41:42] And then it doesn't matter that they come in at routine times. It doesn't matter how often they get treated. It doesn't matter if after, you know, three treatments that you just stop coming because you've got that data that you've got. And then you just don't have more data from that same patient after that point in time. But it allows you to layer all of the stuff together and give a projection of

[00:42:09] probability to the event, which is wound closure. So probability of full wound closure at different times. And then that is a publishable metric. And again, if I can show that there's no survivor bias in it, then people really have to start paying attention because there's nothing else that will come close to showing what we're showing. Yeah. Yeah. Yeah. For all sorts of reasons that I'm putting into a patent,

[00:42:40] but yeah. That's a different thing. Yeah. Yeah. We'll talk about that too, I guess in one of the episodes where, where that stands, how that's going. And I know you're expanding it, right? The patent is, that's what, that's, that's what you're trying to do. You only have a patent. Yeah, actually. So, um, I think while I was there, I told you that our initial claims have been, what did they say? Approved or accepted. So they're actually issuing the patent, uh, the 21st. So like next week.

[00:43:09] Nice. Yeah. So next week we'll, we will get, uh, and, um, an issued patent in the U S I've got a continuation on top of that. Um, and it should be, that should be relatively straightforward. And then also a separate provisional or I'm sorry, a separate patent that is not a continuation that kind of layers onto the top of it. It's more about how and why you would use eyeball,

[00:43:37] what it's really doing and why in different situations. And once I've got that submitted, then I really want to start talking about it as much as possible because I don't want this to be seen as, and to be clear, I'm not getting these patents to make sure that nobody else can do this. I'm actually getting the patents to try and entice people to collaborate with us.

[00:44:06] Yeah. And we can bundle the IP together and say, here, you know, we'll put this into its own entity that is fundable on its own to tackle whatever. Psoriasis. That's a huge market. And, but you know, how much do I know about the, that particular domain? Not really a lot. And do I have a lot of drive for that domain? No, not really.

[00:44:33] So I would much prefer to find experts or people who really feel strongly about that, you know, any individual domain. And if they've got research that, that actually adds into it, great. We'll file more patents that can layer on top of our patents for that specific indication. And you know what? You run with it. And you know, that's, you can do a better job than I would be able to do.

[00:44:59] And I can't focus on multiple different companies at the same time anyways. Right. So I'm focusing on this wound healing one. Now I don't want to run this longterm. Yeah. Um, you know, I'm having to learn all sorts of things about the wound healing industry, but there are plenty of people who already know all of this and already have all of the networks and contacts to be able to really do something well with this.

[00:45:24] My goal is to try and get eyeball to as many people as possible through as many channels as possible and target as many indications as possible. And that's much better to do through multiple entities rather than a single one. And that's the whole idea of the Ionic Alliance Foundation. Ionic Alliance Foundation takes the IP, bundles it into a little thing, pushes it off to an entity, and then we can let somebody run that entity.

[00:45:50] And that allows us to really do all of this stuff in parallel. Whereas a single company, unless you're jimongous, you really can't do that. Yeah. Yeah. And that also lets, you know, the, you know, let's say we did put together, um, you know, an entity for psoriasis. It allows you to,

[00:46:10] to sell that entire company with the license and everything off to some larger company that's already treating psoriasis everywhere. And, um, yeah, so that, that's kind of the ultimate goal here. Yeah. All right. I mean, um, of course we'll talk about this more in the coming conversations. Sure. But this is, well, this was good. I feel like, uh, I know it's never,

[00:46:39] it's not like always ideal to, you know, how you went there, but, uh, but I think it still was a good experience overall going to this and opens new ideas and what you got to do next. Really gives you clarity on that. Yeah. Actually, there is, uh, I just noticed something in my notes that I didn't mention that I think is important. One of the things that I learned in that, uh, wound, wound care innovation, uh, uh, thing that I sat through. Yeah.

[00:47:08] Is it? 25 to 50% of chronic wounds never heal. Never. Never. That blew my mind. Hmm. Yeah. I didn't know that. So again, look at our data. We have not found a single instance where it didn't respond. Now I can't say they all closed because we didn't get to see the closure,

[00:47:36] but we did not see a single one where it did not respond. Now there were a couple of times where it was used on someone who wasn't a diabetic and they put it, they didn't actually follow the instructions and they put it directly on the wound instead of around the wound. Um, and it's done in which case they didn't want to use it again. Um, and so we never saw anything but the, or the doctor never saw anything but the very first thing. And then the patient said, yeah, no, I don't want to do that again. It's done.

[00:48:07] Um, cause remember for the instructions for use actually say, put it around the wound until there is a scab, then you can put it over the entire top. Again, for diabetics, they don't feel the stinging. They have lost sensation anyways, so they can put it directly on the top. And that's why, that's why there's, uh, such, such great efficacy for them. Got it. Okay. Yeah. But yeah, that 25 to 50% of chronic wounds.

[00:48:36] Maybe a reveal. Yeah. Bigger number than I anticipated. I thought probably like maybe 5% at the max. That's yeah. I mean, yeah, you think, but I, I mean, I guess that's, that's what chronic wounds are. Yeah. That's why they're chronic. Yeah. We can't heal it. Yeah. Wow. Well, that's a good, a good tidbit. You added fact trivia, I guess. So thanks for sharing it. This, uh, this has been great again, Jasen Petersen, much appreciated and we'll be back next time.

[00:49:06] Thank you.