10 years ago, and I'm going to show you why you just want to open up a package and give an allergy injection. So, I have not, I don't have any ownership whatsoever to the two types, but I have to show you, of amnion that are there that you're going to see. So, the first thing is, why are we here? You heard yesterday, you know, it's all up at age 13. The biosynthetic activity of isolated chondrocytes is over at age 13. So, we're all on the downhill. So, we're all looking for the answer. And the advantages of the amniotic cells, I will tell you, they're highly plastic. They're capable of differentiating into major different lineages, as you know. And you heard a lot about it yesterday. I'm not trying to use the word stem cells or MSCs. Here you can see, though, compared to study of bone marrow aspirates, there's a higher concentration in that younger child that can provide it than any bone marrow aspirate that you're going to pull out. The growth factors are 10 times more potent in the concentration of it. There's a low immunogenicity, and it facilitates tissue regeneration. It contains everything that you want, whether cells are important or matrix components or growth factors are important or antimicrobials, if you believe in infection, or tissue remodeling. So, it's all there, and it's rather easy. And it will modulate, as it says, cytokine and growth factors and it does do it in an anti-inflammatory way. So, if you need an animal study, they're great. The human studies aren't. That's why we're here, and we're learning together from each other. But here you can see amniotic stem cells versus a bone marrow aspirate in horses, faster return for the horse, and less re-injury was seen when injected in amniotic stem cells. It's a greater proliferative capacity. Whether you like tendinopathy, same idea. You can use it. You can use it with ultrasound or not. You're going to see. I'm an old guy, so I'm not even going to use the ultrasound here. And so, the point is, great healing potential for these amniotic stem cells. Do I understand it fully? No. That's why I'm excited to hear the researchers. And if you want real science, here's a RADOA model, and it went through a cartilage degeneration and then regeneration process with this micronized, dehydrated human amniotic and chorione membrane. The problem is, there's so many out there. And the problem is, there's no one really telling or regulating it, knowing, are they different? What's being offered? And which factors, growth factors, make a difference? And that's why it's great, and Brian's group and others are trying to really look at these things, and they're looking at it in different experiments. So, we are involved in many clinical trials in some of these as well. So, one type, there's two companies I'm going to show you, tell you, you have to have it in a deep freezer. So, it has to be minus 65 degrees, so they'll give you a deep freezer in your office. And you take it out of your hand and you give it to the patient, so they're so excited, and maybe you're getting your 30% placebo effect, and they're warming it up, and then they're going to hand it back to you, and you're going to aspirate the CCs. What I have learned in this company, you need volume of it, 0.5 CCs really doesn't cut it. And so, it's one CC, it's more expensive, this one, than others, I'm going to tell you. And so, you can inject it. Here you can see, it was injected, someone wanted it in their allograft, I'm in New York City, so they tell me what to do, they said, you need to, after you're finishing this, please inject this into my knee. I said, okay. So, we do that. What else? There are times that that company for arthrofibrosis, if you're doing a total knee, or you have other problems, you can place this membrane in, you can place this membrane in, and the idea is, this is used a lot in one of the hospitals in New York City, and they do it, I guess, because they have a high rate of arthrofibrosis for total knees, but they're doing it here, and you can enhance the decrease of the scar tissue when they're placing it. So, there is a way to help it intraoperatively. More exciting is, there's another way of dehydrated intact cells, and this is in the office. The idea is that you want to stimulate the body's response to bring its own healing, and so, here you can see, drawing from the local MSCs of the tissue injury, here you can see, and again, I don't have any kind of financial tie, different milligrams they sell it in, 40, 100, and 160. You just take it out of the refrigerator, and here, you open up the package. This is a how-to video, right? And so, we're going to open the package, I'm going to place in, and so, they'll tell you you want to use saline. I'm a disruptor, and I heard the talk this morning. I think it's all baloney. I've used Marcane for years. It doesn't make a difference, and I can show you, then, the results, because we have to classify it. So, I reconstituted, because it hurts, and I've had injections in my knee. I've injected it, full disclosure, into my own knee, because I need a uni on my medial side, and so, you're going to reconstitute two and a half milligrams of this. You have to use, and there's the betadine site. We never trained with gloves 25 years ago, so why am I going to do that? So, I'm going to use betadine, an alcohol swab. I'm going to freeze the skin, because I want to be nice. I'm going to take a 25-gauge needle, put some lidocaine on a wheel, as if I'm doing an arthroscopy of the knee. The leg is hanging over the side. I'm going to, then, inject. That's the lidocaine on the left, and that's placing the seat. You need about a 22-gauge. If you've ever injected yourself, I'm good for a 25-gauge. That's it, and then, you're placing it in, whether it's medial or lateral, and so, the bigger question is, what do you do afterwards? It was asked last night, so when I started doing it about four years ago, I was told that I had to do crutches, and I don't know why I did it. I don't any longer, and you heard Brian answer it yesterday on the panel. I was saying, well, a dentist doesn't let me eat on that side, so when he fills a cavity, so I'm going to protect it. I don't know that it makes a difference now. We're looking at that, as well. I do want to tell you, and someone said it, it does hurt. It's very interesting, the day later, and so, the description by a Chicago doctor, who does a lot of them, who turned me on to it, it's not Dr. Cole, said, you know it's a war against the good guys and the bad guys, and so, I do give them two or three narcotics tablets, because I don't want to call at two in the morning, and I had it myself. It's very interesting. The more arthritis they have in the knee, the more it hurts, and then they say it's better after the 24 to 36 hours. I do avoid anticoagulants, I do, and then we go back on a rehab program to hopefully make them better. Here's interesting, so you can see something I followed. This is one of our studies. Pre-injection, a lady came in, 19 months, look at the T2. That's a patella tendon that I don't care what surgeon you are is going to get that better, and I didn't know what to do. That's not just an isolated patella tendinopathy. That whole tendon, she went to really smart people at the other hospitals in New York City, and they tried rehab and everything possible and steroid injections, and I said, I really don't have an answer. I called a lot of friends around the country, and I followed her, that's why you can see these, and got her in a study at four months, seven months, and 16 months, and if you look, she was injected directly in the tendon with this stuff, and suddenly now you see the recuperation. I'm not buying that if I waited another 19 months, she would have been fine. That's a long time. We did put her on crutches at first for this one and got restoration. I don't understand the science. I'm the first one, and I tell my patients that I'm not gonna lie. I say I have great animal studies. I'm waiting for smarter people to help me for it. So if you wanna, so to speak, walk on water, that's why you're here today. There's great safety and efficacy for tendinopathy and knees. You need to manage your patient expectations, please. I don't have the optimal concentration, and all these adjuvant therapies may be helping. Maybe that's the answer, but I will tell you, PRP, I do use Stihl for the elbow, and I wanted to share something. Way up, Lee. Way up. Echondylitis. I want you to tell me, what's the best method? You snotty little bastard. Your Honor, I'd like to ask for a recess. I'd like an answer to that question, Judge. The court will wait for an answer. We've listened to the other speakers spew their garbage about open surgery, arthroscopic surgery, silly muscle flaps, and injecting various bullshit yet nobody seems to know what is the best way to treat this. Dammit, Colonel, I wanna know, what's the best way to treat tennis elbow? You don't have to answer that question. I'll answer the question. You want answers? I think I'm entitled. You want answers? I want the truth. You can't handle the truth. Thank you. I mean, there's a lot of discussion. I think I saw Gloria. There you are. Good. I'd be interested in your comments on this if you wear two hats or several hats here. But so many will say that the cells don't necessarily matter. So while there seems to be a narrative about the viability of the cells, the presence of the cells, and the cryopreserve, these are only prior-preserved products. The others are, my understanding, are pretty much decellulized. Anything that's been, is anhydrous, micronized, other is decellulized by the very nature of the preparation. That is correct. So only talking about cryopreserved techniques. So what I've been told, and we've looked at very provisionally, is that these cells are very sensitive to the thawing. They're very sensitive to the needle, going through a needle. And viability may or may not be in question. And the ultimate clinical efficacy may have nothing to do with the cells themselves. So you'll hear a lot of dialogue about all these techniques about, well, maybe it doesn't have an MSC, maybe it doesn't have this, but the efficacy doesn't always depend upon some of the things that we like to think it may, that it's related to. So I guess the basic question is, should we, do we know enough now that we can confidently say that the discussion you had should include the value of the cells? And where are we right now? What's the narrative going on from your company as well? So I'd like to hear from both of you guys. Yeah, before Gloria. So I was asked to present on amniotic stem, so I purposely brought two different things. One was the cryopreserve that you see, you need the minus 65 degree refrigerator. And then there was the micronized cells where there aren't cells and asking the cells from the body to come in. And so a full disclosure is I have changed because we are gonna be publishing the cryopreserve that we didn't have as much success as we are having with the micronized. And so they claimed, one of the companies, again, I haven't seen it, that they looked at all the different various companies as I showed you the various ones and at that time counted cells. And I don't know if cells matter, MSCs, and felt that there really aren't many cells in the cryopreserve when they opened up the packages in the lab. And so I don't have an answer for you and I'd like to hear Gloria from ORS. So Gloria. Thank you. So the truth is we don't know what the mechanism of action is that has this effect. And so there is a lot of work looking at that. We do know that the material itself, with or without live cells, is a stem cell attractant. It tends to bring in cells to the area. It also is somewhat angiogenic. It sort of resets angiogenesis and a little bit immunomodulatory, although it's definitely not anti-inflammatory. I completely agree with your observation that it is painful. And the more painful people are, the better the response is there. And that's repeated over and over. One of the things that we have done that we haven't published on yet is looked at taking the, so the second product you showed is dehydrated and the cells are dead. So there's cells in there, but they're dead. So we've actually put live placental derived cells in vitro with the membrane to see if there's any difference in our bioactivity assays, which include a scratch wound test in vitro that shows closure and simulates a wound closure environment. And also in fibroblast proliferation and differentiation. And there's no difference with or without the cells. Now, that's not conclusive as to what actually happens in humans. So we're getting some biopsy tissues from diabetic foot ulcers to try to understand whether those effects are actually being seen there. So there's some things we just can't understand, but I think there's a lot we can. And so there will be more coming out in the next year or so to help elucidate. Do you have any approach? No. So they don't have, Brian asked what she was speaking about. Do they have a cryopreserved and they don't, but I will tell you there are a lot of happy people and it doesn't have to cost. So I'm gonna deal with you. The company is much more thought provoking in not bring high costs to this as well. Let me ask you that question too, sorry. And then others a chance to ask as well. You know, this is just an injection. So are you charging just for an injection or are you charging a premium because you're giving amniotic tissue? So I'm meeting my costs of the actual ingredient, you know, the amniotics of it. And then in, I work in New York City. So New York City is a little different than the Midwest. So charge a lot. That's what you're getting. So we say we don't have to cause everyone has too much money to get their hair done. So you're doing a service to them. So it's a service. I'm being happy to say, no, they, it's about 800 bucks. It's nothing. 800 for the entire thing? Yeah. For the injection and the stuff? Okay. And then one last question. There is a J code now for some of these for injection. Are you familiar with the language? And there is a code right now for arthritis, at least in Illinois. Could be J, could be Q for the stuff. And it's only applied, I think it was your, no, is it your company? Yeah. So can you help us with that? Is it state specific, carrier specific? And what do we got to do for proper coding? If you guys don't know it, that's okay, but. So for the guy in the back, when he's going to answer, I'll tell you we used that code and it pays us for the Blue Cross $1,700. We got a lot more money back. Right. So Gloria, where are you at with that? I'm actually going to defer that to my colleague, Tim O'Brien, who's our vice president of sales. Have you noticed a difference in those two products and their efficacy? Right, so today wasn't about the outcomes, and I apologize. Yes, I noticed that the efficacy changed, and I said I don't own both of it. I'm not a consultant for either, and I have switched to the dehydrated micronized cells at the present time. Yes.

amniotic cells

tissue regeneration

differentiation

growth factors

immunogenicity