Phil Cole 0:05
Hello, and welcome to class solutions dental education Podcast, the podcast series where we share knowledge and experience to provide value to you and your dental practice. I'm your host, Phil Cole. And today's episode we'll be talking about pH balanced, a new anesthetic for patients to experience less injection pain, less waiting and reliability, more reliability, I should say. And I'm joined by Dr. Scott Keadle, who will be sharing his thoughts and given us a better explanation of what is about to come. So welcome Scott to the podcast.
Scott 0:41
Thanks, Bill. It's, it's an honor to be on here with you. And good morning from Charlotte, North Carolina.
Phil Cole 0:47
Yeah, a little bit nicer weather there than what we have here in Michigan. But that's alright, I'm jealous. Tell me, give me a little bit of information about yourself so that people can can understand where this is all starting from?
Scott 1:04
Sure. Phil, I was a practicing dentist for about 30 years. And I obviously was like a lot of dentists that that, you know, felt like our injections. You know, as much as we try to be gentle, we try to use all the right techniques, all the devices, all those kinds of things, we were still getting, you know, a little bit of injection pain, we're still getting a weight, you know, especially on the lower jaw in order to try to get a tooth known. And, you know, a lot of times, they wouldn't get numb on the first time. Especially if a tooth is inflamed or infected, of course. So for all those reasons, you know, I had always wanted a better anesthetic and wonder why we couldn't have a better anesthetic and I got to talking to my brother's radiologist and he was telling me he he's he works at the VA and they buffer their shots, when they when the NAM skin and by buffering by 1000 times more acidic than human tissue and an injection up to the body pH before they put the injection in. So now it's a neutral pH and it doesn't have that acid in it. And that really cures a lot of those side effects that we see from the acid where it no longer has that acidic sting. It no longer has that delay while you wait for the for the hassle to go away. And again on on hot teeth, it it is more likely to work. So you know, that caused me to eventually invent a dental cartridge, just a standard dental cartridge that had a little tiny chamber inside of it. That would hold some sodium bicarbonate powder, which is baking soda. And when the Lidocaine drug then mixes with the baking soda at the last minute as you as you put the cartridge into the syringe, it's just automatic automatically mixes so it's just like a normal cartridge for a dentist or dental hygienist. They wouldn't know the difference. And then they're they're using this pH balanced drug that just works a lot better. So we have a patent on that. Two patents actually. And now I'm, I'm retired from dentistry. And for the last couple of years, I've been CEO of a pharmaceutical company that is developing this drug and we're trying to get it to market.
Phil Cole 3:52
Excellent. So I guess you've kind of explained a lot about the product already. But what's what was Was there something that was had just happening to you way too many times? Or was is this also you heard it from a bunch of other doctors that makes you this product so important to you. And you know, when why it was worth solving?
Scott 4:18
I'd tell you I always knew it was worth solving. I didn't really realize how, how big the problem was, I guess. I knew it was worth solving. I knew I didn't like waiting on the on the patient to get no I know the patient doesn't like waiting. And obviously, there's no way to gently inject acid into someone's face, right? You can be as gentle as you want. You can use all the gizmos, but acid has asked and you can get around that. So it it's funny because it was sort of a challenge for my brother because I told him I said you know, Dennis, we don't have any way to do that that buffering process really a good way A. And he said, Well, you know, he was kind of being smart aleck, right? Because he's my brother. And he's like, Well, you're a smart guy, why don't you just invent a cartridge that that does this? And so, you know, I gave him the, you know, a hand signal and said, Okay, well, I'll give it a shot, you know. And next thing I know, I talked to an engineer, friend of mine, I showed him what I've drawn. And he said, let's, let's build a prototype. And we did and it worked. So it was, it was really a cool thing. So it's got goaded into inventing something, but but once I did, then I realized, I said, Well, you know, have I invented something that matters to anybody. So, you know, we went out and first thing we did is we just looked at the size of the market. If I asked you to guess how many dental cartridges are used every year in the world, what kind of number would you say? And I would have, I would have had no idea. So whatever you say is,
Phil Cole 6:06
yeah, I was just, I mean, I was just gonna say when when you have what 225,000 dentists in the United States, and how many injections you do per day? I can't I mean, that, would it get into the billions?
Scott 6:17
It's yeah, it's 2 billion every year in the world. Oh, my gosh, you think about 8 billion people almost. And in 2 billion injections. It's, you know, it's a lot of injections. You know, just in the United States and, and more affluent parts of Europe and Japan and South Korea, which is really where we're planning on putting this stuff 744 million units of dental anesthetic by our by our reckoning. So, you know, and you may or may not know about what they cost, but I'll tell you that it's about a buck is a dent? I didn't even know it was, you know, it, it turns out that it's about one quarter of 1% of procedure cost. So if you look at the cost stack, you know, for a provider, it's it's, it rounds to zero, right? It doesn't even show up on your p&l, right, and said that it's it's very important to every single provider, right, we just fundamentally don't do dentistry without knowing people unless it's orthodontics. And so getting that and getting it right, for a provider is just a huge thing. I know that, you know, I gave something on the order of 50,000 or so shots in my career. And I think every single one of them raise my blood pressure a little bit, because as a human being, you don't want to hurt anybody. Right? There's just no way to, right? I mean, you're gonna stick a needle in somebody, and that doesn't feel good. And then you're gonna put acid in there. And that doesn't feel good either. You can draw you want. And yes, I've had, I can hear it out there already, right? Yes, I have also had the patience and the times and all that stuff was added, even though you gave me a shot doc, and those are great. But there's also the times where they feel it. And they don't say anything, or they feel it. They do say something and those are no good. So it's a it's a huge market. Yeah.
Phil Cole 8:15
Well, I'm just gonna say I think that when, no matter what, you no matter how good of a shot taker, you are, right? I mean, you still have, which is always been in the dental industry, the patient that doesn't like to go to the dentist. And it's, I mean, wouldn't you say it's in the 90% above the what's the reason why you don't like going to your dentist, and it's because of that shot,
Scott 8:43
I would tell you that we do a lot of terrible things to people at the dentist office, including give them a bill at the end for all of it right. And when you add up all the everything else, and then you put the shot next to it the shot is is a bigger pain for dentists than everything else on the list. It's 58% was the number we got in our market research. So we when we went out and interviewed patients and then we went out and gave questionnaires to patients. We have an independent research firm do this and I'm glad to share that research with you. But But yeah, 58% of patients reported that the dental injection was the worst part of the dental experience.
Phil Cole 9:23
Which I have to say that I am surprised with that I would have thought it would have been easily in the 90% because that's what you always you know, that's what you always hear is a can it's either that or the high speed noise right? Noise and
Scott 9:38
noise the you know they report that the knee on my chest the smoke coming up bill that I got at the end the wait time in the waiting room you know these are these are all terrible things we do. We don't we try not to but you know we do and this was worth and all that put together. So
Phil Cole 9:57
yeah. So I know Oh, that being in dental for as long as I have been coming close to 24 years, the, you know, the the conversation of this type of a product or the idea of this, and there has been some companies that have never tried it has always been in the books. I mean, you always hear you would always hear people talk about the science books talk about this. So I guess, I mean, I'm know that most actors are listening are going to understand probably what it is, but just for those new doctors that I think are coming out and stuff. I mean, why has it taken so long? I mean, the buzzword is buffering, right? It's like you mentioned the beginning, it's buffering? Why is it taking so long do you think for something that has been talked about in the science books? I know when I talked to my doctors when I was on doing my routes and stuff. It wasn't something it wasn't something like, wow, this is brand spanking new. I've never heard of this. They've heard of it. Why is it taken so long? To? To come about why? I mean?
Scott 11:17
No, it's a great question. So let's, I'll give some of the some of the background. First of all, they know about it, because it's been in their textbook for a long, long time. The the the, you know, the most prolific textbook out there is by Dr. Stanley Melamed, who's a professor and, you know, kind of the guy, you know, in, in dental anesthesia is dental anesthesiologist, his textbook has had that in there. It's an unequivocal statement, you should buffer period into story. There's a ton of literature and research out there that supports buffering. It's, you know, it's it's it's settled science, right in like in medicine, particularly in in really in dentistry. There's been a couple of, you know, small studies that have not been able to show, you know, what we all kind of know, but but for the most part, all the studies have said the same thing buffering works. It's less painful, more reliable, in faster acting. So you got Dr. Malamud, Dr. Goodchild, Dr. Biggins, Dr. DeMarco, all these key opinion leaders in anesthesia I should mention Dr. Mark Donaldson who's not a dentist, but he's uh, you know, he's a pharmacologist, and all these folks, you know, say that you should buffer unequivocally. I'm leaving people out. I'm afraid I'm gonna get a doctor more. I mean, the list goes on. I know, I forgot somebody, but I'll give you a call later, they will ask, if you ask any of these folks, they're going to just tell you, this is this is a good idea. So the question is, why was nobody doing it? And it's less than 1%? Of the people doing it right now? And the answer is, there's just not been a good way to do it. So number one, it's a manual mix, even with the devices that are being sold back up like companies, that still you don't know exactly what you're getting, because the person who mixes it could mix it wrong. There has been no FDA approved formula, right? What is the exact mixture? You know, there's a lot of ice about it. And there's a lot of science around it. But the exact mixture and no one is really said, Hey, this is approved. So you can mix a little more, you can mix a little less, it's it's up to the doctor. And all this is done under the what's what's really the fuzzy.
Scott 14:06
do that because you're so dentists when they do that they're prescribing what they're doing for every individual patient, but they don't have an FDA approved drug mixture that they're putting into that patient. So that's a problem, right? Am I really putting the right mixture in there? Right? Nobody really looked into all this. There is salt in every drug known to mankind that's going to be injected because you put the salt that you tried to put the right amount of salt in so that it's just exactly the right you know, like like in your tears. If you get an ocean is too salty. If you pour distilled water in there, it's not salty enough. Either way it burns. You try to get the right amount of saltiness and we call it isotonic. Well, the current non buffer drugs are pretty much it Same time, so when you add a sodium bicarbonate salt, you get too salty. So our drug is going to take that, some of that salt out of the original formula. So that when you put the sodium bicarbonate in your isotonic, so that's a great thing. Because again, you know, when you when your hypertonic, you're burning, so that's no good. What else, all these other devices and stuff costs money, it's upfront money, it's ongoing money. And then, you know, the the drugs that they're still on, it ends up being after you amortize the devices in and you know, pay for everything. It's probably about $9 per cartridge, per cartridge equivalent. You know, it's still, it's still actually a good deal economically, to be honest with you, if you do that math and say, well, what's the advantage to you? There's no doubt and, and I think people should buffer even given the, the, the difficulty and complexity, because I think it's worth it. But it hardly seems worth it. Sometimes compared to what you're doing, you have to really do that math to know it. So $9 can look a little bit big compared to $1. Again, we're talking about a really small part of the procedure costs. But if you if you say, well, what would three or $4 look like, that looks a lot better, you're still absolutely, still less than 1% of procedure costs, right, and you're still rounding to zero, and you just don't see it or feel it. So I think for all those complexity and economic reasons. And then again, sort of an inconsistent drug and the danger of getting way too hypertonic. If you accidentally gave too much in there, then I think that's keeping people from doing it right now.
Phil Cole 16:48
So when you're when you're talking about the science and stuff again, I mean, I know you're trying to find the perfect blend, right, per se. Is there? Is there really such a thing, though, is I mean, there's not going to be such a thing as the perfect blend, right? It's going to be the almost perfect blend just because of ethnicities, right? Because of I mean, with it being an African American or Latino, you know, us, you know, as, as white, do we have different pH values it based on that? Or is that not the case? Because I know that bone structure, different things like that, if there is when when trying to go into the jaw? So I just was wondering, is that have any will this? No, not the effect,
Scott 17:38
the tissue pH? I'm not an expert in this, but I'm, I'm probably enough of an expert to answer this with with pretty good, you know, the tissue pH is is pretty much the same across all populations. So that's that's not a thing. The right mixture, though, what was thought to be the right mixture? I will just tell you, we we went and did my company did a lot of very expensive chemistry and chemical analysis, he came up with what we think is an ideal mixture. And that was a lot of really, you know, highly educated and well paid scientists that did that. Yeah. So we're pretty darn comfortable with what we're going to submit to FDA.
Phil Cole 18:28
And so to be clear, too, because like I said, the other companies out there, I know that one of them, you gotta have this big green syringe, you gotta turn a dial and all this stuff. And, and although that it's it, you know, it works. Some of the times, you know, once again, it's, there was always that thought process of like you said, there's it's less time, right, it's less setting time. But then you always had to go well, by time you turn the dial by time you do this, pull it out of this machine and Balwant and get it in a syringe, am I really saying that much time plus the expense or you're basically what you're developing is literally the syringe it's going in a normal syringe and your delightful cartridge. Sorry, you're developing just the plain old cartridge. It's going to go into any normal syringe. And you're going to have a pH.
Scott 19:27
Yeah, it's it's a standard and I'm going to use a word that if Dr. Melamed heard me say it he he'd come over here and wring my neck and get on a plane and go in for a carpool. Yes. Is was a was a trade name from a long time. You call these things a carpool tool. It's a dental cartridge. It's the standard cartridge. If you threw yours up in the air and didn't watch I could catch it and drop mine back down. And when you caught it you would no difference. The only thing you were Faster, heartless, more reliable and you're patient. And I want to say a thing or two about this, these these other products. First of all, we're my company and the dentists to you know, kind of founded it. In all the all the scientists that have been working on this project, we're standing on the shoulders of people like Dr. MC Falco and Dr. Davidian who came up with, you know, these these buffering methods. And Dr. Goodchild, and Dr. Donaldson, frankly, who came up with a another buffering method that you could use if you just wanted to, kind of do it yourself kind of thing. These people have been working on it a lot longer than than I have. I can't begin to tell you how grateful I am to those folks. And folks like Dr. Melamed, who, who you know, and the folks that at all the research institutions that have did all this prior work to know that this work, I just found I found a good way to do it in the cartridge. But these folks worked out the fact that this that this was a good thing and promoted it. And frankly, you know, I think like Dr. Dr. Fabrice device, it is absolutely worth it. Because in the end, if you tell me, I've got one way to numb somebody, and another way to numb somebody in this way to numb somebody is better. And and there's no doubt about Dr. Faculties method on Pharma is better. It's better than a than a non buffered cartridge. Right? And so you say, Well, what are you going to do on your family? Scott, what are you gonna do on your mom, your sister, your brother, whatever, I'm going to use Dr. Falco's system, right, it's nine bucks, that's fine. That's my mom, that's my sister, whatever. So I can't look you as a patient or any of my patients in the eye and tell you I'm, you know, me that I'm gonna do something that I would use, that I wouldn't use on my family. So I got to throw this one away and pay the nine bucks and do what's right for my patient. That's the way I feel about it. And I'm sure somebody's gonna throw bricks at me for saying that, but that's just too bad. That's how I feel about if you don't feel that way, you're not my customer. Do bad.
Phil Cole 22:12
Well, and I think that that's, you know, I think that that's something that there's a lot of dentists out there that share that same thing, but there's a lot of dentists, that also still we'll look at that that dollar, and how much it's costing. And, and say, Now, the other thing is, too, is, I think one of the things that I ran that I've always run across is, you know, like you said, I think the only difference is with all the different things out there, which I'm so excited about your product is the guest inconsistency. I think that that's something that you would hear doctors yep, I did it and it didn't work or it worked only 50% of the time or or you know, I just my patients you know, they didn't notice any any difference. I think the one of the biggest things for me that I always tried to express was not the shot itself and how fast acting it was. It was the pH balance that how long the shot or how quickly the shot would go away because for me going to the dentist and if you have to get a shot and now I'm numb for the next hour and a half and I got to draw I can't drink my coffee in the morning and that would kill me. That to me was always too if you want to call it My Selling pitch more than anything because as a professional I always would say a lawyer you know we and I would always ask the dentist when do you have your professionals come in the most usually in the morning so they could get it done get out and start their day right but what is the worst way to start your day with your you know your jaw numb and your lips tingling and stuff so I mean that to me is one of those things that I always thought was the the best selling feature Do you Would you agree with that?
Scott 24:17
Well that does that does not the
Phil Cole 24:19
best selling I'm sorry I didn't mean to say best but would agree with itself with that as one of the features
Scott 24:25
it's actually not a feature this this drug will last the exact same amount of time as his standard lidocaine articaine drum you know, it's it's not going to change that at all it was and
Phil Cole 24:36
that the the the side that are the coming off of the will not change at all. It won't
Scott 24:41
wear off any any sooner at all that you know, they they tried to get a product to to do something about that. It really kinda was a clunker and didn't work as well as it needed to and didn't really, you know, but when when somebody comes up with that trick where you can turn the anesthesia on and then turn it back off again. They're gonna have a big seller there too. I don't, I don't know how they're gonna do it, you know, but maybe someday somebody will. But right now, there's not a there's a product out there, but it's not a real good product. And again, it's kind of expensive and clunky. Well,
Phil Cole 25:15
yeah, okay, so that's so the pH balance isn't going to change anything on that side effect, or Annette whatsoever.
Scott 25:23
It won't change that. And I want to address an issue you brought up about, you know, a dentist might say, Well, I didn't notice, you know, the difference and only work half the time and so on. That's kind of fair. But the truth is, you know, as a driver, when you're going around the track, when you're going faster, you might feel like you're going faster, or you might not, you know, my brother's kid races and is a really good racecar driver. And so, you really got to you got to wait on the scientists to tell you whether you went faster around the track or not. You know, so are you improving the performance? You are we know it? We know it? Because the scientists have studied it, is it always immediately, you know, on every single patient, can you tell it? Not necessarily, but but it might be better, and you just don't quite know it right. And I can't quite tell it on on any individual patient. But I'll tell you this, if anybody ever just goes and I've done this, right, and you just have a double blind person, bring it in, they don't know what they got, they give it to you. They put one in right here and one right here and one's buffered and one's not, you can instantly tell which one was which one hertz lesson it works almost instantly. And the thing for a patient is, you know, they don't like sitting there waiting to be in a chair. So they gotta wait. And then while they're waiting, they're wondering, Am I numb enough. And the odds on them being numb enough at any given time are much higher if you're using a buffer drug. So even if it's 10 minutes, 15 minutes that you decide you're going to wait anyway, you can go check hygiene, or whatever, at least when you come back the odds on that patient, you know, not feeling something when you either you test them or you just start drilling or whatever you start doing. There's not going to be this Oh, Doc, I'm no. And there's a country song about that. And we all know Oh, absolutely. So I don't want to be called some beach. Right. And and dentists don't and you know, one of the things you can do, even if you want to just wait the same amount of time buffer, and then they're more likely to be numb. You know, I understand that. That right now, everybody doesn't really know what buffering is, you know, it's, it's one day in school. And if you happen to be out that day, you probably didn't hear about it. I understand the products are a little bit clunky, and they're a little bit expensive. And I got that I will say to the expense part, even at the $9 that's being charged for the current products. You're you're making up way more than that in marketing advantage. Because if you can tell your patient I'm using the absolute pH balanced, least painful thing that I can use on you or your your child or loved one. And this is where the market research really showed us. Like it was it was a big percentage of patients that said, you know, an issue, but it's like 100% of parents, I want this for my kid. Right? I don't want to hurt my kid and we've got a video we can show you that just It's unbelievable. But the parents really don't want that. And, and again, like I say, as a dentist, I don't want to for any my loved ones. And I don't want for any my patients who really kind of are my loved ones in hand.
Phil Cole 28:44
Right? Yeah. So that that video will be on? Is that on your current website at the balanced pharma.com.
Scott 28:52
I don't know if we've got the patient video, kind of a man on the street video, but we'll get that up. If we don't have it up.
Phil Cole 28:59
Send it to us, and we'll make sure we put it up. Put it up for you too.
Scott 29:02
We definitely have a really nice demonstration of the technology video. That's a 3d animated video that shows the technology and explains it. Yeah, it's only 60 seconds.
Phil Cole 29:13
Excellent. So I always what's your feeling and or when it comes to the FDA? And I know this is maybe a question that you cannot answer. But to me, this is one of those things where I think this is a really, really important product. Right? It like you said, if the families are saying that it's a big deal, and I think it is a big deal. Is there. Is there something that the dental community can do to help get this product out quicker than waiting for the FDA to do what's normal? I mean, is there I don't know how the FDA works. Does the FDA take any type of you know, like, Hey, we're really hearing that this product is needed? Does that help? Does that not? Because I always feel sometimes, like the dental community doesn't when there's something really good doesn't, some all the time? Not all the time, I should say, but some of the times just doesn't back something as much as what you all should do, especially since you're learning that, like you said, in the science books, you know, it works.
Scott 30:26
Yeah, I was, I will say this, first of all, FDA. You know, I had no idea what FDA was, like, you know, you always hear all these stories about government agencies and all this kind of thing. And, and unfortunately, and I'm not a big government person, you can handle it. But having said that, let's, let's be fair, these people, what I encountered at the FDA was brilliant scientists, who were dedicated to their work. They, you know, they, they saw this product, and they're very interested in in making sure that we, that we do what we can to try to get a good a better product to market like this, they understand the need here. I think they are going to work as just about as fast as they can. Really, the big thing that that I think the dental community can do is just start talking about this and just start demanding of the current anesthetic suppliers and their distributors, right Henry Schein, Paterson Darby banco, I'm sure Atlanta, I'm gonna leave somebody out. You know, but, you know, set the Don Perell it needs us in other markets, three M, all these people make anesthetics. And what I would say is, just start talking about it on on the different places, the different platforms that dental talk and start demanding from pharma, that that gets you this product, get, tell these people to help bounce pharma become partners with balanced pharma, and get this product to market. And that will help us get financed faster, spend more money at risk and get FDA because FDA can only do things when we asked them to do it. And we can only ask them if we've done our homework, in our own takes a lot of money, right? We've got to test things and then provide paperwork and so forth. So the better we're funded, the better the faster we can get it to market. And the more that dentists complain about the lack of products, the better, the faster and sooner better, we're going to be funded.
Phil Cole 32:46
That's awesome. Well, I mean, in that, I think that that's a big thing, because I think this is a product that, you know, to me is is needs to be kind of if you want to go back to like the kind of the standard of care like you said, it shouldn't be us syringe that you can only get from from one place that we should be making sure that we get like you said, get all the companies involved, get everybody talking about it and stuff. So is there anything else when when it comes to the product that that I missed, that you feel is kind of a standout for the product or anything on that order that anything that we missed?
Scott 33:32
No, just just that again, we're you know, we're we're out there, trying to figure out how to fund this project. And we've gotten a lot of funding, most of it from dentists, frankly, and providers because they understand, you know, dentists, dermatologist, dental hygienist people who understand this market. We're also now you know, looking for other partners to come in right to help us get this this project funded. As you might expect, it takes 10s of millions of dollars to get this done. Oh, absolutely. We we want to play in the sandbox with all the people that are interested in this all the people that have been out there bringing products to market and and providing products and you were part of that ecosystem. But when you look at you know, den supply set to Dawn Premier, you know, just all these companies, Patterson, Henry Schein and all these distributors, all these folks. They all want to get better products for their customers and better for our patients. And we want to partner with all of those folks in any way we can and and just just play our part in this so
Phil Cole 34:51
that you have a current round available for anybody that's listening that that they could invest in stuff
Scott 34:57
we do. So the easiest way to do that is just go to balanced pharma.com When you can kind of see the, you know, Investor Relations button and punch it in the middle, it'll give you information about that.
Phil Cole 35:10
Awesome. Well, I appreciate the information the time I excited. So I will say that it would be really nice if the FDA make it as soon as possible. But we know how all those things work takes time.
Scott 35:28
I would love to lay the blame on the FDA, but the blame for any delay is on us, honestly. And we're in we're, I think we're going really fast. I think we've done a great job. But but it's the FDA is no, that's not the problem.
Phil Cole 35:46
Well, good. And so while hopefully everybody that's listening, and I can, you know, go to that to your website, once again, which is balanced pharma.com I think that makes sure that my words are coming out right to when I say that it's balanced with a D. So it's balanced pharma.com to go to the website and you are right up in the right hand corner, there is an investor button that they can click on. So anyone that's listening, you know, take a look at the website. And if you're interested in investing, it would be a great way once again to get that product this product out even quicker. So I want to thank you Scott for coming on and and going through not only the science, but the opportunity that we have in front of us to bring this product out to all the dentists I think it's definitely one of those products that is very important and is well needed. So thanks once again. And if you enjoyed our show, please rate us review us on Apple Spotify or wherever you get your podcasts. I'm Phil cold. Thanks again, Scott. And thanks everyone for listening.
Scott 37:08
It's been an honor
