#1209 Glucagon in an Insulin Pump

May 27, 2024Scott Benner

Paul Edick and Sean Saint are CEOs of thier respective companies (Beta Bionics and Xeris). Today we talk about their new relationship and their desire to create a bi-hormonal insulin pump.

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DISCLAIMER: This text is the output of AI based transcribing from an audio recording. Although the transcription is largely accurate, in some cases it is incomplete or inaccurate due to inaudible passages or transcription errors and should not be treated as an authoritative record. Nothing that you read here constitutes advice medical or otherwise. Always consult with a healthcare professional before making changes to a healthcare plan.

Scott Benner 0:00
Hello friends and welcome to episode 1209 of the Juicebox Podcast.

On today's show I'll have two guests, Sean St. Who is the CEO of beta bionics they make the eyelet pump, and Paul EDIC. Now Paul, he's from xirrus pharmaceuticals they make G voc glucagon today we're going to hear about how xirrus and beta bionics are going to team up to help make a by hormonal pump. Please remember that nothing you hear on the Juicebox Podcast should be considered advice, medical or otherwise, always consult a physician before making any changes to your health care plan or becoming bold with insulin. When you place your first order for ag one with my link, you'll get five free travel packs and a free year supply of vitamin D. Drink ag one.com/juice box. If you are a loved one has type one diabetes and your US residents please go to T one D exchange.org/juice. Box and complete the survey when you complete the survey. You are supporting type one diabetes research and you can do that right from your house. T one D exchange.org/juicebox complete the survey. You're helping yourself you're helping other people with type one and you're helping me this episode of The Juicebox Podcast is sponsored by ever since the ever since CGM is more convenient requiring only one sensor every six months. It offers more flexibility with its easy on Easy Off smart transmitter and allows you to take a break when needed ever since cgm.com/juice box us med is sponsoring this episode of The Juicebox Podcast and we've been getting our diabetes supplies from us med for years. You can as well us med.com/juice box or call 888721151 for use the link or the number get your free benefits check it get started today with us med

Paul Edick 2:15
I Paul Edick I'm the CEO of Xerus biopharma.

Scott Benner 2:18
Hello, welcome back. You've been here before I took a look this morning. You're back in the three hundreds in my recordings, and I'm about to post episode 1200

Sean Saint 2:30
It's been a while for years. It's nice to have you back and Sean, Sean St. CEO of beta bionics Okay,

Scott Benner 2:38
now we've never done this before. This is very interesting. So we have beta bionics and seris. Why would the two of you be together on one podcast? Let's find out who wants to go first.

Paul Edick 2:50
Maybe I'll take it if that's alright with Paul.

Sean Saint 2:52
You know, beta bionics has been a wild we've had a vision of bio hormonal glucose control now for over 20 years and said Damiano our founder started thinking about exactly that. And, you know, over the years, there have been several things that have held us up, you know, heads blown through a lot of roadblocks here, but at the end of the day, we needed hardware, we have that we needed an algorithm we have that. And we needed an appropriate glucagon and enters Aris because they certainly solve that problem.

Scott Benner 3:22
So Paul, if I remember correctly, four years ago, we did an interview together. And at that time, you were just talking about G voc as a rescue glucagon and I tried to prompt you I tried to get you just say something about, Hey, you think this will ever end up in a an adult hormone pump? And you wouldn't? You wouldn't really say back then. But have you guys been working on that since then? Like or even longer?

Paul Edick 3:49
The answer is no. We I talked to Ed years ago, and we kind of talked back and forth. Beta bionics ended up with a relationship with Zealand for a while. And we've stayed in touch. And when Shawn took over, you know, we we re kind of re initiated conversations. And the net result is we said, look, we we believe we can formulate an appropriate glucagon for pumps. And we've we've maintained that dialogue. And, you know, we finally put it all together and our aim is to be the facilitating glucagon in a by hormonal system.

Scott Benner 4:24
Wow. So what were the needs? What did you need the glucagon to be able to do?

Sean Saint 4:30
Well, the primary need is shelf stable, right? There has been limited shelf stable versions of glucagon over the years. The early development of both our program our bio hormonal program, as well as a few others have primarily utilized the lyophilized glucagon, which starts to degrade immediately. You reconstituted with water and we've historically used it for up to 24 hours but it's not really a product. In order to be a product. We're going to have to have stability that goes well beyond 24 hours. And again that's I think the primary challenge that that we were looking for. There are others compatibility with the materials that we're using, etc. That's always got to be a concern. But the shelf stability of the of the solution is the main one, I think, Paul, do you have anything to add to that? No, I

Paul Edick 5:13
think that's what we do. We believe that, you know, just like Chivo, we can build a unique formulation that will be shelf stable and enable the dual or model system,

Scott Benner 5:24
what's the amount of time you need it for? Is it just the I mean, I wouldn't imagine you design it just to work for the length of the set. Right. But that's really how long you need it to be good.

Sean Saint 5:34
Yeah, that's what you need. I mean, from my perspective, I would say mimicking an insulin experience is probably a very good goal. Insulin is fine to be stored in the fridge, right? But you do bring some with you, you know, I have some in my backpack right here, that I can carry around me with for a period of time. So I always have some with me, and to me that that's sort of it's I'm not gonna put exact number on it. But that, to me, is the experience that you're looking for. Okay.

Scott Benner 5:57
I'm gonna jump around here for a second, because in the direction of the questions that popped into my head, but, you know, rescue glucagon, for people who don't have good insurance can be expensive. So I'm assuming you're going to want this covered by insurance, and you feel like insurance will cover because you're going to be throwing a lot of glucagon away. Is that right?

Sean Saint 6:17
Yeah, absolutely. I mean, I think it's, it's necessary, especially if I move for being honest, you know, we're talking about high end automated, you know, and closed loop glucose control, we're talking about insulin, we're talking about a pump we're talking about now glucagon associated with that. And it's probably not realistic for most people without insurance, unfortunately, and we'd all like to solve that problem. And we'll work toward it. Certainly, we make our products as affordable as we possibly can, in terms of out of pocket, co pays, etc. But yeah, that would be be a true statement, well, we'll definitely need to work with insurance to make sure it's good. But in order to do that, you want to show a clinical benefit, right. And I don't think we've ever been more convinced that we can do that with a product like this. And the early formative trials that we've done with glucagon and the hormonal system indicate exactly that.

Scott Benner 7:01
Okay, that's amazing. I happen to it's very interesting. We put this conversation together kind of last minute today. But I earlier in the day, put a poll up on my private Facebook group after I saw your press release about what happened today. And I just said, would you want a dual hormone pump? I didn't know we were saying by hormone or I would have changed it to that. And yes or no, I have 367 responses. So far. It's been up for four hours. Yes. 272? No. 10? And the third answer, which was, huh, is that 87. So people came in and asked a lot of different questions while we were in there. And after we talked for a minute, if you don't mind, I'd like to swing back and maybe ask you some of their questions. But overwhelmingly, I think this is a desired thing. Like I had a convert. I had a private conversation with somebody this morning, where I said, I think this is the first step and the next chapter of algorithm pops your press release today. That's what that made me think we completely agree. Yeah. Now the person I spoke to disagreed, and I said, I think there's a desire. I think there's a safety and security component to it. And I think a lot of people are going to run to this idea and enjoy it. So let's talk a little bit about how it actually works. You've done some trials, it sounds like in house like, what's the functionality of the device? How does it actually work? diabetes comes with a lot of things to remember. So it's nice when someone takes something off of your plate. US med has done that for us. When it's time for art and supplies to be refreshed. We get an email rolls up in your inbox says hi Arden. This is your friendly reorder email from us med. You open up the email. It's a big button that says click here to reorder. And you're done. Finally, somebody taking away a responsibility instead of adding one. US med has done that for us. An email arrives, we click on a link and the next thing you know your products are at the front door. That simple. Us med.com/juice box or call 808-721-1514 I never have to wonder if Arden has enough supplies. I click on one link. I open up a box. I put the stuff in the drawer, and we're done. US med carries everything from insulin pumps, and diabetes testing supplies to the latest CGM like the libre three and the Dexcom G seven. They accept Medicare nationwide, over 800 private insurers. And all you have to do to get started is called 888-721-1514 or go to my link us med.com/juicebox. Using that number or my link helps to support the production of the Juicebox Podcast. today's podcast is sponsored by the ever since CGM boasting a six month sensor The ever sent CGM offers you these key advantages distinct on body vibe alerts when higher low, a consistent and exceptional accuracy over a six month period. And you only need two sensors per year. No longer will you have to carry your CGM supplies with you. You won't have to be concerned about your adhesive not lasting, accidentally knocking off a sensor or wasting a sensor when you have to replace your transmitter. That's right. There's no more weekly or bi weekly hassles of sensor changes. Not with the ever sent CGM. It's implantable and it's accurate ever since cgm.com/juicebox. The Eversense CGM is the first and only long term CGM ever since sits comfortably right under the skin and your upper arm and it lasts way longer than any other CGM sensor. Never again where you have to worry about your sensor falling off before the end of its life. So if you want an incredibly accurate CGM, that can't get knocked off, and won't fall off. You're looking for the ever since CGM. Ever since cgm.com/juicebox.

Sean Saint 11:10
Well, you know, insulin and glucagon act like the gas and brakes in your car, right one brings your blood sugar down, one brings it back up again. And it's just that number one, we can help to minimize hypoglycemia. With the additional glucagon, we can potentially be a little more aggressive on the hyper side, because we can then catch you on the lower side. And really, it's mimicking the physiology to human body, right? If you don't have type one, you have both insulin and counterregulatory or glucagon response. We're simply replacing that with this system, which is why it works better or hopefully better. If possible, Scott, I'd love to quickly address what I believe is one of the reasons why not everybody agrees with this. You know, interestingly, your poll showed an overwhelming majority wanted it. But did you tell them what their control was going to be like? No, because we can't know that right? So why did they say that? They said that, because they could see that the main point of it was eliminating hyperglycemia, which means reducing the burden of living with type one diabetes. And yes, we expect this system to give you better blood sugar control. But in my mind, more importantly, we expect it to continue to remove the burden of living with type one, I agree with you. It's a next generation system, we believe the eyelid is by removing the burden of insulin dosing. This is then the next next generation, removing the burden of thinking about your blood sugar at all. We

Scott Benner 12:32
hope you feel like you can move the target on the I let down because of the addition of the glucagon. Yeah, absolutely. Okay. Basically, you're going to be bumping and nudging blood sugars around if the number is not important. But if if the algorithm feels like we're going to get low, you're getting like a micro dose almost of glucagon, I imagine based on whatever the number is. So you're not using a lot of it is there in your testing or even Paul, like what you know of it, like, you know, you'll hear from a lot of people, I've had to use glucagon and I didn't feel well afterwards or like, is that not going to be an issue when you're just using small micro amounts of it? Yeah,

Paul Edick 13:09
so the rescue glucagon, G voc and this utilization of new form of glucagon, very different things, okay. Okay, at the end of the day, the whole situation with rescue is you've got a problem. You're beyond gummy bears, and you're beyond juice boxes, and you're going to end up in the hospital, and you get a fairly substantive dose of glucagon, which will bring your glucose back up and you know, 10 to 10 to 12 minutes, you know, from 25 or 30, up to you know, 65 or 70. That's absolutely necessary in a life saving situation, what Shawn is talking about, and I think rescue has has a future but I also think there's an opportunity to introduce a better way to convert glycemic control. And the glucagon component in a micro dose or mini dose fashion, in combination with many doses of insulin is about control. And the odds are if beta bionics or gets it right, you'll have less rescue necessary. But keep in mind, there's only a million out of eight out of 15 million people who carry a G voc or rescue device, not everyone will have a pump. So you know, there will be a future for both, but they can live together. But the goal, I think, is glycemic control at the end of the day, so you have less rescue.

Scott Benner 14:31
So Paul, you didn't just take g voc and repackage it or reconstituted somehow for this is a different molecule or how much can you say about that?

Paul Edick 14:38
Yeah, it's a different form formulation of glucagon with different compatibility characteristics relative to the components of the pump and versus the the pen, different profile relative to shelf stability and length of shelf stability, etc. So we formulated something that would go into cartridge and sit For a period of time, or we're in the process of formulating, and, you know, will will be adequate and appropriate for that mini dosing and upon it to be clear, it is a formulation, different

Scott Benner 15:12
formulations. So this might be a little bit of a diabetes geeky question here. But, Paul, are you going to have to put it through the FDA? Or is showing going to have to? How

does that work? Yeah,

Sean Saint 15:23
because, you know, in today's day and age, the FDA has, they have increased requirements on the use to right, we don't tend to get like a drug without delivery mechanism. So in our case, as nurses and betas case, the environmental pump, with the xerez, glucagon will be tested together as a system. So we'll take the lead on that. But we're obviously going to be working together on all portions of it. It's

Scott Benner 15:46
interesting, Paul, are you covered by you're not covered by this being a similar to the drug that you've already gotten through the FDA?

Paul Edick 15:55
Now this has got to its head will have its own phase two phase three program that beta bionics is going to have to go through to show safety and efficacy of the product in this system. Okay,

Scott Benner 16:07
Shawn, how long do you think that's going to take?

Sean Saint 16:10
We're probably a little early to make predictions on that. Yes, Scout. But, you know, we're gonna work as hard as we can on it. That's for sure. Okay,

Scott Benner 16:16
what is the next step? Then? There's a good question. Well,

Paul Edick 16:19
the next step is getting getting the formulation, right. And we we think we're well into that we'll deliver that this year, no question, then it's a matter of beta going into phase two and getting an agreement with the FDA on a phase two and phase three program. I say, gotcha. So this year to get the glucagon together, Sean is going to be putting stuff in place as best he can without it. And then he's got Phase Two to go through a phase three to go to.

Scott Benner 16:49
So then you come out there side, we're talking like two years or more?

Paul Edick 16:53
Well, it's not months. Okay. Yeah, we can all agree that it's, you know, this is clinical development. It'll take a couple of

Scott Benner 17:00
years right. Now, it's shown in the meantime, are you guys turning knobs on your algorithm

Sean Saint 17:04
in the backroom? Well, absolutely. But I don't think that we necessarily need to, I think continuous improvement is always something that a company like ours wants to be thinking about. So of course, algorithm is a core competency for us, which means we think about it every day. But the algorithm that we've tested in humans with our by hormonal system, up to this point, has performed in a way that we're very happy with. So

Speaker 1 17:26
even if we make no improvements, that's fine. Are you willing to say what way that is? Meaning? How does it How does it I met him about a range? Is there a range that it's able to, you know,

Sean Saint 17:36
I apologize, I can't quote this directly off top my head. And of course, you had Damiano certainly could. But I believe we've gotten about an average is published data about an average agency of about 6.5 was something like 90 92%, landing below seven, timing range gets up into the mid 80s kind of thing, with effectively very little interaction with the product and no worry of hypo. So yeah, we're pretty happy with that. But I think the important point, as I mentioned earlier, is not so much about our time and range or either even our agency, it's about the burden required to get to that phenomenal control. And that's where I think the answer to your your questions earlier really, really shined because they didn't even know what control they were going to be getting with it. Paul, I

Scott Benner 18:20
have to ask you, when you're considering doing something like this, it can't be lost on you that you might be putting yourself out of business with a new business, right? You know what I mean? Like, if everybody's one day gonna wear a pump, where they're like, I don't I never get below 60. Like, you know, or so infrequently. I'm not scared of needing rescue crews, do you think of this as a possible shift in the future? Actually,

Paul Edick 18:40
I don't see it that way. We don't see it as putting rescue out of business, you know, there, there will be a part of the population that will do very well on on this not everybody's going to have a pump. There'll be I think there'll be a good ecosystem for both glucagon and a pump and rescue device. In fact, somebody who's got the system, if they help man, they still there's still a human element to that system. And if you don't do it perfectly, things can go bump in the night. So I would say regardless of what pump, you're on what you're doing. If you get it right, cool. You might go that for five or 10 years, getting it just perfectly, there's gonna be that one time, why not have a cheapo candy, just in case for the population that large that doesn't have a pump or this particular pump? It's absolutely the you know, it's kind of like, why wouldn't you have it is right. Make sense?

Scott Benner 19:32
I listen, my daughter doesn't leave the house without Chivo chi pen. So if this is a question you can't answer, I wouldn't be surprised. But Shawn, what if another pump company walks up and taps on Paul shoulder and says, Hey, we want some of that too. Can he do that? Or does your agreement not allow for that?

Paul Edick 19:48
Look, our intent is you know,

Sean Saint 19:51
I liked your question earlier about about for Paul and sort of disrupting yourself and I think I'll first say that, you know, look, I you know my history I'm very much a pen guy. I believe in the technology strongly, there's a lot where we can do with pens, I think 93% of people give or take are still using pens instead of pumps across insulin delivery. So Paul's right, you know, there's always going to be a market for, for rescue. But associated with that similar question is, might somebody one day scoop us? You know, it's possible. And I think we, we see the development of this formulation of glucagon is, to some extent an enabling technology for that industry, if somebody figures out a way to do what we're trying to do better than us. Well, that's great. And that technology will be there. Luckily, we'll be in a position to capture some of the economics of that as well, malt, or saris. Paul, what was what do you add to that?

Paul Edick 20:42
Yeah, Scott, we contemplated that is there you know, new technology begets new technology, right? So there's bound to be other systems and other algorithms and other pumps, and disagreement enables beta and Xerus. To both participate, whoever comes up with a pump, or a better algorithm, or even if beta bionics comes up with a different system, our goal is to get an enabling glucagon into the market.

Scott Benner 21:10
That's amazing. I think this is fantastic. I, Paul as you if you may remember, it was a long time ago. But the appearance of of there's that's the first thing I thought about when I saw like, shelf stable like this. That's what I was like, Oh my God, they're gonna get this into a pump. Like because I knew people who were in some of those old studies, long, long time ago, probably before Ed's algorithm had anything to do with beta bionics. If I'm imagining if I'm remembering all this correctly, and they were probably just using, like, the old delete stuff, and just seeing how it worked. Is that right, Shawn? That's correct. Yeah. And you were you were not you. You weren't with them them, but they saw the people. Let me make sure I'm not even saying this as a question. It's a statement, the people I spoke to who are in that study, were very impressed by what was happening to them,

Sean Saint 21:59
I'm actually going to use the word we got. And I'll explain that I was really quite phenomenal in that. I mean, people use the phrase, you know, forgot I had diabetes, which I think is probably the most impactful phrase that as the person with diabetes, I can think of when you think about an experience with the new technology, I said we because oddly, I've actually been involved in this project since way back then, I went up, introduce myself to edit Ada, I think 2011 and offered to help and we ended up having a partnership with him in tandem, I was a tandem at the time, they really helped to enable the the ambulatory work that we did in 2000. And I believe it was 12 and, and 13, with the Beacon Hill trial. So I'm still pretty close to this project for over a decade now. And to be able to meaningfully push it forward with this. It's just a bit of a dream. It's amazing

Scott Benner 22:43
that it takes that much time and yet it doesn't. It's not really that much time, you know, you know what I'm saying? Like, in one person's lifetime, it feels like a chunk. But like the consideration of all that goes into it and all that has to be learned and discovered and proven over and over again. It's it's not that long, really. Pretty. It's actually pretty exciting. Do you guys have anything I'm missing? Or can I go to questions? So, okay, they want to know if the glucagon would be prefilled?

Sean Saint 23:10
Most likely, yes. There is a real concern of the agency today. And it's well founded, that drug confusion, of course, is an issue and I think the absolute worst thing that you could do is accidentally put your insulin your glute Gunsite and your glucagon in your insulin side. disastrous consequences on that one. So,

Scott Benner 23:25
yeah, okay. A lot of people just think it's great. I think this is great. I can't, there are days when I can't imagine swallowing another tablet or drinking another juice. See the look on my daughter's face once in a while. She's just like, are we gonna do this? And it's not like this. You do? This person just says, Hey, listen, CGM technology. Am I okay? Here, like we're gonna be letting this thing make a lot of decisions. And that's a person who clearly doesn't use an algorithm. Now, I answered people all the time. And I say, Look, my daughter has been using an algorithm forever. It is honestly never an issue. But some people don't have as good of experience with CGM. So what if we get a false low or we're going to start suddenly getting a bunch of glucagon? That's a concern, right?

Sean Saint 24:08
Well, I mean, the simple fact is, first of all, CGM technology is phenomenal these days. I mean, we've had some form of automated insulin delivery, I suppose since 530, G and 2000, whatever that was, but 12 ish. It's done nothing but get better since then. Yes, there are occasional errors. And yes, they will lead to slight versions of over underdosing. But I think the beauty here is that if you get a false low, you're right, it will lead to some level of glucagon dosing. But that's better than the alternative, which is, you know, some level of insulin dosing, which is where we live today. And so I see this as not a as an incremental risk in any way but an incremental benefit over the current technologies. And because we're micro dosing, we limit the the negative impacts of the larger bonuses, which are required at times, as Paul said, but I think that's the goal we're trying to do here is to make those those lifts More or gentle. Okay, let's say you saw a

Scott Benner 25:03
false 60. And it gave you a micro dose of glucagon. And then the CGM found itself again and realize you were 110. Is your algorithm going to think Can you compensate for the glucagon with its next Bolus?

Sean Saint 25:17
I don't know is the short answer. The longer answer is, all the closed loop technologies are built to understand that CGM is not perfect point to point. It wanders all over the place just not all over the place within a narrow band to some extent. And our algorithms are designed to be tolerant to that. So yeah, if you end up with a little micro dose of glucagon, you end up with a couple of points higher than you'd like to be, then we'll get you back a couple of points lower over time. And Paul's got some

Paul Edick 25:42
good PA. Just I was going to add to that we get that question all the time. But you know, am I going to have too much glucagon? And is my glucose gonna go too high? The answer is no. It tends to it tends to not keep driving. Once you're at a certain level. I mean, this is a hormone we're almost self regulates a little bit. The other thing too, about CGM is the technology has gotten a great deal better. But there's data out there these days, and people still run low for like an hour out of every day with some CGM. So it's a fine line, I think every every new technology, including the the both hormones, and a pump is going to advance the state of affairs, there will still be outliers, there will still be, you know, situations button there, there's this myth that too much glucagon is gonna get my glucose is going to skyrocket. And it just, it's just not the case. Okay? You

Scott Benner 26:39
know, this might be a good place for one or both of you to put into context for people. How glucagon really works like so the this thing you have in heipo pen, for example, when you inject it, I believe that there's a maybe a false understanding of how it works in the public, right? Like they think that the liquid in the pen is directly the thing that raises your blood sugar, but it really is signaling to your liver, am I right? And can you guys go through that process so that they understand, Paul?

Paul Edick 27:10
You're right. It's not the actual glucose? It's it's glucagon stimulates the production of glucose in the system. It's not straight glucose at the end of the day, right? It's so

Scott Benner 27:24
so there is an amount that you could use, that would stop being effective, right? But you don't imagine that with the system would be you'd get to a tolerance like that. I imagine.

Paul Edick 27:36
Now, you that would be mean, even the rescue doses, or you know, it doesn't, I think in our clinical program, all the people in the program and don't quote me, I don't have that right in front of me, I think people got up as high as 161 70. But you know, no, no higher than that, on average, I think it was even a little bit lower than that. And that's, and that's a full milligram of glucagon in the system that Shawn's talking about, people are going to get a fraction of that. Okay. Now,

Scott Benner 28:04
Shawn, will you have to put in your in your literature that it might not work if you've been drinking? Or what will the impact be of that? Because doesn't drinking? Like mess with the gives the liver something else to do? So releasing glucose with glucagon is not as effective, is that correct?

Sean Saint 28:21
In terms of physiology, I'll let Paul handle that in terms of the labeling frankly, we know. I mean, that's the whole reason that we go through these trials and these discussions with the agency is to figure those things out to make the most responsible and well labeled products that we can. So that'll be determined. Paul, can you comment on the drinking? But yeah, so

Paul Edick 28:38
I don't I don't know that there's a specific contraindication or warning about drinking, I'd have to look back at the label. Obviously, in a clinical study, we didn't have anybody who was drinking heavily, so I wouldn't know. But I, you know, I don't think you're going to have a situation where glucagon doesn't work, it works. You may not have the adequate dosage, and then the algorithm would adjust for that. Okay, or rescue? In any situation, I think you've got plenty of glucagon. So,

Sean Saint 29:11
I'm not a physiologist here, but I think Paul's gotta be right on this one. And the reason is that we are mimicking the body's counterregulatory response, right? And in a person without diabetes, when you tend to get low, your body releases glucagon, which acts on the liver, we're just providing that, you know, separately. And the short answer is people who are drinking are not getting hypoglycemia all the time, or to a dangerous level. So the regulatory system works. I

Scott Benner 29:36
don't know if it's a colloquial thing, but I've just heard over and over again, that, you know, be careful your rescue Gluconic might not be as impactful if you're, if you're drunk. And so I just I wasn't sure if that was something you'd be like trying to look into or not, but you know, I'm sure listen, I'm sure you're gonna have to look at everything if you want to get through the FDA. So

Sean Saint 29:55
I have no doubt I will be interested in one of the arms of the clinical trial. As the alcoholic or what have you, but we'll see how we have to do that. Listen, I

Scott Benner 30:04
don't think you're gonna have any trouble getting 21 year old people to get into your study. If you're like, we're going to need you to have a little buzz while you're in there. That might be the first study that's easy to pack with people.

Paul Edick 30:16
Another good reason to also have GMO content no matter what pump you've got.

Scott Benner 30:20
Now, yeah, you're making it true. Very true. Well, you said you guys kind of got back together again. How long was this in the process? Before we got to today's announcement? And, and Sean, how far did like how much good work? Did Paul have to show you before? You were like, Yeah, let's do this. Yeah, well, I

Sean Saint 30:37
mean, I think that deserves has been. So we've known of Xerus. And at two multiples point, you know, companies have known each other for quite a while. I mean, I would say, probably over 10 years at this point. But as Paul was saying, you know that I'll let him answer. But you know, they went one direction. And that's great. I don't know when they conceived of this new formulation. We've been working together on it for months now. But what I will say is that when they came to us with the formulation, it was quite impressive. It was tailor made for what we needed, and just turned our head immediately. So yeah, a ton of work. I will

Paul Edick 31:10
give Shawn some of the, you know, kudos here. At one point, the two of us just got on the phone and said, Look, you know, it looks like we've got something that'll work here. And let's get this together. And I think it took us what, two months? Yeah. Once we once we just got on the phone together and said, Look, we think we got the technologies. Look, we you know, we put a deal together. Yeah.

Scott Benner 31:33
I'm going to ask you both a question that doesn't have to do with this. And I'm going to ask it to Sean first because I think it's a it's a more fair question to Shawn. I want to give Paul an extra second to think about it. What's the most difficult thing, Shawn, about getting islet into people's hands? Like, what's the speed bumps? You have to get over? Like, we know that? I mean, I don't know how how much people realize this, but of the, you know, almost 2 million Americans that have type one diabetes, not many of them were pumps, like statistically like that, we already know that it's difficult. We also know people generally don't walk around with rescue glucagon in their pocket like so like, you guys make these products that do this thing. And you have this great feeling of like, I've done it this is it here like here, world, take this, you're gonna love it. And then you get to that reality of it's hard to get into people's minds and explain to them what's up. So Shawn, like, what's your biggest, like,

Sean Saint 32:26
I guess speed bump right now, education 100%. And I'll, I want to define or maybe differentiate education, from sales. You know, we are a commercial organization, we have a sales force, and their job is to sell. In our case, we hoped that they do that by educating both the health care provider as well as the patient on what the eyelid is, what it represents, and how to best use it. But given that they have a salesperson that you know, there's some times some of that's looked at with a degree of skepticism, which I can appreciate. You know, I would say that's the biggest one is just letting people know what the hell it is and how it represents a difference in generation and evolution of the generation close with technology, right from something where you are thinking about your insulin delivery, you are using words like Bolus, basil, correction units, carbs, to a system where you no longer think about your insulin delivery and don't use those words anymore. That's very, very different. And it takes a moment to internalize that difference in the impact on your life living with a situation like that. I'll reiterate though, that you do still have to think about your blood sugar. That's not a requirement that we've removed, and hence our hopeful next generational shift in technology with despite hormonal system. But yeah, it's education. Are you wearing your production? Or not? At the moment, I have worn it, and I am, horribly, what's the term? Anyway, I try absolutely everything and wear absolutely everything. So it's going to be honest at at the moment, I'm not. And I think you know, the eyelets great, I love the eyelet if you have a need to fiddle with knobs and look on the worst kind of an engineer, you know, not always the right one for you. But there you have it. Okay.

Scott Benner 34:03
Yeah, I mean, are using a pen right now? What are you using right now,

Sean Saint 34:07
at the moment I'm using, I'm using loop, you know, the way I see these things is, there's your your most engaged, right, and then there's your your least engagement or requirements of engagement. And those probably don't anybody quote me looks something like loop is the most engaged, followed by like, Medtronic, or tandem and then the other one, and then on the pod, and then us, you know, on the bar other side taking, you know, several steps farther in terms of engagement level, and you just got to pick where they want to be on that. Now, listen, I

Scott Benner 34:38
think your product addresses a completely lost group of people that nobody was aiming towards, generally speaking, so I think it's terrific. I really do. Now, Paul, you and I, we're not you and I, but we do some business together. You guys buy ads on the podcast. So I work for you a little bit. You know what I mean? Like and I know how hard it is to educate people over and over again. And man glucagon is one of those things like I go, I speak places. I've stood in front of 400 adults with type one diabetes, and said, Hey, listen, let's take a couple of minutes to make sure we all understand how to use our rescue glucagon, and look up to see that half of them don't even know what I'm talking about. And you know, like, so I'd like to know what that feels like, from your perspective.

Paul Edick 35:21
It's incredibly frustrating. And because, you know, I got into this because of the potential to change people's lives and, and save lives at the end of the day, bend the curve, so to speak. It's not just the patient, people living with this condition, don't really understand how easily they can go from one situation to a really bad situation. But the healthcare professionals aren't helping them to understand either, okay, physicians and healthcare practitioners own a big part of this, that they they downplay the need for rescue glucagon. Because if you were a better patient, if you did this better, if you did that better, you wouldn't need that. And then on the patient side, they don't want to tell their doctor that they have to go to the emergency room because of severe low, because they're going to get the bad patient lecture. Okay. And both of those are contributing to a situation where you've got 15 million people either on insulin or sulfonylureas, which are the glucose lowering agent, that you should have a rescue device handy. It's very frustrating. And but we, you know, we continue to slugging away every single day, the new rescue products are now 80 plus percent of the market and G boek is almost 50% of that. So it's growing, it continues to grow, the market continues to grow. But, you know, we're not, we're not where we need to be. So, word of you know, my only answer is frustration.

Scott Benner 36:56
No, I try to I try to talk about it as much as I can. But you are generally met with that feeling of like, it's not gonna happen to me. Yeah. And I always just think, boy, but I hope it never happens to anybody, but if it does, you do not want to be caught short. And speaking of frustration, you should have seen me sitting right here trying to say sulfonylurea, while I was making your ad, I said it about 1000 times, I had Google saying it into my ear. I had people emailing me phonetic spellings of it, and I was like, never gonna get this right. Anyway, I appreciate you going into that, because I think you're both in a unique position. You Paul, yours is obvious with glucagon, but I think was Sean's, like, I keep imagining that the people who are his target, or maybe people who don't go to endos to begin with. So do you not maybe have to go to GPS and instruct them on what this is to try to so that they have it in their head? You know, in that moment, like, Hey, you should try this. Like, I don't know anything about insulin pumps, but I heard about this, this might be right for you. Because it's simple for us to sit here for me to make this podcast and people to listen. And I'll tell you, this podcast that the 17 million downloads, like it's crazy how many people listen to this podcast, okay. But still, there are a niche of a niche of a niche. There are people who are super focused on helping themselves. And that's just not most people are not not of their own fault. Even like there are plenty of people who get diabetes and think they're doing the right thing, because the doctor told them, hey, just don't worry about it. This is good enough. And they go off on their way. And they think they're doing the right thing. And we're just not reaching people at a level. I'm not, I guess is my point for all the people on reaching, I'm not reaching enough people. And that I find it frustrating as well. So that's why I asked

Paul Edick 38:42
Yeah, you just keep going. I mean, people need to understand you could be doing everything right. You could have the best pump in the world. And and you can be doing everything right. Something might happen. Yeah, for a $35 copay, at the end of the day, to have a GMO that could save your life. happiest

Scott Benner 39:02
thing I do is throw away genotype open. I can't tell you another way to think about it like I have. I'm lucky I have insurance. It's covered. venofer a reasonable copay, like you're saying, but the greatest thing that happens is when that thing, you know, expires, I go, we didn't need that. Throw it away. And I reach right in and pull out the new one and hand it right back to her go here. Put this one in your pocket, or put this in your purse. Keep on your side table. Yeah, no, I mean, I completely agree. Anything I missed that I should have brought up either of you think Have we left anything out?

Sean Saint 39:32
I think we primarily hit it. I'll just say that. I continue to be excited. I have been excited my whole career about the evolutions we've had in the management of type one diabetes in the last 20 years starting with CGM, you know evolving from there, maybe even going back farther to pumps. And I think that what we're doing here today is to your point earlier, Scott really the the next generational shift in management, or at least in availability and tools for people with type one diabetes and maybe beyond. Just I'm pretty excited about that.

Scott Benner 40:00
I am PA, I'm gonna let you talk and then I'm gonna answer Sean did for you. You guys seem like, here's, here's how I should put this. I have never set one of these interviews up so quickly in my life, which made me feel like both of you are getting today. Is that fair?

Paul Edick 40:16
Yeah, I think it's fair, I think, you know, our goal I said at the beginning is to participate in better management of the condition and and on both ends, and we're excited to be a part of it. And you know, to facilitate a pump, like what Shawn is building, and it's, it's important, and we'd like doing important things. So

Scott Benner 40:35
and I'm as excited as you are to be involved in this today. Because I really do believe what I said. I think that, that every once in a while we take a leap. And I mean, today's not the day it's happening. Obviously, there's a lot of FDA stuff and testing in between now and then. But I really do think this is day one, as far as people in the public are aware of. And I do wonder what happens in five years when we look back, and this isn't even the beginning of that level anymore. I'm super excited for people to continue to work on their algorithms, delivery systems, and everything else that helps people live, like you said, Without hopefully having to think about this too much. Anyway, I appreciate you guys both coming on here and doing this really is it's a pleasure seeing both of you. Thanks so much for having us, Scott. Really appreciate it. It's my pleasure. Thanks, Scott. Paul, it's good to see you again. You know, thanks.

Want to thank the ever since CGM for sponsoring this episode of The Juicebox Podcast. Learn more about its implantable sensor, smart transmitter and terrific mobile application at ever since cgm.com/juicebox. Get the only implantable sensor for long term wear. Get ever since Arden has been getting her diabetes supplies from us med for three years. You can as well us med.com/juice box or call 888-721-1514 My thanks to us med for sponsoring this episode and for being longtime sponsors of the Juicebox Podcast. There are links in the show notes and links at juicebox podcast.com to us Med and all of the sponsors. If you are a loved one was just diagnosed with type one diabetes, and you're looking for some fresh perspective. The bowl beginning series from the Juicebox Podcast is a terrific place to start. That series is with myself and Jenny Smith. Jenny is a CDC as a registered dietician and a type one for over 35 years. And in the bowl beginning series Jenny and I are going to answer the questions that most people have after a type one diabetes diagnosis. This series begins at episode 698 In your podcast player, or you can go to juicebox podcast.com and click on bold beginnings in the menu. If you're looking for community around type one diabetes, check out the Juicebox Podcast private Facebook group Juicebox Podcast type one diabetes, but everybody is welcome type one type two gestational loved ones. It doesn't matter to me. If you're impacted by diabetes, and you're looking for support, comfort or community check out Juicebox Podcast type one diabetes on Facebook. If you're not already subscribed or following in your favorite audio app, please take the time now to do that. It really helps the show and get those automatic downloads set up so you never miss an episode. Thank you so much for listening. I'll be back very soon with another episode of The Juicebox Podcast. The episode you just heard was professionally edited by wrong way recording. Wrong way recording.com