Latest / StartUp Health NOW Podcast / Insulin Delivery Innovation: These Founders Offer Solutions for Better T1D Management

Transcript

Insulin Delivery Innovation: These Founders Offer Solutions for Better T1D Management · StartUp Health NOW Podcast

• 0:00
  This week, we celebrated World Diabetes Day. For our T1D Moonshot community, this is an important moment to take stock of how far we've come and how much more work there is to do. I'm Logan Plaster.
• 0:11
  This is StartUp Health NOW, the podcast where we celebrate the entrepreneurs and the innovators who are transforming health.
• 0:17
  [music] Something I've observed is that there's an important duality that exists within every patient community. It's definitely within the Type 1 diabetes community.
• 0:26
  On one hand, there is this strength and pride as families celebrate the resilience of their loved ones who have endured a diagnosis or disease.
• 0:35
  This week, I saw a friend post on Instagram about their 11-year-old daughter who has borne up under the weight of a Type 1 diabetes diagnosis.
• 0:43
  For this particular mom, the struggle has forged a young woman who's a warrior, capable of anything. I see that sentiment a lot, and it's just beautiful. On the other hand, there is a deep and constant frustration.
• 0:56
  When will things get better? How long will we have to suffer under pain and uncertainty? When will the technology and cures that I've heard so much about become a reality?
• 1:06
  These are fair questions and ones that my two guests today are feverishly trying to answer. First, we'll hear from Ole Nielsen, the CEO and co-founder at Gopen.
• 1:15
  Ole has created an affordable insulin pen that could allow millions of insulin-dependent folks transition from syringes to the safer, more reliable pen technology.
• 1:26
  So we are giving the advantages of a pen, but at the price of syringe. So that's something nobody has ever done before. After Ole, we'll hear an update from Bill Irvin, CEO and founder of Bullseye.
• 1:37
  Bill is developing a new technology that helps people who inject insulin know exactly where to inject it so that their medication is always going into healthy tissue.
• 1:47
  Ole and Bill are just two of the innovative founders trying to dramatically improve how diabetes is managed. You can read about our whole T1D Moonshot community at startuphealth.com or watch on our YouTube channel.
• 2:00
  If you're a founder of a company working on T1D solutions, you could also join this Health Moonshot community and link arms with folks like Ole and Bill.
• 2:09
  You can learn all about that program on our website and how to apply as well. Now, let's get into our interview with Ole Nielsen from Gopen, recorded at the American Diabetes Association 2024 Scientific Sessions.
• 2:22
  [music] We're here at the American Diabetes Association Annual Scientific Session. What is it about Gopen you wanna present here at, at, uh, the ADA?
• 2:33
  Well, first of all, um, we were so lucky that, um, last year ADA, they, um, recognized Gopen. Uh, they-- We were part of their innovation challenge, which we won- Okay... last year. Yeah, yeah. Congratulations.
• 2:45
  So, so last year we created a wave, and this year we are surfing it. Nice. Um, Gopen- Yeah... is a company that, uh, are challenging a massive problem. Uh, what we do see globally and also in the US here is that, um,
• 3:01
  payment of treatment is often, uh, difficult for a lot of people. So, so we set out a few years ago, uh, the challenge that we wanted to make, uh, insulin pens affordable for everybody- Right...
• 3:14
  to replace the use of syringes. We can see that, um, between 11 and 15 million people are using syringes. They inject themselves nine billion times yearly. Around the world. Around the world. Yeah.
• 3:28
  And, uh, 3 million here in the US. Wow. So, and, and, and, um, they do that with, with 100-year-old technology. Mm.
• 3:36
  So one of the biggest innovations in diabetes over the last 50 years is actually the introduction of the insulin pen. Now we wanna make it available for the last 20%. And you know a lot about insulin pens, I understand.
• 3:49
  I do. 'Cause of your work at Novo Nordisk. Yeah, I did. So, uh, this is, this is where I got the idea. Yeah. So, so coming back from a trip to, uh, to Indonesia, where I met a man called Pak Baslu.
• 4:01
  Pak, he was 80 years old at that time, and he was going to the doctor every day to get h- one shot a day. Mm. And he got that shot in a, in a syringe.
• 4:11
  So he spent as much money on transportation as he did on his medicine. So, and his whole life was, uh, making sure that his insulin, uh, was, was administered correctly.
• 4:23
  And I came back to my friend, Mikael, who has developed all the Novo Pen platforms and s- and, uh, said to him, "Mikael, can't we fix this?" And now we are here. We are so close.
• 4:33
  Uh, we are-- we've close dialogue with the FDA. Uh, we are in good process with CE Mark on- Okay... getting clearance. So it's, it's, it's, it's, it's a great, uh, place we are at right now.
• 4:44
  Help educate a non-diabetes audience. Yeah. So, uh, what are the main problems with the syringe, and why does a pen solve those problems? First of all, everybody that are having money, they have a pen.
• 4:56
  They have that because, uh, it's a much nicer experience. Okay. It's much more convenient. You don't have to sit and draw up insulin every time you have to take it. Uh- It's, it's preloaded. You know the- It's preloaded.
• 5:08
  You know it. So what we have-- Uh, and so we are giving the advantages of a pen, but at the price of syringe. So that's something nobody has ever done before.
• 5:17
  And, and if you then c- talk about, well, the challenges of that- Yeah... well, if you wanna make something that are extremely cheap- Mm... let's say the development cost of that is very high. Yeah.
• 5:26
  It's like-- It's, it, it's a little bit like Mark Twain when he said, "I wanna-- I'm sorry I wrote a very long letter because I didn't have time." So we are writing, writing a very short letter- Mm...
• 5:37
  right now, but we need time to do it. [laughs] Yeah. So, so that's, that's how it is. Interesting. Yeah. Interesting. Yeah. I'm fascinated by your co-founder. Uh, what makes him unique?
• 5:48
  Uh, the fact that you kind of really got someone on your team who is the guy- Yeah... to do this kind of work. So, no, uh, he is-- he's, he's an interesting guy. So, uh, he's a guy I met while we were in the Army.
• 5:59
  And, uh, why is he now relevant? Well...He worked for 20 years as a consultant to Novo Nordisk. He was part of all the platforms that, uh, Novo has on the market today.
• 6:10
  He's got 29 now, 30, uh, uh, 31, uh, pe- insulin pen patents. Wow. So he- He's the guy... he is the guy. He's the guy.
• 6:18
  So, so and also when you sort of go to, uh, my old colleagues in Novo Nordisk and ask them, uh, "So who is, who is Eistrup?" And they, then they light up, "Oh my God." Mm. "Yeah, that's the guy." So, so yeah.
• 6:29
  Interesting. They- Interesting. Yeah. Uh, are there any market forces pushing against you? Um, traditional insulin pens make a lot of money- Mm... and you're coming out with an affordable one for the masses.
• 6:41
  Are, are there- No. No? No, no. We're not a, uh, we're not in competition with insulin pens. Okay. We are making, uh, insulin vials better. Okay. So, and this is an existing market.
• 6:52
  This is in a market that exists because people can afford it. So we've sort of said, "Let's, let people use the money they have and that they're spending today, but let them spend it better." Mm.
• 7:03
  And that's, that's what we do.
• 7:04
  So we are, we are actually, I think for the big, uh, pharmaceutical companies, we are seen as a friendly competitor because we make their, uh, if you like, cheapest products better for the patient. Okay, okay.
• 7:16
  And then maybe they might see you as an on-ramp to better, uh, I don't know. Yeah. Not better. No, nobody- But- Definitely if, if you- Other insulin pens. Yes, of course. We, we, we create a pen habit by, with everybody.
• 7:28
  So, so and the nirvana, of course, of the best pens are not the ones we make.
• 7:32
  We make a very, very good pen that everybody can afford, but if you want something that is, uh, connected to the sky and can remember, uh, your mom's birthday- [laughs]...
• 7:42
  and, and send signals to your watch and, and- Yeah... and all that, that's not where we are. We are, we've, we've sort of said, what are the basic features that somebody needs to manage their diabetes well?
• 7:54
  Now I understand that you have the ability to refill the cartridges. Yeah. Is that right? Yeah. How unique is that functionality? That is, that is, that is new. Okay.
• 8:02
  So, uh, nobody else e- ever thought about a system like we did, and you could only, if you like, make that, that sort of new insight if you've been designing all the other systems like Michael had. Got it.
• 8:15
  So that's why he could see, oh, there's an opportunity here to make something affordable for the masses that can be, that we can also patent and protect globally. So that's what we have.
• 8:25
  So we have, we now have, uh, uh, two patents that, that, that we have, uh, going on globally. So, so, so that's, that's, that's super interesting. That's awesome.
• 8:33
  So you, you, you described more than 10 million people currently using syringes. Yeah. 14, whatever the number is. Yeah.
• 8:39
  If you are able to get a, a real percentage of that group, millions of people moving from syringe to pen, try to quantify or describe what the life benefit is sort of at scale. Yeah.
• 8:54
  Like, like how is life different for a large group of people? Well, we... Let me, let me take the US. Uh, we, uh,
• 9:01
  our estimate is that there's three million people in the US still using syringes to inject insulin, and, um, they are visiting the ERs more often than, uh, ordinary, if you like- Mm... other, other groups of patients.
• 9:16
  And if everybody was changing from syringes to pens, the US alone, some of our calculations sh- say that, uh, the US alone can save $6 billion yearly in ER costs. If the pens allow them to stay out of the ER. Yeah.
• 9:31
  That's the assumption, right? This is... We were attending D Data yesterday. Yeah.
• 9:35
  This is a group of, uh, of innovators that are all sort of connected together, and, and we knew this about the ER, but one of the questions yesterday was actually about that exact thing.
• 9:45
  How, uh, this, this was to, uh, Humana, how are Humana not seeing, uh, these people that are using the ERs as their, uh, medical doctor- Mm, mm... uh, place? It's the most expensive place to be in the health system.
• 9:59
  That is the ER. Yeah. And in this country, it's, uh, it's just driving up cost, and this group is, is, is, is not helping. So, so yeah, there's a lot of money to be saved by changing few practices- Okay...
• 10:11
  and we wanna do that. Because, just to help me connect the dots, because using the pen helps you to, um, have a more stable- Yeah... um- It's easier to, to do. Yeah. It's more, you're more, uh, y- you're more convenient.
• 10:25
  It's more convenient. And then when stuff is easier to do, it's more convenient, you are more likely to- Okay... take your shot every day. More time in range. Yeah.
• 10:32
  We can see that, uh, 25% of insulin shots in the US are still being skipped. Okay. And, and that is causing long-term complications, and it's, it's bad. Yeah. So, so yeah, that's a lot of technical stuff- Yeah...
• 10:46
  but it's just, it's, it's the fun that we live in every day. Um, um, developing a, a, a product like this is something where you try all the, uh, uh, places of your, of your, um, of your emotional scale. Yeah.
• 11:01
  So, so sometimes you are just up there, yeah, this is great, and other times you have to think about, okay, what's the positive in this situation? Yeah. And then you figure that out.
• 11:09
  So, so that's, that's also a, a nice, if you like, challenge for, for the, for, for, for me as a CEO and for me to sort of spread that, uh, that, uh, can-do attitude also in difficult times to the team.
• 11:20
  You mentioned that yesterday you were at D Data, this, um, kind of symposia prior to the ADA. Yeah.
• 11:27
  Um, were there any innovations, um, any presentations you heard yesterday that got you particularly excited about T1D innovation? Yeah.
• 11:36
  I think, uh, um, what, uh, John Sherlon is doing about Luna, uh, about sort of, uh, nighttime, uh, insulin management is, is quite, uh, quite interesting. How come? Because, um,
• 11:49
  um, when I sat there together with a few, uh, T1Ds, they, they sha- shared with me what... If when I have a pizza night, the blood sugar, or the, the high blood sugar kicks in very late- Mm...
• 12:00
  because of the fat that you eat together with the, with the carbohydrates, and then it's very difficult to manage. So you always get a, a high late in the evening- Mm... from that evening. And that, that is unmanaged.
• 12:11
  That's difficult to manage. So and that's, that's one of the things where these new devices are, uh, trying to make a difference. Okay.The,
• 12:21
  the, the, the, the people that are, uh, doing, uh, multiple dai- daily doses, the ability to have the, the nighttime protection as well.
• 12:29
  So that wa- that wa- I thought that was, that was, that was, that was really nice to see. Um, there's some stuff going on in, in the AI world as well. Yeah, I was gonna ask about that.
• 12:38
  Some of that I think is what I would be in its juvenile stage. Okay. [laughs] Um, uh, some of it is very text-based.
• 12:46
  When you look at, um, at the, at the, what patients are seeing, what we have to present just to get, to get our product cleared,
• 12:55
  um, it's images, it's everything sort of ma- based together and, and reading a full, uh, sort of page of text on your mobile phone, um, I think there are some...
• 13:06
  There's still stuff to do before that really will become something big, but, uh, but it's the right direction I think. Okay. You said right now you feel like you're riding the wave.
• 13:14
  Last year, you won an innovation challenge. Yeah. Now, you're on the cusp of CE. Yeah. FDA feels like it's heading in the right direction. Yeah, yeah.
• 13:22
  We know exactly what to do, and they, they expect us to do this, so, so we are- Okay... having a solid conversation with them. Okay, okay. So what do you feel like the next 12 months is gonna look like?
• 13:31
  Um, I think, uh, 12 months in- uh, we have, we have, uh, two clearances. We, uh... So one in US, one in Europe. We have, uh, raised, uh, another round of capital.
• 13:43
  Right now, we are looking for a lead, uh, lead round, uh, lead investor wi- uh, in a round that is supported by the European Union. Yes.
• 13:51
  We've got, uh, we've got a guarantee from the European Union that they will invest, provided that we come with a, with an investor. So that's actually, uh, very unique that you can gear your money like that.
• 14:01
  It's ready- Yeah... to, to do. Um, we are having commercial deals done with one of the big, uh, companies that, uh, that are in this field with some of the distributors that are divi- di- di- distributing these devices.
• 14:14
  We are in CEO level talks with both types of companies, so it's, it's super, super interesting. That's exciting. Yeah, it is.
• 14:20
  I know in your old work with Novo, you, uh, did a lot of traveling, you did a lot of work in lower resource- Yeah... countries.
• 14:27
  Is there any part of the world that you've worked in, in the past that you just would really love to get to deploy this in, in the future? Just because you've, you've been there, you've done the work on the ground.
• 14:36
  No, but, uh, my heart, uh, started in... Uh, my first job, uh, was, uh, working as a researcher in, in Nigeria. Okay. And it's, uh, one-fifth of, uh, Africans are living in Nigeria. Mm.
• 14:48
  It's a country that should be wealthy. It's... There's so many people that are living, uh, on less than a dollar a day. Mm. It's crazy.
• 14:56
  Uh, and that's, that's, that's a place where I have a, a lot of, uh, a lot of positive, uh, sort of, uh, thinking about. But- Yeah...
• 15:03
  but that is actually, if you look at Sahel, the whole Sub-Saharan Africa, it's, it's super good. But, but it... I don't wanna, uh, um, sort of say it's only there. India, for instance- Yeah...
• 15:13
  is a, is a, is a place where the, a lot of good things is happening, but not everybody is getting onto the bandwagon. We need everyone to have, uh, I would say decent,
• 15:25
  uh, healthcare, and we c- we, we need, uh, every good forces that are, that are, that are in the, in that, uh, world to come together and make that happen.
• 15:34
  And these are things that are so big that it cannot be done by a little company sitting in Copenhagen. We need to join forces. Yeah. That's also why we joined, uh, StartUp Health.
• 15:43
  This is why we, we, we have joined a lot of, uh, of, of these international organization because we are-- we have been working with Medecins Sans Frontieres- Yeah...
• 15:53
  which is, uh, Doctors Without Borders, and it's important to get these groups together because these tasks are just, uh- Yeah...
• 16:01
  important to do if we want to live i- in a world which I hope could be more equitable than it is today. Oh, that's a good note to end on. I appreciate what you're doing.
• 16:10
  I appreciate that you, uh, you know, whether you're riding the wave or maybe getting knocked back a little bit, you, like, continue to bring the energy and continue to come back- Yeah... to the market. Thank you.
• 16:20
  Uh, because it's not, it's not a smooth road, and what you're doing is, is necessary, and it's hard, and I think this is gonna be a big year. So- Yeah... I appreciate you giving me the update. Thank you. All right.
• 16:34
  [upbeat music] I'm Logan Plaster, here on the floor of the American Diabetes Association annual conference with my friend, Bill Irvin, the CEO and founder of Bullseye. Bill, great to see you. You too.
• 16:45
  Thanks for having me. So let's start by just understanding what Bullseye is. I understand it's an innovative product for folks with Type 1 diabetes. That's correct.
• 16:53
  Uh, what we look for is proper placement for injections and for infusions using, uh, AI and other technology to avoid scar tissue, lipohypertrophy, and, um, and really helping the lives of people with diabetes in better absorbing insulin.
• 17:09
  And why do you care about this issue? I care about this issue because I've had T1D for 38 years, and three years ago, I went to my endocrinologist and said, "This is ridiculous. I keep hitting bad spots."
• 17:21
  At that time, I didn't know what LH was. "And, um, isn't there, like, a portable device of some kind that you could use to actually find, uh, healthy tissue before you, you know, inject?" And she said, "No.
• 17:32
  That's a really good idea." Mm. "And, you know, if you ever do anything with it, then let me know." So... What was it about your background that made you think, "Well, maybe I'm the guy to do this"?
• 17:40
  Um, I've been a part of six different startups. Um, had a successful exit in the early 2000s. Um, and, uh, I've always been an entrepreneur.
• 17:49
  I've always been in business development, uh, and sales, so, um, I felt that was a pretty good component. Um, not the greatest scientist of all time. Break down the challenge. You said LH.
• 18:00
  You, you know, you used some, some technical terms there. So walk me through the life of being a, a Type 1 diabetic and the challenges of finding the right spot for insulin.
• 18:11
  So as you would probably think, um, anyone who is either using an insulin pump or using an insulin pen or syringe is taking tens of thousands of injections over their lifetime.And what happens is, for some reason, we all kind of repeatedly inject in the same place over and over and over again.
• 18:27
  And what happens is it causes a buildup of scar tissue, also called lipo-hypertrophy or LH. And so that is something that when you inject into it, uh, you are unable to absorb the insulin.
• 18:39
  And so it's kind of like if I was a doctor, and I said, "Logan, go home and take these two pills every day," and you took one every day, I mean, would there be an adverse effect to your overall health?
• 18:47
  And since this is a disease that is self-administered every single day around the world, um, we need to make sure that everyone is getting the around, uh, correct amount of medicine that they need in order to, to stay alive and not have, you know,
• 19:02
  uh, different terrible events that lead you to hospitalization and ER visits and, and death.
• 19:08
  Oh, it just makes me think about the divide in innovation, um, there's, there's folks who are innovating on types of insulin and glucagon, all these things, and then you're talking about, well, we got to at least get the medicine into individuals and make sure there's not a blockage.
• 19:23
  So, like, make sure that the, you know, they're getting access to the best, uh, medicine they can get. Talk to me about the actual technologies that you'd like to bake into the Bullseye device.
• 19:33
  Uh, so we want to use infrared because that is completely non-invasive.
• 19:37
  Uh, it's basically a device that could be battery operated, could be very small and portable, which is important because people are doing injections in restaurants, you know, at the golf course, anywhere.
• 19:46
  Um, it's completely non-invasive, like I said. Uh, it's kind of a red, red light, green light. So we're really looking, we're looking for healthy tissue. We're not looking, looking for, for LH or scar tissue.
• 19:55
  We're looking to avoid that. Um, but it's something that's very easy to use, and, um, there's no diagnostics going on by the patient at all. Uh, so we want simplicity and, uh, at a low cost, if we can. Okay.
• 20:07
  Um, what stage are you at, and what do you, what is the next, let's say, twelve months look like for you? So I'm very excited. I just brought on two people to my executive team.
• 20:15
  I now have a chief executive or chief administrative officer, uh, who's helping with regulatory compliance, um, funding. And then I have, uh, he's an attorney, and he also has an IP background.
• 20:25
  Uh, then I also brought on a COO, who was a, uh, past CEO, uh, retired, uh, who's going to help me with business development, uh, product development. And I'm also adding to my advisory board.
• 20:36
  I just found a, a great endocrinologist who is going to join my advisory board, and I'm also talking to, uh, some people at, uh, universities, uh, about joining as well. So I feel like the team is really coming together.
• 20:46
  I'm very excited about that. Next steps are to build a prototype, um, do some more studies on, on tissue itself to identify what's the difference between healthy tissue versus scar tissue.
• 20:56
  Um, but I feel better about my company today than when I started it two years ago. Okay. Um, you've been a part of the T1D Moonshot, I think. Have you presented at the Impact Board? Uh, yes, I have. You have. Okay.
• 21:08
  Tell me a little bit about that experience, and, you know, h-have you had any sort of positive response from being in a community of like-minded folks? Uh, yes.
• 21:16
  So I did my, my SWOT analysis, uh, at the Impact Board back in December, got some great feedback, um, got some great pushback, which is great because you don't want people to tell you how great you are.
• 21:25
  You want to get some, you know, constructive criticism. And, uh, so I learned a lot from that. Um, actually made a pivot from ultrasound to IR, infrared, um, based on that conversation. Um- That's, that's a big pivot.
• 21:37
  Huge pivot.
• 21:38
  And another thing I didn't really mention is that ultrasound is, uh, much higher cost, and the user experience is much worse by putting some kind of gel on your abdomen and sticky and messy, and it's just problematic.
• 21:49
  Sure. Uh, so, uh, yeah. And I also learned, um, or I made great connections with that. I've also gone forward, and I've had great conversations with some of the people on the board.
• 21:58
  Um, and then they've connected me with other people in the industry, some industry leaders, so some thought leaders and, uh, yeah.
• 22:03
  Uh, and then as far as, uh, other people that are on the, uh, T1D Moonshot, um, you know, a lot of them are here today, um, and I've got a chance to meet them in person.
• 22:13
  Uh, they have connected me with all kinds of people. We were actually problem-solving for one of the other founders yesterday, uh, about his product. And, uh, so it's great to feel like you're a part of something.
• 22:22
  Um, I think as a-an entrepreneur, a lot of times you feel like you're a band of one- Yeah... trying to solve the, you know, all the problems in the world, and I don't feel that way with this group.
• 22:29
  I actually saw that moment playing out across the room. You were talking to Ole Nielsen from GoPen. Can you just describe just generally kind of what happened in that moment and why it was special?
• 22:40
  It was great because he had pulled out his glasses, and he had built a label to go onto his, uh, syringes that was very small writing. And I said, "Well," I said, "Why don't you just color code it?"
• 22:50
  And he's like, "That's a g- that's a great idea. We, yeah, we could color code it because then we wouldn't have to be able to read it." And a lot of people are older with diabetes who can't see as well.
• 22:58
  Uh, so yeah, it was a neat experience. I mean, um, it seemed like a basic thing to me, but- Yeah... you know. A-and it could actually help him move towards FDA. He was actually struggling with a real, real challenge.
• 23:10
  Um, Bill, it's been exciting to watch your progress.
• 23:12
  Uh, that shift to infrared is fascinating, and the fact that it came out of a community conversation is so cool, and that you could give that feedback to Ole, um, yesterday is just sort of icing on the cake.
• 23:23
  So great to see you, and we're gonna be watching your progress for the next year. [upbeat music] Thanks for listening to Startup Health NOW. We'll be back again with another episode next week. [upbeat music]