Sumita Pennathur, Laxmi Therapeutics Devices - Wearable Diagnostic Device for Diabetes | LSI USA '24

Sumita Pennathur  0:04  
I'm the founder of Laxmi therapeutic devices, where we're really wanting to be the future of continuous glucose monitoring, mainly because continuous glucose monitoring has really changed the lives of a lot of people with diabetes. But we want to make it better. We want to make people with diabetes be healthier. That's what we're aiming for. So we all know diabetes is a huge problem, and since Banting discovered insulin that back in 1921 there's been amazing therapies for it. But it's complex, and it's always evolving. It started with injecting with insulin, you know, and then it went through that injection pens. Now they're pumps, finger pricks, blood glucose meters. And most recently, there's been a solution. The continuous glucose monitor has changed the lives of many people with type ones. Now you just have to put that on, and you don't have to do any more finger pricks. And now you can actually talk to smart pens, talk to pumps. It's really evolving and on top of that, and eventually, we want to get to a closed loop where people with diabetes don't need to have that burden of diabetes. Yes, we all agree. Okay, so there's a problem, there's a solution, and there's a market. Look at the market. The market is huge for the just in America has been a huge annual revenue growth, and in 2022 is 9.6 billion, right? And so it's expected to remain strong. Many more people, unfortunately, are getting diagnosed with diabetes. So you might be sitting here wondering, wait a minute, you just told me a problem, you told me a solution, and you showed me a market. What the heck am I doing? Well, the reason I'm here is because, despite the fact that the CGMS have changed the world and how people deal with diabetes, it has not improved outcomes. So outcomes, HBA, 1c I'm sure all of you guys around doctor is a way to measure you want to get. The lower the HBA 1c the better. This was a image of 10,000 patients with type one in 2012 and their HBA 1c over the rate, 10,000 patients between nine and 99 six years later, after CGMS were introduced, you'd imagine that the hboc should go down, right? CGMS are trying to make people better. No, it actually made people worse. It made about the same. It didn't change anything. For Kids, it made people worse, which I care about, because my child was diagnosed with type one, and that's not okay. That's the problem, and that's what Lakshmi can solve. And the reason is like, so despite patient complications, we haven't actually helped. So that's what the future of CGM, the future of CGM is one where we can actually help patients have better outcomes, right? So how do we do that? Well, the reason is because competitors that CGMS, they go into the subcutaneous tissue. So you see that needle goes all the way down into about six millimeters down, and there's no blood vessels there. So it takes about 15 minutes for the blood, the actual blood glucose, to reach the sensor. So what does that mean? It means that when my daughter is really high, she's not, you know, she's or I see she's high, I dose her a little bit too much, because she's already going down, then she goes too low, give her too much sugar, then she goes too high. So up and down, and we're not at homeostasis. So in fact, I would argue this is even worse. I'd much rather they be stable than up and down and up and down. Lakshmi, our CGM fixes that, because the big IP what we have figured out is how to get something in the dermal layer of the skin. So my background as a professor at UC Santa Barbara actually work in micro nanotechnologies, and I've done many, written, many papers on microneedles. And I'm telling you, microneedles don't work. Microneedles are things that your body's going to try to push out of the skin, like your splinters. Lakshmi has figured out a non micro needle. Way to emulate the skin and have something go in there and stay for seven days. And no one else has done that. Everyone knows dermal sensing better. You lead to better improvements. Lead to no lag time. Lead to better time and range, which we've already shown through IRB trials. Less skin trauma, because it's only going in the dermal space, and because we've just started now, compared to our competitors. We built our software so that it could be open to all the different pump technologies. We've built it open. We've taken all the best of all the apps and made it better to try to make that user experience better. So I'm saying all this, and this is the first time we're actually publicly showing you data. So here's data. We've done two already IRB studies, right? The first study was a year ago, showing eight hour data, just eight hour data with six patients in the IRB. Second one, we did seven day data with 20 patients internal IRB. This is showing 30,000 pair points for all seven days. For those 20 patient data trials, we actually have over 100,000 collected over seven days. And in about a week or two, we're going to be putting this device in the clinic. I've been wearing it for many, many days. We have many internal studies with this. It's going to be external with type one. This one right here, and this is the inserter for it, very much smaller than the competitors. And our actual product device is going to be this big. And what I'm. Be shown from all this data, you can see the Mars are about 10% in fact, if we do head to head, because we've been wearing comparator CGMS with ours, if we do head to head with finger sticks, our Mars are usually always better than the other one. Again, because we have better time and range, because we have no lag, the Mars can be better in terms of rate of change. We also have shown a less than two minute most of the times it's zero minute time lag. For all the data, we've shown that the sensor can stay in the skin for seven days, right, without getting coming out like most other dermal sensors, and basically, it's shown robust performance. So we're now at the you know, we're doing external IRB for IDE study. What else we have done is file 11 patents, two are awarded. We've done a full FTO analysis with the applicator, making sure all the stuff we have does not in cringe on anybody else's patents. We have the presub submitted to the FDA. We have the mobile app, as you saw in the picture before complete. And the thing I'm most proud of is the fact that we have established a manufacturing facility, and this is the reason why we can get such good data in Pasadena. We have a manufacturing facility that's not only able to do our pivotal line, but also our pilot line, we can make 1000s of sensors a week, and we'll be able to put this fully into production, and that's already set up and ready to go with eqvs, and we're starting all the the IQs right now. So we have been exponentially progressing in the last year in terms of product development, regulatory status. We have our IRB trial to inform clinical happening. I say it says q4 but it's actually happening early, you know, in a few weeks, I think the pivotal trial, we're hoping this will be finished, oh, the arbitrary trial will be finished by q4 and we'll be submitting IDE to the FDA. We're hoping to start a pivotal trial, even an outcome trial, to show people, hey, this lag actually makes a difference next year, and then a year and a half or so of clinical trial and testing and such to get a commercial launch. Our meeting is already scheduled for May, the pre sub meeting with the FDA to make sure we're on track to show them the data, to show them what we've had so far. We're hoping to do an ID submission by the end of the year, and because of how good the data is looking so far, we're pretty sure we can meet all icgm standards and submit 510, K again, this is very different than other dermal sensing companies. It's just because of the IP we have on how to actually get that in and keep it in the dermal space. So the whole thing that we want to do is show a truly closed loop system. This is the set to get to an artificial pancreas. The reason why none of the products right now are fully approved is because there is no AI algorithm that can tell you when you ate 50 gummy bears, right? You eat 50 gummy bears. No AI in the world can tell can tell you you did that. And so therefore there's always going to be a spike where we can test that, and people with with time delays can't. So what we have is we have a pathway to really dominate this 3.5 type one market. If you talk to doctors and say, Hey, would you prescribe this to kids who are diagnosed, of course, they would. I mean, my daughter, especially brittle diabetics. They need this, right? I don't want to stay up all night. I can't look at the bags under my eyes. And this is after, you know, not having to deal with my daughter for two days. I have a we're trying to raise a little bridge to get to the IDE submission. We're in talks with strategics now, but we want to get to the pivotal trial start and everything to show you know, we have the IDE to show our data, and then either we work with strategics or we get a big series B round to get us all the way to FDA approval. And that's that's it. I fish. Thank you so much. Applause.