Luis DeTaboada, JelikaLite - Non-Invasive Brain Stimulation Wearable Device | LSI USA '24

Luis DeTaboada  0:00  
I'd like to talk to you about autism. At JelikaLite, we have a neuromodulation device that is designed to treat pediatric developmental disorders. So my background is physics engineering. So if I don't sound like I'm trying to sell something, I'm the tech guy. Now, if you're looking and who is being treated and who you can treat the devices that we have designed, have the potential to address three, about half of the population with these disorders 80 million kids are so if you're familiar with these disorders, they're, they're tragic. I mean, they affect the life of the child, these little children grew up to be nonverbal, 30% of the time, they are 90% of the time unemployed. So this has an effect on the child and it has an effect on their caregiver. Now for some of our founders, this autism is a personal issue. So looking at this market, we're focused initially on autism, for personal reasons in because it is incredible what's happening to the children in the US. If you look at autism prevalence, the last 20 years is more than quadruple. And you're looking at the prevalence of one in 36 children having an autism diagnosis that's significant, not only significant for the child is significant for the US economy. Looking at the numbers, it's projected to be nearly a half a trillion dollar cost to the US economy next year. And shortly thereafter, exceeding the combined cost of diabetes and stroke. What do you do? Today, these children have one access to care, talk therapy. Applied Behavioral Science is expensive, can cost $200,000 to three to a child over four years, I've recommended therapy is largely inaccessible. 49 out of 50 states do not have enough therapies to treat these kids. Anything's 20 hours a week of one to one talk therapy. If you think about these, a four year old autistic child that is now really lent itself to be treated 20 hours to some stranger. And most importantly, the therapy does not treat the pathology of the disease takes care of the symptoms. So what do we do? Well, we design is a wearable initially and clinic use being developed for at home use, designed to neuro modulate areas of the brain that are linked to the disease, the disorders are first thing you got to understand when you ask the question, how does the work it get past this idea that light, which is what we use to modulate the brain does not get to the brain. He does, he has to be properly formatted. And he has to be designed right. But he not light gets through the scalp and does call to affect the biochemistry of the neurons and the physiology of the brain altogether. So how does it work? The light that gets to the brain reaches the mitochondria where itself sorbed That lights energy, increases mitochondrial production, and restores healthy function. Now, once that happens, you get the energy that you need for cellular processes to take care of everything else they need to do, including inter neuronal connectivity. So one of the problems with autism is that the connectivity in their brains is not great. And the pathology does not allow for that kind of activity to be reestablished. This technology allows this to happen. Ultimately, he reduces neuro inflammation and increases cerebral blood flow altogether. That technology has the potential to address the pathology of the disorder, not just the symptoms. So great idea, we figure all this check it out. We have done today three feasibility studies, with the same results every time significant effects in helping these kids live a normal life. Now the aggregate of our studies have produced the same results. The first RCT, we significantly exceeded what the FDA asked us to do to show clinical significance. They said you need four and a half points. We got seven or eight. The second RCT was sort of a crossover where we treated only the sham kids on the first Balaji the second trial and open label. We treated only the sham children in the initial RCT and get the exact same results. The third trial replicated the results. Now with that we got every FDA breakthrough designation, breakthrough device designation. And for those of you in the room that don't know that Basically, the FDA is telling us, we like your technology, we believe your technology is an improvement on the standard of care. So we're going to hold your hands through the process, we're going to take you from here to commercialization help you through the clearance. That's a game changer. Now, four and a half points in the scale. What does that mean? Literally none much unless you're a clinician. So for these studies, where we did is this track the responses from the parents, what do they feel more than justice scale, what we found were responses like these, the mother of a four year old child that says, I cried when my kid says, I love you mom for the first time. Or a kid is going to the bathroom for the first time on their own when they're five years old. Now, that became minimal, meaningful, and he kind of moves it along, it's not easy to get these things to market, that sort of passion. And those sorts of results are important for anybody. But bringing it back to the technology. Having done these before, it's important to have an objective measure, because the first sort of senses what about placebo, this is subjective, these are scales. So I build in a way to measuring the neural signatures of the child EEG, what we found reproducibly, again, is that when the child got better, their neural signatures is starting to shift towards signatures that are more neurotypical. So things are moving in a certain direction objectively. And those changes were correlated to the improvement in symptoms. So you look at the frequencies on the EEG, you look at the Delta power. When that went down, the kids got better. So we have a digital biomarker. Now, of course, these are feasibility trials. So you have to prove yourself right? In a pivotal trial. We're doing that. Based on the feasibility trials, we figure out how many children we need it to get the effect, be able to measure and get it. And he's at children were enrolling in two sites. In New York, we're expecting to have these trials done early next year. And with the FDA is help as they coach us through the process. We expect to have clearance by the middle of next year, early August sort of timeframe. Where we have been up to date, we have raised three and a half million dollars, mostly gone. Devices done clinical devices done several feasibility study done, aggressive portfolio for patents been prosecuted, patents issued. We just got accepted for publication. So you'll see our first paper here in the next couple of weeks. And we're enrolling, so we're we're trying to go. In order to get to the next step, we're doing a soft raise of a million dollars, that allows us to accomplish several things. Three highlights first, commercialization, take the clinical devices, make him pretty get him to safety, put them in clinics. Second, build a second generation device, the second generation device is going to have the sensors built in. And he's going to be for home therapy. So when you think about that, of the 80 or 90 million children in the world that could be treated. Most of them don't have access to care. If you can have a one pound, easy to wear easy to use at home use device. You're helping a lot of children. Finally, get through the FDA and salaries, the rest is just dry stuff. But how are we going to make money. So good friend advised me to say we're working on these. But early on the way we're trying to monetize these, we have it pegged. We have partners that are going to help us with the first two years that help is going to come. What is that? So okay, times up quickly. We're looking at 2,000,025 and by introducing of the homebase device in 27, getting to 60,000,028 when we're looking for an exit, we're talking to these potential acquirers. They're interested who we are, this is us. We've been at this for about four years, we're working without pay, we're gonna make sure this happens. We have a deep bench of advisors that are senior and know what just going on and kind of wrapping it up. The markets are large, they are underserved. There are no therapies that address the pathology. Most of these take care of the symptoms. And they do it with drugs, which have nasty side effects. We have breakthrough technology that's been proven to be safe and effective. No side effects. Finally, you have an experienced and committed team that is trying to make this a reality for a bunch of children. So thanks for your time.