Susan Lutz, Cognivue - Computerized Cognitive Assessment/Test | LSI USA '24

Susan Lutz  0:04  
So just to let you know, you know, we look at this as a global picture. We have 50, my 55 million people suffering from cognitive impairment worldwide. Cognivue is the first FDA de novo cleared digital cognitive assessment device. It's self administered, it's self scored, it's accurate, repeatable, and it doesn't have the biases that might be associated with some of the paper and pencil tests that are going on right now. If we were to even capture 30% of this opportunity to do cognitive assessments, it would result in $396 million of revenue. So we're in a unique position of competitive advantage. We've done 212,000 tests to date. We have 100% annual revenue growth over the last four years. We've had 6000 patients that have completed clinical research studies, and we have six peer reviewed publications with over 3300 patients. We're currently in two ongoing, sponsored studies and involved in 23 investigated, initiated studies. So to let you know, somebody comes to us and says, I'm looking at epilepsy, I'm looking at medication review, they pull in the cognitive, cognitive device to do the first initial assessment, ongoing assessment, we are protected by 18 patents. We were again the de novo clearance. So we had to go through the lovely process with the FDA for a year and a half of what do we compare ourselves to be de novo, and we are ISO certified. So I think there's a lot of things that are going on right now. We're at that tsunami of dementia and Alzheimer's. You know, the next 20 years, we're going to just see an influx of all US, baby boomer boomers, in that 60, 7080, year old range. If you look at at this, they say in 2050 there's going to be a long term care project that $1 trillion to take care of people with Alzheimer's. I think we're at a tipping point, though, because we finally, after think it's 2530, years, have some new disease modifying treatments on the horizon. So what that's done for the industry, it's brought some of the pharmaceutical companies back into, oh, there's a market here. You know, there's somewhere we can look at so we're in a tipping point of we have a drug modifying therapy, whether it's good, bad, indifferent to that, but it's making brain health, you know, at the top of mind of people again, and then we have effective tools for early stage detection, right? So we're all about early intervention, because signs of Alzheimer's stop start very early. So the earlier we can detect, the earlier we can do programs for wellness and hearing and actually get the drugs to the patients when they need it. So our mish I won't read this entire thing because we took two days writing it, but we want to elevate the gold standard of cognitive health assessments, reduce the stigma and empower action while it's still with early detection. We want to define the cognitive healthcare continuum so that we're make making sure we're reaching all communities. We did, just so, you know, we did. We started in 2005 with a neurologist, got an NIH grant, took about 14 years before I went to the FDA to get clearance, and then, as sometimes happens, the original founder didn't know how to commercialize quite accurately, so Tom Golisano acquired cognivue in 2000 and fifth 18 for some of you, it might age me, but our original machine looked like a micro fish machine. It was this big and about 880, pounds. So we took the next couple of years to make this down to the size of a laptop, and we relaunched in that wonderful March 2020, time frame into health systems. So you can know how that goes. So this is actually the medical device. So it looks like a small laptop. It weighs about seven pounds. We like to call cogni Something for everything, but the patient's only interaction is with the cognitive wheel in the center and and our our software is calibrated. It's a unique algorithm that calibrates to every patient's unique cognitive abilities. We also have a portal that the data goes up to we can work with EHRs. So I'm not going to get in the weeds on that, but so we kept, believe it or not, in a 10 minute test. We collect 130,000 points of data across four cognitive domains, including reaction time and speed processing. We're very sensitive and specific to mild cognitive impairment. We again, we're FDA cleared, we're flexible. I'm going to jump ahead. So this is kind of what the test looks like as you're taking it. The first two tests calibrate to your adaptive motor and visual skills, because a 15 year old motor abilities are probably going to be a little different than an 80 year old motor ability, so we don't want to take that to account for their cognitive assessment. Then it goes through three. Four perception test, letter word shape and motion, and then four memory tests, letter word, shape and motion, memory and each test calibrates to the maximum threshold. So every time you take these one minute tests, it pushes, it pushes you to where you where you fail out. We have two products. We have a five minute screening and a 10 minute assessment. The Five Minute screening is more for Allied Health, where we put in audiology and pharmacy, and then the clarity is the 10 minute, which is mainly used by physicians and clinical research neurology. How am I doing on time? I don't know. So just so we have a lot of high profile clients. We're working with the Cleveland Clinic, U of H. We also are have very strong partnerships with the Davos Alzheimer's collaborative, the global Alzheimer's platform, and the Milken Institute, where we sit as strategic advisors and also engage in some of their clinical research trials. So were you? You're we're uniquely, you know, while we focus on MCI and dementia, we're also uniquely qualified, because as we look at what everything that affects cognition, we're looking at epilepsy, we're looking at sleep and insomnia, concussion and TBI is a big is a next big focus for us that I know we're in clinical trials with. So it's not just cognition, Alzheimer's, even though that although that business alone is enough, but we know we have feelers out that there's many other markets that we can go into we just have to prove and validate. This is our clinical advisory board. We always like to show this, because we're pretty proud of this. We have Dr Galvin, who's our chief scientific officer. He's at the University of Miami. He's actually a very much of an expert in Lewy body dementia. Dr Trin, who is here in irvine california, runs a healthy brain clinic, which is a clinical research site. Joel Raskin, formerly of Eli Lilly, retired from the neurology department, and I'm going to Dr Lu. You might know he's a neurosurgeon here at USC. So we just like to show we have a very expert advisory board that gives us great feedback of what our market potential is. Are we going the right pathway and give us product development ideas, so that's it. Thank you. Applause.