In this episode, we delve into the cutting-edge advancements in cognitive assessments. Our host, Christopher Habig, welcomes Tom O'Neill, the CEO of Cognivue, to Healthcare Americana. Together, they explore the pressing questions of how we can improve healthcare practices and whether we should embrace new innovations just because they are available.

The pair addresses the growing concern that our bodies are often outliving our minds, leading to a rise in cognitive impairments, including mild cognitive impairment and Alzheimer's disease. Tom sheds light on the transformation of cognitive assessments, which traditionally relied on outdated paper-and-pencil tests. Cognivue, on the other hand, offers a game-like approach to cognitive evaluation.

The podcast episode highlights the importance of cognitive assessments not only as a diagnostic tool but also as a means to educate patients about modifiable risk factors, such as lifestyle, exercise, and diet, which can significantly impact brain health. Tom emphasizes the need for a collaborative approach in addressing cognitive health, combining innovative medications and lifestyle changes to combat conditions like dementia and Alzheimer's.

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[EPISODE]

One of the perks of being able to run this show is that we get to talk to people on really the cutting edge, the bleeding edge in certain healthcare fields, if you will, of the new stuff coming out there. How do we improve upon what is established? Is there a way to improve upon what is established? I think that's always the first question. Going back to one of a great Jeff Goldblum quote, Jurassic Park, “Just because we can, does that mean we should?” There's a lot of times where it says yes, “We should do this. We should continue to innovate. We should continue to do what's best for the patient.” And in one of those areas, that's a hot topic, is cognitive assessments.

How do we get accurate assessments? How do we get accurate testing? How do we get accurate results, using new technology to try to get people the access to all the different health and treatment that they possibly need when it comes to, really, their brains? The great stuff up top. Please welcome to our show, Tom O'Neill, the CEO of Cognivue. Tom, welcome to Healthcare Americana.

Now, this is where it becomes a challenge is the drug is $26,500 a year. It's not inexpensive. It's very expensive. It also has some pretty significant side effects. So, what CMS also required was what they're calling a registry. The simple way explain that is it's a prior authorization process to get access to the drug and then to be put on the drug. So, there's a lot going on now, which is making everybody from policy makers, like you said, policymakers, commercial payers, health systems, providers, everybody started to relook at how are they going to handle the onslaught of patients that are going to come looking for access to this medication.

So, you mentioned that everything that's out there is 30, 40-year-old paper and pencil tests, and I guarantee, most of your listeners, if they're actually just consumers or patients, understand this because they've either gone through it themselves or they've been the caregiver, helping their mom, dad, aunt, uncle, grandma, grandpa get through it, and there's a better way. There's just a better way.

The difference for us is, ours are no question and answers. Ours are a series of 10 exercises in 10 minutes, and it's adapting to the individual's abilities throughout the entire exercise. All 10 exercises. So, we have an intro video, so everybody gets the same introduction to the technology. It doesn't take staff time. It's self-administered. The patient takes it themselves and it’s self-scored. And it's a little bit of that gamification. So, when we do market research, and we ask the patients, what do they like about it versus a MoCA or MMSE? They like it because it doesn't feel threatening, scary. It's not question and answer. We're not doing an IQ test. All the things you hear from the patients, so they actually liked the fact that it feels more like a game, than it does like a question and answer, paper and pencil test.

In addition to that, making sure that we're educating the clinicians, so whether it's – we have two versions. We have one that is more of a screening. We sell that into audiologist, pharmacist, optometrist. And then we have the clarity version, which is in the MD’s office, whether its primary care, internal medicine, family practice, all the way up to neurology and neuropsych. So, we're making sure that they understand the data that comes out of it, and how that helps them help their patients.

I’ll give you an example, Chris. If you're a student athlete, your motor skills are going to be very different than a 35-year-old with MS, versus my parents who are 79, and may have arthritis or some other motor challenges, and it measures your motor skills, and then adapts the rest of the sub test to your motor ability. Same with visual acuity. The second test is visual acuity, and it adapts the rest of the sub test to your visual acuity.

Now, we're measuring every 1/12 of a second. There's 130,000 data points that come out of ours after 10 minutes. If you think about that, if my mom who's 79 has to look at it to try to make sure the glare is out of her way, and she takes two or three seconds to get to an answer, that can change her score. So, we tried to really focus that patient and measure them in a way that's meaningful. So, to your point, what's different, our test, retest reliability is significantly better than those, the MoCA and the MMSE that are out there. The gold standards, if you will, is what the doctors will call it. But certainly, we have that clinical data to support what we do.

Again, connect the dots for me. So, we take the Cognivue test, and we say, “Hey, look, there's some potential risks here.” Bring us home there with what you mentioned earlier about new medications coming online, where they're having success, actually helping people with dementia, Alzheimer's, stuff that is just crippling and debilitating for really entire families, not just that individual.

Now, if you think about it, though, it doesn't always have to be medication driven improvement. And I think that's really the educational piece of this. I'll tell you a quick, funny story. So, when I first took over here five and a half years ago, I called my parents. They live in Cleveland. I said, “I took over as the CEO of Cognivue. I'm going to bring the device by the house. I want you guys to take it.” My dad's like, “Not a chance am I taking that.” My mom's like, “Absolutely. I'll take it.” I asked my dad, I said, “Why not?” He goes, “I already know I have early Alzheimer's.” I said, “How do you know that?” He says, “Because I forget why I walked in the room and I forget where I left my keys.” And I said, “Dad, if that was the litmus test, then we all got it.” I said, “The fact that you actually recognize that you don't remember why you don't and that you don't, that may be an indication.” I said, “Dad, would it be surprising for you to understand things like I know you have sleep apnea. I lived with you for 25 years before I moved out. I know, you have sleep apnea, untreated. You've been smoking for 64 years.” All these different things that I went through with him, he goes, “No, I didn't know those are all key components to MCI, mild cognitive impairment.”

So, my point being is, your question is a great one, that there are great new medications coming. But there are what they call the modifiable risk factors that if you empower a patient, that they can handle, they can take care of. So, whenever I've talked to doctors, and I've been in healthcare for 30 years, they always say, “Hey, I already counsel my patients to eat right and exercise.” I'm like, “Yes, but this is an inflection point.” This is something they can look at and go, “I got an issue that I got to do something about.” I didn't start taking my Lipitor and watching my cholesterol until I saw what my numbers were.

Here, you have a number tied to your cognitive function. It's going to drive you to do something about it, and that's what we're trying to do is not only empower doctors, but empower their patients to control what they can control.

There's a thing we call the worry well, so you and I were young enough, we may not have it, but we've seen and we've been a caregiver to, or we've seen grandma, grandpa, aunt, uncle, somebody deal with. Because I don't know that you could talk to many people anymore who haven't been touched by dementia, up to including Alzheimer's, were they – we call them the worried well, because they're like, “I’ve seen grandma have it. Does that mean I got this?” So, all generations. It doesn't matter which generation. The thing they're most worried about, not cancer and not heart disease. It's dementia and Alzheimer's.

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[INTERVIEW CONTINUES]

What made a difference for me here was same thing. I saw my grandma go through dementia, which is on that really heavy end of the spectrum of cognitive issues. But I also saw my Aunt Sal. My Aunt Sal, just a quick story, it's very different because it tied to hearing. The easy way to explain this is we hear with our ears, but we process those sounds with our brain. Hearing is the most modifiable risk factor for mild cognitive impairment and dementia. It's fact based, it's study based. It is the most modifiable risk factor. It also takes people on average, seven years to go get their ears checked and maybe get hearing aids.

It is one of those things, whether it's ego driven, or I just don't want to spend the money or whatever it might be. I saw my Aunt Sal go from this amazing, dynamic businesswoman, person at family parties, birthday parties. She'd be jumping around, all the rooms. She’d be talking to everybody, having a great time. Also, I saw her start to try to read your lips, try to interpret what you're saying, to maybe a couple of years later, laughing at the wrong time, because she was trying to just keep up, but wasn't hearing things right. To ultimately seeing her sit in a room, on the couch, and we lost her to dementia, right?

So, it was one of those things where I think it really could have made a difference, had we gotten her to go get her ears checked. Because when your brain has to work overtime to try to process sounds, it starts to have an impact on your cognitive function. So, for me, it was very personal with me, seeing what happened with my grandma, and then also with Aunt Sal. And I think with Aunt Sal, it definitely was something that could have been impacted or changed based on getting her to an audiologist, or hearing information specialist to get her some hearing aids. That's what drives it for me.

In fact, our biggest segment, our fastest growing segment is hearing care professionals right now, because it allows them to have a bigger broader health care conversation with that patient, versus just your hearing. We have an issue with your hearing, it’s also impacting, or could be impacting your cognitive function.

It's first off, they're seeing 30 to 40 patients a day, and they don't have the time to do it. The second thing is, if they do, do it, the payers, the commercial payers, don't necessarily pay primary care, internal medicine docs to do it. They don't have any brothers’ codes out there for the specialists, the neurologists, neuropsychs. By the way, it takes four to six months, on average, to see a neurologist in America, right? So, you got to get to see your primary care doc.

But if the payers aren't going to help make sure that's covered, that's a real challenge. A third is, up until like I just mentioned earlier in the show, there was no prescription they could write. There's still not necessarily a prescription because that drug that I mentioned, it has to be infused. So, they have to go to an infusion center twice a month, for an hour each time, to get the infusion, and then they're going to have to be watched very closely because of the side effect profiles.

Those are the three things keeping primary care and traditional health systems from really integrating what I think you should be the fifth vital sign, which is cognitive testing, cognitive function, into the health system as it is, and I don't care if it's policymakers, payers, the health system itself, or the providers. They're all challenged. So, we were in a lot of discussions now, with this recent drug approval, because health systems realized when Eisai and when Lilly gets approved, and when they turn on to direct to consumer advertising, which is not necessarily going to be just advertising for the drug, but it's going to be educating consumers on mild cognitive impairment, and they're all going to come asking about it.

Right now, the health system is not set up for it. So, when I say it's as much as society issue with this, because guess who's taking care of these patients? It's caregivers, it's family members, it's people that don't have access to neurologist or to those medications. So, to me, it's as big or bigger society issue, because the impact on the caregiver isn't just the time it takes to take care of their loved one. It's the impact of them at work. It's the impact of them in their financial means. It's a society issue.

We also, we’re just very strong supporters of the independent docs, but also independent pharmacists. So, we have a number of independent pharmacies. We don't sell to the big three or four pharmacies, but we do sell to independent pharmacies, CPSN, and others that are really clinically service focused to make sure that they're bringing value to their patients as well. But ultimately, yes, I think concierge docs are a great first step, and the organization you are doing the commercial for, very specifically, they make sure you have access to a neurologist, or a neuropsych, or a psychiatrist, a psychologist. If you need that, as a follow up. If they can't intervene, whatever they can intervene with, they intervene with. If they can't handle it, it's something outside their scope, then they can recommend you to a specialist that can handle it.

Tom, as we come to a close here, I got two more questions for you. One, give us a brief glimpse of what the economic model is behind Cognivue. Is this more of a device sale? Or what are we talking about for anybody who might be interested in exploring more?

[OUTRO]

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