Keynote: Advancing the Promise of a Disease-Modifying Therapeutic Device for Alzheimer's Disease

A conversation focusing on the progress made towards developing a medical device that can modify the progression of Alzheimer's disease.
Nicole J. Walker
Nicole J. Walker
Healthcare Innovator, Board Director, Venture Investor & Advisor, Multiple Companies, Multiple Companies
Brent Vaughan
Brent Vaughan
CEO, Cognito Therapeutics


Henry Peck  0:08  

So Brent Vaughn is the CEO of Cognito therapeutics. Cognito is a novel, novel disease modifying device platform for neurodegenerative disease. And we're super excited to have him here a day after they announced their $73 million Series B close. So congratulations on that and excited to hear. Yeah, and this market. Absolutely. And Nicole Walker who's moderating is a healthcare innovator investor and national board director for the Alzheimer's Association. So some really interesting perspective, from leadership, scientific world's investing community on stage here. Brent, Nicole, take it away. Thank you so much for being here.


Nicole J. Walker  0:44  

Thank you for having us. And good morning, everyone. Thanks for everyone who's up and hopefully everyone's caffeinated. I know I am. And thanks, Brent, for joining us this morning to be able to give your insights in this particular sector.


Brent Vaughan  0:57  

You bet I'm still caffeinated.


Nicole J. Walker  1:00  

So if any of you have had a chance to look at our backgrounds, we were talking about this earlier, it's hard to believe that we've been in and around healthcare now for 30 years. And the last six months in this sector has been a wild ride, who would have thought that we would have to uproot agents out of the agency with disease modifying modification potential within Alzheimer's, but at the same time having an environment where we got pushback from CMS around him reimbursement. The flip side of that is that the VA has said, you know, we agree with the data, we agree with the FDA, and we're going to make give access to our patients. But there's still so much to do. And you're here this morning as one of the leading innovators in the space from a non pharmacological perspective. And so I would love to get your insights on how you're looking at all of this macro effect in our environment right now. And some of how you look at the potential for not only innovation from the device side, but other areas. But it would be great for you to maybe walk us back to 2015 2016. When you had an inflection in your career, you were thinking about your next steps. And you started to kind of germinate around this idea of cognition, Alzheimer's, dementia, what could be a way to innovate in the space without relying on a drug to do so. So and this is before you had Cognito in mind, so what was that nugget that you landed on to say, this is what we need in the space right now.


Brent Vaughan  2:39  

Thanks so much. And thanks, Henry and LSI for give us a chance to be here. Yeah, it was coming through time. And really it was it was even it was there a few more things go on the head. It's been about six years building a company in the behavioral health space company called Cognoa, which now has the only FDA cleared diagnostic for autism in this space. And so that would been, you know, I tend to, as we talked about yesterday, tend to find these products that everyone will tell you aren't going to work. And then I spend way too much time sometimes trying to prove everyone wrong, right. And I think that we ought to transition there, the day that the day that the COVID restrictions for shelter in place rolled through San Mateo County, which is where Palo Alto is, which is where our office was, was the day I handed the company over to the next CEO who was going to drive commercialization after having been there since employee one for six years. So literally, every Monday we would you stand up and I would have weighed about 70 people, right? So I have about 50 people in person, and about 15 people on Zoom who were in airports or whatever, right? That day, they put shelter in place Sunday afternoon, and we walked into the office Monday morning, I had 10 people in the office and 60 people on Zoom to introduce the CEO and as boards like to do this right even though the my management team knew none of the other people folks knew this was happening. And so that was odd. It sounds like a whole story about that. But I was given the opportunity to move over to the investment side with Morningside. Morningside had been our lead investor at Cognoa. And I built a cognitive center the third company I built with Morningside and when I was sitting over at Morningside and started to look at this deal flow of of digital therapeutics of devices of drugs, I've been lucky enough to be able to work in all three areas. I decided there was this opportunity to take non pharmacological approaches to to do what's the next act of digital therapeutics. And we've seen with like the pure announcement that digital therapeutics hasn't really found kind of founded space, right. But building on what was right about that, moving into what would be that next generation that could create drug like value and drive drunk, I like reimbursement and I decided that I looked around I found optogenetics had been had been co created by Carl de Shroff at Stanford and Ed Boyden are co founder here at Cognito And I thought there's a chance to use things like optogenetics to use hardware and software to affect disease modification. And the the only area I could think of doing disease modification was CNS, I'm just not smart enough to figure out how to do it and cardiovascular disease. Because I thought, CNS, at least this is the intersection between electricity and in biology. And so if ever there was a place, we could use hardware and software to affect biology, we should start there. And so I was looking to start a company in this space, I came across Cognito. And at that point, I was just going to right place right time.


Nicole J. Walker  5:34  

I mean, that's a super story and kind of stepping point for our discussion. So when you think back to the early days, and having to, as a newly minted company, go out for that series A, what was it like to pitch this brand new concept of using something that wasn't a drug agent to go into this particular space? Where there have been such a history of failures? What was what was that pitch like for the investors? And how did you think about building that first? kind of book of proof of principle around the space?


Brent Vaughan  6:09  

Yeah, it was, um, it was an interesting time. Yeah. So the company actually had been around for about four years, it had been spun out of MIT, the phase two data was just kind of getting ready to come out and Morningside was was, was the majority investor, we'd raised they raised a small series A before I think when I joined, we had 12 of us. But then we now have, we now have about 50. And things have really moved along last few years. So it was, it was interesting, right, we had to figure out how to position the company with investors. And I think that, you know, I think that I think that early stage, founders and CEO sometimes don't think enough about how you're positioning is not just the problem you're solving, right? So many things when you walk in so many things about whether or not an investor is able to invest in you. Those dice are cast before you walk in the door, right? Where they are in their fund. Right? Do they have competitive investments in the space? Do they have expertise in this space? Right? There's so many things that are independent of how good your product market fit might be, or your technology. And I think for us, we we we figured out two things early on first, I decided that there were probably no risk averse investors left and Alzheimer's. Right. I think all of them left years and years ago, right. So I decided there's no room for incremental ism and Alzheimer's, this is a Go big or go home kind of strategy. So if your idea is you want to nibble on some comorbidity and Alzheimer's, I think it's hard to find, right. And so we decided that we're going to go, we came in we there was some discussions about different things. From day one, I said, we're going to find a breakthrough designation for primary symptomology of Alzheimer's, we're going to go not an adjunct therapy, not something else, we're gonna go after going after memory, cognition and brain function.


Nicole J. Walker  7:54  

And why was breakthrough designation important for you? Because I've gotten that question as an investor from entrepreneurs. Is it worth us going through that that pathway? Did it help you differentiate yourself from other competitors? Did it help with the financing story?


Brent Vaughan  8:08  

Yeah, I'm, I'm a big fan. I think it's a great problem. I think it's a great program that the FDA has put together, I've been lucky enough to be part of three successful breakthroughs and three for for right when we missed on one track record. Yeah. So I think it does a number of things. I think people focus on it. Maybe the backend a little too much. It was so tied in to the the MCI T legislation that was going to drive reimbursement and everything else. Ultimately, that might come around, that would be great. That's actually not why we think about it. I've been, I've been fortunate enough to work on both the drug side with largest molecules as well as device when you open an IND, right? And, and you're dealing with cedar, you can pick up the person who runs the case out of FDA, and you can have discussions with them. And you can have these more real time interactions. And with CRH, you do everything through a preset and then you wait 60 or 90 days for an answer. And then you get a written answer that didn't even answer your question. And now you're out another 90 days, right? At Cognoa. We, we went through and we filed for our product for what ultimately became our de novo. And we told them that we were going to be class two. And they said, Well, we're not sure your class II, you should go file for and so I answered none of our questions. You should file to FY 13 G to see what your designation is we did nine months later, they said oh yeah, you're right. Your class two is a great, you're nine months behind on all my questions, and they said resubmit. Alright. And so when you get breakthrough designation, you can actually have sprint discussions. And so you can learn more in six months as you put together what for us are pivotal study. So you're able to have those those ind like discussions and getting everything right before first patient in, I would argue is more valuable than figuring out how to cut six or nine months off the back end, for sure.


Nicole J. Walker  9:51  

For sure. Maybe. Let's fast forward a little bit last summer, fall over Last year, the team announced some of its early feasibility, feasibility data. And at AIC, which is the scientific Art Forum that the the Association puts on? What were some of the learnings that that came out of that? And I think, how did that shape how you thought about the pivotal study or the approval study in the US?


Brent Vaughan  10:23  

Yeah, a few things. And so AIC, and then some of the even the earlier data at PD the year before. And a shout out for any of you are going to be at at PD next week, and Goldberg will see you there. The a few things. So we found we found signal in the areas that everyone is looking, right. And so our key endpoints that along out of our Phase Two that align best with our mechanism of action were the MMSE, the mini mental status exam, the ADCs ADL, which is activities daily living, right, and we were lucky enough to go through the to the sprint process to get the FDA to agree that those would be primary endpoints. And to your earlier question about investors, I had every investor for six months told me that the FDA is not going to make those primary endpoints they've never done it before. And so we actually paused our fundraising, we went out use the break your process through sprint, got that across the finish line, and came back to those investors and said, Here it is, look, and they're like, oh, yeah, we probably thought they're going to do that.


Nicole J. Walker  11:22  

How do you? How did that affect your learning or thinking around the patient population for other innovators who might be in the audience who are working in the space, in terms of the target patient? Or what the disease profile needed to look like? You know, a lot of times we paid Alzheimer's and dementia is this kind of monolithic profile of a patient? And it's not a homogeneous disease at all. So how do you to an investor or if I was explaining this to my 80 year old mother, how do you articulate what that disease profile looks like? And where you're more likely to, to have success? You think?


Brent Vaughan  11:59  

Yeah, I and I think this is one of those things where you kind of have to stay true to your base belief system, right? Like we talked about yesterday, the brain is the the only major system in the body that we don't have a functional model for, right, we can make artificial hearts and artificial kidneys, and we can make an artificial brain, we truly don't have a unified theory for how the brain and cognition works. We look at empirical evidence. And then we draft a, we dropped a hypothesis around it, which is how we got so locked into the, to the to the amyloid plaque hypothesis, right. And then when the data changes, everybody's views change. And so I think for us, we were always convinced early on, and from my earlier work and drug development and Alzheimer's years ago, of that, we're never going to really solve solve progression in this disease state until we start to deconvolute the heterogeneity of these patient populations. And so I think that although amyloid clearly correlates with disease progression and removing Adeline has slowed depression, as ECI, has shown so well, for the world, it didn't bring that progression to zero, right. And I think, for us, we think about the heterogeneity here, and, and we try to be careful to not become too much of a follower, because everyone else is setting up the race that they want to run, right. And it is really hard to be a follower, run their race and play by exactly their rules, right, and then and still be a winner. And so one of the things that we noticed in our data, we do MRIs, for safety, we analyzed all of our before and after MRIs. And we showed that we were slowing disease progression by preserving brain volume. Right, one of the hallmarks of Alzheimer's is accelerated atrophy. In fact, in the old days, you could look at MRIs before you could do pets, and you could use that to help diagnose Alzheimer's. Nobody talks about this because else, nobody's been able to fix it, right? The antibodies that are targeting amyloid actually accelerate brain atrophy. And so the patients on active are losing brain even faster than the untreated patients, we found that we were we're preserving brain volume. And we think this ties into to our mechanism. And so finding an area that no one else was talking about, and then having the confidence to make that front and center we think is important.


Nicole J. Walker  14:09  

And so maybe extending that question a little bit further. Let's play devil's advocate a little bit for, you know, in my prior life within Abbott Biotech Venture, there was a bias that in order to get to a true target to affect biology, that pharma would have a better shot on goal than anything else. How do you kind of push back or out offer a counter thought to that bias within the both the clinical community perhaps as well as the scientific community?


Brent Vaughan  14:44  

Yeah, I think and I started, I started Lilly, right. So I kind of started on the drug side, I would argue, if you if you if you build an investment group, and you'll hire a whole bunch of advisors that all come out of the pharma business and you ask them how to solve a problem, it should not be surprised that they decide farm is how you're gonna solve the problem. Right. I think there's a little information bias there. You know, I think that I think the key for us is, you know, the underlying approach is based upon our co founder, Dr. Boyden and Dr. Tsai right. And Dr. Syed does basic research and Alzheimer's. So she's looking at novel targets of etiology is now Alzheimer's. And Dr. Boyd actually comes out of from engineering and Edie co invented Optogenetics. And this idea of using electrical impulses electrical activity across the brain, to start to change biology. And so I think when we go out, and we talk to investors, my my thought here, right, and there's, there's many ways to skin this cat, is


Nicole J. Walker  15:42  

Why we brought you here.


Brent Vaughan  15:42  

Yeah, you got to be careful about what are the what are the battles you want to fight? Right, I think that we talked about digital therapy just a little bit. And my my advice was always, if you have a novel product, in a novel in a novel space, you better have a tried and true business model for how you get paid. And if you want to invent a whole new business model, then you better have a pretty tried and true product, right? Novel product, novel business models, you got to start with a lot of money, right? And so I think for us, we kind of we kind of looked through how we were going to pitch this and we thought, listen, we're an intersect, we're kind of a tech bio play, right? We are an intersection of technology, and biology. Everybody out here who's raising money that thinks they're the intersection, but that thinks they're kind of this joint? Remember, remember Venn diagrams are my backbone or school, right? Everyone thinks your investors are the union of the graphs. I'll betcha they're the intersection. So you think you've got this huge sea of investors, but you actually have a sliver who have probably and then and then the broader group might come along, right. But those the people are going to give you a term sheet is going to lead. And so we actually had a bit of a conundrum, right? The investors that understand Alzheimer's are drug people, right? And they don't understand device and they're like, this probably will work. But we have no idea how this gets paid for. Right? And the device, people look at it, and they say, We don't understand Alzheimer's, right? Actually had one. One med tech analyst is like, well, you know what, I'm not gonna get a consult from the from the bio guys. I'll just figure out Alzheimer's, how hard can it be? He didn't come back. Turns out it's kind of hard, right? And so I think for us, we looked at it and we said, Listen, what are the we've got a novel mechanism going to target space? How do we make our story look like just another biotech story. And as we talked about every biotech deck in the first 10 slides, right, there's a management side, there's a pretty side of the picture on it, right? There's a slide that says, here's the unmet need, it is a lot easier to raise money to solve a big problem, that small problem, right, and so Alzheimers, pretty big problem. And then somewhere in there, there is a slide and it's always the same, we have a novel technology that allows us to have an advantage in targeting this space that no one else can target a heretofore untargeted space. And so we realized that there's this really crowded target space protein pathology, and there are drugs that have been developed to inhibit protein production for for tau amyloid Alpha synuclein, right, to change how proteins fold, right, or to start to remove those proteins with antibodies. And that in turn effects this space of, of electrical dysregulation across the brain. And we realized that we could tell our story that way. There is a novel target space, which is electrical dysregulation across the brain, we are going to modulate those targets with electrical activity that we drive. And so we have a we've did we've, we have discovered a novel target space that is uncrowded that no one's been able to target before. And we have a proprietary platform to drug those targets. So we tried to make it look like things that investors were used to consuming. Okay.


Nicole J. Walker  18:46  

Thinking about it from the going back to the comment around the agency and CMS and their reluctancy to to reimburse, at least for the drug opportunities that have come forward so far. And even back to the comment you made around PIR and digital therapeutics and the challenges that we've had there, did any of those headwinds shape how the team thought about the design of the study? What you would need to have not only from a regulatory approval process, but also on the back end of it from a market access adoption perspective?


Brent Vaughan  19:19  

Yeah, I think that in since there's a lot of med tech at this conference, right? I think that there's there's some real differences between coming from a device but I mean, we, we decided to be really clear about how we're going to already paid for we are a DME. There are codes that are established for DME ease, we know how to get paid for, right. You know, keep in mind on the drug side, once you get approval, everyone assumes it's gonna get covered paid for, right. And so that's kind of your finish line. And you can sell a company on approval data, right? On the med tech side, once you get approval, you have a whole second it's like you it's like you run the marathon, and then they come back and say guess what, you got 15 more laps on the track. Right, because now you got to get covered. There are lots of devices that are FDA cleared that never gain coverage. And so I think for us a couple things we did, I brought in a very senior level commercial person that understood better than me, right? How these things I hired him over a year ago. I brought him in early on because I understood investors were going to say, we're not sure this is going to work. And then you finally they say, okay, it probably works. But how do you get paid for? And so we tried to get ahead of that, right. Try to anticipate where the obvious questions are going to come from. And then also try not to get whipsawed a little bit. I mean, bankers are great, because they can tell you where the markets going. But they drive down the freeway looking through the rearview mirror. Right. When, when Agia helm got its conditional approval, I actually had multiple bankers and investors say, is there any point in investing in Alzheimer's research, Biogen has solved it, right. And like three months later, when they pulled the product for the market, they came back, right. And so you've got to be you can't gotta listen, but you can't let them yank your leash around.


Nicole J. Walker  21:01  

I think that's a great point. And and so making that commercial hire so early in your process? Is that something that you would recommend to your fellow innovators? Or is this specific you think to like being in the Alzheimer's and dementia category? How do you look at it?


Brent Vaughan  21:16  

I think that more and more people are doing it right. I think that even on the drug side, this idea that when you get approved, it just gets covered and paid for, Biogen would argue against that, right? Look at what they've done at Eastside with a can be. Obviously, Biogen is the partner there, right, there were tons of lessons learned from agile home that are being applied to it, we can be. And you know, where I started my career, I guarantee this people in Indianapolis are watching this closely, and seeing how it rolls out. And so I think the the, the idea of just get it approved, and if you're solving an unmet medical need, everything takes care of itself. I think those days are kind of passed. Right. And so I would advise everybody to be thinking down the road about this, because, you know, when I was on the drug side, we always talked about you just work back from the label claim, right? What's your label claim? And let's work back from that. And I think now you have to think about how is this going to get paid for how is that label claim going to fly through CMS? If Alzheimer's right, we're about 90%? Medicare, Medicare population, right. So you can't ignore CMS here. And so I think doing that early on, because ultimately, you know, I think if everyone is followed, you know, I think that, you know, there's a couple Keytruda is a famous example, right? There's a couple key interesting drugs out there, where you have multiple companies with almost identical drugs, and yet you see a five or 10x difference in in revenue. And this is because they figured out how to position and how to drive coverage for those molecules. And devices going to be saying, you know,


Nicole J. Walker  22:46  

Let's talk a little bit about the concept of access for these patients. That's, that's something that we spend a lot of time working through at the board level. Since this is such a heterogeneous condition, as you've thought through the process of recruiting, and enrolling patients into the hope study, how did you think about access because one of the stats that came out in the facts and figures update for this year from the Alzheimer's Association, was that it's still a disease that's disproportionately so for women, and people of color? So was it was there a conscious effort to try and mirror that in the enrollment? And what are some of the things that the team is trying to do to make sure that that there is more of a diversified picture in what you're looking at?


Brent Vaughan  23:32  

Yeah, this is increasingly becoming a big deal. And for those of you that are thinking about registrational trials going forward, do a little homework on this right, a little shout out in the Alzheimer space to a group called GAP, which is a global Alzheimer's platform, John Teuer, runs this, one of the things that they bring to the table is you can actually hire them alongside your CRO, and they will help drive to make sure that you meet your enrollment diversity requirements as part of your filing. And the FDA is paying more and more attention to this right. And so I think that those are, it's just one more complexity on top of what we do already, which is pretty hard. Right? And so I think that, I think that that's, I think that that's key. And I think that this is another place where you you don't want to go too color too far outside of the lines of what everyone else is doing an Alzheimer's, but you need to be a little creative right there. The Alzheimer's Association reports over about six and a half million people in the US with Alzheimer's, about 55 million worldwide. And yet, every CRO will tell you there's not enough Alzheimer's patients for our studies, right? Well, they're clearly out there. Right? You have to figure out how you can find them. And so we built our own in house engine to use Facebook, AdWords and be able to target that way. We layer that alongside working with the gap group and layer that alongside the organic efforts that we drive through through local Kol and CRO and so I think that, you know, we're we're kind of doing a full court press against this, but I do think that you you need to think about there are lots of There are lots of patients out there, how come we're not getting to them? And the reason we're not getting to them is we're just not getting in front of the right people at the right time.


Nicole J. Walker  25:08  

Is it? Is it access to the physician? Or is it more patient reluctance around having the discussion, even with the clinician, do you believe?


Brent Vaughan  25:18  

You know, I don't, I don't think that's the case. And I know we have we have a few neurologists in the room that actually see patients, right. And so I think that there is a little bit of a catch 22, where physicians tend to be reluctant to talk about degenerative diagnosis with patients, if they don't have a modality of treatment right there. And you used to see this oncology a lot, where they were reticent to talk about the real heart outcomes because they couldn't do anything for the patient. And I've had multiple neurologists telling me that they and physicians told me that they, they prescribe a mantiene and Aerosoft. And after the first or six, eight months, when the benefit is mostly receded, they're really writing that script for the family. And so I think that that's part of it. But I really think it's more about just trying to break through the noise level because I have a I have a family member, my on my wife's side that is struggling with with advancing Alzheimer's right now I lost my grandmother to Alzheimer's. I think that one of the differences here between cardiovascular diabetes, some of the places we worked, here's a patient population that is looking at an inexorable decline of their peers, and are highly motivated, right, our device, our doses that patients were at an hour a day at home. In our phase two study for patients that completed we had over 90% compliance to deal adherence. And it's because they want to do something right. They actually, if you think about diabetes, right, people would love to have their diabetes will manage without them having to do anything, this patient population wants to feel like they're doing something. And I think that that's something that that's that we can leverage.


Nicole J. Walker  26:52  

We both bring a personal take to the challenge that we have in front of us. I stand here, or sit here as a director within the Alzheimer's Association, but also as a daughter and advocate for someone who's in the later stages of Alzheimer's. And I think a lot about what more we could be doing, not only from the, the non pharmacological perspective, more medtech, do you think that there's a potential for additional innovation within the space of additional tools or services that would help outside of just having a therapeutic, which is hugely important, but to either increase the ability for patients to communicate, or to make these technologies more adoptable by the clinicians at the end of the day, because the reality also from the clinicians perspective, is that it takes a specialist a lot of time to intervene and make the a diagnosis here, and there aren't many specialists. And it's not evenly weighted in all states. And one of the things we talked about at the association is that some of our states have a neurological desert, there might be only one neurologist for every 10,000 patients in a given state. Right. So how do you think technology can help bridge some of those gaps that we have here as well?


Brent Vaughan  28:13  

Yeah, so I think, I think the diagnosis and the tool is being used to effect a, a much quicker, much less invasive diagnosis. This is moving along pretty quickly. We're gonna see dramatic changes over the next couple of years. In when we were doing our negotiations with the FDA, or on our pivotal study, we eliminated pet as a requirement. So for us to enroll Alzheimer's patients, we are actually using a simple blood test, we're using a p tau 181. Lilly just announced yesterday that they're now partnering up with Roche to commercialize another version of this. And so there are lots of things happening in digital therapeutics, right? We're working with a company called Linus out in the Boston area that uses tablet based interventions to create a a cognitive trajectory of patients to be able to identify them. I think the blood tests, like what the folks at CTN are doing, combining right. Things like p 21. So I think that's gonna be quickly. And that's just not in our wheelhouse to solve that. Right. I think the big one, I think we see with a Kimia 27% slowing, we were fortunate enough to see about a 75% Slowing progression in our study. We hope to repeat that right. I think that the other area that is huge that people I'm sure are focusing on at home care partner burden, right. One of the things that we one of the things that we learned when we reach out to at home care partners, which is usually a family member, right, is that they actually like the slightly longer screening and onboarding appointments. They liked the fact that our treatment is an hour a day because we always everyone's always self conscious about the thing. They think we should do better, right. We would love to deliver this in 30 minutes, not 60 minutes, right? The Home Care partners say You know what, it gives me an hour off, right, they really liked that. And so if we can make it shorter would we force right? But I think that you need to think about what's the environment you're placing this product into. And right now with the, you don't have to worry about adherence compliance quite so much with with the antibodies, because they're they're going into infusion suites right there, like oncology patients. But I think when you start to think it aging at home, supporting healthy aging and home, then finding a way to better engage that care partner, it's a part of the equation. And there's so much data, which we don't have time to go into about how this impacts the care partners and the families. I think that's a huge unmet need.


Nicole J. Walker  30:37  

Well, one of the stats that came out was, in addition to the 6 million people who are affected by the condition, or 11 million caregivers associated with the problem as well. And the estimate is the cost associated with Alzheimer's treatment, and management is just shy of $350 million or so. Sorry, $350 billion. And we think it might go as large as a trillion dollars by 2050. So this is something that we really do have to wrap our arms around, I just want to do a quick time check before we go to sorry, I can't see him, I'm sure. Thank you. So maybe an in the last five minutes or so we can talk about one some of the things you wish you knew when you started this adventure, and I do call it an adventure of trying to create innovation in this space. And the the feedback you would give others who are kind of in that similar stage of development right now. And maybe for the investors who have shied away from this list historically, especially in the med tech side, what you would tell them about why there's an opportunity here now based on where we are,


Brent Vaughan  31:46  

well, I mean, I wish I would have known then when I know now because I think that when you're when you're leading a company, whether it's with your board or with your investors, you know, I always try to tell my team, part of what the board pays me for is to be able to predict the future and then make it happen, right, you want someone to clocks in and says, here's what's going to happen. And by year end, and you're and you showed that you deliver that thing that happened, right. And and you do that a couple times, and people start to trust that you can predict the next future development


Nicole J. Walker  32:13  

doesn't always happen on a purely perfect Gantt chart,


Brent Vaughan  32:17  

it almost never happens on a fairly. When I was at Chiron, we had Gantt charts that went all the way down the hallway right there 17 years long. And it's like, why did you really need to print those last 10 years. So I get they drive the financial model. But that never happens that way. So I think, you know, trying to trying to do that a little bit. And which means if you back out from that, try to predict entire success to things that you can figure out how to how to deliver on your own. Right, that you can drive a little bit more. I think that, you know, the thing that I would say to investors and people that are have either been in the space in the past or are thinking of coming back or moving into it for the first time. Is, is I think that we're at a really exciting time. Right? The The story talks about lunch a little bit, I think I'm sure I'm sure everyone Oh, well actually, I want everyone to know they're not. Some of the people aren't old enough here, including me. But prior to 1954, it was established fact that no one could run the mile in less than four minutes. And there were scientists that actually wrote large papers saying why the human body can't maintain this 15 mile an hour pace for four minutes. And if you did it, it would have to be this optimized athlete in perfect conditions. And then in 1954, this, this mid distance runner who was actually not the greatest during that day, named Roger Bannister broke the four minute mile on a day that wasn't perfect. And everybody wondered if this was just like an anomaly. In less than two months, someone else broke the four minute mile. Before the following year was out, there was a race where all three of the top three people crossed the finish line in less than four minutes. And we've had almost 2000 people that are in competition that have run a four minute mile since then. So it turns out that this actually wasn't a barrier, right? This was just a goal. And once people understood it was a goal and not a barrier, people started breaking it right. And I think I think that's where we are in Alzheimer's. Right? We saw the first disease modification even though there are a lot of issues around our home, it showed that there was a way to do this, like Kimbia has now followed up, Lilly I think will will will gain approval going forward. And so I think that we're going to see, we're gonna see more progress and Alzheimer's in the next in the next 36 months than we've seen in the last 20 years. And going back to this idea of predicting the future, right when I sit down with bankers or investors, I say listen, we all love asymmetry of information financial markets thrive on it, right. I'm I am sure that we are sitting in quarter three of what is going to be about eight consecutive quarters of generally positive news, right when, when East when when Biogen announced their conditional approval accelerated approval the top 10 public companies, the Alzheimer's space gained $70 billion in market cap within 14 days. And a lot of that receded when there was the bad news. When ECI came out with a top line date in September, same companies added 50 billion in market cap within about two weeks. And so this is truly a rising tide that is lifting all boats. And I think if I think it is the most hopeful time for investors and Alzheimer's, but also patients and families,


Nicole J. Walker  35:24  

Do you think that there is any particular or specific way that a med tech or device solution is positioned in the background of all that?


Brent Vaughan  35:34  

I do, I think that you know, I used to I used to joke when assuming I was on the drug side that you know devices is is the unloved stepchild of of, of drug and pharma a little bit right? We actually have an advantage if you look at all of the issues that have happened with drug approvals, right? These are all very, very CBRE, focused, right? Agile home debacle was was an issues were over at CBRE, McKenzie has been able to navigate that, CDRH has actually been has been we found quite progressive and good to work with here. We think we're excited about the way Jeff Sharon is leading building the team there. I have investors say Well, geez, you know, up until a few weeks ago, what is Billy done gonna think about this. I'm like, I were pretty sure that gesture and CDRH is not going to it's that's a matter, right. And so I think that this is actually CRH is showing that they're willing to provide clarity and path forward. That is a little bit more rational, then, and there have been a little responsive. And I think siebrand cedar is, I think a little more difficult path. So we're kind of we have a little bit more Clearfield running in front of us. And I think that's good.


Nicole J. Walker  36:42  

Excellent. Well, at least from my perspective, and I'm sure for many in the audience, fingers crossed, right, because if you look at the clinical need, the size of the market, the financial impact that we have on our economy, economy and our families, there's no this is one of the top areas right within our industry where it is ripe for innovation and better solutions today. So I want to thank you for your time this morning and your insights in the area and for all the success that the Cognito team is had to this point and to thank LSI and everyone this morning for taking taking the time out to listen and hopefully you'll have a great rest of your day.


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