How Health Economics Drives Medtech Growth with Christian Howell, CEO of Cognito Therapeutics

[00:00:03] Hello everybody, welcome back to the Outcomes Rocket podcast, recorded live here at Device Talks Boston. I'm so excited to be with Christian Howellll again. He is the CEO of Cognito Therapeutics. Christian, so good to see you again. It's always great to be with you. It's always good to see you. Long time friend in the space. Great to spend some time together. And for those of you guys that haven't heard my previous interview with Christian and I spent some time at Metronic together, and I've been following his work at Cognito.

[00:00:29] So they're doing impactful work that I want him to tell you about. So why don't we kick it off with that, Christian? Yeah, so Cognito is a fascinating story. So we're a neurotechnologies company that is really pioneering an entirely new type of therapy. And so what we're using is we're using sensory stimulation to drive activity in the brain that generates endogenous biology that is incredibly important to preserving brain structure and brain function.

[00:00:58] And so the way that the therapy works is we use sensory stimulation, light, sound, even touch to drive a persistent and consistent activity level in the brain. And then when the brain is at that activity level, it prompts biology that is incredibly important to things like synaptic resilience and myelin production and reducing neuroinflammation.

[00:01:25] And so the hope is, and we use that term purposely as is at the name of our large clinical trial, that we'll be able to leverage the learnings in the preclinical environment and in our early clinical studies to really have this massive impact on patients. And so we're starting with Alzheimer's. And so we are currently a knock on wood somewhere. We are at the time of this launching, we have just a little bit about a dozen participants remaining.

[00:01:54] And what is the largest non-pharmacologic clinical trial that's ever been done in the neurodegenerative space? So we'll have 673 participants. I was going to ask you, because I remember chatting with you about this almost two years ago. Yeah. And the number was big. Over 600 and you have 12 left. 12 left. So we will... It hasn't been busy. Busy.

[00:02:17] It's such a credit, not just to the clinical operations team at Cognito, but the PIs and the coordinators. We conducted a study at 70 sites around the United States. And we asked patients or participants to wear it for an hour a day every day. And so that's not an inconsequential ask to the participants and to their caregivers.

[00:02:42] And what I'm thrilled to see is that our compliance in the study is at 85%, meaning 85% of participants are utilizing the device at least 50 minutes a day, at least six days a week. Amazing. And so that's incredible. And we're also seeing one of the things that you do when you do a study of this size that's sham controlled is that you do what's called an open label extension. Okay.

[00:03:08] And so that gives everyone that's on the sham therapy the opportunity to enroll onto an active therapy and everyone that's on active therapy to remain in the study. And we're going to do that for an additional 12 months. And we're seeing huge numbers of participants wanting to stay in the study and stay on the therapy. So it's really exciting. It speaks to the effectiveness, ease of use, right? Yeah. We're cautious to use terms like effectiveness until we go to the FDA or safety, but you're right.

[00:03:36] What it speaks to, I think, is the huge need in this market for a impactful, not invasive, at-home therapy. We've not had a device-related adverse event. So that, I think, is something that really resonates. And so our hope is to have the last patient or participant come out of the study here in July. Okay. Share our top line. We're around the corner. In August. Awesome.

[00:04:06] And then we are breakthrough de novo with the FDA. So we'll most likely submit in the November timeframe. And then our aspiration is that we'll have a therapy for about 7 million families in the United States that don't have access to a biology-modifying therapy. So it's incredible. It's an incredible opportunity. That's awesome. And kudos to you and the team for getting it this far. Thanks. You're around the corner almost. That's right. For commercialization, that's the next step, right? Once you get there.

[00:04:36] It is. So we think about it as the ARCs. So we think about it as the first one is the readout and making sure that we put as clinically validated a study to the market as possible. We want to think about the regulatory path. We don't want to take anything for granted. We want to make sure we are leveraging the breakthrough status. We're kind of connected with our review team as possible. Reimbursement's a major issue, right? This is we are an entirely new class of therapy. This is not like anything else.

[00:05:05] This is activity that's inducing restorative biology. And so we don't really have that type of model. Yeah. And I love that you have the studies because, I mean, when you go to a payer, that's the first thing they ask for. That's right. And I think it's remarkable. I give the Cognito team an incredible amount of credit, which is we really developed a comprehensive evidence strategy. I think far too often tech companies think about evidence in a bit of an episodic way.

[00:05:34] Do I have the evidence necessary to meet the regulatory threshold? Do I have it to meet the clinical validation threshold? Do I have it? We really want to build as robust and dexterous a data set as possible so that we could use it not just in clinical validation and regulatory, but also in conversations with reimbursement and conversations with clinical thought leaders and families. And we were chatting about access, right? So the challenge of access. So there's 7 million people, but how do you get it to them?

[00:06:02] It's the thing that keeps me up at night, which is when you have a truly breakthrough technology, there is understandably going to be an enormous amount of urgency. And we want to make sure that we do everything we can to make the technology available to those to meet that urgency. But we also want to be really thoughtful to build something that's durable. Because that's how you'll sustain and really be able to impact as large a group of patients and families as possible.

[00:06:29] And we've candidly, we've seen this in neurology, which is the monoclonal antibodies have come to market. And unfortunately, there wasn't the ecosystem built to support the diagnosis and then the delivery. And they've run into real struggles. And so we're being very thoughtful about creating what we call brain health collaboratories, which are partnerships with leading health systems and academic institutions like Rockefeller, No Sciences Institute at West Virginia, or Ochsner Health,

[00:06:58] to make sure that we understand from diagnosis to treatment delivery all the way to... We are a big believer that we should only be paid for if we do three things. If we demonstrate that there's a company, that we demonstrate that there's a clinical response, so that the patient is responding to the therapy, and that we're demonstrating clinical utility, that we're having some sort of impact on the preservation or cognition of function. If we're not doing those three things, we should not be... Should be paid for it. Yeah. And so I don't know who would... I don't know who would disagree with that.

[00:07:27] That's a very reasonable approach. I love that. Christian, one of the things that I like is this quote that's, you're the average of your five closest friends or peers. And I know you've had an incredible career from our time at Medtronic, your work with Omar and the team over there, to now. What's your thoughts on that? And how do you feel about how your past has shaped kind of where you're going with this one? It's funny you ask that question because I was thinking about this today. Oh, really?

[00:07:55] And I was thinking to myself, turn 50. And so... Happy birthday, man. The big 5-0. Big 5-0. And candidly, I am very proud and humbled by my career. I had an opportunity to serve my country. I had an opportunity to serve an incredibly committed and passionate group of people at Medtronic. I've had the opportunity to do the same at a company called Etienne and now leading... Oh, yeah. You were at Etienne. I forgot that. I forgot. And now leading Codmito. And often times get asked that, oh, what's your leadership style?

[00:08:24] And you try to draw from others. And I will say, really, it's gained clarity for me recently, which is... And I was saying earlier that it's sort of three things I like to promote and one thing I like to protect against. Okay. Well, three things I like to promote are one is a perspective of assuming the law. I think it's so important for us to be service-focused, to be thinking about having a North Star of who we're positively impacting, whether that's patients, whether that's our team, whether it's those that we're in service to. Yeah. I think approaching it with a real sense of humility is important.

[00:08:54] I think that we have to be constant learners. I think, oddly, often there is this false facade that CEOs, startup CEOs feel the need to give that I have all the answers. And I think what most investors and I think really what most employees and teammates want is a recognition that you don't, but you're willing to learn. Yep. Yep. And then for me, there is this laugh speech with this humor. And so it's this idea of one, being able to laugh at yourself, create an environment where you can be self-effacing and people can laugh with you because I think it creates

[00:09:24] a safety and a freedom of, right, where people... And then the thing I protect against is hubris. And I have seen it crush companies where they let optimism become optimism bias. And then they're not open to criticism. They're not open to... And so we really try to fight against the hubris. And we think we have this incredible responsibility to steward this once-in-a-generation technology.

[00:09:50] If we approached it with arrogance or if we approached it with a lack of humility, I'd be really disappointed because I think it is something that will allow it to reach its full potential without kindly us getting in the way. I love that. That's a really great... Let's call it an algorithm. Yeah, exactly right. Vote three and protect on what? That's the Christian Howe algorithm on leadership, folks. That's fantastic. I don't know, man. Maybe a book come in there.

[00:10:18] A book deal after this one. I love it. What's one thing you're betting on or excited about, Christian, for the rest of this year or going into next year? Yeah. I mean, I think for... Obviously, for us personally, it's so much about the readout. And then it's about getting regulatory ready. So that's the back half of the year. I think the thing that I am maybe on a more macro scale most excited about is the sort of

[00:10:45] ecosystem alignment I'm seeing for patients and families that are struggling with Alzheimer's disease. So I am seeing a sort of reduction in the sort of... I'm seeing health systems and payers and neurologists and CMS and FDA. And everyone's coalescing around this idea of this is probably the most urgent need in healthcare. There are 7 million people, 15 million people with mild cognitive impairment, 15 million

[00:11:14] people around the world without access to a therapy. This has to be something that we align to share data, drive care pathways, make sure that we're identifying and diagnosing patients, creating an environment where patients feel comfortable to raise their hand and say they're struggling, right? We can't... We have to remove stigma. We have to remove some of the fear that comes. And I just think there's this really wonderful dynamic that I obviously hope persists not

[00:11:43] just for the end of the year, but moving forward because there's such desperate need for it. And I'd say that's also a call to action, wouldn't you say? For sure. Like you're seeing and feeling it, but I feel like we need more. We do. And I think we need everyone. You know from my time at Metronic, I'm a massive believer in removing subjectivity and that data. And I am a firm believer in that. And God, we trust everyone else bring data. And so I think what we should all commit to is... That's a good t-shirt, by the way. You know, Deming.

[00:12:12] So it's, I love this idea of being committed to clinical validation and then driving objective decisions. So making sure that we're identifying patients that are going to benefit, make sure we're getting them at the right point in their care, make sure that hospital systems are driving compliance to care pathways so they reduce variability and they can get the optimal outcomes. Building commercial models where you're paid on outcomes. I think it's a call to action to remove subjectivity because subjectivity is not predictable. It's not sustainable, right?

[00:12:42] Quality care costs less and variability destroys quality. We have to find ways to reduce variability. And the way to do that is to drive objective, data-driven, evidence-driven decisions. And it's a call to action to med tech companies to bring data. It's a call to action to health systems to drive care pathways and reduce variability and subjectivity of decision-making. It's a call to actions of payers to reward those that do that and bring into regulators

[00:13:09] and the payers to pay for and to approve these therapies that commit to this. That's the call to action. That's awesome. Very clear. And certainly something to look forward to as you get to the next two R's in your model here. We're certainly rooting for you. If people wanted to learn more about you or the company, where can they reach out? Yeah. So they can go to codmitotx.com.

[00:13:34] And then I think come August, the spotlight's going to hopefully be very bright on, as we read out the top line results. And I think that'll be an incredibly important, really, I think a cultural, I don't want to overstate it. And I am the dog that caught the truck, right? I am not the founder of this company. I am incredibly fortunate to be the CEO. But I think it's going to be this incredibly, we named the study Hope for a reason, because

[00:14:00] I think it will be an incredibly hopeful moment for patients and families. And I think I don't want it to be lost that this is something that they can take action against, learn again, learn about and reach out to. So that's great, Christian. Well, I really appreciate you doing this podcast with us. Yeah. And certainly look forward to hearing how the rest of the study goes. Yeah, that's right. I appreciate it. Thanks for taking the time. Of course. All right. Folks, thanks for tuning in to this episode of The Outcomes Rocket here at Device Talks with

[00:14:29] Christian Howell, CEO of Cognito Therapeutics. Check out the show notes on all the ways to get in touch with him and the company. Keep up with the hope studies when that concludes. And then in the new year, when the technology becomes available. Thanks for tuning in. And Christian, thanks again. Thanks, Mark.