Medsider: Learn from Medtech and Healthtech Founders and CEOs - Shaping the Future of Mental Health: Interview with Magnus Medical Co-Founder Brett Wingeier

Episode Date: July 13, 2023

In this episode of Medsider Radio, we sat down with Brett Wingeier, co-founder and CTO of Magnus Medical, a privately held medical device company whose FDA-cleared SAINT™ Neuromodulation System aims to revolutionize mental health care. Brett is a prominent figure in neuromodulation, leveraging his expertise in medicine, biology, and engineering to advance the arena within medtech. He was part of the pioneering team at NeuroPace and also co-founded Halo Neuroscience. In this interview, Brett shares valuable insights into understanding the system you're working with, balancing consumer and provider perspectives, and ensuring cost-effectiveness for successful reimbursement.Before we jump into the conversation, I wanted to mention a few things:If you’re into learning from proven medtech and health tech leaders and want to know when new content and interviews go live, head over to Medsider.com and sign up for our free newsletter. You’ll get access to gated articles, and lots of other interesting healthcare content.Second, if you want even more inside info from proven experts, think about a Medsider premium membership. We talk to experienced life science leaders about the nuts and bolts of running a business and bringing products to market.This is your place for valuable knowledge on specific topics like seed funding, prototyping, insurance reimbursement, and positioning a medtech startup for an exit.In addition to the entire back catalog of Medsider interviews over the past decade, premium members get a copy of every volume of Medsider Mentors at no additional cost. If you’re interested, go to medsider.com/subscribe to learn more.

In picking the projects that we focus on, in figuring out how to move them forward, there's really, there's no substitute for understanding the system and nailing the effects us. Welcome to MedSider, where you can learn from the brightest founders and CEOs in medical devices and health technology. Join tens of thousands of ambitious doers as we unpack the insights, tactics, and secrets behind the most successful life science startups in the world. Now here's your host, Scott Nelson. Hey everyone, it's Scott. In this episode of Medsider, I sat down with Dr. Brett Wenggeyer, a prominent figure in the neuromodulation space. Brett was part of the pioneering team at Neuropace and co-founded Halo Neuroscience as well.

Brett is also the co-founder and current CTO of Magnus Medical, whose FDA cleared saint neuromodulation system aims to revolutionize mental health care. Here are a few of the key things that we discussed in this interview. First, you need to understand the system you're working with and aim for a significant effect size in your clinical trials. Second, when developing new technologies, try to balance consumer and provider perspectives to ensure a smoother path toward regulatory approval. Third, your product has to make financial sense to raise capital and ensure reimbursement. Once you prove the business model, you'll enjoy greater opportunities in follow-up financing rounds.

Before we jump into this episode, I wanted to let you know that we just released the latest edition of MedSider Mentors Volume 3, which summarizes the key learnings from the most popular Medsider interviews over the last several months with folks like Jim Persley, CEO of Hinge Health, Carol Burns, CEO of Cajent Vascular, and other leaders of some of the hottest startups of the space. Look, it's tough to listen or read every MedSider interview that comes out, even the best ones. But there are so many valuable lessons you can glean from the founders and CEOs that join our program. So that's why we decided to create Medsider mentors. It's the easiest way for you to learn from the world's best medical device and

health technology entrepreneurs in one central place. If you're interested in learning more, head over to medsiderradio.com forward slash mentors. Premium members get free access to all past and future volumes. If you're not a premium member yet, you should definitely consider signing up. In addition to every volume of Medsider mentors, you'll get full access to the entire library of interviews dating back to 2010. This includes conversations with experts like Nadine Yared, CEO of CVRX, Renee Ryan, CEO of Cala Health, and so many others. Learn more by visiting medsiderradio.com forward slash mentors. All right, Brett, Lungeyer, welcome to Medsider Radio.

Appreciate you coming on. Yeah, thanks so much, Scott. It's great to be here. Yeah, this would be a fun conversation, especially considering we share somewhat similar backgrounds in the sense that our paths kind of have let us down, you know, traditional med tech paths as well to kind of some work in the consumer health space too.

So with that said, I recorded your bio at the outside of this episode, but it's relatively short. So if you can maybe spend a few minutes, walking us through your professional background leading up to your current role at Magnus. Yeah, absolutely. So I got to start with the fact that I'm a biomedical engineer. I knew I wanted to do that from a long time back. And really, because what lives at the intersection between medicine and biology and engineering, it's really fascinating. It gives us the chance to make a difference, but also interact with this really untapped frontier in technology.

Now, being a BME sometimes means that you're decent at a lot of things, but you're not really specialized in many things. And I've been lucky enough to specialize through grad school and now in industry in neuromodulation. But you really keep coming back to, you know, when you're doing biomedical engineering, it's the notion of taking this very, very broad, very, very full-stack approach to the whole technology system that you're building. In grad school, I focused on electric fields in the brain with the obvious connections is what I'm doing now.

But then I knew that I wanted to be an industry. And right out of grad school, I wound up. I was part of the first wave of employees in a company called Neuropace, where we spent many, many years making the world's first responsive implantable neurostimulator for epilepsy. It would watch for seizures about to start and then stimulate to try to stop the seizures. And it was really, really an amazing journey that taught me a lot of the things that I still use today. And we finally got that product on the market. We got approval in 2013, and it's helping a bunch of people now.

Got the chance in the meantime to work on some other implantable projects. And then back in 2013, co-founded this company called Halo Neuroscience, where we saw the chance to work at the boundary between consumer health tech and medical devices and neuromodulation and make some products that were relevant to human, performance as well as down the road medical applications. Had a great run at Halo, which put me in the right time and the right place to jump on board with the founding team of Magnus, where we're now making a really groundbreaking new treatment for depression. That's awesome. And we chatted a little bit before hitting the record button about your experiences at Halo,

right? Because I kind of share a similar background in the sense that I spent most of my career in the cardiovascular space. Then kind of on a whim started this photo biomodulation or red light therapy company. and it's class two device, but we commercialized it entirely online, direct to consumer. We raised awareness and kind of promoted the use of the therapy and the device through a lot of the same influencers, right? Dave Asprey being one of them. I think Ben Greenfield, if I remember correctly, uses the, uses the Halo.

Yeah. So a lot of the same, we worked with a lot of the same folks. But with that said, we'll go back in time and learn about, you know, kind of your journey and your experiences, not just with Magnus, but, you know, kind of previous work in the, in the space as well. But before we get there, talk to us a little bit about the Saint neuromodulation system that you're building at Bangus right now. Give us maybe a high level overview of what it is and then maybe touch on kind of the origin story, like how this technology even came to be. Yeah, absolutely. So, so Saint is, it's the first really rapid acting, powerfully effective and now FDA cleared treatment for treatment resistant depression. Now, let's unpack a few parts of that. I'm sure I don't need to convince. you or anybody, what a huge need there is for better treatments for depression. We all know,

if we're not affected ourselves directly, we all know friends and loved ones and family who are impacted. And it's a huge problem, not just for the folks affected, but for the world in general. And there's never medications work, but they take a really long time to be effective. And the effect size is remarkably small in a lot of cases. And there's half the people are, never really well treated by the medications. And there's this particular part of that need that inspired the early development of Saint. Put it this way, everything else that could go wrong with your body, you come to the hospital and they say, welcome to the hospital. We have things we can do. We have, if you have a stroke, you come and they have TPA, they have stents, they have imaging.

If you're hospitalized for psychiatric disease, then it's a very different and a really, really tough journey. You meet with a psychiatrist, you get diagnosed, you may be sitting in the hallway of the emergency room for a couple days at a time in the meantime. Finally, they find a bed for you, but there's not really a lot that can be done acutely. And there's a huge human cost there, in addition to a huge cost to the system. Now, my co-founders are psychiatrists, and their team at Stanford University. They, you know, as medical psychiatric health care providers, they were frustrated by this. And they engineered a technology that would take advantage of what we know about the brain. No surprise, every brain is different. Every brain has a precise target and a way of

stimulating and interacting with it that can yield powerful effects. So the founding, the research team at Stanford figured out how do we use functional MRI to figure out exactly the right target. and then how do we stimulate that with a powerfully effective pattern of pulses and sessions and doses? And what that yielded, and this was shown over a couple of studies that were done at Stanford, what that yields is it's a powerful treatment for treatment resistant depression over five days of treatment, a 79% remission in a randomized controlled, sham control, double-blinded study, which is it's really poised to change the world of psychiatric care. Wow, that's pretty cool. So in this device, it's used in the hospital setting in it, right? It's not like a, it's not something that's used like in a clinic or at home. It's as of right now, it's intended to be used in the hospital over the course of three, four, five days. Yeah, great question. So it's a piece of equipment that's used in the hospital or in a clinic. It's 10 treatments a day for five days.

Okay. Okay, cool. And then if you could, I mean, to the layman, right, because I don't have a ton of experience right in the world of, you know, cognitive science, let alone neuro, neuromodulation. but give me like the layman if I'm a consumer like what are you doing you're stimulating aspects of the of the brain through electrical magnetic pulses is that kind of what's going on yeah exactly so the when you look at the biology of depression for instance it comes down to brain networks and what's happening under the hood in depression is there's a deeper network that is responsible for the symptoms of depression inwardly directed negative thoughts that kind of thing and there's there's a another network and the prefrontal cortex, the dorsolateral prefrontal cortex is part of it, that other network is responsible for modulating the deeper network. And if you don't have depression, then those have a certain balance. But if you suffer from depression, then there's a balance that can be, there's an imbalance that can be remedied by stimulating the prefrontal cortex as part of this network in exactly the right spot to modulate the deeper network and treat the simple.

got it that's that that's super helpful and you mentioned something earlier in the conversation i want i don't want to get too sidetracked right because i'd like to cover a fair number of topics here in this in this conversation but you brought a good a good example right like if someone has a stroke if someone has a cardiovascular event a perforovascular event an orthopedic you know issue etc lots of great technology especially here in the u.s right to treat the uh the symptoms of of that particular disease or illness or whatever but when it comes to cognitive issues you're right i mean they're just hasn't, there's just not a lot available. And it seems like, at least maybe more within the consumer space, mental health is, there's certainly like a much more, you know, there's much greater

awareness around mental health, but significant like sort of, you know, disease in the form of depression, it's, it's large, I mean, it just, it seems like there hasn't been a lot of innovation here. Any, any, any, like, high level thoughts around why? Like, why, why is that the case? Yeah. And it's something that I've learned a lot about in this journey at Magnus, even. It's, it's, it's taken us a long time to understand much about the brain. And that's led to, it's one of the reasons mental health issues are stigmatized sometimes. It's led to a real lack of parity in treatment of mental disease, you know, worldwide, but particularly in the U.S. And there's whole parallel systems of how does care get paid for, you know, how is, how is everything

set up? And, you know, we're really at the start. of a journey here of bringing more biology and science to that process and bringing treatments that are really interventions. We and our partners are trying to work to kind of create this field of interventional psychiatry. Got it. Good stuff. One more kind of quick introductory question before we kind of step inside the old time machine and go back and learn a little bit more about the lessons you've learned along your journey. Give us a sense for kind of where you're at in terms of sort of the life cycle of Magnus. You mentioned FDA clearance.

So congrats on that. That's a huge, I know it hurdles across. But give us a kind of an overview, kind of where you guys are at today. Yeah. Yeah. So as you say, we got FDA clearance back in September of last year, which was a huge milestone. And right now we're in the middle of a couple things. We're working on some updates, what you call productization.

And it comes back to we're really trying to, you're trying to, you're trying to, you're trying to make this as easy to use as possible. So as we scale more and more, we can we can put this in the hands of psychiatrists and make it fit into their practices and make it really easy to use. We're in the midst of that. Next year, we should have a larger scale, a larger scale release that's supported by that work. And then in the meanwhile, there's a lot that we're thinking about and working on that goes into being able to. to do this sustainably and make sure that everybody's well supported and able to get great results, but also get the technology paid for.

Not only are we bringing an interventional kind of technology to a field that has used historically less interventions, but reimbursement, as you know, is a multi-year effort. And it takes time. It takes time to continue building the data. and make it clear to everybody in the system what this does and how it works and how it helps the whole system. But that's, we lay the groundwork for robust reimbursement for the system. We've laid the groundwork with the studies we've done.

We lay the groundwork with the work we're doing now. And that's really, really at the forefront of our minds. And it'll keep doing so in part because of this whole issue with the way mental health care gets paid for is really complex. And in some cases, there's a lack of parity with other types of healthcare. Right. Yeah, it's one of the biggest, you know, kind of hurdles. Maybe the biggest hurdle to cross is like an early stage company. You're already trying to, you know, push a boulder uphill in terms of developing the technology running clinical studies.

And then you sort of have to have to strongly consider how is this going to be paid? You know, who's going to, you know, who's going to cover and reimburse this, et cetera? So, I'm sure we'll maybe get into that in a little bit more detail. So we'll spend the next, you know, maybe 20, 30 minutes or so covering. some of these functional kind of topics, right, and learning a little bit more about your experiences and things you've learned along the way. But for those listening, if you want to head over to the Magnus website right now,

I wonder a little bit more about the technology. I think there's a lot of people listening in the audience that probably are just naturally curious, but may know someone, right, that suffers from depression and don't really kind of are at a sort of, you know, maybe at a loss for like how to move forward. And so if you're interested in checking out the website, we'll link to it in the full article summary for this particular discussion,

but it's magnusmed.com. So, M-A-G, N-U-S-M-E-D, MagnusMed.com. You can learn a little bit more about Brett, the company, as well as the technology, or technologies that they're building. So with that said, Brett, let's go back in time. And we'll start kind of with, you know, probably is your wheelhouse, right? Which is, you know, early stage, development of early stage technology, right? And so, you know, thinking about your experiences across Neuropace,

Halo, and now Magnus, and maybe put yourselves in this, of other, you know, med tech, health tech, you know, founders and entrepreneurs are really try to be capital efficient, right, in the early days. Rapidly iterate, but, you know, be capital efficient at the same time. Any like words of wisdom, recommendations that kind of surface as you think about this topic of really how to move fast with a relatively lean budget in those, in those early days? You know, for me, the answer to that comes down to effect size and understanding the system that you're trying to interact with. And I really, I can't, I can't, say enough how important that is. And there's examples throughout my career, but I'll point to a

couple things from both Halo and Magnus. I think we in neuromodulation feel this particularly painfully because until now we've understood so little about the brain. And there have been a lot of neuro technologies in particular, some like deep brain stimulation for Parkinson's, where they've been a great success because you can say, here's the targets. And sure, we learn more over time. But by now we know what we're trying to target with DBS for Parkinson's. We know what we're trying to target with spinal neuromodulation, and those have been very successful fields. But in neuromodulation, especially non-invasive, there's so many cases where we don't understand all the mechanisms that are going on in the brain. And there's a lot of ways, if you have a brain that's

suffering from some kind of disorder, where you can push it a little bit and things get a little better but and sometimes sometimes that can be helpful but it doesn't lead to the type of effect sizes that can give you a real tailwind as an entrepreneur in doing all these other things that we have to do doing our trials getting you know getting regulatory clearance to market the device to getting reimbursement and so on so it just for a couple examples at halo we were we were leveraging what what was known and expanding the field a little bit in transcranial electrical stimulation of the brain. Now, TDCS and its relatives, there is an effect size there. It's a fairly diffused field of what you're doing at the end of the day is making it somewhat

more likely that neurons will fire together when they do fire, which has some effects for plasticity. And if you're trying to learn something in the meantime, you know, in our case, movement skills, sports, music, things like that, then if you're training mindfully, you get better a little bit faster. Now, one lesson there is you can have something that's a meaningful effect size in the lab, but when it comes time to put all the other pieces together, whether it's a consumer product or a medical device, if you don't have a bulletproof effect size that makes people stand up and say, wow, this is amazing, then you can do all.

these things, but it's going to be an uphill battle in some ways. And we found that particularly in the markets we were addressing with Halo, where as a consumer product, you need something that makes that individual user stand up and say, wow, and not have to track their progress over four weeks of careful training in order to have that experience. The key to that effect size is understanding the system. And again, it's painful with the brain, but it's really, really necessary work. If you don't understand the system that you're trying to modulate, then you can't design a good treatment for it. One example that I like to give, you know, now as a, as somebody working in the space of psychiatric disease, there's a good analogy is if

you're trying to, if you're this case now of knowing so much more about the physiology of depression than we did a decade ago. Let the team at Stanford, whose work all this is based on at Magnus, really engineer a treatment and say, okay, how do we modulate that network? How do we go right to place we need to treat? How do we deliver based on neurophysiology, the exact right pattern of pulses and sessions? And that finally unlocks a really, really market effect size. And once you have that, then you've got to, stuff's hard, but you have a tailwind behind everything else. And So my biggest piece of advice to other device entrepreneurs would be it may be frustrating to slow down and take time at first to generate those data in the lab or in the clinic. And if you don't understand the system, then there may be basic research that needs to happen first.

But in picking the projects that we focus on, in figuring out how to move them forward, there's no substitute for understanding the system and nailing the effect size. Yeah, you described that in a very kind of intellectual, you know, sophisticated manner. And kind of me hearing you kind of lay out, right, your sort of thesis on how to, how to make key decisions right in these early days. And I'm just thinking of like how, if you're an entrepreneur, you need to be asking yourselves, does this technology that I'm working on, right? My idea, this concept, et cetera, doesn't truly move the needle, right? In a deck or maybe in a hands-on demo, am I, is someone going to stop to your point and say, wow, if I had that, that would be amazing? right or that would be really game-changing if it's incremental if it's like you know so-so me you know maybe it's caused to your point to kind of go back and and you know maybe truly better

understands for the system and what's really going on you know before before moving forward and and and you're you know your your your competitive advantage as an entrepreneur the the IP you can carve out all these things they also depend on on understanding the system you're trying to modulate because otherwise we're just trying to make lucky guesses and leverage stuff we don't understand. Yeah, no doubt. Let's transition to, to kind of this topic of clinical and regulatory, right? Like I said before, you've got some unique experiences in developing technology that's kind of meant or intended to be used, you know, by both consumers, right? And then in the case of Magnus, it's clearly used by,

you know, by trained clinicians. And so talk to us about that approach because that can be kind of, that can be kind of interesting, right, balancing those two, you know, those two worlds. Obviously, you have a much more narrowed focus at Magnus. But when you think about how to approach kind of the Reg-Clen pathway, what key things have you kind of learn, you know, throughout your experiences at Neuropace, you know, Halo and now and now Magnus? Yeah, yeah. So there's a couple themes on that.

So let me try to pick off a couple of them here. But, you know, first on the consumer to medical spectrum, when it comes down with it, the principles are really the same. It's just how do we apply them? There's this foundational principle of how you think about, is this a medical device or a consumer product that makes sense to release? And what's the risk versus the benefit? Now, on the consumer side, the risks have to be very, very low. And the benefit might be viewed differently. And on the medical side, you still have to think through risk and benefit that the tradeoffs are different. But there's still this very fundamental notion of, you know, how do we do risk analyses? How do we think about the benefits that's core to both processes? Now, when we started Halo, one of the reasons we went consumer first was, well, first off, we knew we had a safe technology, but also there was this general wellness guidance that was really starting to clarify a path. What would a consumer health tech device be? And it was a spectrum of thing.

We were on one end of that spectrum with a brain stimulator. There's another end of that spectrum that's, you know, things like your Fitbit used for, for tracking. in your health books. Hey there, it's Scott, and thanks for listening in so far. The rest of this conversation is only available via our private podcast for MedSider Premium members. If you're not a premium member yet, you should definitely consider signing up. We'll get full access to the entire library of interviews dating back to 2010.

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