In this episode of the Flex Diet Podcast, I’m joined by Erin Silver Lee, the CEO of Flow Neuroscience. We dig into some seriously cool stuff — including Flow’s recent acquisition of the Halo device, which uses non-invasive brain stimulation (TDCS) to boost both athletic and mental performance. Erin and I talk about how this tech works, what the current research says, and how it’s being applied to improve focus, sleep, neuroplasticity, and overall brain health. We also get into the real-world side of things — from navigating FDA regulations to running clinical trials and shaping the future of personalized brain optimization. If you’re curious about where neuroscience meets performance — and how safe, evidence-based brain stimulation might fit into the next generation of recovery and training tools — you’ll want to check this one out.
In this episode of the Flex Diet Podcast, I’m joined by Erin Silver Lee, the CEO of Flow Neuroscience. We dig into some seriously cool stuff — including Flow’s recent acquisition of the Halo device, which uses non-invasive brain stimulation (TDCS) to boost both athletic and mental performance.
Erin and I talk about how this tech works, what the current research says, and how it’s being applied to improve focus, sleep, neuroplasticity, and overall brain health. We also get into the real-world side of things — from navigating FDA regulations to running clinical trials and shaping the future of personalized brain optimization.
If you’re curious about where neuroscience meets performance — and how safe, evidence-based brain stimulation might fit into the next generation of recovery and training tools — you’ll want to check this one out.
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Speaker: Welcome back to the Flex Diet Podcast. I'm your host, Dr. Mike Nelson. On this podcast, we talk about all things too. Increase performance, add muscle, improve body composition, do all of it within a flexible framework without destroying your health. Today we've got a great program. We have Erin Silver Lee.
She is the newer CEO over at. Flow neuroscience, you may be familiar with them if you're in the us. They took over a previous device that was called the Halo device. And the halo device was using non-invasive brain stimulation, uh, sometimes called uh, TDCS. And the original Halo device was for more on the motor cortex for enhancing athletic performance.
And I purchased one of the early devices quite some time [00:01:00] ago. Um, played around with it and it was pretty interesting. The product was pretty solid, had some pros, had some cons, but it was the first kind of consumer grade version of it. And if you look into the research on TDCS, it's pretty interesting and pretty substantial actually.
So when I saw that they were acquired by, uh, flow. I reached out to her and wanted to have her on the podcast to explain everything that was going on. So, uh, this was not a sponsorship from them, but I looked at a lot of the research and stuff they were, uh, doing and wanted to chat with them more about it.
And she was very kind to offer up her precious time so we can have this chat. And so we talked all about just the background with flow neuroscience, the acquisition of Halo different aspects of this technology for mental [00:02:00] performance, uh, impact upon sleep and even neuroplasticity, focus and concentration.
What are all of the benefits? And then we also talked about navigating FDA regulation. Uh, the difference of that versus consumer. Approval and kind of what is their path, uh, going forward. So it's very interesting technology. For the most part there's been not much in the consumer area in this area, and the ones I've seen, uh, haven't really had much data to back up their device.
So, uh, I think you will really enjoy this conversation with Erin. Who is the CEO there? And if you want more information from me, check out my newsletter. Go to mike t nelson.com and up at the top you'll find a button that says newsletter. We'll put a direct link in the podcast down below here, and this will have you hop on.
And if you have any questions, you can just hit reply there. I send out [00:03:00] newsletters primarily daily on everything related to all the items we talk about on the podcast here. So if you want more information, I'll hop on there. Uh, we'll put links to all of the great stuff over at Halo and Flow in the podcast here too.
So make sure to check them out. So without further ado, here is my chat with Erin.
Dr Mike T Nelson: Welcome to the podcast, Erin. How are you?
Erin Lee: I'm great. How are you?
Dr Mike T Nelson: Good. Thank you so much for doing this. We really appreciate it. Yeah. I guess the, the main question is, I know you guys took over what used to be Halo neuroscience and do you want to give us a little background on. Why you did that and how you started and kind of pivoted to where you're at now.
'cause some people listening to this podcast may be familiar more with the Halo device than the newer device. So maybe give us some background and kind of give us up to [00:04:00] speed of what's going on.
Erin Lee: Yeah, absolutely. So, um, flow Neuroscience as a business, which is the company that acquired, uh, halo Sport, we've been around for about 10 years.
So we were founded in Malmo, Sweden in 2016. And really our mission and vision is around driving accessible and affordable non-drug based treatments for, uh, the world's leading mental health conditions. And we have been plugging away in Europe for the last four years. Uh, we have 50,000 users.
Um, we work with the NHS 900 clinicians regulated. We're awaiting FDA approval for our dep, our clinical depression product. And in early 2020 while we were sort of developing the clinical product, unfortunately Halo as a business, I think fell victim to the early days of COVID. And one of the things that was very interesting and remains very interesting just about Halo Sport was their focus on [00:05:00] motor cortex stimulation.
Dr Mike T Nelson: Mm-hmm.
Erin Lee: As a complimentary or supplementary stimulation mechanism for what we're doing with the frontal stimulation. So we really see ourselves as focusing on first like clinical indications for the left oral lateral prefrontal cortex. Then also wellness indications or mental performance indications.
And you can imagine how much more powerful that becomes with the integration of. Sort of that motor cortex, physical stimulation. So that sort of, that was the impetus behind, uh, the acquisition. I think during COVID it was very difficult to do. I think the product itself, uh, needed some work. And I think what we've learned is maybe the communication wasn't as, as strong as it should have been during that handover.
Um, what I will say to former Halos Sport users, 'cause it's far and away, the number one question I get when I speak to folks is, are you done with motor cortex? Does Halos Sport die? That was
Dr Mike T Nelson: one of my questions. Yeah. I'm sorry.
Erin Lee: Like, is Halo Sport done? Well, we can dig more into this.
Dr Mike T Nelson: No, that's good.
Erin Lee: No. [00:06:00] Your answer, no.
Dr Mike T Nelson: And so the. The newer device then is focusing on a different part of the brain from the motor cortex, correct?
Erin Lee: Yes. So we focus on the left or lateral prefrontal cortex, which is associated with executive function. That includes things like memory, fine motor skills focus, concentration, sleep, mood. And what we've seen over the last, you know, four years across those 50,000 users is there was actually quite a large subset of folks who were not depressed at all who were using the product.
And we saw meaningful improvements and things like sleep concentration. Uh, I think, you know, in, in three weeks. 60% of folks had improvements in sleep, 65% had improvements in concentration, and that's for people who aren't depressed. And then we also started to see a component of sort of athletes, super performers, whether that's business or sports, who were using it to [00:07:00] improve their overall sort of mental performance.
And that was the impetus behind relaunching the Halo brand with the goal of sort of saying, we're gonna focus first on mental performance, which is a big part of overall performance, as I'm sure most athletes will tell you. Uh, and then later sort of layering on the physical component.
Dr Mike T Nelson: Awesome. So if we dig into that a little bit more, one of the areas that surprised me, as you mentioned is sleep.
How does stimulating that part of the brain affect sleep? And then, since most of our listeners are on audio, do you wanna just give a brief description of what the device kind of looks like so they have a frame of reference that they can kind of picture in their head?
Erin Lee: Yes. Okay. Asking me to be descriptive.
Um, I'll start with sort of the overall divide. You know, when I first saw it I sort of, it sort of reminded me a little bit of, um, like a sideways Sony Walkman headset, if that makes sense. Yeah, yeah, that's a good one. Disservice. But, you know, the sort of old school Walkman headsets, but flip, so it's [00:08:00] centered on your forehead and there's two, uh, electrodes for stimulation that target.
The left do or lateral, uh, prefrontal cortex. Very lightweight. DD uh, device. Very easy to use. I think I get a lot of questions on the arc in the middle because you may see other stimulation devices that sort of are just a headband that serves a couple different purposes. You can't put it on upside down.
You can't put it on backwards. Um, reduces things like headaches When you're wearing, uh, sort of a tight headband, you can also have headaches. So, uh, that was an intentional design choice. And you wear the device 30 minutes a day, anywhere from three to five times a week, depending on what you are focused on from clinical to nonclinical indications.
And so sleep is a really interesting one. And there's a couple different schools of thought. The first is, particularly in sort of a depressed population, when you have sort of an overactive or underactive control of. Those [00:09:00] of the left or lateral prefrontal cortex that affects not only sort of your working memory, your processing ability, but also your ability at the end of the day to downregulate mm, go to sleep.
Right? And that's true to an extent with your healthy users, right? So there's a reduction in, uh, your, your lack of ability to downregulate improves your overall sleep architecture. In terms of, I'll sort of try and simplify this a little bit. Um, no,
Dr Mike T Nelson: you can get as geeky as you want.
That's fine. Geeky as I want.
Erin Lee: Okay. Um, so if you look at sort of REM sleep and slow wave sleep in particular you can see a reduction in dorsal lateral prefrontal cortex activity. I gotta come up with a shorter, it's interesting
Dr Mike T Nelson: they abbreviate everything else, but they rarely ever abbreviate that when people are talking.
I've noticed. I don't know why, but,
Erin Lee: well, it's like the abbreviation I don't think is that much more helpful because No, it's
Dr Mike T Nelson: not.
Erin Lee: So that's in some ways harder to say. So it [00:10:00] is. So anyways, the simulation sort of decreases overall slow wave activity. As I mentioned. It improves, um, sleep architecture. Uh, so there's a, a couple of different mechanisms of action.
And what I will say is like we continue to learn what's driving sort of. What we see in sort of the, um, symptom treatment. Like we know that symptoms respond and we're trying to understand what are the different components that drive that for a particular user. 'cause it's gonna vary.
Dr Mike T Nelson: So would a radical oversimplification be that for people who have the air quotes, the monkey mind, the racing thoughts, that type of thing, would this device potentially be more beneficial for them since it's trying to quiet and downregulate certain parts of the brain that we know tend to be overactive before sleep?
Erin Lee: Yes. And it can also be, you know, when you think about overall emotional regulation, right? It's increasing neural, that stimulation is increased, it's actually increasing activity. Improving [00:11:00] neuroplasticity, which in turn can also drive improved connections to other areas of the brain, like the amygdala, limbic structures, things like that.
And so when you have an impaired impaired activity in this region, you might be overreacted. So to your point. By bringing that back to sort of a steady state you're reintroducing the ability to self-regulate and control sort of that pre sleep arousal, for lack of a better word.
Dr Mike T Nelson: So you might be, how I also think about it is coupling it better to other parts of the brain, so you're getting a little bit better communication.
Like this little part of the brain is not off on its own island, having crazy thoughts that it can't regulate the rest of the body, that you're trying to couple it to other parts of the brain that are having a better overall control of both the body and, and the mind so that they're kind of, lack of a better word, cooperating a little bit better.
Erin Lee: Yeah, exactly. And I think, you know, sleep, just like the brain itself and depression and, and other symptoms, everything is [00:12:00] so interconnected. So it, and it's obvious when it's obvious when I say it, right. But I think people, particularly those that don't have clinical depression or are generally otherwise well, may not initially recognize the impact of even sort of your average stressful day subconsciously on sleep and that type of activity, or, you know, an athlete training for a major, um, performance or competition.
They're, in many ways, they're some of the most controlled in terms of mental state, right? They spend
Dr Mike T Nelson: years
Erin Lee: straining. Uh, but even so, there's still this subconscious element, um, that sometimes people can't put their finger on. Now, for those that suffer from chronic insomnia, which we sort of do not claim to treat.
Uh, they can have a much different experience and there are certainly other providers that focus more intently on insomnia itself, which is own sort of clinical indication
Dr Mike T Nelson: and the, the [00:13:00] 30 minutes. Do you do anything at that point? Because I think one of the questions for people is, oh, do I just have to hang out and stare at a wall for 30 minutes when I do this, or what?
So
Erin Lee: the, you sort of the impetus behind the platform and why we built a platform and not just device is, you know, while you're stimulating your brain is actually primed to drive better habit formation habit, behavior change. And so that was the impetus behind a lot of the content, right? So while you're stimulating, it's actually a very good time to start to build bedtime habits if you're doing it before bed or, my colleague Sam uses it in the morning to prime for focus and uses that time to really lock in.
Uh, and prepare. So the short answer is like, you should, and, and many people do take advantage of that time. Now, for others, they, they need to do it passively. Like some people use it in the car. I don't, but, uh, some people do. And in that case, again, it's a, it's a more passive [00:14:00] interaction. So again, it depends.
We recommend that you take advantage of the neuroplasticity, but you certainly don't have to. And there's many folks who don't and also see very good results.
Dr Mike T Nelson: So the theory then would be if you're using it before bed, like you are increasing neuroplasticity. So hopefully those other associations with your PM routine, maybe you're doing some, I'm a big fan of downregulation.
Do some breath work. Like teach your brain and body that it is the end of the day. You're not gonna get up at 3:00 AM and work on your paper or work on your proposal or whatever it is. Like, have that sort of repetitive nature so that you can sort of. And train your body and your physiology. And if this is increasing neuroplasticity, maybe you can shorten that sort of time period because now you have a more plastic brain that's more receptive to some of these changes that it can kind of, like you said, lock into it a little bit sooner instead of maybe, taking six weeks to feel better.
Maybe I'm just making up numbers, like three weeks, two weeks, whatever. It's [00:15:00] shortening that, that time period of where you get those better associations.
Erin Lee: Yeah, that's right. And it, again, it's, it is mental training in the same way that we do physical training. And so you've gotta build neuro pathway pathways in the same way that you're building muscle fibers, right?
Mm-hmm.
Dr Mike T Nelson: It's
Erin Lee: mental, uh, mental memory. So, you know, you start your stimulation, you turn on your red light or you know, turn get off the blue light, uh, cell screen and start to, yeah, lock in for sleep or. Mellow out. And then I think over time that becomes a habit, which is accelerated again by the stimulation.
And a lot of users see it as me time, right? It's sort of my time to disconnect. It's something that I do for myself. It's less of a, clinical treatment. It's more of, I guess spa time is probably pretty strong, but it sort of sets the tone for what's ahead
Dr Mike T Nelson: and for people that are new to the device.
Are there different program settings on it? Is there one that's kind of geared more towards sleep, or is it just [00:16:00] kind of the same general mechanism you're, you're trying to hit and you're just doing it at different times for different things?
Erin Lee: So, um, for now, the general baseline montage is standard. Uh, there is some flexibility on the number of sessions per week, I think.
What you'll see from us, uh, over the next couple quarters is the ability to drive a much greater degree of personalization. Mm-hmm. But we learn from users, we learn from what's happening in the real world from our clinical studies in terms of, you know, who benefits from doing this at night for sleep, what does that protocol look like versus a focus protocol versus like an athletic protocol.
And I'll, I'll be honest, some of the work around music where we have a lot of interest and a lot of users and athletics is very much day zero. There's still quite a bit of, for us, um, to optimize even in terms of, um, is within a, within a montage. So today we try and make it very straightforward, one size fits [00:17:00] most, uh, but over time you'll see that, uh, expand.
Dr Mike T Nelson: Yeah, I think that's very interesting. And I know it's very, probably difficult to have slightly different protocols for each one or whatever, but I think there, from a consumer thing, I think there's definitely something to. Oh, this is my sleep protocol or this is my, you know, focus protocol. That very much the singular focus, even though, a lot of these things don't work that way directly on the brain, but I think from a consumer standpoint, they're very trained for better or worse, to, oh, this is my supplement for sleep, or this thing only does this thing.
They're very, it's, uh, the one thing only type thought pattern.
Erin Lee: No, absolutely. And you know, I think it's interesting when you look at the clinical studies, it's not always evident. That a greater degree of personalization drives better results, at least sort of at a high level. Now, again, like we are very bullish on personalization and there's absolutely reason to believe that will change, particularly around [00:18:00] sleep, where REM patterns are particularly personalized.
That seems to be less true for things like focus, mental performance, fine motor skills. And again, like you'll see that over time, our challenge is how do we make the technology accessible for as many people as possible, while also giving some of those early adopter super users. And there are people out there absolutely keeping us on our toes.
I think they've been doing some Oh, I'm sure.
Dr Mike T Nelson: I mean,
Erin Lee: and I love talking to 'em, right? They're like, you know, I have this device, I've tried this one. And I'm sort of like, wow, it's, you've got like a science lab in your basement. Yeah. And that's great for you. And we absolutely wanna learn and partner from those users.
But again, in terms of like regulatory approval, there, there are some limitations in what we can do from the gate.
Dr Mike T Nelson: So it was a theory that it may improve REM sleep, which then in theory could improve. I think of like skill acquisitions. We know that a lot of times skill acquisition is hugely associated with the amount of REM sleep.
I think it was some of the old mice studies, the first time [00:19:00] they showed this, they put the little connectors in the mice's head and they were trying to watch what they were doing after Maze running. And they saw that the mice were the same neural patterns were going, that they were running through the maze, but they were going at a much accelerated rate.
The thought being that you're kind of consolidating maybe some of those motor patterns you're learning during the day with REM sleep.
Erin Lee: That's right. And, and I think everyone knows how important REM sleep is just generally to overall. I mean, anyone who's not had it for a few nights, like creatine aside, I haven't found that that works for me, although I know there's some thoughts that, doubling down on that can improve that perceived REM sleep.
Very powerful. But yeah, I think you've summarized that better than I could.
Dr Mike T Nelson: Yeah. Is there any potentially early effects on deep sleep or is it too early to tell anything yet?
Erin Lee: Too early to tell for us, and I think what, uh, what we've really been focused on is how can we continue to introduce, uh, a greater level, level of objectivity in terms of the way that we're measuring and understanding the brain.
And so, uh, you know, [00:20:00] quite a bit of our early evidence, and some of, the early open label results were really around self-reported information from users, what they were perceiving, what they see, from their aing and their use of, um, flow and now halo. And that's very helpful for us.
We're indebted to them, but really the future is, can we measure those waves directly with those alpha waves or those gamma waves? Can we understand a particular user? And then can we really deeply understand what's driving change for an individual user? And that's very important for us because.
There's a lot of snake oil out there. Right. And we can hypothesize and we can say, this is a theory. Yeah, yeah. Action. But we'd really like to know, and I think our challenge is like, in some ways the measurement capabilities haven't kept up with our stimulation capabilities. But I think we'll get there in, in short order, so.
Dr Mike T Nelson: Awesome. And we'll talk a little bit more about the wonderful data you guys have been working on too, and a little bit more background on the device. Does it do measuring [00:21:00] and how does the measuring affect the output? Or is it purely looking at output now? How does that work from Um, you could probably even explain a little bit about anytime you hear, oh, this thing's zapping my brain, it it sounds like a, a bad idea.
No,
Erin Lee: I know. And you know, it's funny, you're absolutely right. And I, I probably shouldn't say this, but I do because I think, I am not a neuroscientist by background. Um, and I think that's important because we. You know, my goal is really to make the technology as accessible as I can to as many people as possible.
And I think there's this belief that, you know, if you're not a neuroscientist, you can't understand it. But when I first started, you know, working with Flow, my parents were like, is this like one flu over the Cuckoo's Nest? And what are you doing? You're
Dr Mike T Nelson: zapping humans', brains, what are you working for this company?
Crazy person.
Erin Lee: Yeah. You know, I think. There's this concept like having, like how outdated and how, you know, like feral really. And I [00:22:00] think the reality is as a, you know, you know, really as humans, we are electric. The brain runs on electricity. I think ECT is sort of this wicked stepmother of a technology and it has had some horrible effects.
Dr Mike T Nelson: Um, and that was electroconvulsive therapies electro that was used many, many decades ago, with very decades ago. Very brutal videos if you ever watch 'em, which I would not recommend. I, they're, I can't watch any of them. No, I
Erin Lee: mean, they're horrific, right? Yeah. And you, you hear horror stories about people who had it inflicted on them.
Um, on the flip side, in, in some studies, it's actually tremendously effective, although that extreme strength of current came with those horrific side effects. Yeah. Many of them permanent, um, to a lesser degree. It's a similar mechanism of action to TMS. Right? So that uses magnetic stimulation, must be done in clinic, must be done by a clinician because it's so strong.
Whereas our technology is really very mild can be done at home safe enough for home use, yes, some tingling and redness, [00:23:00] but overall, like an incredibly safe technology with very limited side effects. We really do see this as the future in a number of different indications. And so I think we're trying to bring back maybe we're trying to repair the reputation of electricity because it certainly hasn't been good to date.
Certainly hasn't been good to date.
Dr Mike T Nelson: Yeah. And does device do measurements also or is it just kind of applying a set protocol or how, how does that work I guess? Yeah,
Erin Lee: it kinda open-ended our first device in, in terms of the montage set protocol, like I said, there is some flexibility that can be adjusted by clinicians in terms of the length, so.
30 minutes or more than 30 minutes per session and the number of sessions. And you know, I think if you look at the sort of clinical literature out there far and away, the largest impact that we can drive on outcomes has to do with the length and frequency of those stimulations, right? So the number of stimulations, um, and how long you're stimulating per day [00:24:00] may seem obvious, right?
The do overall dosing. Sure. Uh, before you even get into personalization. Now, having said that, obviously as I mentioned earlier, our, our big bed and our belief is that personalization can and, and should matter. And we have a second device that will hit the market early next year that integrates measurement, um, and should unlock a degree of personalization.
Now, again, we have to do that in a way that's accessible. But we've already seen incredible results on our ability to predict someone's response to stimulation, like anywhere from 85 to 90%. And then obviously you can imagine what we can do with that on the stimulation side. So the short answer ISS coming,
Dr Mike T Nelson: and once you have that ability to sort of listen to the response, I would imagine that opens you up to be more of a closed loop feedback where you could give a, a signal or start at a certain protocol or whatever, and then, you know, air quotes, kinda listen to see what's going on.
Do I see the right, pattern? Is this what I expect? Oh, kind of goes this direction, so maybe I'll [00:25:00] do this. Like it kind of gives you more personalization options I would imagine at, at that point.
Erin Lee: That's right. Um, and you know, I think people who are passionate about the space always, you know, they, they jump to like, let's talk about how we can personalize the, the wavelengths and the stimulation patterns.
And trust me, no one is as excited about that as we are. But what I think was interesting, and again, probably not surprising. Why we focused more on sort of that core experience and that standard experience is one of the challenges we have is, as with everything, is getting people to consistently create the habit of stimulating Yeah.
Brush our teeth. Um, and so a lot of the personalization that we did initially was actually in the app around the app experience and starting to help some very basic habit formation without being overwhelming. Right? Because it, it, it can certainly be at least sometimes when I open my Aura ring and my eight sleep and all of the other apps
Dr Mike T Nelson: like
Erin Lee: information overload and just can be sometimes [00:26:00] more stressful than helpful.
And so we try and work up to that. Before we sort of unleash that,
Dr Mike T Nelson: you mentioned, uh, creativity and, and focus. Talk to us a little more about that because I think we're sort of seeing, this is my prediction, the. Incoming of all, all things neurology, cognition, even autonomic nervous system regulation. I feel like in the next, yeah, starting this year and next couple of years, those are gonna be still very, very, I hate to use the word trendy, because there's actually really good data and there's a lot of really interesting things coming that way, but maybe a lot more awareness focused in that area than what historically there has been.
Erin Lee: Yeah. Um, so we can talk about focus, although that's typically regulated again by the left or left dorsal, lateral prefrontal cortex. That was one of the areas where we saw the fastest response for both depressed and non-depressed users, as I mentioned, like, and our co-founders [00:27:00] use it before work for that exact purpose.
And it really is driving, again, neuroplasticity, priming you for performance, driving increased connectivity across the brain. They swear by it. Now, I'll, I will say this in full transparency, I have certainly tried to use it for the same, does it work for me quite as well as it does for our, our co-founders and others.
So, again, I'll be a good candidate for some of the personalization in this space. But, you know, to your point, I think a lot of the treatment or focus on the focus concentration space has been focused on pharmaceuticals. I think they can be effective, almost certainly, but they come with extreme side effects and they can form sort of long-term dependence.
And I, I think we'll find, as with physical activity that sort of priming your brain in the same way can drive meaningful improvements focused. And, and we've seen, like I said, 65, almost 70% improvement in three weeks. And the ability to concentrate for our well users. [00:28:00]
Dr Mike T Nelson: Is that something that would be the similar protocol?
Like they would do this as part of their, it seems like everyone has a 17 step, um, ritual now. Would it be part of that or is it something you could say, Hey, I gotta, I, in my case, I have to sit down and have to write this newsletter. Could I put it on and do it while I'm doing the work? Or is it something I have to do separate to sort of prime my brain to get into that state and then I wouldn't use the device while I'm actually doing the task?
Erin Lee: No. So one of our, um, one of our co-founders uses it while they start work, get into the day, you know, and it, I think it helps focus him on those activities are other, um, are other sort of my other colleague Sam, who. I sort of use him as an, as an example of like one of those Tim cook's, like wonderful morning protocols that we always have.
He gets up, he does his yoga, he does his mindfulness, he wears flow. As part of that sort of gets into [00:29:00] the zone, that is not me. Like my eye wake up, my eyes are barely cracked to take coffee, you know, and I sit down for, again, some of this is, some of this is user based and again, it's what are your habits?
Where are you trying to reinforce, rebuild those habits, drive sort of the right activity at the right time. So again, we fully appreciate it's not one size fits all and, and the sort of answer, it sort of depends.
Dr Mike T Nelson: Got it. And. More in, I guess my own curiosity. I spent 10 years working for a medical device company In the past they were more in the cardiac space.
Okay. So I have a little bit of an idea of in the US the amount of FDA regulations and who popping and all the Dodger t's cross your eye, you know, all the kind of stuff that goes in there. And I believe in the US you're looking to get FDA approval for more of a clinician model, but there'll still be a consumer version also.
So you're kind of taking both tracks, is that correct?
Erin Lee: Yeah. And sort of the impetus behind that was, look [00:30:00] we have always believed. 'cause I think another question I get all the time is like, why now? Like why are you entering the market with Halo now? Is it a money grab? And that, you know, as I remind people like look, we've been around for 10 years, we've been commercial for five.
We could've been in the US market five years ago. Our goal was really to legitimize the technology. Right. And I think, again, there's been so many bad actors unfortunately that have promised the sun, the moon and the stars.
Dr Mike T Nelson: Yeah. Uh,
Erin Lee: I think TT CS got a bad rap and so we invested in clinical trials, we invested in clinical partnerships, very much wanted to build a reputation as a company you can trust.
That obviously started with our depression treatment in Europe. We save, you know, try it. If it works for you, great. If it doesn't, no problem. We'll refund you. I think, you know, our clinical trial was published in Nature Medicine, showed that we were twice as effective as leading antidepressants. None of the side effects.
We've invested in regulatory approval in Europe, which is not an easy task in and of itself. Yeah. The RCE marking and then [00:31:00] FTA and I think. Maybe some of it was naivety, maybe some of it was based on all the feedback we had on how successful our trial was and all the real world evidence that has been much more challenging than we anticipated.
I think we'll get to a good outcome here. I think it's what's really frustrating is, you know, when you look at benefit risk of our technology versus drugs, like, when we're run away more effective with way fewer side effects, but there's still a stigma around the technology, particularly technology we wanna put in the home.
And so I think, I think it's fair to say that we've been held to a much different standard than other technologies. Some of that's first move or disadvantage. But it is what it is, right? I think we stand behind the data and I, I think we'll get to a good outcome on the clinical product.
Now, in parallel, since we have 50,000 users, we have this in over 800 clinics in Europe, we've seen a lot of real world success. And I think when you're committed to accessibility [00:32:00] and ultimately affordability, there is a need to get the technology to as many people as possible as quickly as possible. And that was the impetus behind releasing the Halo product in the us.
We would not have done it if the results weren't there. Doesn't benefit, you know, like I think people say money grab, like quite frankly, that's not what this is. It's, it's really about getting it into the hands of users who need it. And I think the outreach we've had from folks looking for solutions because, you know, modern medicine has left them behind sort of speaks to that.
And then I guess the only thing I would say is, you know, our goal has always been to cover the entire. Sort of continuum of health. We started with the very ill, our goal is to get you back to baseline, maintain your results at baseline. And then there's always the question, well, if I'm not depressed or if I'm at baseline, can you make me sort of a superhuman?
And I'll say that we're not there yet. But I think we can optimize the way that, that people live their lives and that hopefully we can bring some improvement. So that's the impetus behind Halo and Flow, but you, you will see them [00:33:00] together.
Dr Mike T Nelson: No, I think that's great because a few other companies I've worked for just consulting and a few off things, they, they had the option of going the medical device route or the consumer route.
And we're actually advised don't even bother trying to get FDA approval, just do the consumer version for. Obvious reasons of money, time, resources, everything else. So kudos to you guys for, for doing all that stuff because it, not that I'm not a, not to sound very conspiratorial, but the FDA historically is very set up for pharmaceutical trials, pharmaceutical setup.
We saw this with what, you know, maps even did you know some of their work with psychedelics, even though they worked with the FDA to try to figure out what is the best way. And yeah, there was some of their issues there also, but. It's just like the whole mindset is very set up with this randomized, placebo controlled pharmaceutical type model.
And if you're outside of that, it's, it seems to be exponentially more [00:34:00] difficult on top of everything else.
Erin Lee: I mean, I, I guess maybe some of this was even our, maybe how naive we were at the time. I think we always felt, you know, the data would speak to, would speak for itself. We have, we had a randomized placebo controlled trial.
We had two arms. And I think, you know, when I tell people our FD application was PMA, which is the most strict process, right? Mm-hmm. Yeah. Typically reserved for implantables, like very high risk devices. And that's because of the, uh, depression indication. I think people are really shocked and, you know, we've spent
Dr Mike T Nelson: millions
Erin Lee: of dollars on regulatory approval, and I reiterate that because I think a lot of the devices in the space haven't done that.
To your point, there often is good reason for that, but if you believe in the technology, there are no shortcuts. Right? And I say that as someone who is frequently frustrated by regulators, I do not think incentives are aligned, even if there are good people within the system. I think we've seen incredible bias, but again, we will never be able to [00:35:00] compete with drugs if we don't at least have that same validation from the regulator.
And it has not been easy and it has not been fair. But life's not fair. Um, and, and the technology is too important. In the meantime, we are going to do everything that we can to get the technology to those who need it for other indications where the risk is obviously much lower. So, I think at this rate, every new indication is like a three year regulatory process at a minimum.
That's crazy when you think about how long that
Dr Mike T Nelson: would take
Erin Lee: to get it to folks. It's just, it's too long, in my opinion. I don't know what the answer is. Uh, we, we can do what we can do.
Dr Mike T Nelson: I also feel like there should be some, and I know the FDA can, they don't have to follow what the recommendation of the panel is, depending upon what type of approval process you go through and all the other, weird things that go with that.
But I think there should be more put into that process if you're trying to treat things like depression and [00:36:00] PTSD and things that historically we just don't have a lot of other good options. So I think you could, at least, my argument would be, and this hasn't really gone over well with the FDA historically so far, but in those areas, to me, you should be allowed a little bit more leeway that if you can show safety, you can show outcomes, you're, you're running a reasonable trial that I feel like sometimes we're, we're, we're missing was the dollar bills and trying to pick up pennies.
Right. We're trying to argue about these really, really infinite of these small points when currently this, this and other technologies could be a great treatment for things that we historically just are not treating very well. I just feel like there should be a little bit more leeway if you're working in that area versus, oh, we're trying to improve this or that disease by like 2%.
It, it doesn't even feel like it's a comparable thing. But again, I don't run the FDA or have anything to do with that. No.
Erin Lee: Hey, I, I totally Look, I agree with you and I think, you know, [00:37:00] we applied for breakthrough designation, which I think like. On its face. The F FDA A says that they agree with you, right?
Yeah,
Dr Mike T Nelson: yeah.
Erin Lee: We wanna fast track technologies that have disproportionate impact. We were the first at-home stimulation device to get breakthrough designation. We've been talking to the FDA for three years. I think what they say in theory and what they do in practice are two very different things. And again, I'm painting the agency with a broad brush.
I think there are,
Dr Mike T Nelson: yeah. Yeah. In general, we're not talking about the people there. We're just saying as an institution of approval as its whole. Yeah.
Erin Lee: And to your point, like I think there's a, an awareness never, you know, people get so tired of hearing about the mental health epidemic, but the reality is, it, it gets worse every year.
We've never had more drugs on the market. We've never had more discussion of behavioral therapy and psychiatry. Like something is not working. We have this technology that, by the way, is approved in Europe and is seen as so safe that we can sell it over the counter for depression. And I don't think I have to tell you, but Europe is [00:38:00] not historically like very light on regulation.
Like we no light bulbs over here. Right? So I think that has been frustrating and, and as an American I always, you know, I'm like, we're the innovative country. Like we should be embracing new technology. And if, you know, and I think what we see is literally every other country we've engaged with has approved the technology except the FDA and, and you, you do start to, you see, start to wear a tinfoil hat at a certain point when you see the drugs that continue to get approved and their impact and you're just like, well something's, something doesn't seem quite right.
But I, I do think when I look around the market, I think that the winds of change are blowing and I think that's driven by consumers and I think it's driven by people who want better for themselves something else. And in this case, I believe like popul populous demand will drive regulatory change.
Maybe that's always the case, but I, I think we're already starting to see that, so I'm hopeful.
Dr Mike T Nelson: Yeah. And I think there's been a lot more education around those areas now about how ineffective the historical treatments we [00:39:00] have are. And again, they're definitely needed in some cases that can be really beneficial for, you know, a fair amount of people.
But if you look at the actual data that's been published, there hasn't really been a lot of innovation over the past few decades. It's been very, very, very tiny. So I think people are realizing that, oh, there, there are other things out there that can be beneficial. And I think the public pressure is probably the main thing that will bring the biggest amount of change,
Erin Lee: hopefully.
And look, we're all about choice. I'm not even to talk you that. I mean, I think there's people that say, well, you know, you know, Sr. Have saved my life. Fantastic. That is amazing. And I, you know, better living through chemistry. But there's also huge swaths of the population who are not well-served by that or existing technologies.
And don't we deserve to have really personalized and dynamic options and, and that's all we're advocating for. And by the way, we're much less expensive, uh, and more accessible than many of those pharmaceuticals, which I think people find hard to believe. So [00:40:00] again, like we just want to be held to the same standard, not a different standard as everyone else.
And I think people will really benefit from it. And if we didn't believe that, and if the data didn't back us up, it would've been very easy to walk away because it's been quite a brutal struggle. But all it takes is to hear the stories of the people who are as skeptical as anyone that give it a shot, use it for three weeks, and it's life changing.
Right? Not for everyone, but, but for a lot of folks. And, and I think that that's what keeps you going.
Dr Mike T Nelson: Yeah. And I think people, my biased opinion is everyone should be able to make their own decisions. Obviously work with your healthcare provider, work with your physician. They should help educate you as the end person using this.
Here's the pros, here's the cons. Here's this option here, here's this option here. And then you and your physician, psychologist, psychiatrist, you know, doctor, whatever, like you're working with someone who's educated in that field and they can help educate you on the pros and the cons. And you can kind of work out an agreement of, okay, let's try this.
We'll do this for X amount of time. If that doesn't work, [00:41:00] we'll go here. So it becomes more of, um, educational process. Then you know, what the pros and what the cons are from the available research. And hopefully you have more options to pick from. Right? I feel like now it's not really that, it's like, oh, let's try this drug, or let's try that drug or this one.
And it's, uh, so hopefully it'll be better in the future.
Erin Lee: No. And you know what? And I will give a, I think the one thing that I spent a lot of time at being very negative about the regulators. But I would say on the flip side, the one thing that has been pleasantly surprising to me is the response from clinicians in particular the primary care space.
I think there was, we didn't have to tell them about the limitations of drugs. They're just as frustrated as their patients. Right? Yes. I don't have anything to offer folks. Right. They don't have the optionality. Yeah. They're like, show us the evidence. Show us that it works. Tell me the pros and cons. Yep.
Let me understand what profiles this works for. But in Europe, they were the first ones to drive it off label. Right? You know, I think so. I didn't expect that. I thought that they
Dr Mike T Nelson: would
Erin Lee: a lot more skeptical. But the [00:42:00] frontline clinicians have really embraced the technology and the product. So I think that that more than anything gives me hope that I think we'll see stimulation really take off.
Dr Mike T Nelson: Yeah. The ones that I know I've talked to are, I think, are equally frustrated with the process. You know, they're like, I get seven minutes to talk to this person. I've only got like these four options. Like, this is like woefully inadequate for what I'm trying to do my job. I'm trying to help people, I'm trying to do the best I can within a system that's just not making any of it easy.
Erin Lee: Absolutely. And you're gonna spend five of those seven minutes trying to enter stuff and your EHR in a way. Understand. Right. It's a mess. Like I, you can't fault them. So they're like, gimme something easy that, you know, I doesn't double the time that I have. And, and I think that's what we've seen in Europe.
So I, I guess I'm hopeful.
Dr Mike T Nelson: Yeah. Yeah. And tell us about some of the trials you guys have done, which are actually pretty impressive.
Erin Lee: Yeah. So we had our, um, our pivotal trial, which used for f FDA approval was on, uh, moderate to severe depression. That was two arms flows a monotherapy and flows an [00:43:00] adjunctive therapy.
And that showed that we were twice as effective as the leading 21 antidepressants done at the drug side effects. As I said, sort of only significant side effect was sort of stimulation redness, tingling at the site. But in parallel again, we really are science driven and data driven. And so as part of our partnerships with the NHS, we've published an additional eight studies on everything from sleep to patient and clinician uptake.
We've looked at postpartum depression, elderly comorbid depression acute depression. So I think folks with community mental health pre and post hospitalization, we're about to kick off a trial on minors. We are now looking in the US partnerships on pain and overall wellbeing pre and post-surgery, for example, like can we minimize the amount of drugs that someone is on?
Uh, we've now kicked off pilots and addiction. Uh, both as a comorbid indication, as a direct indication. We have interest on TBI, traumatic brain injury, PTSD. We're about to [00:44:00] kick a bipolar trial off, and I start to rattle these off and people are like, what? Like that is so ma like how can that be? Like, how can there be those indications?
I think you'll all see them clustered in the same area, the same region of the brain. And where individuals are typically poorly served by traditional treatments. Do I expect us to be as successful in all of them as we've been with depression? Absolutely not. But I think we'll be in successful and more, uh, than people, than people think.
Dr Mike T Nelson: Well, that's awesome.
Erin Lee: Yeah.
Dr Mike T Nelson: Related to that, like one of my favorite, I guess, brain theories is the tropic brain theory from Dr. Roger Carhartt Harris. And the theory is that because it, when they were looking at even just some of the data on psychedelics and how they're overlapping with many different areas.
Brings up the question, even like what you were saying, Nick, you've got multiple indications and different trials for different things. I think historically, at least, I was taught that this part of the brain only does this thing, or even in physiology, like your cardiac [00:45:00] system only does this, and everything was very siloed.
And what we've learned over time, if anything, there's things of way communicating more than we ever thought. You know, brain derived neurotrophic factors probably produced mostly by muscle, but exerts its primary effects in the brain itself. So there's a much more crossover and complimentary things going on.
But according to his theory is that the different diseases, you can mark them on this scale of entropy or this scale of disorder. So on one end, maybe you've got people that are bipolar. They've got way too much entropy, way too much disorder in their brain, so much so that they split off different personalities to try to deal with it as a coping mechanism to the other end of the brain.
Where maybe you have like OCD where people just don't have enough flexibility. They're very rigid, they have to follow the same patterns, uh, all the time. And their argument is that if it is a flexibility issue, maybe things like, you know, potentially like your device [00:46:00] or they're looking at, uh, psychedelics can increase entropy and maybe different parts of the brain and different mechanisms.
And we can push people closer to what would be more of a air quotes normal type function. So I would imagine with the area of the brain that you're treating, is it something that from a big theory is kind of similar. You're just trying to get that part of the brain to work a little bit better.
You're trying to get it back to be more coupled and coordinated. With the other parts of the brain. And then you see a lot of times these benefits across multiple different areas that on its face value would appear like they're completely different things.
Erin Lee: Okay. That's right. That's a fascinating theory.
I don't, I hadn't heard that one, so I'm gonna look that one up. But I think, again, it sounds kind of like a cop out, but I, you know, I, I think we need to be more transparent in, in that the reality is we still understand very little about the brain and Yeah. How it works. You know, we talk about it as this, you know, this holistic [00:47:00] organ entity, whatever, um, but we still don't really understand even what causes headaches to a certain extent, or, you know, we have these, everyone has the same biology, sort of, charts of the brain. But I think that's been shocking to me. And there's this hesitation, I think, in the research and, and to some extent in the medical field to acknowledge that there's very, that we actually don't understand and we don't really understand how drugs work or what they impact. We understand the side effects.
And I think the more transparent we are about that, the faster we can get, get to answers. Um, whether that's about stimulation, psychedelics, you know, I think there's incredible potential if we just ask the right questions.
Dr Mike T Nelson: Yeah. And I think the, the question you're asking initially is a good one is, does this thing actually work?
Right? Because I think sometimes in, in science, we get too involved in mechanisms right away without showing that, hey, oh, this thing does move the needle, or this actually doesn't, and then. Once we have good ideas that, oh, this does move the needle, you know, then you can kind of look at, [00:48:00] you know, well, why is this?
Because you know, I've argued this with even clients I work with, that if I showed them 17 studies of this thing we did that don't work, but it worked for them, they don't give a rat's ass about the 17 studies, right? Not saying we shouldn't do the studies, I wanna read the studies, I wanna know what's going on.
But at the end of the day, on an individual level, that person is hoping that this thing actually is working for them. They're less likely to know about the mechanism. I think the mechanisms and understanding that are definitely good. We should definitely spend money doing that, and that allows us to get maybe better therapies and to get other things.
But I think sometimes there's a little too much mechanism, madness of people using it to justify everything without having an actual trial or a study done showing that this actually did do what it was supposed to do. Yeah.
Erin Lee: And that is partly why so much of the focus for us on personalization, at least initially, is around identifying for a user whether or not [00:49:00] stimulation and then stimulation for an indication will work for them.
Dr Mike T Nelson: Right.
Erin Lee: Although again, like we've invested quite a bit in, in trials, and I, I probably shouldn't say this either, but I think people forget that trials are run in part to make sure that trials are successful. And so those outcomes while important and certainly in driving literature forward and our understanding, are often not reflective of the average user who will then be faced with using, um, that technology or that, or that drug.
So I think that's also worth remembering.
Dr Mike T Nelson: Yeah. In a previous life I sat in, we'll say many meetings of what should our clinical outcome and outputs for this thing be and lost many hours of sleep and many, many hours of, okay, if we have them big enough, we can drive a bus through. We'll probably get approval.
But do we as individuals and humans feel that that is a safe thing that we would then release on the market if we make them so tight that we are 99.99%, that this is [00:50:00] gonna be the best thing ever and it's gonna be the safest thing ever? Oh, well we may never get approval on that either, right? The amount of time, the money and everything else.
Plus you're doing the trial 'cause you don't know exactly what's gonna happen. So what is that, that in-between point where everyone in the room feels safe, like, yes, I would want this device in myself or one of my loved ones, but you also have to get these new things onto the market so people can actually use them.
Otherwise, they're no good if they're, you know, 10 years later they're still on the bench and never been implanted. This is an implantable device company. But you know, the same ideas of we want things to be effective. We want them to be safe. But we're probably never gonna be a hundred percent right away.
Can we kind of minimize the downside? Can we show that it is effective in different populations and then kind of learn, you know, as you're going and then iterate, trying to make it better?
Erin Lee: Absolutely. You know, I, I hope more people get into regulation and, and again, I think TBD [00:51:00] what AI means for society at large.
You know, some people think it's gonna end it, some people think it's gonna raise the bar, but I am hopeful that it, particularly in the space of research and regulation, there is incredible potential. I hope to accelerate new technologies and, and new treatments into the end of users that doesn't take decades or multiple, multiple years.
Just it's too long.
Dr Mike T Nelson: Yeah. Yeah. Cool. As we wrap up, um, I'm just curious about since you're in this role, like what are things you do related for your own brain health? Like, what are things that you've kind of put into to practice? I'm always curious talking to people who, have a lot of insider info and not expecting you to share any of that, but just what have you found as you, as an individual that's most beneficial?
Erin Lee: Um, so I, I think it's gone. I've gone through phases. Um, I was very into right when I joined supplements and like [00:52:00] the neurotropics, and I think my husband used to say that maybe I had the most expensive pea on the planet. I, I wasted a lot of money on like the, the mushrooms, not the fun kinds, like the lions made.
Uh, I can't say I noticed a difference. From that I would say I had actually a pretty bad PA case of COVID. Oh. And I noticed for the first time. I was like, is this aging or is this COVID? Like I, I felt for the first time I couldn't recall words. Mm-hmm. And again, the whole time it went away. But that's when I really started to actively stimulate.
I looked into things like hyperbaric chambers. Hypobaric chambers.
Dr Mike T Nelson: Yeah.
Erin Lee: I don't do those regularly, but they are something that I have used to affect. Uh, sauna is a big one for me. Just from the body and very boring. I've cut out really all alcohol. I haven't drunk in years. Hmm. Uh, and so it's really around healthy lifestyle.
And I think for me right now, manage stress management is the big one. And I think that's what our clinical medical [00:53:00] officer is big on, which is, you know, you can do everything else right. But if you don't manage your stress and you don't manage like, all of those. Demands, it's, it's not gonna matter.
So it's, it is really more about whole person health. I am not a regular faster, I've tried that. That just doesn't work for me, like, you know, your green juice. Although I will say I used to do a prolonged fast about once a quarter and I did have incredible mental clarity. So I do think there's something to that and I do try and, and do that.
That's about as close to a fast as I get. So, fasting sauna stimulation I do use some creatine and coq 10, but those are basically my only supplements now. And then regular exercise, I try and get out in the world and touch grass.
Dr Mike T Nelson: Awesome. I think it's this great irony that people who are busy running health companies, or I've often joked that, like when I went back to do my PhD, it was probably the most unhealthy period of my entire life by far, for sure.
This great irony of like you're trying to. Keep it all together to do these [00:54:00] things that are, you know, on the grand scale, super beneficial, but making sure you keep it together on an individual level too.
Erin Lee: No, absolutely. And you know, I got, you know, there was a point where particularly when you start to get into the space and the wellness space and the longevity space, you know, you start to be like, should I be on stem cells?
What is this methylene blue? Yeah. And you know, we're, but we're working 20 hour days and I'm not moving from a chair. And I think, you know, our medical director, Dr. Garza, is just like, you need to get up and take a walk. Like you need to go do some physical exercise. And I think, you know, there is a tendency to look for quick fixes in a way.
And there's a lot of stuff that we just get back out in nature. It's like, don't drink clothing, die. Okay. Just take a walk. And I, I, you know, I think sometimes simple is, is best, but yes, you, you go to some of the health conferences and you wonder like, is is this really healthcare because people are, are unhealthy visually so.
Dr Mike T Nelson: Yeah. Awesome. Well, thank you so much. Where can people learn, uh, all about the device, best places to go?
Erin Lee: Yeah, uh, you can find [00:55:00] us@haloneuroscience.com or flow neuroscience.com. Um, thank you for having me. It was awesome to be here.
Dr Mike T Nelson: Yeah, thank you so much. I would highly encourage people to check it out and thank you for all the great, uh, science and everything else you've published in that area because as you know, that's a, a rarity with devices and whatever.
It feels like everyone throws whatever on the market with the zero background at all. So it's awesome to see that there's actual, uh, data behind it, which is great.
Awesome.
Awesome. Thank you so much. Appreciate it.
Thanks.
Speaker 2: Thank you so much for listening to the podcast. Really, really appreciate it. Uh, huge thanks to Erin, uh, for taking her time and coming on the podcast and just giving us the rundown of everything, uh, that is going on. As of this podcast, I'm still testing the device, so I don't have any too much feedback, uh, yet, but maybe later.
I, I definitely will. And if you want more information, you can check them out in the [00:56:00] links, uh, down below. And if you want more information from me hop onto my newsletter, which is free, and get all the cool insider information, right. About 90% of the content I put out goes exclusively to the newsletter, and it's free to hop on and we'll give you a cool free gift also.
So we'll put that link down below, or you can just go to mike t nelson.com, go to the top and go under newsletter. So thank you so much for listening to the podcast. We really appreciate it. And if you could help us out by leaving us whatever stars you feel are appropriate, subscribing, downloading, hitting the like button, uh, especially subscriptions on YouTube, uh, helps us a ton.
Most of our podcast is audio by far but trying to work on growing the YouTube area a little bit more. And thank you so much again for listening. If you have someone who is interested in this, uh, please forward it on, appreciate it, and we'll talk to all of you again next week.
Speaker 3: Did you see that? [00:57:00] Yes. The frog is certainly taking a beating on this show. Yeah. It's hard to feel sorry for him. We take a beating every show.
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