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Lumia tracks blood flow to the head with Daniel Lee

EPISODE 231

November 10, 2024

Engineer and tech founder Daniel Lee created the Lumia to be a personal wearable device that fits in the ear and measures blood flow to the head, along with several other measurements and a phone app. This allows POTS patients, researchers, and others to track how their activities, foods, medications, and other environmental factors are affecting blood flow to the head and symptoms of POTS. He explains how it all works and also shares interesting findings revealed by the Lumia in their research partnerships with major academic centers and also from POTS patients wearing the Lumia in normal life. Daniel is a wealth of information about POTS, especially coming from the perspective of circulation to the head.

You can learn more about the Lumia device at https://lumiahealth.com/.

Episode Transcript

[00:00:00]

Jill Brook: Hello, fellow POTS patients and most appreciated people who care about POTS patients. I'm Jill Brook, your hyperadrenergic host, and today we are speaking with Daniel Lee, who invented the Lumia device and is founder of the tech startup using the Lumia device to gain new insights about POTS and to help POTS patients.

Daniel, thank you so much for being here today.

Daniel Lee: Thank you so much for having me, Jill. I really appreciate all the work you do with POTScast.

Jill Brook: Well, I know that you've been working really hard in the POTS world lately, and I'm just wondering how you got here, like, can you tell us a bit about yourself and how you became interested in orthostatic intolerance?

Daniel Lee: Yeah, for sure. So, so I actually had initially gotten interested in orthostatic intolerance from my father. He has a slightly different form, but it's kind of the same physiology. He has a very severe orthostatic hypotension. And now, a little over four years ago, he had been falling very frequently.

He just kept fainting, and he had fallen and broken six ribs at the time. And that's, that's how I, [00:01:00] decided like, this is a problem I want to start to understand and see if I can help on a solution for. So that's how I initially kind of got interested in, like, trying to help in orthostatics. And that's where also, like, as I was learning more and more and trying to build technology for my dad and orthostatic hypotension, we kind of soon quickly discovered that the world of POTS was much more, I guess, like, eager for, like, willing to have help.

I think my father and a lot of the orthostatic hypotension population is more like, nothing's wrong, it's fine, I'm okay, like, don't look, whereas POTS is like, no, something is wrong, there's something wrong here. So that's kind of been like, how we're like, okay, let's, let's we, we have a much more I think that's where we decided, like, let's, let's really help in the POTS area first.

It's, it seems more appropriate. So that's kind of how we stumbled into POTS specifically.

Jill Brook: I'm so happy we were a good fit for you. And you were an engineer designing ear pieces before that, right?

Daniel Lee: Yep. Yeah. So I've been doing [00:02:00] actually, like, like a very niche area of very tiny ear pieces, basically my whole career. I've been doing this now well over a decade and like my, oh my gosh, that is weird to say that, because yes, I've been doing this, I've been, my, my first startup was like a very tiny we made like smart earplugs that people could sleep with and then so I was doing the engineering behind that, and then joined Bose to basically redo that product as Bose Sleepbuds, and so I was kind of like, leading architecture and engineering for that effort.

And then, and then I was doing some like health product innovation at Bose for a while, doing various kinds of like sleep and ear related things. And then ended up leaving to work on this problem. And then, and that's kind of how, like that, that is yes, I am the small tiny ear pieces that go on your ear guy.

That's me.

Jill Brook: And you got interested in something called cerebral blood flow. Can you talk about what that is and how it relates to your ear pieces and orthostatic [00:03:00] intolerance?

Daniel Lee: Absolutely. So, so I mean, one of the first things that I did when I was kind of trying to understand what was going on with my dad was read the literature. There's a huge amount of decades of literature trying to understand orthostatic hypotension and various orthostatic intolerance syndromes. And there's, as you know, there's blood pressure, and if you, if your blood pressure happens to drop when you stand up, then you get a label of orthostatic hypotension.

If your heart rate overly spikes like crazy when you stand up, then you get labeled as POTS. But there's a huge group of people that, I mean, it's actually that there's a few literature papers that are kind of showing it's like 20, like 3, 22 percent to like 58 percent of people that have orthostatic symptoms.

They get up, they're dizzy. Their heart rate and their blood pressure look totally fine. They don't meet the POTS and orthostatic hypotension criteria. But they have abnormal cerebral blood flow if you measure it using ultrasound. And so that's where, like, that was the literature that was initially like, oh my gosh, like, why are we measuring heart rate and blood pressure?

Like, that's important, it helps with some people, but [00:04:00] it also is misleading on so many people that their heart rate doesn't go up high enough, they're very clearly having very bad blood flow to the head. That makes sense, like, that's why they're dizzy and lightheaded, but and so that's kind of where I was like, we really have to be measuring cerebral blood flow.

And fortunately, from the literature, learning that, that was a key insight for us is, all of these things are not enough blood flows getting in your head. Not, the heart rate and the blood pressure are secondary effects that sometimes correlate with that. So, but we really should be measuring blood flow to the head.

And hey, fortunately, I'm the small ear wearable guy that knows how to put something on someone's head for a long time and, and like do the biosensing. So maybe we can actually measure these blood flow changes to your head. And so that's kind of how, like, it just happened to be, it was serendipitous that like my, my previous experience and the physiology just happened to have a good fit of what I can build and what is actually important in measuring in these conditions.

So that's how I got involved and interested in cerebral blood flow.

Jill Brook: That's so fantastic. And it's a great reminder that [00:05:00] it seems like about a million things can go wrong in the body, but we only know how to measure a few of them relatively. And if you don't have the right tool, it's, it's, it's terrible. And wow, we're so excited that you have invented a new tool to, to measure a new thing, i. e. cerebral blood flow. Now your product is called the Lumia. Can you tell us exactly how it works?

Daniel Lee: Definitely. Actually, I do want to just put one quick caveat in that the literature has shown cerebral blood flow, that, that means blood flow going to your brain is lower when in POTS patients and in people that don't have POTS, they don't have orthostatic hypotension, but they have symptoms on standing.

What we measure is we actually don't measure cerebral blood flow. We measure blood flow going to the external carotid artery. So there's actually two arteries that go to your head. One is the internal carotid that does measure cerebral blood flow. And the external carotid kind of goes to a lot of things outside of your [00:06:00] skull, like your ear and parts of your face.

And so we actually measure the external carotid. We actually are very careful to say that what we measure is a proxy to cerebral blood flow. We're not measuring directly cerebral blood flow, and we call it blood flow to the head, and, because it's, it is still getting to your head. And fortunately, in various studies that we've done for orthostatic people, those correlate very strongly.

Like, when you stand up, the reason that not enough blood flow is getting to the head is it's just because the heart is not pumping out enough blood and so it affects both the external and the internal carotid. That's a little bit of maybe too much physiology, but the point is we actually call it blood flow to the head and not cerebral blood flow.

Although cerebral blood flow is the one that has been studied in the literature and we've just shown that we, we correlate very strongly with cerebral blood flow.

Jill Brook: Got it. Okay, no, we appreciate that you are exact about what you do. So, okay, so how does your product work?

Daniel Lee: Yes. Okay. So I guess I kind of accidentally explained a little bit about that, but how it works is we do use light. So we use a a [00:07:00] little infrared light to shine on a very specific artery in your ear. And as mentioned earlier, it is a branch of the external carotid artery. And what we look at is flow changes that are changing

to the external carotid artery. And so we're continuously measuring that. Very similar, think like what continuous glucose monitors do for diabetes. We kind of do the same type of experience. We're measuring blood flow to that artery, which is what we call blood flow to the head. And and then, and, and so the, the earpiece itself is it's actually, I mean, we've been working on this for well over four years, it's, it's a little, kind of like an earbud that sticks into a little upper nook in your ear and actually can just stay there. It's about the size of an espresso bean. It lays, weighs less than a gram total, so it's very light and out of the way. And so you can just leave it in there through, through sleeping, showering, et cetera, and and it also has a little tiny solar panel on it.

We use very little power, so we can actually do light harvesting and solar harvesting to power the device. And so we're just constantly measuring the blood [00:08:00] flow there, and that can sync to to a light station which is a Wi Fi and Bluetooth like, charging dock that you, that we provide with the system, as well as it can sync to your smartphone as well.

So that is that's kind of how the system works. Think like wearables, similar to like Apple Watch or many of the other ones out there, but it's measuring a much more important metric in blood flow to your head, which is what really matters for orthostatic syndromes.

Jill Brook: So you're saying that the light shining on that blood vessel can basically detect how much blood is going through it?

Daniel Lee: Yeah, it's basically how much, yeah, exactly. It's more the way that the technology works in depth, which you can look at, we actually have a webinar on our website at lumiahealth. com where we talk about the exact way that the technology works. But we're really looking at kind of the, the shape of the blood, like the pulse of blood that hits your head.

And so it's, it's really, that's how, cause, cause [00:09:00] what happens with when your blood flow drops in orthostatic syndromes, what's the, what's causing the blood flow drop is when you stand up, gravity pulls blood into your legs, and for a lot of people, actually everyone, even people that don't have orthostatic syndromes, that happens to everyone, and a lot of people, if you get up really quickly from a laying down position, you'll feel dizzy for maybe 5 to 15 seconds, but your body will quickly squeeze the blood vessels in your legs to squeeze that blood back up towards your heart so it can be pumped to your head.

But with orthostatic syndromes, that doesn't happen correctly, and the blood is pooling in the legs, and so there's not enough blood flow getting back to the heart, and that blood is then not getting pumped to the brain because your heart's not getting filled with blood. So what's really happening is the heart is not pumping enough blood with each time it pumps.

And that changes the shape of the pulse that like, when the pulse hits your head, it looks, it's a much shorter pulse. So rather than being a nice, long, big, long, like heart pump, it's like a little tiny spurt. And so [00:10:00] that's that kind of difference is what we're able to measure at the external carotid.

And that's how we see, oh, the blood flow to your head is lower because this, the shape of the pulse waveform that hits your head is is a lot shorter and spurtier. So that's basically how the technology works.

Jill Brook: That's so cool and that's also so validating. So I know there's a lot of listeners at home who just need to take a second to do a little dance that somebody is confirming that there's something real and measurable happening and that they're not just imagining all of this. So you have collaborated with researchers at Harvard, at Johns Hopkins, Duke, and other researchers, which is amazing.

You've been validating your device and doing some other studies. Can I ask what you've learned?

Daniel Lee: Yeah, so we've been actually, there's so many different things to study with this new, I mean, we kind of like to kind of think of it as like a telescope, like where we're now have a new tool to actually see what's really going on with many of these [00:11:00] conditions. Before you can actually do much, you first have to validate your device and make sure it's measuring what you think it should be measuring.

And so like some of our earlier studies were like we published in the Journal of American College of Cardiology last year of a tilt table study that we did at Johns Hopkins, where patients that were being tilted up, we were measuring the blood flow to their head using a Lumia device and seeing drops in blood flow well before the other metrics like heart rate or blood pressure showed anything.

And we, we, we, we saw like between two to 12 minutes before they passed out that their blood flow was abnormal. And then it just gets really abnormal when they pass out. Now this was a smaller study, but like, that's like one example of like, blood flow is way more sensitive than kind of the secondary metrics.

Like those are kind of late alarms of like heart rate and blood pressure sometimes. And so that's where, that's part of it. Now there's also been various studies that we've done [00:12:00] where at Duke, we've been doing comparisons against transcranial Doppler ultrasound, which is kind of like the well understood in the autonomic circle, like, for how to measure blood flow to your head.

And we've also done, so in the collaboration with Duke, we did had, had people wear, there's actually been a series of studies here. So, one of them was like having people lay down and stand up actively, like what they're like on their own, and then sit down and walk in place and do breathing, various things like daily activities.

And then we were just trying to see does Lumia correlate well with transcranial Doppler ultrasound. And so that study, we shared an abstract on it at the Dysautonomia International Conference, but we are actually we're working on a peer reviewed, like larger paper about this. But we found through a lot of these on 18 different orthostatic intolerant patients we have like a point Pearson correlation coefficient of 0. 92. For the not statisticians, like that, that's like a really like one to one correlation, like, yeah. I mean, it's like a, yeah, so, so like that was, that was really exciting, [00:13:00] actually. We shared this also in that webinar back in August, but that's like one of the types of like comparing against gold standards.

We've also just done studies where we've had a bunch of people just like lay down only and then stand up and compared that against healthy controls. And we see that similar to all of the great literature, there's so much great literature from Dr. Visser and Van Kampen, Dr. , Dr. Dr. Dr. Rowe as well, Dr. Novak over, and they've consist, what they've shown is like, cerebral blood flow is low in all these people, and sometimes heart rate or blood pressure is fine. We've kind of seen the same exact thing, that we, we compared like, I think it was like 20 ish orthostatic intolerant people, had them lay down and stand up, and their blood flow dropped like 17%, whereas healthy controls only had like a 6% ish drop on average.

So, like that's, there's clearly like a we've done studies there. You can also find abstracts of these on our website. Again, these are going to be published in larger peer reviewed journals as well. But like, just basically showing we can see [00:14:00] blood flow abnormalities in orthostatic intolerant people using the Lumia device when normal people don't have as big of a drop when they stand up.

So, just further, like, kind of paving the path for showing, like, we can be a new diagnostic tool for helping understand this. We're not there yet, but that's kind of like our, like the path we're on. So there's, there's quite a lot here. I apologize. I'm kind of all over the place there. We're in the middle of a, of a beta madness right now as we are shipping products.

So, I'm a little scatterbrained, but thanks for your patience, Jill.

Jill Brook: No, no, this is great. But speaking of your beta program, now you are making this available to some POTS patients and they use it along with an app that goes on their phone, I think. Can you talk about how the device and the app go together and how a POTS patient would use it?

Daniel Lee: Yeah, absolutely. So, so I have to be clear that as of right now, we are not yet a medical device. We are working on the path to becoming an FDA approved diagnostic tool, because we want to provide something separate than just [00:15:00] the tilt table, which is really the main tool that doctors have. Now, what we are doing right now in the beta program is not that.

It's not a diagnostic medical device. It is, what we're building is, think like, Apple Watch, Whoop, Oura Ring, these kinds of consumer wearables where they're creating an, an app experience that's all about self management. It's about providing metrics to help you better understand your body and modify various things in your lifestyle to help you perform at your best?

You can also, the FDA allows us to do the same for various patient populations. So that's where we're building that type of an app for POTS and other orthostatic intolerant patients. And so, that's kind of where we are from a regulatory standpoint is it is a device much more for self management.

It's not for diagnostic use. It's not for showing doctors that there is something wrong with you. It is for learning about your body, learning about various triggers, learning what helps you restore the flow to your head, so you can just better manage your symptoms. And so, this device [00:16:00] does sync to a phone, so I would say much more, very similar to Continuous Glucose Monitors, it syncs to your phone and you can see your flow in the app, and you can see how various things that you do increase or decrease your flow.

And so that is what the, the beta program, and that is what we're doing to start. Just to make this technology available to the many people that we have that we believe we can help with this technology. And, and we're doing that in parallel with the continued research and validation of, of this as the new diagnostic.

Jill Brook: Wow, that's really exciting. As somebody who used to faint a lot and sometimes in not the best places and sometimes not knowing why, I mean, this is, this is pretty cool. Like, so this, this says you've put it on real people living their real lives. And so what have you learned about blood flow to the head in a POTS patient going about their real life?

Daniel Lee: Yeah. So, I mean, this is actually quite a novel thing. This is part of [00:17:00] where we are able to see what has never really been seen before, and that we're seeing blood flow to people's head vary in real life, in the real world, not just in a cold laboratory tilt table environment. So, that is, we are actually learning quite a bit around what's happening and, and there's, there's a lot happening.

It's, it's, there's actually so much work to make sense of everything that is happening. So what we know so far about blood flow to the head in the lab environment is you stand up and your blood flow drops and your blood flow drops abnormally when you're very symptomatic. We know that, actually there's so many studies that have proven that.

Now, what we are finding is as you go home and as you're in natural environments, there's so many triggers. There's like hundreds of triggers that can cause you to drop your flow. Very many patients, like if they're in too warm an environment, they vasodilate and they have really bad POTS symptoms. It's because not enough blood is getting to your heart and to your head.

If you have, and, and you don't, they don't study that on the tilt table because it's a cold lab environment. They we see food [00:18:00] dietary responses. We actually had one of our, like our community and marketing Shivani she's, she's now joined us full time, but she's she, she has been using Lumia for now many, many months, and like, one of the very cool things that we saw was when she ate, like, a donut, for example she had a big blood flow drop as well, and we're like, what's going on there?

And it's like, oh, okay, it turns out that, like, that we found this study from Vanderbilt where like uh, there's, there's, they believe that when you have, there's a glucose response where it causes your, your like intestines to secrete extra vasodilation in your gut and then that causes you to not get enough blood flow to your head.

And we saw that and we're like, okay, so there's actually a match there too. Like there's all these like triggers and so that's, I mean, these are, there's, those are two of hundreds and so that's kind of what we're learning and that's like a big part of like how we want to help is like help people see, Oh my gosh, that really tanked my flow.

I should try to avoid doing that. I mean, you actually have data to help you like make those decisions.

Jill Brook: That is awesome. [00:19:00] That is so awesome. Now, last time we spoke, you shared a couple of other insights that I thought were fascinating, and so I was hoping that you could share them with our audience, but one of them was about blood flow to the head with different body positions, because POTS patients tend to sit in a lot of different weird positions.

Have you noticed anything there?

Daniel Lee: Yeah, I mean, so what we see is and fortunately, there's been so much great researchers that came before us that we're just like kind of piggybacking off of it. And but like what we've seen is like, what has been studied for a long time is you have someone tilt on a tilt table, when you're laying on your back flat, and then you tilt it upright, so you're basically standing, you see a big drop in blood flow.

That has been shown pretty, like, consistently. But what we're seeing is, it's also just, like, when you are, for example, if you're laying on your back and then you put your feet up, that actually increases your blood flow a lot. So it's laying, there's many forms of laying. It's not just laying flat, but laying with your feet up actually increases flow [00:20:00] quite a bit more.

We've also just seen like, being upright, there's, there's levels. There's sitting upright there is also standing upright. And standing is way worse than sitting upright, but sitting upright is way worse than laying down. So like, there's, there's kinds of a, kind of a gradient that we're seeing with a lot of these of like, like, body position matters a lot.

Ultimately, a lot of it just gets back to like, how much in the position that your body's in, how, how likely is it that, how much are you allowing blood to return back up back to your heart, that's really what matters. And, like, putting your feet up, that actually helps that a lot. And so, that's like, one of the things that we're finding is, it's not just lay down, stand up, it's sitting makes a difference too.

And and as I mentioned earlier, like, at least for the sitting one, that has been shown in the literature with Dr. Van Kampen and Dr. Bisser, they've shown that like, orthostatic intolerant patients just sitting, they can have a severely reduced cerebral blood flow. I mean, it varies. This is for very severe patients, but I think like, what we're finding in [00:21:00] real life does match that study as well.

So, that's like one thing that we've been learning about. Body position, there's a lot of flavors to body positions, and a lot of different types of body positions, and they all matter.

Jill Brook: That's validating too, and I'm gonna bring this up if I ever get called for jury duty, which is one of my big fears in life, because sitting still upright, yeah, I don't think I'd be able to stay paying attention.

Daniel Lee: And if it's a hot room sitting still...

Jill Brook: yes!

Daniel Lee: ...it's game over. So, yeah, that's exactly the types of things that we're seeing. It's like, it's not as simple as just, Oh, just don't stay standing still for a while. Like, there's actually a lot more things that kind of compromise flow to your head. So, it's not as simple as that.

Jill Brook: You know what? I think I want a Lumia device to have on hand just in case I do get called for jury duty so I can show them. Anyways, enough about my issues. Okay, one more. What about blood flow correlating with other symptoms, like breathlessness or something like [00:22:00] that.

Daniel Lee: Yeah, yeah, so I, we had, when we had chatted briefly earlier, I had mentioned that like when you think of blood flow going to your head like you would think that makes sense with dizziness. That makes sense with like brain fog and the various things in your, your brain's not working properly. Like that makes sense.

You're not feeding it with enough fuel, then it's not going to work properly. But turns out it's not just your brain. Like when you're, when orthostatic people get up, the heart is not pumping enough blood out. That's what's causing not enough blood flow getting to your head. And so that also affects many other parts of your body and not just your head because your whole body is actually under perfused.

Your whole body is not receiving as much blood as it would want. And so, parts of those for example, like coat hanger pain or various like pain in the the shoulders, like a lot of these are actually, you know, get better when you lay, lay down and put your feet up. And so, so there's many symptoms.

It's not just in the, in the brain. Even breathlessness is another one that a lot of patients kind of say like, Oh, I have air hunger. Like, I feel like I [00:23:00] can't breathe. What, what's actually going on there, this is actually really, there's been a couple of papers one very fascinating one by at the University of Calgary with Dr.

Satish Raj. They, they published a paper where it was actually a rat like it was a, like a mouse study, but what they were showing was that, like, so let me explain what's happened to the human physiology first and then I'll explain what happens with what their study did. Basically, when you get up, right, not enough blood flow is getting to your head and there are in your body, in your neck, there's something called baroreceptors.

These are in your carotid arteries and they measure, is there enough pressure of blood getting to your head? If there's not, then your body's like, okay, I need to start pumping my heart faster and squeezing the blood vessels in your legs. So that's, that, that is part of how your body regulates blood flow to your head.

Now, next to the baroreceptors, there's also chemoreceptors. Chemoreceptors are basically measuring, like, how much oxygen and, and carbon dioxide in your blood, and so they're kind of in the same [00:24:00] location. And what, what goes on when, when you're upright that breathlessness often gets worse and there were some people that believed, oh it's because not enough blood flow is getting and the chemoreceptors are measuring that not enough oxygen is getting to your head so it's telling your body to breathe faster, like that you need to get more get more oxygen.

But it's actually very paradoxical because what's really going on is it's not enough, your, the blood oxygen is fine, you don't need to breathe more. It's, what's going on is just that there's not enough blood flow getting in your head and the chemoreceptors are getting tricked and your baroreceptors are basically, it's like, I'm not getting enough blood to fill up my head, let me bring, breathe faster to try to increase that.

But that's, so there's kind of like a, a confusion that your body has there. And, and the irony of that is when you breathe faster, what, what actually, you'll, you'll see that when you try to breathe faster, faster in those situations, it gets worse. The reason for that is as you breathe faster, you're getting rid of carbon dioxide.

And it's like a hyper, it's like you're hyperventilating. And if you [00:25:00] hyperventilate, that causes the blood vessels in your head to constrict. This is a pretty well known phenomenon. And so your body does the wrong thing, actually. It spirals into the wrong direction because you're like, it gets tricked to say, Oh, I'm not getting enough oxygen to my brain.

Let me breathe faster. But if you breathe faster, then you're going to cause less blood to get to your head because the blood vessels in your head vasoconstrict. And so it just, that, that's kind of, a like, so that's what's going on with like breathing is blood flow to your head can actually trick your body into making it worse by telling you to breathe, like have air hunger.

Now. So hopefully that was understandable. What, what, what Dr. Satish and his team had shown was that basically, like they, by increasing the pressure at the baroreceptors in a mouse model, they can cause the rats to hyperventilate or not. So they're just showing the exact phenomenon that actually just blood flow to the head is really what's driving like the, the air hunger response.

And so that, that's like, there's many things that it's just your whole body's not getting [00:26:00] enough blood flow. So everything is kind of like out of order.

Jill Brook: And that's so fascinating because I know for a while there were patients who were talking about how their, their doctors were saying that the hyperventilation was causing all the other problems. And my understanding is that Dr. Raj's research and what you're saying is showing that no, it's the blood flow to the head that starts the problem and the hyperventilating comes second,

so...

Daniel Lee: and that's exactly it, and I think there's been a couple of trains of thought on this. And I think, like, Dr. Raj's was one of the, like, the basic science ones that, like, were shown in very strong strongly that, like, like, there, you don't, they actually took away the chemoreceptors and it, but then, and so they're only modulating the hyperventilation by the baroreceptors, just how much blood flow is actually getting pushed into the brain.

So it's not, it's not even, so, so, so yeah, it's like, there's a very strong causative effect of not enough blood flow causes at least a mouse, [00:27:00] mouse brain model to say I need more oxygen, let me breathe faster. So it's a it's a strong case for causation, which was pretty exciting.

Jill Brook: Yeah, and I just have to give a plug for standing up to POTS because we gave a research grant to Dr. Raj's team to do some follow up studies on that. So, we're excited to see where that goes. So, yeah, this is great stuff. Okay. So, can you tell us about your startup company? And is this available to patients yet?

And if so, how is that working?

Daniel Lee: Yeah, so I started a company we actually so we actually did like a like a pre ordering campaign last last fall or last, last fall into winter. And like, we started shipping those in beta in August. And so right now we're still kind of like in like back order because we still have to fulfill like our beta units and the pre-orders, but we should be taking orders again,

we are targeting to reopen, order taking in November [00:28:00] and, and then, that those devices would then be shipped out starting January. So that's our current focus. We still have to fulfill our existing customers first and make sure they're all doing well. But after that, that's kind of like our target right now for making available to future people that want to use the self management version of the Lumia device.

Jill Brook: Very cool. Okay. And so then they use that along with the phone app and they can learn what their personal triggers are, what helps them get better flow or not. Yeah. And what about people who are outside of the United States? Do they have any chance to try this?

Daniel Lee: So, we are, right now you do have to be a resident of the 50 United States in order to use Lumia. There are some limitations just because we're still kind of in beta and we're just learning and we have to start small. We don't want to try to put the cart before the horse and try to scale before we we want to make sure that we're really doing a good job in helping patients.

Like, that's our main focus and we want to start in a smaller [00:29:00] limited rollout for that. But once we are confident in that and things are going well, then we do want to kind of help there, I mean, this is a global problem. This affects every, like, it's not just US people. So we just want to make sure that we're helping and then we want to scale the helping.

So that, that's kind of the, the order of operations here, but that is on our timeline looking to be like, we are hoping that that is, start starting that work in next year. Like it's coming up pretty quickly, so it's going to take some time to open up to all like every market that just, there's a lot of regulatory to go through for that, but we will be looking at the expanding as soon as we're confident that we're doing a good job in helping people.

Jill Brook: Exciting. Wonderful. Okay. Just a couple more questions. Is your dad really proud of you? You don't have to answer that.

Daniel Lee: Yeah, yeah, yeah, he's, yeah.

Jill Brook: Is he using one yet?

Daniel Lee: So I mean, there's kind of an irony there in that. Life is so full of ironies. And I mean, this is kind of more, I don't want to end on a [00:30:00] bad note, but it's just like, he's kind of, he has been getting, it's, it's kind of, for him, he's, he's an older gentleman, so he, like, it's, there's various other things going on as well as there was he had to go through a procedure that his left external carotid artery was unfortunately removed and, and so that actually just makes him no longer a, like, really a good candidate for our technology, which is like so ironic, and that's just the way that life is sometimes.

But that's so, but he's, he, he's he's very happy in, in like being the origin story on this, even, even though he's not necessarily able to use in the same exact and like be the patient zero as we wanted him to be.

Jill Brook: Yeah. Well, we're sorry for what he's gone through, but it sure has ended up being lucky for the POTS community. So just a shout out to your dad. So anything else in your future, or are you thinking about anything beyond getting out these products in the next round?

Daniel Lee: So yeah, I mean, [00:31:00] we, we have so many different things and parallel kind of efforts going on. We, right now it's the most, the biggest priority for us is have the self management tool really be a helpful aid in helping patients better manage their symptoms. Like that is, that is like the majority of our focus.

But we have as you, as I've mentioned, and you can find on the website at lumiahealth. com, you can see various studies that we're doing and are continuing to do to validate the device for medical diagnostic purposes, as well as just kind of like empower the whole ecosystem to start measuring the right thing.

Like there's now fortunately many different companies and awareness to these orthostatic syndromes. A lot of it came out of long COVID, but there's now more like interest across many like whether it's pharma, other medical devices, procedures, etc. And so we just want to, like, we're trying to support those various initiatives [00:32:00] as well in giving them a better thing to measure as they're, as they're validating what they're doing.

So there's kind of that work as well. As I mentioned, we're trying to expand to more countries where one other thing is we want to like, for example, like right now it's limited only to to adults over 18 because we just haven't validated at all on the younger population. But we know POTS has a lot of people that in their teens, it starts to get really bad and like, that, that's, we want to obviously be using a kind of pediatric use case too.

So there's just like a continuously like, making it more generally applicable and usable in the many people that suffer from this. But that's, and that's kind of like in our future, is continue to expand access, continue to expand who, who it can be helpful for and also just like reimbursement.

Like we, we know that like, like a lot of the patient population, these are, these are debilitating conditions. These, these a lot like take away work for so many people. And so like, it's going to be hard, like, like we see basically [00:33:00] reimbursement as like a very important path to really helping the people that need it most.

And so that's kind of like, that's like another thing. Like we actually have to prioritize that too, in addition to just making a good product. And so there's so many kind of angles to this that we're like trying to push many different fronts at the same time. And so, that's, that's on like, that's like some of the stuff I mean, there's like probably seven other initiatives I forgot to mention, but those are some of the ones that come to the top of my mind now.

Jill Brook: Wow, well, this is so exciting. Where can people learn more?

Daniel Lee: Yeah. So lumiahealth. com, I mentioned that earlier. We, that's where you can sign up for our newsletter. So you can, we do give monthly newsletters out so you can kind of follow the progress. We share both research updates as well as just kind of what's going on in beta and and the self management programs.

We also have an online community you can join. We, we use Facebook groups quite often to facilitate just discussions and and yeah, the, the email newsletter subscription is in the footer of the website. So make sure to [00:34:00] just scroll down there and you can, you can join for more news there.

Jill Brook: Wonderful. Well, thank you for all the work you're doing. Thank you for understanding POTS so well and contributing to the literature and good luck. All our best to you.

Daniel Lee: Thank you so much, Jill. Appreciate you having me on.

Jill Brook: Okay, listeners, we'll have that link in the show notes and that's all for now, but thank you for listening, remember you're not alone and please join us again soon.