BoneChat #37 - “Game changer startup Green Sun Medical - Treating early scoliosis with The Whisper”

So, uh, welcome to Bone Chat Discussion 37. Uh, I'm thrilled to have Jamie Haggard here today. He's the CEO of Green Sun Medical. Uh, they're helping kids suffering from scoliosis with an intelligent brace. This is one of my favorite startups because Green Sun has no competition other than antiquated clamshell braces. They've created a new category. They have strong tailwinds from patient advocacy groups, and there's no VAT committees to deal with. So it's like, it checks a ton of boxes. So handing, anyway, handing the mic over to Jamie. It's all yours.

Thank you, Tiger. I appreciate it. And let me share my slides. It throws my screen all around. So Let me make sure I can see.

We can, we can see it.

You can see it. All right. So like you said, my name's Jamie Haggard. I'm the CEO and founder of Green Sun Medical. I spent 18 years in the spinal implant world and I had my co-founder said, you know, I think we can keep a lot of these kids out of surgery. And as soon as you start helping kids, the hook gets set and you don't easily get away from it. So let me kind of introduce you to my world. For those of you that aren't deep into spine, when it comes to scoliosis, if a kid has over a 10-degree curve, they have what's considered a diagnosis of scoliosis. They're monitored until about 20 to 25 degrees, and then they receive a prescription for a brace, plastic sham clamshell brace. If the curve— if they struggle and the curve progresses past 45, 50 degrees, then the next option is either tethering, a fusion, or a dynamic device on the— posterior side. There's about 100,000 kids a year that have curves over 25 degrees. These hard plastic clamshell braces, the Boston brace was developed in the '70s. There's been some advancements in colors and some shapes, but they're still plastic clamshell braces. They're pretty uncomfortable, and it leads to low compliance. About a third of the kids are compliant, about a third are partially compliant, and a third are not compliant at all. This leads to about 18,000 surgeries and it burns the healthcare system by about $3 billion a year. So for these kids that are wearing these plastic braces, the reason they have such a low compliance is that they impede their natural movement, they restrict airflow, can cause overheating, causes core muscle atrophy, it leads to low compliance, and then it also results in these strained parent-child relationships. What our team came up with is we said, okay, if kids need to correct their teeth, they wouldn't just receive one Invisalign, they would apply continuous pressure and receive a series of trays. If kids are born with clubfoot deformity, they receive progressive casts to correct the deformity. So we wanted to apply continuous pressure in a dynamic brace. This young lady had been wearing Boston braces for 3 years, before she started with her Whisper, and this was her first experience. Oh my gosh. How far can you bend forward? So with the Whisper, we wanted to be able to provide them freedom and mobility and motion. We wanted unrestricted eating and breathing. It was one of the biggest complaints that kids had. The other thing they complained about in the summer with these clamshell braces was it was way too hot. So we had temperature control through an open airflow design. And then we wanted to apply continuous corrective pressure with our string— our spring system on their spines. It's leading to improved compliance, better outcomes, and it also makes much better parent-child relationships. These parents start to be our fans. As far as driving in the pediatric market, we're seeing it on social media. We just had a convention last weekend in Chicago with over 400 attendees, and we had a whole group of Whisper kids there and their parents celebrating it. They're getting on Facebook groups, they're getting— they're posting TikTok videos, and it's starting to be, uh, get a groundswell of attention for us. Um, the little girl that was in Wiggling and Giggling in the previous video is the young lady in the gray shirt. She's going to these conventions and she ends up being our sales rep of the year. But a very wise man told me, you know, that brace looks great, but if you can't measure it, it didn't happen. So we wanted to develop a compliance system, an app that these kids could actually measure how many hours a day they're wearing the brace. So we applied to the National Science Foundation. We've had over $1.8 million in grants to develop intelligent brace monitoring. We have a 12-pad sensor system and we do compliance and corrective spinal pressure measurements with integrated force sensors. They're synced to a SaaS platform via the patient's phone. The parents and the patients can actively track the wear time and the patient and the parents can encourage compliance and also help 'em receive rewards. If you hit your hours, we're gonna do something special this weekend. The physicians are gonna be able to bill for remote patient monitoring or more therapeutic monitoring, and they can actually ensure that their patients are receiving the proper treatment. Within this pressure sensor, we are tracking pressure, temperature, and position data. This, the blue line is an average of the pressure throughout the day. We're doing 1,400, uh, uh, measur— oops, sorry. Uh, we're doing 1,440 measurements, one measurement every minute.. And then on these 12 sensors and then with the temperature and the accelerometer, we're getting over 18,000 measurements per day. We're tracking their positions. So this girl was starting at noon, if you see on the screen, and she was taking a break on a Sunday. She spent the afternoon wearing the brace, watching a movie. Down here is when she went to bed at night. And then when she got ready for school in the morning, I know she put the brace on the floor and set it down where horizontal and, uh, the temperatures, the green line, it went down. Then she went to school and she was mostly vertical, standing, sitting, or walking throughout her whole day. What we're able to show is we're maintaining the same pressure no matter what the activity. And we're also gonna now add instantaneous measurements. So when they get an in-brace x-ray, we're gonna have a baseline to start from and show them if they're wearing it correctly or not. All of this data is connected via the patient or parent's phone and it's hosted on an AWS HIPAA-compliant server. We also received a $100,000 grant from AWS to use their AI models on our data. What we're really trying to do is, if you look at Tesla, they build a really fancy car, but they measure every mile, every minute that those cars are being driven to improve their autopilot. We want to develop the autopilot for scoliosis bracing so that we can show the exact amount of therapeutic pressure you need to apply to the spine and how many hours a day you need to apply it. It's been great for the kids, and we only advertise for the kids on our website, but we get an amazing amount of calls from adults who have degenerative scoliosis, and they're in significant pain, and they wanna reduce that pain. It's a lot of this that we try to help is muscle pain around the curve or from a balance shift like this young lady from Southern California. These, these adults, they go through 1 million physician visits a year specifically for scoliosis, leads to 42,000 surgeries. And if you guys know anything about large spinal deformity surgery, you can have a 2-year recovery and marginal outcomes. We put together a just stellar team of industry veterans. Mark Bland is the general manager of Intuitive for North America. He just joined our board along with some other great leaders. We've gotten advice, quite a bit of advice from Alan Olson, who's the founder at Danek, and also Mick Farrell, who is the CEO ResMed. And then we've had some of the world's thought leaders in scoliosis surgery join our team. Many of them are design team surgeons at other companies, yet they've joined us to help keep these kids out of surgery. Right now we're raising a $3 million SAFE round, and it'll lead into a $10 million full commercialization round. We've received $13 million in previous rounds from angel investors, private or angel groups, angel investor I'm sorry, angel groups, private investors, VC, the world's largest racing company, DJO and Novus, led our A round. And we've also received NSF grants of $1.8 million and another half a million in other non-diluted funding. We raised $2.5 million in venture debt to qualify for the NSF grants. And with all of these funds that we're raising right now, we're going to hire a chief marketing officer for direct-to-consumer. And geo-targeting healthcare providers. We're gonna, we need additional field clinical specialists for training the orthotist to do the patient fittings. We need more distributor support for our VP of sales. And then we need to put instrument sets in each clinic, which run about 8 grand. We're gonna do some scale up now and we need to do some optimization on the brace to lower COGS and go to full-scale manufacturing. So we'll be hiring a veteran VP of R&D. Including new molds for cog reduction. We're also adding a cover for aesthetics. We need to expand our inventory production. We're using working capital for that, hiring of assembly techs. We're also going to expand our IP portfolio, and then we're going to most importantly expand on this intelligent bracing system, sensor system. We're going to improve the, the platform itself. We're going to dial into the analytics with AI to try and figure out some treatment insights and, and help provide better protocols for these kids. And then we also want to increase better battery life in the user interface. And so we know that we're going to become the new standard of care, and we imagine a world where these kids aren't stuck with an old brace, where they have significant pain reduction and they have dramatically improved outcomes. That's us.

Jamie, explain kind of the typical patient, like the degree of deformity and then what the degree of correction kind of is.

So I would say we get two kids. We get like the families calling with a 55-degree curve hoping for a Hail Mary, you know, and, and moms in tears and all of that. Now, some of those kids, it's like, hey, the best outcome, a grand slam, is we delay surgery a year and you don't get any worse. Right? We're not— this curve is going to go. Once you get past 50, they really like to tip and go. But mostly we get these kids from 25 to 35-degree curves. They're like that little girl, Emmy, who was wiggling and giggling, and they've been okay. And then they start to lose off on their hours, and moms are desperate for something different. They're desperate for a better outcome for their kids, and they're desperate to not be— wear the black hat all the time. You know, I don't want to be just the voice of the brace and like hammer them all the time.

So you take a 30 and you can get it to maybe a 20 or something like that.

Yeah, we've had, we've had a bunch of kids where we've, if so, we've had correction on kids. We had our first commercial patient, turns out lives 5 miles from me, so there was no pressure there. Can you imagine running into somebody at the store who's worn your device and not do well, but she had a 48-degree curve. And I said, I told the mom, you know, this is the, hey, a great outcome is gonna be delaying surgery. But she, we, we had some decent correction on her. She's been able to get down to 35 degrees. But the secret to that was she was hyper-compliant. So she was hitting 20, 22 hours a day. She had growth throughout that, that time. We made adjustments about every 3 months. So we went back in, added a little bit more pressure and was, basically like the orthodontic model. And every 3 months we add pressure. In the first year, she was able to get down to like just under 40. And then by the second year, she was able to get to 35. So—

Oh, wow.

Having that, you know, and we probably got lucky in there, to be honest, at some point too, right? Because there are kids that you could put them in a vice and their spine's going to go. But the data shows— there was a New England Journal of Medicine published study. It was funded by NIH. And they actually randomized kids bracing or not bracing. And they actually had to stop the study early for the kids who weren't getting a brace 'cause they were progressing to surgery much faster. But what they did in the study, they came out and they said, okay, if you hit 17.9 hours a day, you actually have a 92% chance of not progressing to a surgical outcome. So we know bracing works. It's getting the kids to wear it was the whole—

Yeah.

Yeah. Compliance.

Yeah.

And so we get— And the continual pressure just rather than static pressure.

Yeah.

Right, 'cause if you're in a clamshell brace, and if you guys have kids, you know they grow, so you're putting pressure on 'em. And then as this kid grows, you're, you know, a year later, even 6 months later, you're not necessarily putting pressure in the same spot. With our brace, it actually grows with them a little bit. We have adjustments to lift these rings up and let 'em grow so that at 12 months, you're still putting pressure in the right place.

Cool. Hey, Asher's got the first comment.

Thanks, Jamie. It's super exciting to see— oops, shit, my computer froze. It's super exciting to see all the progress you've had. I actually applied for your company like 6, 7 years ago when you guys were super early stage. So it's exciting to see all the growth. I had scoliosis as a kid and that's kind of why I work in the spine industry now and I had to wear a brace. So I mean, I completely relate to what you guys are doing. I had a sort of two-part question. With the mobile app you have, and this may be difficult with HIPAA compliance unless you like opted in, Have you ever looked into gamifying it where you can kind of see rankings of what other kids are doing to kind of incentivize them to almost compete with each other? And then is there a way, because you're marketing to kids on TikTok, where you can kind of customize your brace and get it like Marvel-themed or, you know, like, you know, Elsa from Frozen-themed or whatever, you know, whatever the kids are into nowadays?

Yes and yes. So we're looking at some custom modifications or custom things to do on the covers that we're doing for it. And then as far as on the app side, I'm not a big believer in phones for young kids, right?

Yeah.

Except if they have scoliosis, then I'm like, they should have their phones on them 24 hours a day monitoring their brace. Yes, we want to do almost like a Snapchat thing. And like, if you look at Snapchat, part of the reason it's addictive is it's like, how many times a day, how many days in a row did you—

Yeah, that's exactly what I was thinking.

Yeah.

You want to do all of that? We actually want to add— we've just got quotes for all of this— add a platform. If you are new to scoliosis, here's kind of an educational side on it. Here's some of these scoliosis support groups you can go to and other resources. Here's some kids you can connect with. We help with, uh, it's a group called Higgy Bears, and then we just did this huge convention. Um, they host Zooms, and we have kids on there that are, you know, supporting other kids and walking them through that. So we kind of pair with them on that patient support. But we want to do a lot of that through the app, and you don't even have to have our brace. You'll be able to download the app on Apple Store or Google Play without needing to have the brace yet, but we know it.

And are you guys targeting— so I guess beyond marketing to the kids and families, are you targeting them when they get to the pediatric orthopedic surgeon stage or are you targeting at the PCP level before they even get referred out?

Yeah, right now it's, it's either through social media they're finding it or through the spine surgeon. We just got the paperwork and we may be going to American Academy of Pediatricians in October.

Okay, that makes sense.

Yeah. If you look at, uh, uh, High Ridge now, you know, they, they have a huge booth on tethering, right, to the—

right, that's what I was thinking. Yeah.

And it—

the—

with that, it's, it's not like you have to fully educate the pediatricians, but, um, tethering is much more complicated with kids. And bracing, it's like, it's a pretty obvious indication. Once you get over certain degrees and you were low surgical range, you get a brace. Here's a different option for you.

Yeah.

So we get 'em to get the information, then it's gonna be helping us quite a bit.

Yeah. And I'm, I'm assuming because it's an accessory, you can almost, you know, kind of almost, I don't wanna say skip, but you know, really reduce the dependency on marketing to the healthcare professionals and just have kids sort of market it themselves to the appropriate demographic. And then, then it sort of catches fire and it becomes like a trend amongst, you know, the sub-18 crowd.

Yeah. Just after this weekend, just this scoliosis convention and what they're posting, we're getting a ton of leads on it. Yeah, where we've had success, it's like in accounts where, you know, we knew the surgeon or met them and kind of showed them, and then also a parent comes in and says, okay, you know, I want to try it. And then it's like no risk for the doctor. They're like, okay, I do know a little bit about it, but okay, we'll give it a shot on your child. Um, one of the places is Riley Children's in Indianapolis. Was just there on Tuesday. Um, our very first patient, we got very lucky, the mom had contacted us and was a patient of this doctor we already knew. And she said, okay, I'm gonna have insurance pay for the Whisper brace. I'm gonna have, I'm gonna pay for a Boston out of pocket. I wanna compare 'em both and do x-rays on both. I just, I don't wanna take any chances. And that's fine, you know, whatever you want. And so she did it and she was driving home and she had to pull over for 20 minutes after the girl was wearing the Boston. She's like, I gotta take this thing off. And she did put her Whisper on. And 3 weeks later the mom called me and said, I can't believe you let me talk her into buying the, or let me buy a Boston brace for her. You should have told, talked me out of it. I said, I can't get in the way of your decision. But they didn't even take an x-ray on the Boston. The doctor was like, okay, I think this thing's working pretty good. And that's led to, you know, more prescriptions.

Yeah, it's super exciting. That's the luck with everything. It's really exciting to see all the growth.

Yeah, it's, it's been a long process in a crazy world.

I'm gonna let Wee Sam go first 'cause he's gotta drop off. Yeah, you probably, Uh, thank you guys so much for the invite. This, this looks pretty slick, honestly.

Um, when you measure heat, are you measuring like body heat or, or skin temperature or, uh, it's on the, um, it's somewhere in the pad. Uh, it's, uh, it's not skin temperature cuz it's embedded inside the pad. So, but it's, they have right now, you'll see a lot of places have what's called an iButton and all it is is a food, uh, heat sensor that they, they embed into one of the pads. And if you get over a certain temperature, it shows compliance. The problem with that, you leave it in your car while you're in gymnastics, it hits the right temperature, it shows compliance. You get creative and put it in your— on your dog, it can show compliance. Leave it in the window in the right, right conditions, it shows compliance. Like, I've heard everything about how these kids are lying on their, their hours.

Yeah.

The one thing that just kind of hit me, like, does it matter when, when the kids wear it?

Like, does it—

like, do they sweat? Does it matter if their body temperature goes up or down or Yeah, I'm not as concerned of that. It's kind of like the last backup validation besides accelerometer and pressure. Where I think we can go down the line with adults is if they get pressure sores. If they're in rigid braces, they tend to get more pressure sores. And that has to do with humidity. And we're looking at adding that and temperature. So it's like temperature, humidity, pressure. If someday we could try and figure out, hey, they're at risk for a pressure ulcer because of things happening, we could be preventative and, and definitely improve outcomes compared to what out, what is out there. Have you thought of implementing maybe like some sort of a gyroscope into your app or the body temperature itself? For the body temperature? No, but we're still, yeah, maybe the app, it might not be a bad idea honestly. Like if somebody has like an Apple Watch or whatever, like a gyroscope Might be interesting to know kind of their mobility, et cetera.

I don't know.

I, I, that's why we put that accelerometer so we could show, you know, if they're vertical or laying down and that, at the conference I had Noel Larsen, if anybody knows her from Mayo, came in and spoke. And one of the studies she had done was she had kids tracked on just a step sensor and they were, they had scoliosis and they averaged 12,000 steps a day. And as soon as they got their brace, it dropped to 3,000 steps a day, which is like what chronic illness is. And so she's like, I think we can use your technology and like go back to that. And I wanna see the difference in, in kids with your brace versus what I collected before. Awesome.

Cool.

Thank you. Yeah, absolutely.

Thanks.

Kyle, good questions.

Do you have a lower age limit?

We don't have a lower age limit. We have a lower size limit. So, you know, we, we kind of did this, going out for 10 to 18-year-olds basically. And so around 10 is around the age. It's more the rings can get down to about 22 degrees on their way or 22 inches on their waist. So that's, that's our lower kind of size limit. They have to be just tall enough and then have a big enough waist. It crushes me. We were at this conference and we had a line of these 8 and 9-year-old little tiny peanuts, you know, that, that were just too big for. But they're like, all right, we're on the list, you know, and they've got the measurements and they're going to be watching their waist. And seeing when they can get big enough to get it. So we've got a couple of big doctors in the juvenile scoliosis world that want to work with us. We're going to go after NSF for another grant to do a juvenile version of the brace.

Okay. Second question is, is discomfort the only reason for noncompliance or is there some other sort of restriction? Like if they got to use the toilet, they got— they have to take it off and then they leave it off or things like that.

Absolutely.

So, you know, number one is motion and all these, we did a lot of surveys, like we had a, a basic design, but it was like we, you had to get in the mind of the kids and the parents. Why aren't they doing it? Motion was number one, kind of tied for second was heat, breathing, and eating. You know, you couldn't eat full meals in these, you know, it's like a Victorian plastic corset. So you couldn't eat full meals. They had trouble breathing, which leads, leads to more anxiety if you take away their, full breathing capacity, it increases their anxiety, which they already have in a brace, and then temperature. So if it, if the air can't flow through, you know, in the summer right now, I can tell you when a heat wave is going through certain areas because that's when we get pinged on our website. So it's, that's kind of the main things. The Velcro is really big. So we have these magnetic buckles and they, we thought they were really cool because they just kind of snap on and then you can easily pop them off. And kids all said they loved them. And I finally said, why? And they're quiet. And I said, okay, what does that matter? And they said, okay, when I'm in the bathroom and I shut the door and people hear the rip of the Velcro, everybody's like, what's that? What are you doing? They're in gym and they hit the Velcro, kids come around the corner and look at them. We put hinges on the brace. It wasn't just to get it on and off easier. It was actually so it could fold and go in a vertical locker in, in the gym locker room. And so the girls liked it cuz they can have it under their shirt, pop off the magnets, open it up and slide it in the locker.

Brilliant.

Thank you. And yeah, Jamie explained the name Whisper, which is fascinating because girls can wear this underneath their clothes and their friends don't even know they have a brace on. And so they whisper to their friends, which is a brilliant name.

Yeah, I heard it in a— I read it in a Tom Clancy book. There was a line that said, no amount of yelling in the White House amounts to a presidential whisper. And it was because a whisper is so powerful from a president. And that's— I thought about that. I'm like, we want something really powerful, but almost on notes. I love it. And because we got in the mind of a 12-year-old girl, all the braces out there are called a Boston brace, a Providence brace, a Rigo brace. So they're named after Old guys or cities? The 12-year-old girl didn't care about that, so we tried to go in a different direction and see exactly, you know, what would appeal to them.

Excellent.

Anthony? Yeah, Jamie, great presentation.

Um, are you guys anywhere outside the US?

Uh, not yet. We get a lot of requests, um, from Japan to Canada to Europe. We've had families fly over from Europe and get a Whisperer, but we haven't gone over there yet. I mean, it's— I— there's demand. I know we could go there, but you gotta stay focused on your key sites here and, and do what you can. Kind of started to spread out geographically. You know, we're trying to be— if you can drive 4 or 5 hours, you can get a Whisper in most of the populated areas of the country. So yeah, Mark.

Great presentation.

Um, thank you.

Early part of my career, all of the orthopedic residency directors were mostly pediatric orthopedic surgeons, and they were the very best doctors that made the least amount of money. I had great respect for those doctors, and scoliosis was their foundation. And so my question is, your B2C program, how are you doing that? What is that? Is that for the future? Are you doing that now?

And How's that work? So we've got to— we've started bringing on distributors to handle the physician side. As far as the direct-to-consumer, all of our inbound leads have all been, you know, it's TikTok, Facebook, and that. We're actually not posting. We're encouraging it. We're supporting the parents and everything and supporting— we do a lot of support for these big scoliosis meetings for these kids, but we're not actually— we haven't spent any money on, on marketing for any of this stuff. It's all been word of mouth, um, parents sharing to other parents. So, and then, you know, with the distributors, we're working with distributors that are, you know, have relationships with these pediatric spine surgeons. So it's kind of a double, double approach, you know. It's like you've got to— it's, it's one of the few medical devices you can go direct to the consumer. And it is amazing with these parents, they look at this and they're like, they, they could care less about their surgeon at the end of the day. They're like, if this guy's not going to do it, we're going to go somewhere else. And I don't ever try and pull anybody from their surgeon. But if somebody's like, yeah, you know, I just don't know anything on that, I'm not willing to do it. They have— the parents will leave in 2 seconds and go somewhere else. So we've been, you know, because their, their idea is like, hey, the surgeons, once we get to surgery, for now, I want to do the best brace that I can for my child. That's pretty cool.

I did a LinkedIn Live event earlier today on remote patient monitoring and chronic care management. 'Cause I run a platform for the Medical Association called Indie Practice and we try to bring new ideas to independent practices. And this is much, much probably too specialized for those guys. Although I don't know, maybe not. It might make a really interesting LinkedIn Live event one day.

Yeah, I'd be happy to participate. And that remote monitoring side, they came out with new RTM codes. There was remote RPM, remote patient monitoring. Codes. I think it was last year or whatever, year before, they came out with RTM codes. So it was pretty specific to musculoskeletal remote monitoring. So you had to be providing a therapeutic event, bone growth stimulator, therapeutic device, bone growth stimulators, things like that. And they had to be connected. And so we've— what we've seen with our advisors in that, that do that, like we're going to be able, as we have the establish the physician dashboard, they're going to be able to bill for that.

Yeah, that would be really good. That would be a great LinkedIn Live and have a panel of different remote therapeutic monitoring products and experiences, of which that would be one. So anyway, I really enjoyed your presentation.

Thank you very much.

Hey, Jamie, walk us through. So a patient sees a doctor and they, they learn about Whisper and they say, okay, you're a candidate, tell me, walk us through how the customization happens, how long it takes.

Yeah, so, um, we kind of follow the same workflow if they were just getting a regular brace. Um, they, they get a prescription from the doctor. Some institutions have employed orthotists like Shriners and that. Most of them have an outside vendor that either rents space in the hospital or they have a clinic outside the hospital somewhere. Hanger Clinic would be the biggest one. They have around 1,000 clinics throughout the country. So they take a prescription. They get an appointment to go see the orthotist. The orthotist uses a 3D scanner. I actually have mine right here. So they use a 3D structure scanner or something similar. And they take a scan of the patient. They stand there, and they walk around them about 3 feet away. And it gives them a three-dimensional— OBJ file of their torso. They take that, the— we have a measurement form and they send that to us and with their X-rays. And so we pair the X-rays and the patient's torso and we can— the brace is modular, so we can custom build each brace specifically for each kid. We have different angles on the pieces going around. And so we custom build a brace for a kid. We like to say 2 weeks. Mainly because if they're new, newer orthotists and not going solo yet, I've got clinical specialists that can go around and attend the fitting. And we like to, you know, especially with their affair nowadays, nowadays it's nice to book it out a couple of weeks. So they go through that process usually within 2 weeks to 3 weeks depending on usually the patient and the orthotist schedule. We come in and fit them for a brace. What's nice about ours is like if you get a, if you get a regular clamshell brace, you kind of get it, you break into it from 1 to 6 weeks depending on the surgeon, and then you come in and you get an InBrace x-ray. If you had a 35-degree curve, you know, they'll see how much correction you were able to get on it and is it aligned properly. We do the same thing with ours, except we let the kids, we don't put full pressure on 'em to begin with. We let 'em get used to it for a couple of weeks Then they come in to see that orthotist again, and then we crank it up a little bit more to full pressure and then send them in for the X-ray. And so when they do that, they tend to do a little better because they've gotten used to it and then they can, they can get a little bit more.

Push them a little bit. So the X-rays are just plain films like sagittal, coronal?

I usually just do a PA X-ray, although just recently at the POSNA meeting, they were starting to show how important sagittal balance is in, in bracing, not just in surgery. So we're starting to see a little bit of shift to that where they're doing an AP and a lateral.

No CAT scans or MRIs or anything crazy.

No.

Okay.

They just do the X-ray. And for us and for, for any type of brace, you have markers in there. And so you wanna see that that brace is aligned and applying the pressure where it's supposed to, you know, scoliosis isn't super complicated. You have a curve, you put pressure above it, below it, and on the apex. And then you try to de-rotate it. So you just want to make sure your pads are lined up with the apex of their curves.

Got it. And what about pricing and reimbursement and all that?

Yeah.

So depending on the braces, there's customized braces out there. These, you know, the kind of fancier clamshell ones, those I've seen for $5,000 to $12,000 or $13,000. Sometimes insurance reimburses them, sometimes they don't. Average Boston brace, we see anywhere from like $2,500 to $4,000 cost to the patient. Ours is $6,000 cost to the patient. So it bills insurance $12,000, but they— almost all of them are contracted about 50% for the braces. So, and for— we haven't really had— we've had a couple get covered under Medicaid, but it's usually private insurers. We do really well on Blue Cross Blue Shield and a couple of them. United is a challenge on most things. So we get probably a little more than half of them covered by insurance.

It seems like you could charge more. I mean, people will do anything for their daughter's health. I mean, you know, Taylor Swift tickets are $5,000.

Yeah, I need the Taylor Swift version of the brace.

Yeah. Oh, man. Yeah. Get her to talk about it. Go crazy. What can, what can we help you with? Where's your pain in the business right now?

You know, right now it's like, okay, we got to this point, you know, you're raising money in that and it's like you got to hit an inflection point. Like our, our growth constraints are capital constraints right now. I need some more people to get out there. I need the instrument sets. I need that because we get these shops that are like, oh, we'd love to have it here. And I'm like, okay, we can add you next quarter or whatever as we go along. You know, we can only build so much or cover so much. So we really wanted to, you know, hit an inflection point, especially with this last convention, having all these kids wear it. We were at the same convention a year ago and we had one kid. And so we were this novel kind of unique idea. A lot of people kept their eye on us. Now they saw 8 kids walking around with this and those kids were just hammered by other kids with questions. And then the parents of those kids were hammered by other parents. And it's— it was really a takeoff moment for us.

So how many, how many, what's your throughput? How many patients could you do per week, per month?

Per month, we could do about 25 right now.

Okay. But one a day.

Yeah.

Yeah.

One a day. But like adding another assembly tech, it, we could start 'em on Monday and by Friday we could have 'em going and, and they could be building 'em. Um, one of the things we used in our NSF grants that we're working on right now is it takes like 3 to 4 hours to design the all the parts for the brace or put the thing together. We're going to reduce that probably by 80, 90%, uh, where we've got some software coming where we just put where we want the ring and it auto-fills it and puts all the parts together for us. So that's going to reduce our, our design time, which will increase our throughput. Um, we're also like, our brace right now, like the bigger ring has, could have 20 to 30 parts in it. Um, we've done analysis on our last couple hundred braces and we're going to be able to sit there and take it and go down to, you know, 3 to 5 parts per ring instead of all of those pieces, because we see where, you know, there's a lot of similarities between them. And so we're going to be doing new molds with longer parts instead of just these little inch-long parts. Got it.

Any questions from the gang? It's, it's just, you know, we talked in that Jamie and I have been talking for years and I would love it if you guys didn't use the word brace.

You know what? I hate the word brace.

I don't want to brace.

Try and go through insurance without using brace. Yeah, yeah. And I'll code and it's all of that. If we were outside of medical, we would just call it the whisper. I only call it the whisper. But like, you've got to, you got to stay within the coding system. You have or you won't get any of them covered.

Yeah, I got it.

So we're going to go after our own unique code. We had a clinical study going. We had 4 sites shut down because of kind of post-COVID, the great resignation. I mean, we had, we had doctors that were chiefs at Children's Hospital Los Angeles, been there like 25 years. Our primary investigator moved. That happened at 4 different sites where we were studying this thing. And so we kind of, and we had the whole clinical team at a Shriners leave. And so We said, okay, let's, let's shut this down right now. We're working on this sensor system. Once this comes out, we've got such a greater accurate measurement of compliance. We'll be able to have much better data and be able to show very accurately what we're doing. So we're going to get that started back up soon. We actually have a lot of independent sites that want to study it doing different things, like I said, from step counting to motion to pressure.

What's— what was the regulatory path and what, what claims can you make?

Uh, we're Class 1 device right now. We're providing clinical decision support. Um, at some point we'll gather enough data and once we switch over that, as we study it enough to go, okay, this is, this is what you need to do, here's the minimum you got to maintain and all of that, then we'll have to upregulate and do that. But we don't have to cross over that line yet. That's awesome. Yeah. And this, you know, is so everybody knows, like, Tiger was part of the Magic Rods, right? And I saw, like, the playbook's already— I've already read the book and he wrote a chapter in it and it was, hey, you've got this, you'll get parents supporting these things. Because when they were selling the Magic Rods, they went into hospitals of, like, if they didn't sign up, they were like, okay. And they'd get calls back because the parents were like, I'm leaving. If you guys don't do this, I'm going to somewhere else. So it's like he says, the parents will quickly change facilities or physicians if they aren't what getting what they think is the best treatment for their kids.

Yeah, we had, yeah, we had patients writing and patient families writing letters to the FDA for years. We, we didn't even know about it. And, and then when, when kids got a Magic Rod, they, they wanted to come to the company and hug the engineers. And that was something we had to get used to. You know, our CEO would say, all right, we got a visitor today at 3. I have no idea, are they, they're going to be in a wheelchair? You know what? And they would come in and, you know, they wanted to hug the engineer that designed the Magic Rods. That was just incredible.

Yeah, it's, uh, there's a whole— I was in spine forever. I actually sold Harrington Rods, if any of you guys know. Yeah, I'm that old. Right. You know, you— there's such another level of responsibility with this because I, you know, I've gotten to know a bunch of patients and families and that. And it's like they're looking at you like, man, you have to do everything you can to help my kid, you know? So it's, it's completely different than selling screws and cages and everything that I did before.

Yeah. Alessa is not on the call, but she did Send me a note about the adult market.

It's huge.

It's so, yeah.

So we all sit there and say like, people will do anything for their kids. Let me tell you, adults in chronic pain from scoliosis would sell a kid to get out of it. I mean, they will call you up crying. They will, they are so desperate. Not only in scoliosis, like I've got the president of Sherman's Kyphosis Foundation that wants us to, you know, can you do modifications to help with that? And just, just a little bit of dynamic pressure to help with pain relief. So that market between that and, and adult degenerative scoliosis, it's 10 times the, the adolescent market. So we're applying for another NIH grant, um, for through National Institutes of Aging specifically for adults.

Wow. And is that, that's Class 2 again or Class 1 again?

Class 1. Yeah, it'll be a Class 1.

Wow. Love it.

Yeah.

So, and, you know, I was like, are adult deformity surgeons going to, you know, want to prescribe this thing? These guys want it now. And their thing is, I've got this lady in my office. She comes in every 6 months, takes up 45 minutes. She doesn't want surgery. I don't want to operate on her and I can't get rid of her. And if I could give her this, if you lowered her pain 20%, she would be ecstatic. And that's what we saw. That lady that I showed in my, my PowerPoint, She's like, I, I used to struggle getting to my mailbox and, and back. And she sent me a text this the first day she got it. She's like, we just walked around the neighborhood and I haven't done that in a couple of years. I can't thank you guys enough. And it was just because, because she was so far out of balance. She had all this low left back pain. And if you get— it wasn't even about correcting her curves. It was about getting her balance over. And once we were able to do that, it significantly lowered their pain and she was able to get out and walk in ways that she hadn't been able to in a couple of years.

Fascinating. Yeah. Eric or Dr. Shiroff, any—

Hey Jamie, congratulations. It's always great to find that extremely rewarding unmet need. Yeah. So good for you. That's, that's That's what keeps us going, isn't it? I had a question. Are you thinking about any other indications for, for this device? I mean, it's applying load, you know, upward load or in different directions. So there's indications that could use some, some offloading of the spinal elements? Have you considered that? And I know you're probably laser-focused right now, but—

Yeah, laser-focused. Like I said, there's Sherman's kyphosis, there's, you know, the whole adult market. You know, if you have a degenerative lumbar curve, right, and they've got a radiculopathy, you can go in and kind of decompress that, but then it can end up collapsing. So we have docs who are like, hey, if we can go in and, and see if you can provide any relief, or if you can Hey, they got to wear their brace and stabilize it after we do the foraminectomy. We think it could be very helpful because you're keeping that pressure off the nerve. And they'll know, like, hey, if you're pinching on that nerve, it's hurting again, put your Whisper back on. So we're looking at things like that. But it's the same thing. It's resources. And you got to have laser focus. It's really hard to deal with all the patients that we get. And the one thing that we've expanded into a little bit is neuromuscular and degenerative neuromuscular. Scoliosis as a result of other diseases like Friedrich's ataxia and that. If anybody has neuromuscular issues, you put them in a plastic clamshell, you want to talk about muscle atrophy. They already have major problems with muscle atrophy, and now you're enhancing it. They might be stable in a regular brace, but you can't— they're going to have a decline in muscle atrophy. So we're starting to help with some of those kids.

Yeah. So, so the one thing that I, I was, I was thinking of is, is maybe, maybe the, you know, biggest market that we have that, that still is, pretty much, you know, under, underserved is, is, you know, back pain secondary to degenerative disc disease. Yes. Where, where, where offloading there can, can, you know, you can get some healing or you can, you know, hold off some surgery for 5 years.

There are a few things we're looking at and maybe talking about partnering with a company on. So I— that is a huge market too. And, you know, if I have a partnership and the capacity to do it, yes, I'll do it. Right now, like, I've got kids to help. I got to prove it in this space, get the money to complete that, and then we'll work on other markets. You know, I learned that quickly. You try to shotgun, you're not going to gonna help anybody.

Yeah, completely. Well, let me know. That's been my life for a long time.

I can, uh, yeah, I would, I would love to connect with you on that. I mean, I, I, and, uh, as someone whose, uh, uh, wife had a huge disc herniation and discectomy and then eventual fusion, like, it's, uh, I understand that whole, that whole market, uh, all too well. So, or at least have lived with it all too well.

Great, great. I'll, I'll ping you then.

Yeah, absolutely.

Could it be used in a knee brace to like offload the medial compartment?

That's kind of what we're thinking on that.

Yeah.

Right now we're not doing any distraction. All we're doing is lateral pressure, lateral medial pressure, and then we're doing rotation, but we could add distraction too. So it's one of those things that's, that's on the, on the board for things we'd like to do. So, but we haven't gone to—

you got to focus. You can file patents, but you got it, but you got to run your business.

Yeah.

You got to run the business. Right.

Yeah. We, we talk about that often. The number one killer for startups is lack of focus. It's not lack of money or lack of—

right.

Or technology. It's lack of focus.

And so, but right now we're, we're just on that, getting people trained and, and going. It takes us, you know, 5 to 10 patients depending on how quickly they come in to get an orthotist comfortable so they're going solo. So, you know, I'm sending in a team making sure they're good, but once they're going, it's just, we get an order, send a product and nobody has to be there. It's great.

Excellent. Dr. Shoroff, you have a question?

I have a quick comment. It goes along what you just said, Tiger, and, you know, venturing potentially in the knee, but the knee business, you know, is very busy. Potentially also, you know, looking at the extremities. So ankle bracing is, you know, quite a big market and that could potentially also be very attractive, maybe easier to get in than into the knee.

Hmm, yeah. We've looked at Clubfoot also, you know, and if we could integrate our pressure sensor system into it, like it is, it is, they've been doing the same thing for a long time and it's great, but they don't really know how much pressure they're putting on and they kind of have a, a standard they go with, but it's not dependent on each kid or how flexible or limber their, their ligaments are in that. So if we could kind of figure some things out about how to you know, do it until the next brace. I know there's some opportunity there also. Yeah.

What are the, what are the follow-up times for patients? I mean, you talked about 2 weeks, you sort of go in and tighten it up, but what are the other follow-ups?

They come in for a follow-up with the orthotist and an X-ray to make sure it's, it's aligned. And then it's usually 3 to 6 months to come in with the doctors. They usually do an X-ray out of brace every 6 months., and they go through skeletal maturity. So, you know, 14, 15, 16 in girls, more 15, 16, 17 in boys.

Got it. And, and when, and once, when do you, when do they stop using the brace once they're skeletally mature?

And skeletally mature, and then, you know, there's starting to be more data where these kids in, in regular braces, like, okay, even if they've had some correction, they went from 35 down to 30, and you can't just pull 'em out right away because the curve will bounce back, right?

5 or 10 degrees.

Makes sense. So you gotta wean 'em off slowly. Personally, if it was my daughter and you had a curve over 25 or 30 degrees, especially to begin with, got up into the 30s or 40s, I would try and get 'em into nighttime bracing like a retainer through high school. There's, it's not gonna cause any harm., and it could prevent a lot of things, you know, where these kids, if, if they quit too early and they have another little, little bit of growth left, you can see curves accelerate very quickly. Yeah, it makes sense.

What does your team look like in Denver?

Uh, so we just have, uh, a couple of us here in Fort Collins, and then my sensor team is down in Denver. Um, and then I've got, uh, engineering office and, and that in San Francisco. And then I got a VP of sales and clinical specialists in that, and we're kind of all spread out a little bit.

So, so all the building, all the customization's done in Colorado?

No, all the actual assembly and everything is in San Rafael in California. Oh, well, that's where the smart— that's where the smart people are.

Fascinating. Everybody, everybody got it really quick. There's no other questions or comments, or, uh, somebody tell me I'm crazy. So I, I think you gotta run like crazy with social media. I, rather than the patients doing it themselves, I think you've gotta have, you know, you YouTube channels and Facebook groups and yeah, we just, so we did all the recordings on this, on this conference.

We've just set up a YouTube channel, Scoliosis Whisperer, and we're gonna be offering all this content and then we're gonna have It's got— I want an educational platform because all these parents are drinking from a fire hose, you know, as their kid gets diagnosed. We have a lot of information on our website, but if we can be the YouTube source to kind of walk them through like a scoliosis university, these parents will absorb it. Our average time on our website's over 7 minutes. That's an eternity. That's a long time because we have all this stuff, all these videos. I mean, the parents— I talk to more parents are like, like, I've read— I stayed up till 2 in the morning and I read every single page on your website. And then I went over to Facebook and, and we Googled you or searched you on Facebook. And they, you know, see all these different parents. And, and we tell parents, hey, like, look us up on, on Facebook, reach out to any parent. We have a very open attitude for that because they will— parents will trust other parents more than physicians or anybody from industry. So we're in, we're in some very big and some private groups that I'm not allowed into. It's only parents and, and I hear back from parents, you know, different ones reporting things, but it's amazing how they communicate and, and, and give each other confidence in them.

Yeah.

Like you were, you know, go ahead.

So Jimmy, you might take a look at a company called Simple Show. They make Simple Show. Show. They make educational videos that are They look very rudimentary, but they're potentially very valuable for the audience that you're looking for, for, for kids that want to communicate, understand something, parents that want to help their kids understand and easily shareable. They're an educational development company. You can make a couple-minute video for a couple thousand dollars, but perhaps more cost-efficient for you is they have an authoring tool where if you got a member of your team that likes being creative, you can, you can write the script, you can put in the images you want, you can drop in different things and it'll, chew it up and spit out a video that's put together and you can render it. And if you're, if you're using it a bunch, you might get videos for a couple hundred bucks a pop. It's, they're fun to work with and it's a neat tool.

Okay.

Yeah.

And it's, you know, one of the things we're doing, so I've got this, we're gonna have all this content on our YouTube page. We're gonna kind of have a Scoliosis University and here's everything you go through. As a parent, we're gonna have a scoliosis university for kids. And it's gonna be taught by other kids because these kids are very educated. They, they try to pick up as much information as they can. One of the things we do, this 3D scan of 'em, one of the biggest anxieties kids have over bracing is the scan. I learned. And 'cause they get told some guy is gonna scan their body to, to make a brace, whether it's a Whisper or other one. Make a custom fit brace. Most of them assume they're gonna— some guy is gonna walk up and be touching their body and scanning it. They don't understand that you're standing 3 feet away. So we just filmed a video for that that we're gonna put on there, like, this is what your scan looks like. And I know that's probably gonna be our most shared video on our YouTube series because the kids are so anxious about that. If you've never been in bracing and you just told you're getting scanned for a brace, imagine if you're 11, 12 years old and you're going to see some guy to do that. You have no idea what's coming.

If they've ever seen an MRI machine, that's what they're gonna expect. Yeah. Something terrible.

Yeah. Something terrible and whatever. And it's like something that when that young lady told me that, I, that was my biggest fear. And then I started asking other kids and it was like repeated among all of these. So it's like if you can tap into that and be the, the resource for that, that's how you can explode, you know?

So SimpleShow also lets you control voiceover. So if you wanted to have a kid record voiceover for it, then you would have no problem with it.

And I got a ton of volunteers. We now have Whisper ambassadors that are taking it and talking to other kids and doing stuff.

So yeah, you were joking around. Your sales force is all these kids and parents and it's—

Oh, it's, it's insane. And they, and they don't even know, you know, they're just like, oh, I can bend over and I can do this and, and whatever. Like that little girl wiggling and giggling and laughing that has been seen tens of thousands of times, you know, more parents we talk to say like, I watched that video and that I wanted my kid to laugh like that. She's so miserable. Boom, that's it, you know? So it's, it's very powerful. You want real stories and I want them to connect with, with parents and that go ask them what they think, how it was going before, how it's going now. Is— does any kid want to wear a brace? No. Like they don't even have to love the Whisper. They have to not hate it. And we have a home run, right? Like literally they hate bracing. So if they don't hate this and yeah, I'll, I'll do it, then it's a home run.

Yeah.

I liked, uh, Kyle's comment about gamification. That wasn't me, but I was thinking that was Asher. That was Asher maybe.

Yeah.

Yeah.

Um, I couldn't agree more with that. I, there is so much we could do with this on that app side. I think the gamification may be as powerful as the whole sensor system as far as, you know, we'll get the clinical adoption and studies in that with our pressure sensors. But being able to do it from, with the gamification is going to be huge for these kids. And we already have some in there. Like we have it, all right, you hit 4 hours and it does this badge and you hit 8 hours in that and you did this many days in a row and there's some random things that'll, it'll show up and do a badge. One of the things one of our parents has done while we've been working through this is she's like, her phone time, hours time are dependent on her brace time, right? So it's like, oh, like, dang, all right, you hit more time, you know, getting to use your phone and things like that. And so the parents were like, that was the ultimate reward for her. So she got to be able to use it, you know, depending on her brace compliance. And if you missed a day, it's like, guess what? We got to get our hours back up. And, and so you can try your phone again. I love it.

And they, and they, unless the whisper is clasped together, the Wi-Fi doesn't work.

Yeah.

Is it?

Yeah.

Yeah, exactly. That would be great. You know, something like that. It's, it's, you know, there is, there's a whole science to that on gamification of devices and that we've looked into and you can, you can spend some serious money, but it's, it's about, it's mainly about, you know, senior hours and doing that and kind of competing with other kids. But the biggest thing in all of this is feel— is not feeling alone. Scoliosis is the loneliest disease for these kids because even if they have great parents, great friends, they get diagnosed, they're alone. Um, we do these teddy bears. Do they bring— here it is. So, um, kids get a teddy bear with a whisper and has the magnetic buckles on it. So, you know, instantly— and that's what this convention we were at is called HiggyCon, but it was started with Higgy Bears. So giving kids, you know, a little bear to connect with and somebody understands when they show up at these conventions. I would say 80 to 90% of the kids that were there for the first time had never met another kid with scoliosis. And so instantly, yeah. And so instantly they're sitting there going, oh, this one mom, like we were still setting up the first night. Mom came in and she's like, yeah, we're from, from Missoula. We go to Spokane Shriners and that. She's like, my daughter's never met. Anybody with scoliosis. And I knew these teens, these 15-year-olds that were right by us. And I'm like, "Sweeta, this young lady's never met anybody with scoliosis in this whole group." Like, and we're on her and it looked like Taylor Swift talking to a young 10 or 11-year-old. And they're like, "Let us see your brace.

How's it going?

Yeah, this is the one I got." And whatever. And showing them pictures on the beach. Like, I wear mine on the outside all the time. And this girl was just blown away and the mom was just kind of tearing up behind her like, holy cow, I can't believe this.

Event.

And it's amazing, like, at this event, the amount of kids that are new the first day, at the first break, they go find their mom. If they're not wearing a brace, they're like, can we go back to the room and get my brace? Because I look like an outsider if I'm not wearing them, right? So it's like the one place in the country where these kids, you know, are— feel safe, look like an outsider if you got a straight spine. So, and by the end of the weekend, these kids are wearing their braces on the outside. Ride going through the airport and everything. They're not hiding them anymore. So, you know, the more we can support groups like that, the better off we'll do.

So how does a family find a surgeon? So is there a surgeon locator?

Uh, we're putting that on our website right now. We've kind of been expanding and doing it. So, um, it ends up, you know, with a lot of it, it ends up to new leads with surgeons too, because it starts with the parents, you know.

Right.

I, I, I, I was in implants for 18 years. I've had doctors call me up on the phone, hey, I've got this patient requesting a Whisperer. I just pulled up your website. I know a couple of those docs in that. Can you tell me about this thing? And then like, yeah, this looks good, let's do a prescription. And, and I mean, I've never had that in implants. So we're actually getting new business. Half our business out there doesn't even have distributors yet. I know we can do better in those areas. And so we're kind of, you know, evaluating distributors. But like in Mayo, we're getting that business just because she found out about it from patients and, and, you know, the different groups. And then I met her.

So it's the biggest thing that the biggest advantage you can have is that push versus pull. You know, as soon as you've got other people advocacy for you and man, you get a lot of tailwinds. You need to, you need to just run with that as far as you can. The communities.

Yeah, it's all of that. And it's so powerful. The head guy at Rainbow Babies.

He's—

he looked through it and everything, and he goes, all right, this is the way I look at it. You know, those other braces work 30, 40% of the time. You might work 60, 70, maybe 80, 90. I don't know, we'll see. But I'm pretty sure that if I don't offer that to a family, they're going to go to somebody who does. And if they ever do need surgery, they're not coming back to me. And that's exactly the way it goes, and we've already seen that, you know.

So, all right, well, this has been great, Jamie. Thanks. This is, uh, Thank you, everybody. One of my favorite startups and, you know, they're killing it and you guys can see why. It's a unique solution, solves a problem in a unique way and it's a new category and huge tailwinds from patients and families. So congratulations.

Thank you. I appreciate it. Good luck.

See you, Tiger. See you. Thank you, everybody.

Awesome.

Thanks, Jamie.

You bet.

Have a great day.