BoneChat #130 - The Future of Joint Preservation with 3D-Printed, Lightweight Off-Loading Devices

Okay, so this is Bone Chat Discussion 130. Today we're diving into a great little startup that I've been talking to for about 5 years, Ikaros Medical. Met them back in '21. I just first, met the founders, Evan Eckersley and David Johnson. And without taking any VC money, these guys have just quietly killed it for years. And they fundamentally changed the way that joint, the joint preservation game by turning an old clunky traditional bulky knee brace market into a 3D-printed digital workflow. Process. I can't wait to hear more, so I'm going to turn the mic over to Evan. Welcome aboard.

Yeah, so just a little background on Icarus and our story. So people always ask why the name Icarus, right? Uh, not, not the brightest tale, but it's actually very telling of our mission and our story. So if you're not familiar, so Daedalus, the father of Icarus, was a prolific inventor and he was trapped in a labyrinth of his own design. And so to escape, he actually made wings out of wax and feathers for his son Icarus. But he cautioned him, you know, don't fly too close to the sun. But he also said, don't fly too close to the sea, don't fly too low. And so we take that as a cautionary tale here at Icarus. But we also see it as a story of our patients, right? They're trapped by their knee pain, their mobility limitations. And so we're here to design solutions to help them get back to doing what they love. And that's really our mission, right? We're here to improve the quality of life and elevate the standard of care for our patients who are suffering from joint pain using advanced biomechanical models and digital technology. And it really all starts with, uh, the story of Dave Johnson, our CEO and founder. So he was patient zero, and he had a an injury playing high school football that later in life developed into a pretty severe case of patellofemoral arthritis into his 30s. And this is actually a picture of his knee. So he's got zero cartilage in his patellofemoral joint. And for him, you know, he's too young for a knee replacement. So all that his doctor, could say for him was, well, you know what, give up the activities you love, you got to slow down. And for Dave, that wasn't an option, right? So he researched what other braces were out there to help with his condition and discovered there wasn't something for him, right? Traditional braces, they didn't have the functionality to unload the patellofemoral compartment. They were bulky, they were not personalized, and they lacked the adjustability that he needed you know, say to go snowboarding, right? So he sought out to develop what became the first patellofemoral unloader. I'm going to turn my camera back on here. So we call that the Ascender, right? It's a first-of-its-kind brace, and I'll show you how it works in a moment here. But it's designed to fit all those gaps, right? Personalized through custom scan-to-print. You know, very lightweight, improves compliance in the patients, and most importantly, it has significant improvements in pain relief for our patients. And, you know, this points to our methodology overall as a design company, right? We'll talk about some other products that we've developed like the Ascender, but we always start with a patient zero and a clinical advisor, and we bring these groups together with our engineering team to solve problems on the spot, right? So we involve the patient very early in the design process. This is just a, again, a bit of our process, but we're constantly churning out new innovations to address a number of clinical gaps that we've seen in the space. Now, the first problem we're solving— so again, if you look at Dave, um, Dave has a condition that affects roughly 1 in 10 Americans, knee arthritis. And in fact, if you look at recent literature, patellofemoral knee arthritis is actually the most prevalent form, right? Some literature indicates that around 60% of OA patients have patellofemoral arthritis. One paper I saw indicates 94% of patients had radiographic evidence of patellofemoral involvement in their knee arthritis. And a lot of these patients, like Dave, are not candidates for a knee replacement surgery, which can be effective. But, you know, either they're too young, too old, they need to lose some weight, they have comorbidities. So there's really a lack of an effective and conservative treatment method for these patients with patellofemoral or multi-compartment knee arthritis. And that brings in the Ascender, right? So the Ascender is designed with a new biomechanical principle to actually unload weight from the knee. And so there's a dial and the patient can really, adjust the amount of assistance, extension assistance in the device, and it acts like a spring, right? So when the patient bends down, it's going to spring them back up. And that provides a substantial amount of unloading force. Really all that it's doing is it's assisting the quadricep. And when you reduce quad work, right, that's directly reducing pressure within the patellofemoral compartment of the knee, right? So you can see in this biomechanical diagram, When a patient's standing or sitting, anything in flexion, it's gonna generate a substantial net force in that patellofemoral compartment. By strapping on the brace, dialing it up, you're directly assisting the quadricep and reducing that force as a result. And it is very significant. But most importantly, the result of that is substantial pain relief. So I'm gonna show you a quick video. This is a story of one patient. We see these patients Every day, right? Okay, so, um, like 3 of them. Yeah, 2. Now, now go, go ahead and, uh, just kind of bend down a little bit. Sure. And tell me. Oh, that's pretty painful. That is very painful. Yeah. Okay, so now let's crank up some tension. How much pain was that, 1 through 10? It's jumping up to like a 9. Oh, okay. Okay, now make it deep squats. Okay, go to that same kind of position. Take it easy though. That's much better. What's that feel like?

What did you do?

Magic.

I'm sorry, like, that's crazy. What did you do? I rotate. That's crazy. Okay, now try it again.

The quad mechanism is so important. People don't realize how important it is. And it's like multiple magnitudes of your body weight goes through your patella when you, when you climb stairs or climb a hill or get out of a chair. Hmm.

Yeah. That's such an important point, Tiger. That was, that was really integral to the design is, like you said, you know, because the patellofemoral joint, it's, it's actually a fulcrum, right? The force within that joint is a multiple of body weight depending on the flexion angle of the knee and the intensity of the activity, right? So that's why a lot of these patients you see with patellofemoral knee arthritis, they haven't been able to do a squat in years, just like this patient. So this was a veteran. Dave bumped into him at the VA when he was seeing a doctor and he reported 9 out of 10 pain score. On a VAS scale. And, uh, with the brace engaged first time, um, he said he had no pain, no pain in his knee. Right. So, um, it's a very instantaneous effect just by assisting the quad. And, uh, you know, these, these anecdotal, um, stories we have, you know, they're backed up by a broader study that is actually just publishing now, uh, should be coming out any week. It was done in conjunction with Dr. Yankee and some other prescribers at Midwest Orthopedics at Rush. And, you know, relatively large patient population of 134 patients provided patient-reported outcomes, Q scores, VAS, quality of life scores. And we saw, you know, about 98% of those patients have significant pain reduction, 59% on average on a VAS score. And what was really interesting is that are KUSS scores, um, are— have never been reported, uh, for bracing, right? So we saw a 27% improvement in the KUSS pain subscore and a 30% improvement in the KUSS function score, right? Um, and those are actually 3 to 4 times better than the, you know, only other study we found that shows pain and function improvements for an unloaded brace. So, um, we're really excited to see what this data does for the community. Um, but for us, you know, it's really important that we study these products and actually back them with data.

And, uh, Steve, uh, Stephen's got a question.

Yeah, I love what you guys are doing. Uh, this— I, I think Tiger has heard this before. I had an OATS, I had a DFO, it failed. I have patellofemoral issues now. I think this is awesome, this is needed, but the question I have in your studies is, is the long-term patient compliance is one of the biggest questions you have to try to figure out how to solve for. As someone— this is year 4 that I'm dealing with it, and I still have a hard time going downstairs specifically. So how do you essentially, you know, work with building that into potentially a soft good that is something that is more patient compliant? I don't know, just kind of throwing that out there as someone who's been dealing with this for a long time, who would snowboard every year, who is I'm happy if I go down a couple stairs now.

Yeah, well, you know, I'd love to connect with you and pick your brain. Um, you know, compliance is critical. If patients aren't wearing it, um, it's not going to help them. And, uh, as you know, that's particularly bad in the bracing industry, right? So, um, this study— again, now you mentioned the need for long-term compliance, right? So this study was only a 4-week survey period. So we are looking to survey these patients on a rolling basis, but at least in that short window, we saw that the majority of patients are actually wearing it at least 4 days a week, which is great. So, you know, that's a good start. And, you know, we think that's a combination of the fact that, you know, one, we have great outcome scores and it really helps the patients, so it's worth putting it on every day. Two, you know, I'll get into the custom fabrication, but the, the form-fitting aspect is really important. As well as the fact that it's really lightweight because it's 3D printed. I mean, this thing weighs about a pound.

Um, wow.

Yeah, yeah. So it provides 40 pounds of assistance, but it weighs, um, a pound. So, um, but that's key, you know. And again, I think this is a benefit of, you know, um, Dave being patient zero, is he just kept tinkering with this thing, um, to make it better and better for himself and for our patients.

So The best startups come from scratching your own itch. You know, it's incredible because you have a purpose. You know, I love that. Let me interject a question, Evan. So why didn't DJO, Breg, and Ossur figure out how to unload the quad mechanism? What, they just missed it or?

You know, we have theories. Well, a couple reasons. You know, it is a totally new mechanism, and again, it takes someone like Dave with a problem and also a background in research and engineering, um, being at the right place at the right time to solve this. You know, one potential reason is that the device— so the reason that the device is 3D printed, um, isn't just because it's cool and it's lightweight, right? Um, it's very expensive, right, to 3D print. Uh, and, and so I think other big bracing companies looked at it and said, you know, it's not durable enough, um, it's too expensive, the margins aren't going to be there. Um, but the printing has gotten to a point where, you know, that we use HP Multi Jet Fusion printing, and that solves a lot of the durability problem. Um, you know, both the method but also the design of our product. Um, and then we have a lot of proprietary software we've built to automate that design.

So yeah, so in a nutshell, they, they, they're not good at 3D printing and, uh, they're not good at the digital world, probably.

That, that's part of it, you know. And it is, uh, a more general statement, but taking on a project like this or any startup really, it's, it's a high-risk endeavor, right? And so maybe companies like DJI, they wait for smaller companies to develop these technologies, and then maybe they grow through acquisition. Um, yeah, or look to replicate technology in-house. But again, we have really strong patents on this, this device because we're the first ones here. And, um, just to that, another nuance around that 3D printing piece, you know, this has relatively intricate internal channels. And so you actually cannot manufacture this brace's design using traditional methods, right? Pretty interesting. Yeah, exactly. So you could not injection mold this product, for example. 3D printing allows you to, you know, we could have a mesh geometry or something crazy and 3D print it. So I think that's also part of the puzzle.

Yeah, 3D printing opens up design constraints completely to new things you can't, you can't do with turning and injection molding and machining. Yeah.

Cool. Yeah.

So I just think you guys, I, I know you're talking about the product, but I think you guys, you have great product, but it's, you've completely changed the workflow. I think you're incredible. The innovation is more in the workflow almost from scanning the patient to shipping. So I'm going to shut up and let you talk about that.

I'm so glad you brought that up. That's great. So, um, you know, this all starts with a scan. So there, I like to say that we have really two technology platforms in this company. The first are these adjustable tensioning systems that allow you to manipulate force across a joint, assist the quad, you know, unload the knee, relieve pain. But then we have our, our workflow. And so we've really, uh, leaned into vertically integrating, developing, and owning every part of the process. We've developed our own scanning app. You can go to the App Store, search Icarus Medical, and you can open it up. It's free, and there is a free pro version available that you can access. But essentially all you do is take a quick scan. It takes a matter of a couple seconds, and what that's going to do is create a point cloud dataset, right? And then you can submit that scan directly to Icarus, and we begin the process. Now, um, that's really only the tip of the iceberg in terms of what we've developed. So a lot of the work has been in developing the backend automation software to process, orient that scan data, and then design a brace that is custom around that patient. And the customization for us, it's not just fitting to the form of the patient. We actually take certain clinical information into account when we design that brace. You know, for example, if the patient has medial OA, we might provide some adjustment, right, to the Q angle of the knee. But yeah, so we, we take the scan that can come in from anywhere in the world. Starts being designed instantly through our automation. We have engineers do some of that process, quality check the brace, gets queued up to print. And you can see here, yeah, so scan, modeling, and then the braces are nested in a build unit like this and queued up in our print farm, right? This is a snapshot of what our print farm looks like currently. These are all HP Multi Jet Fusion printers, so You know, think of it as like a washing machine, right? You filled up this build unit here with nylon powder. That's it, just nylon powder. You load it into the machine, you nest the braces virtually like this, and then it prints it overnight. And so we're running this thing 24/7 practically, and, you know, expanding relatively quickly in terms of capacity. So then we do some post-processing. Assemble the braces in-house. I showed you the assembly space over there, run some final quality control, and then we ship them out. So we've got it down to be really consistent. We're turning around custom Ascenders this morning. I think I saw, you know, 4 days from order to shipment. We've done it in 24 hours for VIP patients. So, wow.

Yeah, yeah, it's like the Dell model almost, you know, the secret to Dell when they were customizing laptops 20 years ago is they would get paid before they even got invoices from their suppliers. I mean, their cash flow, they, that was their secret. It was since they were selling direct to consumer, they would get paid in advance before they even built, built the product. That's really, yeah. So tell me about, tell me about where the scans come in from, uh, individuals, orthopedic practices, partners, you know, walk us through who you guys deal with.

Yeah, yeah, all the above. So interestingly enough, a bit of history. We started the company about 6 years ago, right in the middle of COVID perfect timing. And it was, you know, basically Dave, myself, we have an advisor, Ed, who's our CTO, brilliant guy. And then, you know, one or two others, Carter, who does— now oversees our entire manufacturing department, but he was our first brace builder, right? Um, but yeah, essentially we started out as a direct-to-consumer company because it was very hard to get in front of doctors, um, with no data, new technology, um, no network. And so we stood up a website and found patients with a problem, and then we'd help them get the brace. By getting a prescription going through their insurance, right? Since then, we've become more focused on going to the clinic, right? You know, largely a B2B company. And so we have the clinics submitting scans is the most common source. Our reps use the app to submit scans, but on occasion, yeah, patients will also submit scans. It's super easy. I showed you, you know, they can download it anywhere. Pull it out, scan it.

So at the clinic, who makes the buying decision, Evan? Is it an orthopedic surgeon or PT? Who says you need a custom brace and I know where you can get it?

Yeah, typically the orthopedic surgeon. We also work with O&P clinics. So sometimes the orthopedic surgeon will just say, hey, you know, this patient needs an unmotor brace. and then they send them to Hanger, right? And those are close partners of ours. We really like to work with the OMPs. And then the OMP will say, you know what, this, the Ascender is appropriate for this patient. So, you know, we really strive to work with the entire ecosystem. PTs are also important as a source of patients, and they really understand the value of this technology, but typically they cannot prescribe the brace.

Got it, got it.

Yep. Um, and, and just so quickly on this slide, you know, uh, we've, we've expanded these platform technologies to other, uh, clinical applications where we saw gaps, right? So, um, we have a series of cathos for patients with stroke or neuromuscular disabilities or spinal cord injury, right? That, that's done quite well. We have a Dorsi Assist AFO. So again, applying the same technologies, right? This, this adjustable dorsiflexion assist, right? That's been great for patients with foot drop. We just had a CEU on that. The post-op brace is interesting. So we have a study underway. We realize again, by assisting the you're actually reducing ACL strain, right? And so our clinicians, you know, have asked the question, can this promote faster return to sport, right? Or faster return to duty for the military, right? So really interesting study there. This is called the Adonis. This is a new class of unloader for medial or lateral OA. It employs what is called a, Here. A joint distraction hinge. And in some early radiographic studies, we're seeing evidence of the brace generating joint spacing in a weight-bearing state, which is—

Yeah, yeah. So, man, you are really getting into— So, the vast majority of knee arthritis is medial. And and I've, I've seen studies. I'm a kind of a knee geek, but I've seen studies that show if you can offload, if you can offload the joint and anywhere in the body, the cartilage will actually regrow. And, and, and you're, you're probably enabling that. Um, the patient's gotta be, it's, it's gotta, they have to be active.

Mm-hmm.

But if you can offload, that's kind of what the, um, the MoxiMed device, that implant device does, but there, it's very invasive and it's a huge surgery and there's complications. But you can do the same thing as MoxiMed with a wearable. That's incredible.

And you can feel it if you're a patient. I've, I've been in a cadaver lab with you and you can literally feel and see the thing. So you're gonna be touching it the whole time.

Wow. You, you absolutely nailed the inspiration on this one. You know, we looked at knee joint distraction studies. Some of them use fixation devices. And yeah, I have seen the data that indicates that cartilage can regrow when the joint is fully unloaded, but it's, you know, invasive, right? And so we said, what if we could do that externally with no risk? And so as you can see here, as the patient extends and goes into a weight-bearing state, the hinge actually expands.

And so that's going to push, it's going to push varus or valgus a little bit.

Yeah.

Wow.

Axial force directly across the joint in synergy with the strapping system. So really great results at an early stage on that product. Like everything else, you know, we're going to, we're going to keep studying it and see how it works. And then We have a hip brace coming out now actually for Trendelenburg gait, which is another condition that's prevalent but without a lot of great solutions.

So, well, and then the unspoken part here is once if you have a patient with OA, then they end up being sedentary. They just sit on the couch all day watching Netflix and they start to atrophy and it just, it's a vicious cycle. But if you can get 'em up walking pain-free or that they, their quality of life just goes up dramatically. You know, they can pick up grandkids and they can walk, you know, long distances again. It's incredible.

Yeah. Yeah. That's well said. And I, I think that is where we see our, our mission, right? Or our, our role in this, this picture is, you know, there's an OA cycle, right? Patient, experiences symptoms of knee OA that results in pain, that results in reduced activity, that results in weight gain. Every pound of body is a multiple on the joint, right? So the pain gets worse, the activity is reduced, the quality of life suffers, and ultimately a number of comorbidities are associated with knee OA. So if we can provide an intervention that immediately relieves pain and allows patients to get more active, which is what we've seen in our studies, then that helps them escape that, that whole cycle, right? So, um, yeah, in a broader sense, that's, that's why we're here.

But yeah, I mean, well, yeah, that's the future here.

Wow.

Yeah, this is the broader— I, I feel like we haven't talked about this, Evan, but I keep feeling the last 2 years there's a trend with American patients where they just don't want surgery that cuts things off anymore. There's a, there's a trend towards joint preservation. Yeah. That's really active. And obviously everything's online now. And so do most patients find you online or do they find you through an orthopedist?

You know, both. I, I'd say Predominantly, most patients are coming by referral through an orthopedist or an O&P, but we haven't been as focused on, you know, direct-to-consumer marketing, right? We realize that, again, you know, it's 1 in 10 patients have some degree of knee OA, or 1 in 10 Americans have some degree of knee OA, right? So we simply just put these testimonials out there on social media and we get a wave of interest, right? And so we want to be able to connect those patients with a local partner, be it an O&P or an orthopedic clinic, to see, hey, is the brace a good fit for you? And help them get it.

Yeah. Yeah. And the consumer purchase is obviously a better margin for you guys than probably going through a clinic.

Is that true? It can be, you know, the volume is not there, but yeah, it can be. So And it's a— yeah, we, you know, the reason I mentioned referrals, we want to partner with the clinics, right? And, um, you know, provide them the revenue stream. We don't want to be seen as competing, uh, with, with the health systems and the OMPs and all that. So, but we think it's a win-win when, you know, we have an interested patient who would benefit from the technology, we connect them with a local partner, they get great service Um, but yeah, no, I mean, we, we, we can, uh, directly handle patients as well.

Uh, Stephen, two things I would love to talk to you about—

becoming a patient, I think, be great.

Yeah.

Um, actually, three things. Have you ever heard of the company Stoco?

Yeah, yeah.

That's the only thing that could— I've— that, that saved me. I was able to kind of prolong the surgery another two years, and that's why I said a soft good is if you could find a way to do— because I would wear that every single day as it's just a sleeve.

I hear about your experience. So, um, the Stoka provides more compression, right?

Well, they have a system of Dyneema cables that run throughout, so they've got essentially two anchor points. So it's more like dynamic bracing. When you get into a compromised position, it kicks back in with boas on the back so you can tighten the compression in. So, um, rotation stability, compression as well. But from a pain point, it helps significantly.

Nice.

So, but the, the other question I gotta have for you is the difference between, I'm just on your website here, the Adonis and the Ascender. Personal question mainly, but just kind of curious.

Yeah. Yeah. So the, the Ascender, again, this was our flagship and, and this is the one that unloads the quad. So, yeah, designed for patellofemoral or multi-compartment OA patients as a result. It also, you know, it's a double upright, so it's going to provide more stability. To the patient. A lot of patients we see, you know, just have medial OA or lateral OA, right? Yeah. And so the Adonis is a newer technology for us, and that's designed specifically for those patients. I mean, the thing I mentioned, the Ascender weighs a pound. I think this thing weighs 8 or 10 ounces. It's super lightweight, and again, it provides that directed axial force, that unloading directly across the joint. We call it a joint distraction hinge.

Yeah, I think that the size of it looks much smaller and enticing as kind of an everyday wear. Do you have representation? I'm out in Colorado. Is there a group out here that's utilizing it?

Yeah, yeah, we have a number of groups. We also work with the, uh, the Colorado Health System. Okay, I'll make sure— yeah, I'll follow up with you, Steven, and, uh, yeah.

Rep and yeah, yeah, or if I can just go to you guys, that'd be fine.

So I think I put Evan's email in the chat. OK, Stephen, yeah.

I can't see that for some reason.

I'll just send it again. It's, yeah, it's funny how the chat is. It's timed. I put it in again. Yeah. So what are your, what are your, um, where's your pain right now? Before Mark's question, is it just growing pains? Is it capital? Is it manufacturing? Is it finding new customers? Is it sales? And what is, what is it?

Yeah. Um, so just a little backstory. So you mentioned we hadn't taken venture funding and that was the truth for a while until very recently, right? We, Okay, bootstrap this company, and, um, we, we figured out how to be lean but still to grow quickly and solve problems. And, um, by doing that, we really figured things out. We figured out the sales model, we figured out the manufacturing model, we innovated, we improved the product, and, uh, you know, that worked. And then we recently brought in some, uh, venture investment. We closed a Series A Originally we were targeting 5, but ended up pulling in 7.2, and that is purely just to accelerate.

So yeah, that's weird. It's, it's a Series A is usually for the discovery phase, but you guys are using it as the growth, growth funding. Yeah, because yeah, it's, it's really interesting. It's really smart.

Yeah. And so I'd say our pain point now becomes, you know, we, I think we have a really good strategy But can we deploy this capital as planned and just grow faster? Right. And the bigger you get, obviously it gets harder to grow at these rapid rates. But we think we have a good path to doing so.

Yeah. Mark.

Mark. So yeah, I've got a lot of questions. First of all, well done. 6 years. Super. Super good story. Thank you. The, the, the concept of the joint preservation that Tiger was alluding to. So I'm on the board of a Canadian company and we're actually totally rebranding ourselves and doing an RTO to go from a cartilage repair international company to a total joint preservation company. And we're changing our name and everything. Interesting. So yeah, yeah. And so we're looking at acquisitions of companies that do preserve the, the knee joint.

Uh-huh.

And you're certainly right in that line. And I'm not suggesting anything, I'm just saying I love what you're doing.

Yeah.

It's fantastic. So what, what is, I guess, you know, this is it. I looked up the L codes real quick for the knee bracing. I guess your insurance is probably pretty good for you. And, um, is there, is there a certain amount? What's the ASP and what's, what's the patient pay? Because this is kind of an expensive brace, right, to make?

Yeah, it's a good question. So we've, we've been able to drive our cost of goods down. Um, well, I'll answer your first question. So for the Ascender, uh, it's an L1846 for the custom fab, um, L1852 or 45 the custom fit code for our off-the-shelf. Early stage, we realized even though there's unique functionality, we want our products to fit existing codes and billing pathways, right? Strong reimbursement, right? So this single upright, L1844, this reimburses, I think, like $2,400 in California for that code, for the custom fab. In terms of the patient cost, right? So if, if there's insurance coverage, um, we've seen the patient typically owes $200 or less out of pocket on average. Um, nothing.

Yeah.

Wow. So that's, that's great, right? And, and it's covered by, uh, commercial insurance. Now Medicare tends to pay the most, um, as does TRICARE. Um, Anthem pays pretty well. Uh, some of the other payers like United, um, not as much, but we still have, have good margins in terms of our costs. Yeah, it, This gets back to an earlier comment, right? Maybe a reason that other companies haven't gotten into the space is because the perceived high costs of additive manufacturing, right? But the key for us is all of the automation, right? If you can completely automate the design of the process, then our cost of goods on a custom braze that bills, you know, $1,600, costs us the same to manufacture as an off-the-shelf, which might bill $800, right? So, um, it's the, the software is the key for us. Um, and then another little note there, so there is additional functionality, right? And now that is backed by these published outcomes. And so we are looking at the opportunity for additional codes around, uh, you know, say the hinge or some aspects. So we have a consulting group that's helping out with that. Is that something you're familiar with, Mark, or any, any advice or thoughts on that?

Um, not off the top of my head. I mean, Tiger is very insightful. Uh, he noticed— he talked about your workflow and the automation almost instinctively, and I agree with that. Are you, are you seeing anything, um, internationally that's going to give you a run for your money from some of the more legacy companies that are pretty tuned into patellofemoral bracing, like say Bauerfeind out of Germany. Mm-hmm. Uh, they're a fantastic brace, uh, traditionally with a unique historical legacy. Uh, I don't see anything like this coming outta Europe yet, but I'm sure that you're gonna, you're gonna get some competition, which is good, you know? Yeah. You know, business breeds business. He'll just get bigger.

Yeah, yeah. So, um, yeah, we, we expect it. Again, we have very robust IP. We have 23 patents now and counting, and, um, that includes in Europe and in certain Asian countries and in Australia. So, um, so we've been, you know, trying to get ahead of the curve in the international markets. But yeah, we're keeping our eyes out to see if anyone else tries to come up with a similar solution. So not yet.

Not yet. Not yet. Cool. All right. Well, I appreciate you being here today. I'm, it's been great. You know, I just, Tiger, I dunno if you saw, I just joined the editorial board for Ortho This Week.

I did not know that.

Yeah. Yeah. And so my focus is trauma and technology and the technology play here from Evan is obvious. The way in the workflow, the automation, the software, that's, you know, that's, that's, that's where, that's where your genius is. I'd love to maybe talk to you about that one day.

Yeah, I'd love to connect on it, Mark. I mean, it's, it's all interesting stuff.

So it's funny, I actually just emailed Steven earlier today.

I just emailed you back.

I just saw that because, uh, you're— yeah, hey, this guy You should talk to him sometime about what he's done. And, you know, like Tiger, I'm a huge fan of the lean, mean model. And boy, I tell you what, AI is letting you get so lean, so mean, so fast. You know, and was it Malcolm Gladwell's books? The only measurable quality or of predictive analysis for athletic prowess is speed. If you're looking at 12-year-olds, nothing else. If they're fast, they got a shot. And you know, that's, and the same thing for war. Yeah. The best book written on war was by a Polish cavalry officer named Clausewitz. If it's not on your shelf in your library, it should be. Yeah. Called On War. And he worked, he was on Napoleon's staff and the reason they won so many battles is they learned how to get, how to move large bodies of men, equipment, and supplies long distance fast. Yeah. And his concept, the thing that he overcame was something he called friction. And we Irish call friction Murphy's Law. You know, everything that can go wrong will go wrong, and you gotta think of it all ahead of time. It's crazy. Yeah.

Yeah, that's interesting. I'll give that a read.

What was the book name? Uh, On War by Clausewitz. C-L-A-U-S-W-I-T-Z. I mean, it says important to, you know, as the, uh, the Chinese book on war.

Yeah.

So anyway, yeah, Nimble, you got— you, you're check— you guys check every box. I mean, you're like custom solutions, speed, nimble. You're bringing products that don't exist, never existed before. I think you have your own category. I'm always interested in never use anybody else's old category like bracing. You create your own category. And I like, I love the unloading name. I wouldn't call you yourselves a bracing company. I would just call you a joint preservation unloading company or something. You know, you can do way better than that, but yeah. So how can you, can you give us a feel for what your sales are and if you're profitable yet? I mean, you don't have to be profitable yet, but no, absolutely.

Yes, we actually broke even last year. Excellent. Yeah. And again, I think it was just out of necessity because we stayed lean. We didn't raise a ton of capital, relatively speaking, and we just had to reinvest our cash flows from sales. And because of that, sales have to keep going up, right? To pay for the equipment that prints the braces and the people, you know how it goes. But that taught us how to be lean and efficient. And now I think with this additional tranche of capital, we can scale faster and responsibly. In terms of revenues, yeah, we were named on the Inc. 5000 list last year, number 302. Last year we did about just under $9 million. So that was our, really our 5th year on the market. We really launched the product at the start of '21. And, um, let's wait and see at year-end how, how much we've grown even faster. I'll just say that.

So, Evan, what are your biggest— are you trying to find more doctors, uh, distribution? Kind of what's, what's the, the goal right now?

Yeah, um, really exposure, you know. I think the, the motivation of the Series A and where a lot of the funds are going is into sales and marketing. We've had very little marketing historically. We've recently brought in some additional senior experience in sales and marketing, and we're just trying to build out the team. And so we've gone from really a horizontal structure of, you know, 10, 12 sales reps all over the country to now building out a much larger team but under regional directors and then a CCO. And, um, A lot's happening very quickly, but it's allowing us to scale. So, but finding great salespeople, getting connected to doctors who are innovation forward and, you know, outcomes motivated for their patients. Yeah, exposure. I mean, that's the number one thing. Yeah.

Yeah. If you're shipping 50 to 75 a day, let's say, 60 a day last year, that's about $15,000 divided into 9 million. That's about $600 each.

So yeah, yeah, our, our ASP, and again, this is across the whole product mix, last year was about, uh, $758 or something. Okay. But yeah, yeah.

So that, yeah, so it's probably a little bit less than 60.

Yeah.

Little higher ASP, but cool. Yeah. Yeah.

That's great.

Yeah. Yeah. I'm gonna give you, I'm gonna write about you guys next Monday as a hot startup to watch. So, and I'll, and I'll put in there, you know, you're looking for reps or, you know, I can put anything I want in the bottom of the article.

What about foot and ankle?

What about foot and ankle?

What are you doing there?

Anything? Yeah.

Yeah.

Great question. So this is our current product on the market. We call it the Hermes. And it's for foot drop, but we're actually working on something that might be even more interesting called the Achilles. Maybe not the best name, maybe the perfect name, I don't know. Achilles heel, right? But it's what it sounds like, it's an Achilles unloader. So this is dorsiflexion assistance, that one's the opposite, it's actually provides plantar assistance, and what that will do is it'll effectively unload the Achilles, same cases of Achilles tendonitis or even, you know, post-op repair, right? And so we're working with a doctor out of Northwestern who's very keen on that technology and helping to develop it with us. So, yeah.

I've got a super good foot and ankle surgeon on the other side of my door who's in there watching the World Cup. You got any questions? I'll drag him in for a minute.

He might be upset.

There is, CSU up here in Fort Collins is working on a specific protocol for Achilles proper tensioning and how to identify that. They're one of the few programs I know that are looking into doing that right now. I think there could be an awesome opportunity for you guys on that 'cause they're looking for more companies that need, they're looking for that data.

Yeah.

Another really good market, another really good market is the custom AFO. That's the product that bought a lot of Harleys for those O&P shops. Hmm.

Yeah. Yeah.

What is that again, Mark? AFO. What is that again?

It's an ankle foot orthotic. It's for a variety of ankle problems. And they're all very, they custom, they require a plat, you know, cast, so forth. There's an Irish company named TruLife that really blew it out. And they're still around and they're strong. You see 'em on LinkedIn and everything. I think the VP of sales, the guy named Brian Schloess.

Yeah.

I remember his name 'cause Schloess means castle and—

And he owns a castle?

Yeah, and I used to live in Germany, so it's pretty cool.

That's cool. Yeah, so these are actually custom fab powered by the same technology as the— You take the scan, you put some notes in and we make it fit.

So, so the Achilles offloader, so when you do toe off when you're walking, it gives you like an extra boost, like 20, 30 pounds or something like that?

Yeah, yeah, yeah, that's about right. Yeah, in terms of the, the amount of force.

It's amazing how just a tiny bit of force help just takes off all the force in a joint.

It's Incredible.

And it gets, makes the difference between sitting on the couch all day and being active.

It's, yeah. Stephen, I'll, I'll have to reach out about that collaborator for the, the study or people for that, for that study.

Yeah. Yeah.

I'll have to put up, we just finished an animal study up there. They're top notch. We actually get our results back in 5 days. So very excited. But, Yeah, they're, they're an amazing group. They've done so many biologic companies as well. Now they're really focusing on— I forget what animals they were, but essentially identifying what the proper tensions are that are needed for Achilles to properly heal. So I think, you know, what you guys, you just mentioned, I think that'd be phenomenal.

And like I said, they're a great, great group.

They're not cheap, which kind of sucks, but they're, they're phenomenal. So I'll make that intro for you.

That's great. I really appreciate that.

Yep.

Achilles is a, is a slow recovery, man. If you, if you sever or tear your Achilles, that is one of the— Yeah. I don't know if you guys saw the Aaron Rodgers Netflix thing, but he, I mean, he was, he got back in record time, but he had a Regenitin on. Oh, really?

So they had a Regenitin wrapped around, which greatly enhanced the, the, the, the, essentially reducing the stresses significantly. I was old rotation rep and Regenitin rep. So, you know, it really helped get back much faster. But yeah, he put a Regenitin on and Arthrex won't, let people really know that.

So, wow, interesting. Good information. Yep. Hey, hey, Mark, you want to grab your foot, your foot and ankle surgeon and bring him?

Do—

we'll do like a 5-minute sure thing if you're interested in this.

Evan, this is— tell them we're replacing the walking boot.

Okay. All right.

People would love that.

Well, that's what we're trying to do.

So how do you do your surgeon targeting now? I'm just kind of curious.

Yeah, um, we have a number of methods. So, um, we have access to a database. It's a software called Alpha Sophia, um, a number of other sources. You know, we gather prospects through the years. We do a lot of conferences.

Uh, this is Dr. Michael Bednarz.

Hey, how are you? Great to meet you. From the World Cup, if that's the case.

Sorry.

Yeah, nobody's— hopefully nobody scores in the next 5 minutes.

Mexico almost scored 3 times. They hit the post twice just now.

Wow.

Evan is the co-founder of Icarus.

Icarus.

Okay. You ever heard of them?

No.

Yeah.

So the sky.

Yeah.

Yeah.

Quick, quick summary. So a company started out developing the first patellofemoral unloader. Dave, our founder, actually had a pretty severe case of patellofemoral arthritis in his 30s and set out to make, yeah, the first conservative solution for that. And so, the way it works is there's a tensioning dial that we've developed and there's an elastomeric hinge. So, you crank that up and it assists the quad. Oh, cool. To about 40 pounds of offloading and we've seen really substantial cous pain and function improvements in a study.

Yeah.

But then that leads us to, you know, we've applied that and then we do everything with a digital scan-to-print process. So it's all custom 3D printed. Awesome. And so we've applied that to an ankle device. So this is a dorsiflex assist AFO for foot drop.

Mm-hmm.

We're now developing the opposite, a plantar assist device for Achilles tendon repair. Very cool. That would be—

they do a ton of Achilles, a ton.

It's all additive manufacturing. Yeah. Uh, you guys out of North Carolina?

Uh, Virginia.

Virginia. Yeah, yeah, yeah, yeah.

Very cool.

And they did about $9 million last year. They just raised $7 million in additional funding to, to explode their growth. So I said, hey, I just happen to have a foot, very busy foot.

And so great time to ask about the drop foot one is interesting because I, I do see a good number of patients that have diabetic polyneuropathy. And if you've had that for a long time, that affects the, the, the motor sensory nerves in the leg, not just the sensory nerves, but also the motor nerves in the leg. So I'll get patients that don't have foot drop per se, but they have diabetic neuropathy and they drag their toes and they'll trip. And I, and I see that all the time. And I, and I look for these things online to try to hook up to their shoe. I'm sure you've seen them where you twist it and it pulls pulls the shoe up. Yeah. Ultimately, they don't work. So that's something—

that's a big problem.

That's a huge problem.

Yeah.

That means there's a big—

yeah, you want— you don't want to just look at foot drop. You want to look at any form of, of motor sensory neuropathy, not just sensory neuropathy where they can't feel hot or cold on their foot. There's a motor component of it where they don't know where their foot is in space, and they end up either twisting their ankle or tripping over the, the toe of their foot because it drags.

So they lose their proprioception.

They lose their proprioception.

Their foot doesn't know where it is.

There's no idea where it is. Wow. But that's something you guys definitely want to look at for that.

That happens to my mouth a lot.

Yeah, me too.

And what about, and what about recovery from ACL repair? What, what does a patient need for that?

Well, I don't do ACLs, but I can tell you about it.

I'm sorry, Achilles, Achilles.

Sorry. Yeah, um, for the, for the Achilles, the main thing with the Achilles You want to stress the collagen so it heals correctly and it doesn't lay down parallel. You want that cross-hatching, and that's only by stress. So if you got something that forces— for like right now, when I do an Achilles, I, I'll put them in a Vaco boot, and everyone hates it because that Vaco Achilles boot weighs 75,000 pounds, and it's hard for them to lug it around. When I do my Achilles, I do an Arthrex percutaneous, so my incision is literally that big. And I don't need to put them in that giant boot, but I have to protect their foot. So something like that that goes dorsally that they could wear would be a lot easier. Yeah, if, uh, and then, and then also patients that don't necessarily have an Achilles tendon rupture, but someone that has Achilles tendonitis, that's something that instead of putting them in a big giant CAM boot that's bulky, you can throw them in something like that.

While it calms down.

So, uh, his rep is in the next room. I'll put him in touch with you.

Yeah, hey, we'll send you a couple samples. Would love to, uh, get your feedback.

All right. Yeah, I definitely would like to look at the, the, the dorsiflex and the plantarflex for sure.

Yeah, absolutely. Are there any other major problems that you don't have a good solution for?

Um, no, but the CAM boot one is huge because every day I give somebody one, they yell at me. 'Cause they hate it.

Doctors don't like to be yelled at. Yeah.

All right, we'll let you know when we solve that one.

Cool.

Well, thank you. Yeah, no problem. Appreciate it. Glad I was over here.

Thanks.

Yeah.

Have a good one.

Great job.

Thanks.

Make sure you guys focus on the polyneuropathy aspect for the drop foot, not just the spinal cord.

Thanks.

Wow, I love, we got a new problem to solve. I love it.

I gotta run back to the engineers.

Yeah.

Thank you.

Yeah, yeah. Hey, this has been a great hour. This is, we're wishing you the best and we'll give you a little exposure, Evan. You got follow-up calls with, I think, Steven and Mark, so.

Yeah. I'm helping run a custom search right now. Every physician or physical therapist that have talked about your platform in the past 12 months on LinkedIn. So I'll send you over a list. Wow.

I think it's pretty cool.

Wow. It's a new tool we're rolling out in the next 30 days.

Yeah, hopefully they're safe.

Thanks guys, this has been— take care, this has been great.

All right, thanks guys.

Yeah, thank you.

Bye-bye. Yeah, we love to do a quick little tour. So this is part of the building here, you know, you come in through this courtyard and, uh, How's it going, Tharp?

Hello.

So we've got some art here from a local artist. Tharp. Wow.

How many employees are roughly?

We're over 50 now. We're approaching 70. We're going through a growth phase here.

Wow.

But yeah, so the engineering bullpen's right over here.

Excellent.

That's his office there.

I love the open concept.

Yeah.

Hey, hey Dave, how's it going?

Good, good. This could be fun. Giving you guys an awesome talk today.

Yeah, yeah, this will be, this will be a lot of fun. We're looking forward to it.

Here, give them a preview, Evan. This is a product development here happening.

I love it.

New product categories being created. Yeah, so it's where the magic happens.

Yeah, I love it.

We do all the assembly work. So I'll talk about this in the presentation, but we do 100% of the manufacturing right here in Virginia. And that starts with a digital scan from our app all the way through the 3D printing, the assembly, and the shipping of the custom products. So that's just a little snapshot of part of our office here. So, yeah.