BoneChat #117 - The new OSSIO KneeBar Treatment for Subchondral Insufficiency FXs

Okay, this is Bone Chat discussion number 117. We're thrilled to have Osseo back. I interviewed Orem, who's the founder of Osseo, 5 years ago now when—

I can't believe it's been 5 years.

Wow.

Yeah.

And they only had, back then, they only had a hammer toe kind of IM pin, one product. And I tried to tell everybody that Osseo has cracked the code on a super strong biomaterial and people didn't believe me. And it's come true. Now they have tons of products, incredible sales trajectory. So today we're gonna hear from Oram and Sam, who is the head of marketing for sports medicine, about the knee bar procedure. And I'm going to hand the mic over to Oram and Sam. Welcome aboard.

Great. Yeah, thanks. Thanks so much, Tiger. And I have to say, it's one of the great things about Osseo in those 5 years since we connected was really the building of a great team. So first of all, really thank you for all that you've contributed to that since that obviously is a big part of the company's success.

Yeah, people are everything.

So, Sam, yeah, I'm gonna— I'll pull up the deck right now and we're just gonna do a quick, you know, 10-minute overview of the topic today, which is the knee bar procedure, a biointegrative solution for patients with subchondral insufficiency fractures of the knee. So, Arun, if you want to kick it off. Are you—

Sure. Yeah, we'll do a brief review shortly of the technology that has facilitated this. But what's so exciting about what we're going to talk about today for us is that most of what we do at Osseo is we take existing procedures, and it could be anything, a bunion, an ACL repair, rotator cuff, and we just slide our technology into procedures that have existed and hopefully can improve the clinical outcomes just through the material technology. But with knee bar, it's actually an entirely new procedure, but in some ways evolutionary. And so that's what we're gonna take about, talk about today. And this project really came to being in collaboration with Dr. Brian Cole out of Rush in Chicago. And so I just wanted to give credit where credit's due. We, together with him, identified that a, a problem that has plagued really the sports surgeons in particularly as they seek to preserve joints and knee joints in particular is, is what we call subchondral insufficiency. It's a type of a stress fracture that appears typically is diagnosed usually in MRI by the appearance of edema or the accumulation of fluids in that subchondral space and can, can cause pain and obviously discomfort to the patient. So if you want to go ahead, Sam, to the next one. And this is a problem that is frequently overlooked. It's not— it does not appear in X-rays and really, you need to have the patient go to MRI, which is not always— will not always occur for every patient. And for years, we've really thought about cartilage as being the driver of pain in joints and the knee and a little bit overlooked the bone. And so now there's an increased awareness in recent years. And actually, the literature on subchondral insufficiency has really started to come on since 2017, 2018, where there's a, a renewed awareness of the bone damage actually driving a lot of those clinical symptoms. And so when we start to discuss this with Dr. Cole, he recalled a traditional procedure which is— has been used historically for acute tibial plateau fractures, which is known as raftering, where you would come under the joint surface with a number of screws in a raft, raft formation, you know, one after another like you build a raft out of logs, in order to prevent that joint surface from collapsing. And this was historically really done only in the case of really a joint at high risk for failure. Because obviously getting in there under the joint with metal screws is increasing the risk of that local area to the patient to some degree or another. But what— when Dr. Cole became aware and learned about the Osseo technology, he understood that now we have a technology we call biointegrative technology where you can put the nails under the joint surface and actually have them turn into bone and actually help promote a biologic healing response in that bone. So it's building off the historical mechanical procedure but now adding this biological aspect. And that's really where the kind of leveraging the technology into the procedure gives you this added bonus that enables you to, to do this procedure. And, and for those who have not heard the overall Osseo story, everything that we do at Osseo is based around the OsseoFiber technology, which is a fiber structure based on mineral fibers that are made out of silica-based mineral composition, very similar to the bioglasses that are used in certain bone grafting type products. And by building that into a matrix, we're able to get great strength out of the platform, as well as great biologics. When we say biologics, we mean an interchange with the local bone, which is driven by the mineral release into the local environment and an interchange that will happen really very early on after the implantation. Just to give you a sense of how early, really even within a couple of weeks you start to see that, that ingrowth into the implants, which is pretty unusual, you know, for any fixation implant. This is something you might see more in a bone graft type material, but we've actually been able to bring that into the fixation implant. Also, obviously, the surface is very important. This is what helps signal to the surrounding bone that this is a friendly implant. Then these are actually a microscopic image where you can actually see the fibers at the surface. So when the bone sees that, it's, it's aware that it needs to grow onto this material and grow into this material rather than just encapsulate it. There's some pretty, uh, some pretty pictures here, uh, what this looks like in, in some of the animal studies, uh, having— after it's replaced, that would— that's where screws were, um, to fixate an osteotomy, um, and after 2 years it's just turned into bone. And in terms of a strength perspective, uh, this is the first time you have a non-permanent implant that actually is both stronger and with a higher elastic modulus than healthy cortical bone. And that allows us to do the fixation. Just coming back to that mineral release point, because it's so important here where we're talking about rehabilitating that local bone. And so some of the minerals we're all familiar with, the silicons, the calciums, the magnesium, these are what we're releasing into that local environment in those first few weeks following implantation. And so, so, so basically after this kind of concept came about, we jumped into an initial study with this with Dr. Cole, and that's— that was really, you know, to his credit, understanding the logic of the procedure and the benefits of material and doing those first 9 or 10 patients to see that this was actually going to work. And those patients did very well, which I think we have in the next slide. And now we're actually rolling that into a— there you go. Perfect. Thanks, Em. And so those patients saw a nice 20, 30-point jump in some of the key knee function indicators, which is really nice for a minimally invasive procedure. But even more importantly, in the patients that, that didn't see as big improvements, we actually learned how to do the procedure. And there we had done it with just one nail, and we saw the patients who didn't improve as much actually had much bigger volumes of edema, like you see in, in the patients on the right side. And so as we rolled into the next study, we now have learned that for patients with bigger volume, you need to put a nail about every, every centimeter to help support those areas as well. One, you know, one, one small nail is not enough to support the entire joint if you're going to have a lot of damage in there.

Yeah, and I just wanted to jump in here and just talk a little bit about what's happening in the real-world data too, because in addition to the clinical study that we're doing and we're kind of wrapping up here, we we are seeing just encouraging improvements in pain and function and strong outcomes for patients just being treated outside of the study. So this slide says which patients should be considered. And of course patient selection will ultimately come down to surgeon discretion and what your individual patient journey looks like when you come across a knee wear patient, including if they have concomitant pathologies or anything going on additionally. But generally speaking, it can be an important conversation to have if a patient has localized knee pain and subchondral insufficiency for extra-visual and MRI. To date, because of, of that, we've seen over 900 patients being treated with the knee bar procedure, over 1,500 implants placed. We're just seeing meaningful traction, right? So this is driven not only by the outcomes that we're seeing in this multi-center study, but also what surgeons are seeing on their own when they're doing this in the real-world patient population. So that combination has been really nice for the clinical data, plus what surgeons are seeing in their own patients to drive the growing interest in the procedure just across the board in orthopedics. And then, you know, the goal here with KneeBAR is just driving meaningful patient impact. So that means improvements that patients can actually feel, so reduction in pain and improvement in function. We're also seeing that it's important on imaging as well. In many cases, these follow-up MRIs, what you'll see here, so you have your pre-op MRI and your 6-month post-op, that insufficiency fracture is resolving. And then this is just a really nice summary slide. So just stepping back and circling it back to this knee bar procedure in general. Here's a nice little screenshot of what this looks like for procedural steps. So it's designed to be simple, effective way to treat those patients who have knee pain associated with SIFC. So it's, it's very straightforward. It's minimally invasive. It's relatively quick. It's designed to fit naturally into a surgeon's workflow. I think What's important here is that it's, it offers surgeons a true surgical option for patients who find themselves in that floating period of care that Arun talked about. So they've gone through exhaustive conservative management, they don't really have a clear procedural path forward, and this is really addressing that, right? Providing regional mechanical stability, supporting biologic healing of the subchondral bone. And it's just, it's designed to address that underlying pathology that's driving the patient's pain. So I think the combination of those two things, having the mechanical support and that biologic integration, it's enabled by the OsseoFiber technology itself. So yeah, with that overview, I'd love to finish up here and open it up to discussion and hear your thoughts.

Maybe I'll just add that is— sorry, go ahead.

No, go ahead, Oram.

Yeah, I just want to say, so that actually the 50-patient cohort that we finished at that multicenter study, we're just about— We just finished a 6-month follow-up on that. So we'll have an initial readout on the data really in the next month or two. And then we're going to follow those patients out all the way through 2 years. So just a really exciting timing to be talking about this since it's— this is kind of the ground floor. And it's just been a lot of fun to see the great results that we've been able to see with this procedure.

Awesome. I mean, Osseo is a platform. It's incredible and it's the, the, the applications are endless. I mean, it's just, uh, and this is a great place for a non-metal, you know, resorbable. Any questions? Uh, kick it off, anybody?

Yeah.

Oh, Kyle, go ahead.

So looks like you guys have focused on foot and ankle largely to date, maybe a little bit of sports medicine platform technologies like this very commonly. What happens when you start branching into something else? The infrastructure on Salesforce and the call pattern of a new, a new doctor. How has that process been with getting into the knee for you guys?

Yeah.

Take that one.

Yeah, I was going to say you could jump in there.

Yeah. Yeah, I mean, I think it's been a challenge, but something that we're certainly addressing. We've put a lot of focus into sports specifically this year, especially with the kneebar procedure and that growing interest. Hybrid strategy is probably best for us, making sure that we have people who are directly focused on selling kneebar and then also, you know, using some of our— the people who have helped us grow sports out in a 1099 model as well.

And you have, I mean, you're selling suture anchors too, so you're in sports.

You just— Yeah, we have a big presence in sports and I think that, you know, we've been able to grow the sports business significantly over the last 2 years. So, you know, leaning on our existing relationships to drive interest in the knee bar procedure because selling suture anchors, of course, we have a lot of different procedural penetration in the sense of, of course, rotator cuff anchors. But if we're talking knee specifically, you know, ACL repair has been a really big procedure for us. So we have a lot of, knee surgeons who are already using our products, especially for ACL repair. We're selling a lot of those anchors. So it's really an easy way to introduce them to something that could also be beneficial to their patients. So we use those, leverage those existing relationships. And then in areas where we might not have as much coverage based on, like you're saying, the, the call pattern of, you know, specific reps, I think meeting those with direct sales hires and a hybrid model of coverage is, is our strategy.

Well, what you didn't say is we're going to make our foot and ankle reps go start approaching knee and sports docs, which I was guessing you weren't going to say, but that would be a challenge. That'd be a real challenge. But it also is a challenge because you're kind of doubling the number of people that you have in your pipeline and your infrastructure and more contracts. And now you're starting to get into new hospital contracts because it's different. And yeah, but it sounds like you're trying to— it sounds like you're in the process of managing it.

Yeah, thinking about it realistically too, right? Some— there are some foot and ankle reps that are really talented, have relationships across the board, and, and we take those relationships seriously, but we're not expecting every single foot and ankle rep to start selling sports, right? So looking at it realistically.

Good, good question. Dr. Milone.

Cool. So the subchondral lesions, you know, this sounds like a lot better technique than injecting methyl methacrylate or non-biologic things. And we've all seen that because, you know, the problem is real, the pain is real, and not everybody's ready to have a total knee and off with their head. Some of them are a little younger than that. Here in Atlanta, we have a, a practice called Atlanta Orthopedic Institute, Dr. Raj Pandya, who has a procedure called panplasty specifically addressing this. And he uses a lot of biologics and so forth. So when your guys are, are, uh, are doing your procedure? And this is mostly at Rush?

No, no, at this point it's— I mean, at this point, the, this, the second stage of the study is— yeah, it's where the second stage is at Vandy and Stanford and— okay, at Dr. Aukman over in Wyoming. It's spread out now. Yeah, we've— it's, it's, it's gone nationwide at this point.

Yeah.

They, are they using any biologics in concurrence? With this procedure?

Yeah, it's a fantastic question. Um, so, so in the study, in the initial study, we did not allow it since we wanted to try to control for that. But I will tell you, it was hard for them not to. These guys love to, uh, to use biologics, PRPs, uh, the B-Max. Um, and so, and so, yeah, in the real world, we've definitely seen, uh, quite a bit of combos, which again, you know, we want the doctor to treat the patient as they best see fit. And so if that means injecting PRP before you do the knee bar, that's, you know, that's fine. We've seen a little bit of the cement use with the knee bar. You could inject the cement and then put knee bar through it, but more so perhaps in more, more challenging geometries. Actually, even in the femoral head, I've seen seen of the hip, for example. But in the knee, you don't necessarily need any mechanical support beyond the nails.

Well, you practically anticipated my next two questions. One was, has anybody used it for avascular necrosis of the femoral head for that coring procedure? And how are you using it on ACL for interference screw or what?

Yeah, so the AVN in the hip is really new to us. We've done just a handful of those cases with a couple of surgeons, and those patients are doing very well. So it's a— but that is absolutely the next frontier. So I don't want to speak too much to it because we don't have enough data to really talk through it right now. But yeah, that's kind of been the next place people are taking this. In ACL, we are actually going to launch Sam's baby, ACL interference screw, later on this year.

Okay, okay. Yeah, but with the strength that you quoted, it's kind of a no-brainer, and that's a great— that sounds like a really good application. So, yeah. I'd like to read more about that.

Yeah, we're excited about that. We see the tunnel— filling those tunnels after the ACL, we see as being an area that we could really show some benefit in because of the bio-integration. Sometimes if there's— with some of the types of fixation you might use, you have to come back afterwards and fill the tunnel separately. But we feel like this will solve two problems at the same time. So we're excited about it.

Pretty cool. Thanks.

Thank you.

Yeah, let me say something about ACL. When I was at that meniscus startup, uh, Active Implants, I learned, you know, I learned that every single ACL tear has a bone edema in the tibia because as soon as the, as soon as the, as soon as the ACL snaps, boom, your tibia gets slammed And it doesn't show up on x-ray exactly. You have to do an MRI. There's blood, there's like a blood bruise underneath the subchondral plate and that's the pain. The pain comes from that, not the ACL. And so if you fix the ACL with a graft or whatever, you still have the bone edema pain and the patients aren't happy. So yeah, it's It is an overlooked problem for sure. Interesting. Yeah, I think the secret sauce— when I talked to Orem 5 years ago, the secret sauce was 2 things: incredible strength dialed in with, with the bioglass in any direction you want— torsion, bending, anything you want. And the other thing is it, it melts from the inside out, or it resorbs from the inside out. Most Resorbables are like a chocolate candy bar and it melts from the outside in. I think those were the two things that nobody's ever done before.

Yeah, we're very proud of the platform and, but, you know, as you said, I think the field in general is learning more and more how all these pathologies are connected, right? It's like we like to look at things one at a time, but if you look at the ACL and the meniscus and It's all just about how the body manages the stresses and the forces coming through it. So we need a kind of a series of tools, and I think that will include ways to repair the meniscus, ways to repair the ACLs, and of course, ways to actually repair the bones. So we're excited about this. You know, one of the big areas— we were talking about some of the other technologies that people might use to try to address subchondral bone. We've actually found that In terms of how we think about the market, it's actually more about surgeons being aware of how much they can help their patients by treating the subchondral bone. That is really, I would say, the conversation we have most frequently rather than some other products. Like if you're fixing a bunion, you know, it's like, oh, why, why should you use us instead of the competitor? But I, I find myself much more frequently just talking overall about subchondral bone health. So I don't know, Sam, if you feel the same way or if you Completely agree with that.

Yep. Yeah, it's an overlooked, it's an overlooked pain point for sure. And it's hard to diagnose. It doesn't show up on plain films sometimes.

Yeah, I mean, it's an exciting place to be though at the beginning of this because it seems like an evolving conversation, whereas people are actually looking for this more. Patients are thinking about it more. I mean, you see all in a lot of the society meetings, the big trends toward talking about subchondral bone in general and how that is a source of a pain generator. So, you know, the surgeons who are using this frequently, they're looking for it in every case. When you have patients with knee pain, right, they're looking for this with— and, you know, as long as it's ongoing knee pain, not necessarily the first time they show up with knee pain, they're ordering an MRI. But just having the, you know, the interest to order an MRI on your patients in general rather than just saying, oh, let's just wait it out and see if it gets better, and then waiting months and months and months and sometimes years and years and years. You see surgeons who are actually ordering MRIs a little bit earlier saying— and then and then seeing these large areas of SCIF, or subchondral insufficiency fracture.

Is there any way— I don't know the answer to this— is there any way you can do ultrasound instead of MRI to do it in the office? Can you see the bone edema within it?

So, that's actually the perfect question because this is exactly what we're trying to figure out now is how we can help the surgeons diagnose this more readily. The first thing we were looking at was really X-ray. There's a lot going on in the AI radiology world, as I'm sure you all follow, you know, recently with the acquisition of Gleamer and, you know, several other— some other M&A activity in that field. And it seems that the technologies are really coming along to the point where you can diagnose osteoporotic bone. And in some ways, there are similarities between subchondral insufficiency and osteoporotic bone in that the trabecular structure is impaired. And so, you know, everybody gets an X-ray still today, right? You go even to your GP and they're going to send you for an X-ray. So if we can pick this up on X-rays using AI, that would be, you know, that would be a really big step forward. So that's kind of our initial target. But actually in other markets like here in Israel, ultrasound is very readily available. And, and I think that is also definitely a way that this can be done. Obviously, ultrasound can identify liquid, fluid accumulation. It's just, it's a little bit less common for the orthopods in the US to kind of jump into ultrasound. So it might be hard to drive that as a new mode of diagnosis. But yeah, technologically, it's it absolutely can be accomplished.

Interesting. So it's really an education. The knee bar is really more of an education. You're creating a market. I mean, like you said, the raftering has been around a long time. It's just waiting for the right material. Nobody wants to put metal bars across their tibial plateau. So yeah, fascinating.

Yeah, I mean, I think it's good news for the patients ultimately. Osteoarthritis and just generally degeneration of the joints something that, you know, everybody's going to deal with at some point in their life. And the more we can do to get out ahead of that degeneration and try to slow up those, slow up those processes, both mechanically and biochemically, you know, that's, that's where we need to be to, to settle this down. And as Dr. Malone said as well, obviously biologics also play, play a part here. We're not a biologics company, but that, but that doesn't mean that we don't see the benefit of potentially using the biologics.

Mark, where are you? Where are you internationally? And by the way, when Tiger calls me Dr. Maloney, he's just referring to my longevity in the industry. So where are you internationally?

So our primary market is the US, certainly. I'm, I'm based in Israel, and so we do have a small commercial presence here, but mostly because it got embarrassing already where friends were like, well, I really want to have my surgery with OsteoFiber. I was like, well, you have to go to Chicago. So we, we do, we do, we do a little bit of work here. And actually this year we're, we're properly going international for the first time into Taiwan and Mexico.

Okay.

So we're just starting that process.

What are the regular— do you have to file regulatory for a new use of the same material like knee bar, or is it just, it's general use for bone fixation?

Yeah, that's a great question. So, so for stress, stress fractures or insufficiency fractures and acute fractures or chronic fractures are not, not differentiated by FDA. When you fixate a fracture, you know, you're fixating any and all fractures. That said, we do envision ultimately potentially having a system or, you know, instrumentation system specifically around this indication that we would, we would obviously seek specific clearance for. We don't have that yet. This is actually, it's actually a product that is used for a number of different fracture fixations that we've purposed for this clinical indication and started to build a whole body of data around. So it's actually a kind of an unusual medtech story in that it's really an organic development to a new clinical indication.

Interesting. When you did the study with the knee bar, was there a control or did you just—

one leg? So, yeah, that's a great question. So when we were looking at this, we keep thinking, talking and discussing what is the ultimate knee bar study. And what the situation today is that the standard of care is actually not treatment, which meaning suggesting to the patient that they, you know, don't, you know, just let you lay off it basically. There's the, the other injections have never really taken off as, as, as a standard of care. It's kind of been more on and off over the years. And so we find that what we most need to show and demonstrate is that you should treat these patients. That's kind of the— so the, the control group in some ways would just be decompressing perhaps the edema site and then asking the patient to not be weight-bearing for period of whatever your protocol is, but, you know, several weeks to at least, and versus treating it and letting the patient weight-bear immediately and then seeing, you know, how they heal better and do better after. So, so some of the studies you might be familiar with in terms like cartilage defects and things like that, so you think about that similarly, it's, it's kind of running this like treatment versus standard of care. That would be the— so we, we'd call the control group here really standard of care, um, and that's how we're thinking to structure. But we're doing a few more, uh, pilot studies around specific areas such as knee bar plus meniscal root repair, knee bar plus biologics, things like that, to fully understand, uh, um, how this works and what patients benefit before we jump into a, you know, a proper RCT, which really, when you— once you start launching one of those, you want to, you want to have a lot, a large body of initial data to really know where you're at.

So that's fascinating. So if the standard of care today is decompression, so they're going to put a drill in there anyway and to take the pressure out, right? I mean, that's how they decompress. As long as they're going to do that, I mean, gee whiz, slide in a few knee bars. It's like I mean, you're doing surgery anyway. That is, man, that is interesting. Wow.

Yeah, that's why actually you need to, you need to run these studies out a little bit longer because you'll feel better. The patient will feel better right after surgery just from getting decompressed. But then if you go out 3, 4, 5 months, it's just going to come back with a vengeance. And so that's why we need to look at that 6 months, a year, 2 years. And so with the initial patients we have who are already out 2 years, not only do they sustain their benefit, it actually, their benefit actually increased. To me, they're actually healing. Um, and so that's what we wanted— we want to be able to show, because if you're just decompressing them, uh, you know, that it'll just come back. They, you know, they won't— they won't, uh, unless they're the, you know, the magically perfectly compliant patient, never wear weight-bearing on this for, you know, but that doesn't exist in the real world.

Well, the reason I was asking about the international presence is, uh, The, I sit on a, one of the boards I sit on is a Canadian company that is, does cartilage repair internationally, but not in the United States. So they have a really good commercial presence internationally. They are right now looking to augment that offering with other products that are joint-preserving, motion-preserving, pain deleting, pain eliminating. So when I see something like this that might be sort of synergistic, I ask that question and see if you might be interested in meeting or talking to them.

Yeah, absolutely. Yeah, no, we're, you know, as Kyle brought up before, you know, one of the biggest challenges, and I always feel like people don't talk about this enough, one of the biggest challenges for small companies is, you know, your commercial presence and and basically being able to have that spread of distribution. And so, you know, there are pieces of the overall knee treatment pie that we're not necessarily going to have. Like, you know, we don't have a cartilage replacement technology. That's not what we do right now. So absolutely the same representation, right, could potentially be representing those products, whether— and so So we've had actually some conversations in those directions. And I think ultimately, you know, wherever Osseo ends up, you know, this is going to be part of your overall— we call it Save the Knee, right? The Save the Knee portfolio. And so, yeah, we, through the right partnerships, I think we ultimately would have the full Save the Knee portfolio.

Okay. I'll introduce you by email.

Thank you. Perfect. Appreciate that.

Awesome. Yeah, the AVN thing is really interesting. I mean, when I was at Wright, we obviously had a lot of biologics, synthetics, injectables, and we invented this thing called MIG, which was a higher strength calcium sulfate. And we, we actually talked to a lot of surgeons about early AVN intervention. It, you know, you can go in the lateral femur easy and you can drill right up to the, the cortex of the head. Easy. You can see it on fluoro. It's really easy to do and decompress. And then you fill it with something, uh, that creates bone. And it's just, yeah, it's a, that, I think that one's wide open. Um, yeah, go ahead, Kyle.

So we've got a portfolio type of question for you that if, if you don't want to answer, I will totally understand, but I would— I suspect that you guys have obvious areas where you can address something. Metal gets removed, hardware irritation and prominence, infection risk. And it's like, okay, for a resorbable device, this is a great fit for us. We're going to go put this knee bar thing in the knee. I'm curious if the opposite is also true. Are there any indications where metal's used and there's the potential for there to be your material applied, but you're like, ah, that's just a really bad fit. Now, I mean, the obvious example is like maybe a total hip stem. It's just too much load under— say, okay, but what else might fall into that category where you just go, terrible fit for us?

Yeah, that's a great question. Obviously, obviously the whole world of total joints is something that we, we don't do, or, or, you know, even you know, unicondylar knee implants. You know, we really started off in the foot and ankle area first because there is a higher removal rate. There's also a lot of— most things that you're doing there, you're looking for healing. And so anything that can— that where you're actually wanting the bone to fuse or heal, you know, that is, you know, those are areas where we see OsteoFire being tremendously, you know, productive. I'm trying to think of an example where a surgeon might want a hardware to stay in there for a long term to kind of, for some reason. Obviously, I'm a little bit evangelical when it comes to Osseo, so it's hard for me to think in the reverse. I don't know, Sam, do you have anything jump to your mind?

I'm also racking my brain. I'm trying to think of different types of fractures that might be under a different load, but really, The platform is so endless, it seems, as long as you're dialing in the strength at different areas of the material, you can meet the need, right?

That probably means that—

If you had a patient who you didn't think was going to heal for whatever reason, you know, a patient where you just, you really, you didn't think they had any, and that does happen. I mean, I've seen it maybe with a very nasty diabetic, foot.

Yeah, smoker, obese, all of that, for especially with foot and ankle patients. But your surgeons are going to probably be doing some self-selecting with that as well. Yeah.

So yeah, yeah, okay. Yeah, but that's a good point. I mean, I think, you know, there's also— I'll be honest, I think the biggest issue in today's healthcare system is we have not a few surgeons who would love to use Osseo all the time, but from a cost perspective they're just going to get pushed back on, you know, on that really hard. So they might select to use Osseo for the pediatric patients, for more sensitive patients, for a more active patient. And if you have, you know, an 80, you know, 82-year-old bunion repair, use a K-Wire. Like, you know, so we do see some price selection as well, which is just the realities, I think, of, you know, today's situation.

That, so that makes sense. And what, so back to your first part of that answer, and Sam reinforced it, is it might just mean that you guys are making decisions beyond material technology for what you do next. Like, do we want to get into the upper extremity? Because it's an entire new group of surgeons, an entire new group of sales reps, and it's too early for that. We don't want to divide and conquer. So it's fascinating. So there's, you guys are in business building mode. So clearly there's three legs to the stool, right?

Yeah, yeah. No, it's, uh, I mean, that's exactly— as a technologist in my, in my heart, you know, that's, you know, when we brought out— started bringing on some, some of the colleagues who, you know, who, uh, you know, Brian Barrier, the CEO, and Brendan Morrill, our Chief Commercial Officer, who have, you know, decades of experience on commercializing technologies. And I came, I came into this very naive in terms of— I was like, but it's so much better, everybody's gonna want this technology. Well, okay, well, we need to build this out. And you know, it's, it's, there's a lot, there's a lot more that to succeeding in med tech than just having a great technology as, as we all know.

Every, yeah, it's my, one of my favorite sayings is, I think Osseo is like a mosquito at a nudist colony. Everything looks good. And, but you gotta say no. You have to say no to, you gotta pick, you gotta pick and choose your applications wisely. Otherwise you get— you lose focus.

I'm never— I'm not stealing that analogy, Tiger, because it creates too much of a horrifying visual.

So it's a terrible thing. Uh, what can Sam and Orem— is there anything you, you can ask the group? Is there anything we can help you with? Um, anything business?

Yeah, actually, No, I mean, I— my question is really just about like building awareness and what strategies you guys may have, um, run into, especially with an underdiagnosed condition, right? So what approaches have worked to really building awareness to something so specific, a pathology, not necessarily procedure? Because when we're talking about osteofiber, um, that tends to be really easy, right? It's, it's an obvious switch for a lot of people. We're talking about knee bar. This is now a pathology. So a lot of our efforts are really spent bringing awareness to the pathology itself, and then we have an obvious solution for you. We have a surgical approach that actually helps your patients get better. So just want to pick your brains on, um, maybe what, what's worked for you if you've run into similar situations before.

Mark, so my career is basically on building new markets and you've just described a perennial challenge and problems. I start with basically doctors sell doctors. Yeah. And the challenge there is that people can't buy something they've never heard about, you know? And if they didn't learn about it in residency or fellowship, they don't, they don't know about it, and their knee-jerk, their knee-jerk position is, that's stupid because my mentor didn't teach it to me. So I mean, the challenges are really, really high, and the reasons for not adopting something like this can be nothing more than no one taught it to me 20 years ago or 10 years ago. But there is the— but in making a new market, the challenge is always of finding those that are early adopters, open-minded, and that, you know, it's that needle in a haystack. But again, it goes back to doctors tell doctors. You gotta have people on the, you know, you gotta have people talking about it. It's a thing that's, that's a kind of an expensive proposition to, you know, get those speaker events over and over and over and over again, especially in this NIBOT. 'Cause I'm with, with the guy here, the practice here in Atlanta, Raj Pandya's practice, He's an advocate, but his technique is a little unusual. He doesn't really do anything except inject a biologic. He's not putting anything in there, and— but he gets great results, he says, you know. And doctors don't do things that don't work for very long. If the patients come back bitching, screaming, and suing you, you stop doing it.

Great.

Wow. Good luck. But it's fun. I mean, I say good luck in, but in a very positive way. It's the most fun part. It's the most fun part to do.

So yeah, Mark's, Mark's done this many times and I, you just have to find the early, the young orthopedic evangelists that are really into subchondral defects. And, and you, I don't know if you can, There's a way you can use Google or AI to find out everybody's ever written a paper or presented a poster. But that's probably your evangelical group of surgeons is probably your best way to move the tide over to, there's a way to treat this now.

For sure.

I mean, when you have a surgeon who is interested in subchondral bone or has been interested in this pathology, the conversation is so simple. It's so easy. I mean, they believe in it already. This makes sense to them. And, you know, I'm really just trying to think of anything maybe we haven't thought of because it is actually going really well. And I think the traction is just unbelievable for something that is, you know, an underdiagnosed market. Like, you would think that this would be trickier, but when you actually do have these conversations, it's so— especially seeing how well the patients are doing, it's easy. In that sense, but it's just what else could we be doing? How else could we open the doors? So it's always just fun to hear, you know, any type of creative way that people have done this previously.

Is this a practice expansion opportunity for a surgeon? I mean, there's, there's a reimbursement code if you're putting parts in, but yeah, with other technologies on the market, our doctors more often erring towards no treatment, and in the presence of this device, they now can take more patients to surgery so it can build their practices. Is that the dynamic here?

Yeah, yeah, definitely. Actually, so, so one of the things is I think personally in the conversation to have, I have a, I have a lot of success when I'm talking to a younger surgeon who's kind of looking to, you know, to make a name for themselves and especially with joint preservation. And you'll see these, these are the guys who are going to be getting into a lot of these technologies like, you know, primary ACL repair, for example, some of these things that, that are still considered fairly innovative. But patients, patients really want, want preservation. You know, patients kind of inherently want to keep their knees. And, and so you see this more and more where, you know, especially in community doctors, I'm not even talking about the big academic centers because they have they have some of their own, you know, interests, but I'm talking about guys who, who will just be a community doctor and they just really want to be able to offer their patients more options for, for keeping their knees healthy and pain-free. And so, yeah, I've found that to be tremendously true. And that's almost my favorite conversation. Somebody who's just a couple years out and, you know, has kind of gotten the ball rolling, but is now looking to take that next step in their practice and make a name for themselves. And this is, this is a great, great opportunity for that. I know, Sam, would you agree with that?

Yeah, absolutely. I mean, it's definitely because it's a something that they can offer to their patients, right? And I think patients are interested in this too. So it's a really great way to connect. I mean, I think that strategy as well, your direct patient, having patients hear that there actually is an option for them and then being directed to a surgeon that is trying to build their practice, that is a obvious marry-up.

So maybe say something controversial.

No, yes, say something controversial.

I'm a big fan. So I think a lot of us have worked also with small companies. Tiger has written some things about, you know, kind of the benefits of working for a startup, a small company. But what we all know is you're out there competing with some gorillas, and, you know, some of these big guys will really twist the arms of surgeons to even if they might like your suture anchor more than the big company suture anchor, it can be hard to get that business if they're getting sent on these kind of attractive consulting contracts and everything. And so this is really nice in that respect, in that you're not actually, you know, you're not just trying to replace somebody's suture anchor and kind of fighting those, you know, big consulting contracts and those the other forces that make change and innovation hard.

You're at—

you're, you're just bringing something new that, that helps patients in a way that they didn't have, that the surgeon didn't have before. And you're kind of sliding, you know, sliding underneath all the other types of agreements and contracts and stuff that they're doing. Uh, so that, that's kind of been a really interesting to see how it is when you're, when you're able to come in and not face all that inertia.

How big is your advisory group of doctors?

Uh, uh, that's hard. I, I'm trying to like count in my head. I don't know. Any sense of what the overall size?

Well, it really depends, right? So it's for every facet of the business. Like if we're talking specifically Nebar, um, we have a group of, you know, 6 to 7 KOLs who really guide us on a lot of the, the knee bar strategy, but different segments of our business have different groups of advisors. But, you know, sports, we have, you know, maybe somebody specific to shoulder, smaller group. We don't have a lot of shoulder products, but we, you know, smaller group of surgeons that advise us. So it really depends on what we're talking about. Knee bar, about 6 or 7, I would say, are really help us lead the charge on how to penetrate the market.

Okay.

I mean, to me, the best advice I ever got was, um, when you're— to— when you're forming your advisory group is to find young doctors that want recognition and don't pay them anything. That's the delineation. And, um, the desire for— the desire for recognition is stronger than the desire for revenue. Now in today's market, it's, it's gotten a little contaminated certainly, but still. And the guy that told me that, he said, if you can get 10, get 10. Well, the doctor that told me that, he was, he was an entrepreneurial inventor. Uh, actually it was Tony Russell in Memphis, Tiger. Mm-hmm. He said, if you can get 10, get 10. If you can get 100, get 100. He said, that's your sales force.

There you go. Anyway, it's a good way to think about it. Yeah, and I like that.

So another thing that comes to mind—

go ahead, Kyle.

So another thing that comes to mind, and this is— you guys are working on the opposite end of the spectrum because this is potentially younger patients with an earlier pathology, but I've seen in the past where surgeons kind of become the center of gravity for a certain procedure because they can let their sphere of of relationships and influence kind of know like, hey, these patients you probably don't need to waste your time with, send them all to me. Now, I've seen it on the side where it's somebody's gonna be doing some sort of hind foot fusion reconstruction and there's a ton of doctors around them that want no part of dealing with those patients. And especially a younger skilled doc might just be like, you know what, I like nailing all of those, send all of those my way. Again, this is a little bit different because you guys are on the other side of the spectrum. But I wonder if that's something to think about too, where, you know, because a doctor like that, that's especially younger, is not a threat to the knee doc in town that's doing 600 total knees. That guy doesn't— he's doing great. He doesn't need to worry about adding subchondral bone defects to his portfolio of treatments for patients. But because he's a knee doctor, he might see patients that fall into that category and he might kick them right over to the person that wants to focus on that. Have you played in that space at all?

Yeah, it's an interesting concept. And I think we go back and forth a little bit because I know of a lot of total joint docs that actually really love this concept. And they say, oh, I see these patients and I don't really have anything for them. And they kind of, they wanna treat them. But then you also see these high-volume knee bar docs that are just kind of scooping every single patient that falls into this category. And this is usually these surgeons who are maybe dual fellowship trained. They've done sports medicine and total joints, or they see their patients through the continuum of care. So, they are seeing a lot more of this. But, you know, I think there's just so many things to consider, whether or not these patients are even getting imaging, right? And that, that's what it boils down to. It's like you could be a surgeon that would collect all of these cases, but that would mean that every, every patient needs to get MRIs. So, that needs to be a thought within your institution that every surgeon is sending these patients for MRIs if this could be a potential pathology for them, which would then funnel them there. It's a little— we're kind of working backwards here of how do you get patients to be even identified first? How do you get them to get MRIs in the first place? How do you get this to be a common thought within your institution, your hospital, you know, whatever group you're practicing in, so that you can funnel these patients in a certain direction for the, for the surgeon that believes in it? Because it's a really great way to think about it, getting, you know, patients to funnel to one doc, because it does work in certain areas of the country and certain surgeons who are doing these for high volume. So Yeah, I mean, I love the idea. It's just the, how do we get there?

It sounds like you almost need a diagnosis kind of campaign to help, you know, the pain is not, you know, the pain's coming from the tibial, underneath the tibial plateau. It's not coming from the cartilage or the ACL or meniscus. And you, I mean, I wish there was an MRI, I mean, ultrasound wand that would work great for this that every, every orthopedist had in their office because the MRI is—

it's actually great. It's so interesting you said that. Now that you're saying that, I'm feeling like I should talk to some of these companies like Butterfly or, you know, some of the other companies that have these mobile systems. Can you kind of talk them into driving and driving a campaign around it? Be a win-win.

Yeah. It's an awareness thing. Well, anything— do you have anything, Orem, that you want to ask for the group before we wrap up? I think you could be frozen.

Yeah, sorry, the bandwidth has been very wonky here since the beginning of the war. So no, I think my biggest questions really have to do with, you know, how you go out there and, you know, and compete with the giants every day. I find that to be one of the most kind of interesting questions, uh, when, you know, in the way with the contracting and the, you know, the capital equipment deals that they're doing now, it, you know, you really have to have justification for getting there. I mean, obviously technological difference is, uh, you know, great, but also, you know, just, just managing, uh, you know, managing those relationships around kind of around what else they got going on. I don't know if anybody had any other thoughts on that because I always find that to be an interesting topic?

Well, I'm a big fan of creating your own category. And I, I would be great. I mean, knee bar, you guys have got that trademarked, right? So you own that. I mean, knee bar needs to become a verb and somehow, are we going to knee bar this knee or just decompress it? You know, so I think you got to create a new category completely. I think, you know, the best, the best example is Kyphon, right? Kyphon, a new category out of thin air. And to Kyle's point, it enabled every spine surgeon to make more money. It's just a brand new procedure. They could do them all. They could do them every 15 minutes. I really like Kyle's comment on, can you show a surgeon how they can make more money? I really like that idea. I don't know what the answer is. But that'll get their attention.

Yeah. Oh, so long as you can also show the sales rep that they can make more money and then everybody lives in harmony together.

Yeah.

Yeah. Yeah.

Good, good, um, good luck with the war. Stay safe.

Thank you so much, Mark. Appreciate that.

Yeah.

Yeah. Stay safe. Well, thanks. This has been, this has been terrific. Um, yeah, this We, we welcome the best. Uh, I think you've— I never thought you guys would go into subchondral decompressions, but, uh, it makes sense. It just totally makes sense. It's the right material for that procedure finally. And it'll be interesting to see what other, other areas you get into because you guys are a mosquito.

Yes.

That's a beautiful, beautiful imagery to let you end off on, Tiger.

Great. Thank you so much.

Thanks, guys. Appreciate the time today.