BoneChat #144 - Defining the Standard of Care for Orthopedic Tissue Preservation & Restoration

Welcome to— this is Bone Chat 144. And just to context, we've been talking all year about how we're kind of in the golden period of sports medicine. So today we have Jamal Rushdie, the CEO of MIAC Orthopedics.

Hi.

Jamal has 30 years in sports medicine and regeneration. Tournier, DJO, Collagen Solutions, Curo, and many more, including some strong exits. And Jamal's gonna give us an update on MEOK, and he's gonna give us a glimpse into the kind of the future of tissue preservation and restoration. So get your questions ready. Handing the mic over to Jamal. Welcome aboard.

Great.

Thanks, Tiger. And thanks everyone for joining. I know some of you, and for those who don't know, nice to meet you. Like Tiger said, I've been in the industry for about 30 years. I've been very fortunate, had some really— we were just talking about one of my mentors, Doug Coors, a great guy to learn from early on, a guy named Paul Nichols from some of my early days. Had, I think now we're up to 6 exits. I'd say, you know, certainly batting a lot more than .500, Not 1,000. And we were just talking off camera earlier that it's really fun. I wouldn't have it any other way, but it's challenging. There's a lot of work to do. These aren't for the faint of heart. About 100 days ago, I was fortunate enough to join MIAC Orthopedics as CEO. Spent, I'd say, the first 70 days in every city I could to meet our surgeons and our sales reps. And I think that's a great way you can learn what you can from the outside, but from the inside, didn't have a really changed perspective, certainly learned a lot of things and just great opportunity. So Tiger asked me to talk a little bit about MIAC and just a little bit of how I see, having seen this journey, I think my first exposure to orthobiologics was back in the mid-aughts doing actually even prior to joining Tornier, but I was tasked with leading the M&A and licensing to build a sports medicine and orthobiologics group within Tornier. And that was a good exposure. So that was quite some time ago. So what I'll do is I prepared just a few slides, you know, just a little excerpt from our company presentation and a few custom thoughts that I had for this group. Give it a go, assuming people can see this.

Coming in, it's there. Yes.

Great. Excellent.

Excellent.

So this is what we like to see is we think it's great to be mission-driven. I think in what we do in healthcare and especially in what I would call regenerative medicine and tissue engineering, it's great to be purpose-driven. And what I've come to learn is we still are evolving and trying to define what is the standard of care for preserving joints, preserving tissue, and restoring natural tissues. I always, when I started at this company and even prior companies, especially Collagen Solutions, where we're focused on tissue engineering and biomaterials, is that, you know, I think we're going to see the day where we're going to have a lot less metal, plastic, and electronics in human beings to make them feel better and to restore their health. And that's a very simplistic way of doing it, but it's true, whether it's cardiovascular, or neuro or wound or dental, certainly orthopedics. That is really the flow of history I think that we're seeing. I just start with what I would call a selective history of orthobiologics and how the world of where we're all part of have advanced the standard of care. If you've been part of another company or think I've missed something, you're probably right. In fact, I left out many of my own companies and projects, but these are a few that I thought would help tell an interesting story. I see it in kind of 6 buckets. There's advances in cartilage, tendon, meniscus, bone, this kind of catch-all of autologous cells, the magic pixie dust that people have been trying to figure out and thinking we're getting there. And then our niche on ACL. I would say my first exposure was in cartilage, which is probably one of the hardest things to do. My boss at the time, Doug, came in with a yellow pad and about 6 ideas and said, go take a look at these companies. And here's a couple of very smart PhDs that are going to help you understand this. And one of my first assignments was to go to the ICRS course in Warsaw, Poland, sat through all the lectures, read the literature, and came convinced that ACI was the only really technology that Worked. Work as defined as, does it survive past 5 years? 'Cause 2 years seems like just about anything worked, and 5 years seemed like nothing worked. And that was one of the first leading technologies to be supplanted by MACI, that next generation, Agility just recently. But you see, you know, you see the advances in cartilage there. In tendon, I would argue GraftJacket was probably one of the originals, great exit there with Regenitin down the road. more recently, a couple of high-profile next-generation scaffolds. Meniscus, I still think hasn't been solved yet. There's still a lot of work to do in meniscus. And we'll see how this new Rejuvene does, but I think there's plenty of opportunity. Bone is probably one of the more higher profile. Everyone, I think, knows the Envy story. And autologous cells, you know, what kind of PRP works? It's not all the same. Again, I call it a little bit of the magic pixie dust because there's a wide range of whether it be PRP, BMAC, fat cells, there's a lot of ideas of how do we bring biology in? And is it really the cells or is it really just the signaling mechanisms? So, you know, there certainly is a lot of research there. And then finally ACL. When I came to BEAR, I actually came with a healthy skepticism. I remember seeing the very first presentation at a Canaccord meeting prior to BEAR getting approved. And my thought was, well, good luck because all these other companies have tried and not succeeded with FDA. The clinical trials didn't work, what have you. And I was floored when they got the de novo approval. Again, hats off to the prior team at Bayer that, and many of them still with us today, of doing the work, doing the homework, the science that we needed to do to get a next generation of ACL. So that's kind of how I see is all of these were trying, a lot of work, a lot of money, a lot of science, a lot of surgeons getting very passionately involved involved in what can we do to save tendons, save joints, and really advance some alternative to just having a mechanical solution to orthobiologics. So our story at Bayer. So again, I just joined the company, so you always want to stand on the shoulder of giants. I'd say that the giant here is Dr. Martha Murray. If you don't know Dr. Murray, She's a researcher. She's actually now in the leadership position over at Boston Children's in Harvard. She started this back off in the late '80s. The story is very interesting. She had a friend that had to do an ACL reconstruction. She was going to be a mechanical engineer and curious engineering mind said, this makes no sense. Why does the ACL not heal? Why do we have to rip it out? when you can repair everything else? And that kind of put her on a track to research and med school, and, and that, that's where she began the research. Fast forward a couple of milestones is back in 2000, there's some pivotal work about the blood clots being identified as key to ACL healing. The ACL is one of the few areas where blood clot doesn't successfully form, and comparing that against Why does the MCL heal outside of the synovial fluid and an MCL does heal— or excuse me, an ACL does heal within the synovial fluid? So, um, Schiller did very good work on those data and then began publishing preclinical data first. And then back in 2015, the very first— fast forward under 90E, the very first patient had a BEAR. It's called the BEAR-1 study. We did— they did 20 patients, 10 with BEAR, 10 with hamstring, and randomized it and Perfect results, you know, almost too perfect, but it was good enough to kick off the next study. MeOc was founded in 2016. So, again, you know, many, many decades later after the first idea, and the idea there was to, let's get it approved through the FDA, let's commercialize it. The BEAR-2, that's a pivotal study, and we saw the results that were non-inferior. We saw a lot of advantages of what the BEAR can do. And we got the de novo approval in 2020. Launched in December of 2021, so I actually call it 2022, first full year of launch. Crossed a milestone of 2,000 patients in '23. And fast forward to today, we just crossed— in fact, we're going to do a press release on this pretty soon— 10,000 patients. Earlier this year, we got an FDA new claim that if you have an ACL surgery with BEAR, it significantly reduces your risk of post-traumatic osteoarthritis. That to me is a game changer amongst what it means for patients. There's a lot of work to do for surgeon adoption, but from a patient perspective, that really tells a story of we're trying to save joints. And We'll talk a little bit about that, why that's so critical. That's probably a 2-minute kind of overview of the history, but I would say, you know, hats off to a lot of people did very good work, including, you know, some of my predecessors in the company, but really for Dr. Murray and her vision of we can save the ACL. So, what is the BEAR implant? Well, It's pretty simple. That's the implant that you see on the left-hand side. It looks like affectionately a marshmallow, but it's actually a sophisticated collagen graft. Like I said, I've been in regenerative medicine tissue engineering for quite some time, ran a collagen company for 8 and a half years. There's a lot of IP behind how this is made, including the sourcing of the tissue, which we can't talk about as a trade secret. But it's, as I dove into it, it's actually very unique. And it took a lot of work to get that mixture right and to get the scaffold right. As with anything in tissue engineering, there are 3 components. It's a scaffold, it's the signaling, meaning the growth factors and other signals, and then it's cells. And what BEAR does is you mix it with the patient's own blood at point of surgery. The anesthesiologist simply draws it, hydrates that collagen implant with the patient's own blood, and you're bringing signals and cells to the to the mix, and then it's implanted through a standard ACL technique. There's a slight modification that we do, and that's a big part of our medical education, but you're not really impacting the workflow of the surgery center or the hospital. In fact, with our experienced users, you're saving a lot of time here, which is good, but that's not the real key aspect. The key is what it does and how it really saves the ACL. I'm sure I'm speaking with a group of experts here, but just to give the basics is what's the way it's done today is traditional ACL reconstruction. So your ACL tears and the surgeon will either harvest a quad tendon with or without bone, a patella tendon with the bone, or a hamstring tendon, and they'll prepare it in some way, especially with quad tendons and hamstring tendons, sew them up. And I've had surgeons describe it as almost, it's a staging operation to a total knee replacement. And they say it kind of tongue-in-cheek, but it is true. You're removing that perfectly good ACL tissue that's just staring you on the scope right in the face. You're drilling holes, significant holes into the femur, into the tibia. You're putting a tendon in place where a ligament was, and you're expecting that tendon to change into the features of a ligament, which it does sort of over time. But we know there's clinical problems, and it isn't talked about as much on the podium, but there are plenty of papers. I've cited some of them below, but probably the biggest one is early post-traumatic osteoarthritis.

I had—

I've had surgeons explain this to me really 2 ways. The first thing they said is, because I always asked them, like, what got you started? And they say, well, I was looking at this scope, I'm looking at this perfectly good remnant of an ACL that's bleeding, that has proprioceptive fibers, that has a neurovascular bundle, and I'm destroying it and I'm putting a hole in it. I'm doing something else and there's got to be a better way. And, uh, to me that just speaks to save the meniscus, save the ACL, joint preservation. It's, it's where the industry, I, I'm convinced, is going. Um, so they were gonna try to figure out a way to save this with or without BEAR. It just happens to be that BEAR came out with a really, really elegant solution. But the challenge is you have between a 30% and a 50% chance of developing early post-traumatic osteoarthritis within 5 to 10 years of the surgery. Surgeons have described it as, I'm putting an old knee in a young kid. You know, a lot of these patients are young, they're soccer players, they're their skiers, their lacrosse, you know, what have you. Not all of them are going to be D1 athletes, but if you think about what we're doing is, okay, if you have, let's just say 10 years, let's be generous, 16-year-old kid, what's their late 20s, early 30s going to look like? Well, maybe they can't run as much, their knee hurts, something, you know, that old ACL injury is acting up, that sort of thing. Well documented in the literature. of the challenges with the long-term impact and sequelae of the ACL reconstruction. So what BEAR does is it restores it, and it's not an easy thing to claim or say. And, you know, again, hats off to the MIAC team that have done so much work and their surgeons of studying this because the bar for both cartilage and ACL is high to make because the failures are high. And how do we show that it works? So with the BEAR, there's— we're not harvesting a graft, there's no second surgical site. It does really just naturally heal the ACL. Our claim that we just got through the FDA is a 6x reduction in post-traumatic osteoarthritis. So specifically what that means is our 6-year BEAR-2 data says that of the hamstring group, the control group, 33% of them developed post-traumatic osteoarthritis as determined by the study endpoints, and we had 5.7%. So significant reduction there. Obviously, you have no donor site morbidity by definition. We're preserving the proprioceptive fibers, so you're not ripping out that native stump in the correct position, that correct anatomic hourglass insertion point. Very important for athletes like, you know, Chris there on the right, who's our first commercial BEAR patient. But you got to know where you're inserting. knee is in space and time position. You're not harvesting your hamstring tendons in the case of a hamstring allograft or your quad tendons in the case of those. And so you have your normal muscle strength. What's very interesting, we have the data, we just submitted this to the FDA that demonstrates when you restore your ACL with a BEAR procedure, Versus when you reconstruct your ACL and at the same time you happen to have a meniscus tear, 50% of these ACLs also have a meniscus tear, we have a 60 to 80% reduction in retearing that meniscus. So the biology of BEAR is also improving that entire joint environment and actually helping your meniscus stay stronger and heal as well. And then finally, we're seeing even our data, a trend in the reduction in our opposite knee. Makes a lot of sense. These patients rehab better, they have less pain, they have a normal knee, they have normal strength. So guess what? They're not favoring their quote unquote bum knee. They're not overloading their good knee. And we're seeing that, in fact, you're not having— you're not tearing, excuse me, your opposite knee. So there's so many benefits to the patient with respect to restoration. And really, it's about how do we bring the surgeons along? How do we— Teach something different that 30 to 40 years of training says to do it otherwise. And that's really where we are with, with BEAR. On a very high level, again, this is an unfair and very simplistic summary of 15 years of research by Dr. Murray and others. But what this does is just gives you a basic mechanism of action. The first thing that BEAR does is it actually does 2 things. It both protects the healing environment of trying to form that first blood clot, which is really important, and it forms that scaffold of scaffold cells and signals so the ACL can regenerate. From a protective environment, the basic research was— and Dr. Murray was very curious— well, why does the MCL heal but the ACL doesn't? So, she looked at basic science data. Is there anything different about the healing cascade? Is there anything different about the collagen, about the fibroblasts? The real big difference is the, is the synovial environment. And the synovial environment would actively break down and prevent that blood clot from forming, whereas the MCL, which is not in the synovial environment, does not. And by forming a protective scaffold around and through the wound site, And ensuring— and really, it almost acts as an enzyme sink. So it draws the slings and arrows of the synovial environment rather than the healing response. So that allows your blood clot to form. And then over the next 6 months, normal regenerative medicine takes over. And this is kind of the basics of regenerative healing. If you can prevent the repair mechanism, the scarring mechanism, the fight-or-flight evolutionary response of just get rid of the bad stuff and just scar over, then you can allow the body to heal itself, which it normally will do. The body turns itself over every 7 to 10 years anyway. So there's a natural process of breaking down tissues and forming new tissues. And within BEAR, that provisional scaffold is formed within that first 6 months. And then by about 12 months, you've got a newly restored ACL. That's not very much different than what a reconstruction goes through, except in the reconstruction, again, you're not, you're not preserving those natural fibers, that natural footprint. And you, you don't necessarily have a native ACL. You have a tendon that's been turned into a ligament. But the timeframe is still about the same. You still have to go through that remodeling process. So that's the basics. The BEAR is the scaffold. prevents the enzymes from breaking it down and encourages the growth of fibroblasts and other materials to regrow that native ACL. Again, very simplistic summary of our clinical data. We have 74 publications, actually, I think now 75, one should be published this week, 45 preclinical, about 30 clinical. The big take-home here in our BEAR-2 data is the 6x reduction in post-traumatic osteoarthritis. But I will say one of the challenges with BEAR is that early study of BEAR-2, the same data that we got the osteoarthritis data, is our retear rate was a bit higher. It was about 13 to 14%. That's often a criticism or a question that comes up. When we dive into that data at the time, and again, I made mention that BEAR-1 was almost too good, the safety data was almost too good, it really was throwing The toughest patients with the most aggressive approach. Median age is 17 years old, going back to rehab at 6 months, which is really not done anymore. Even, even with reconstruction, it's 9 to 12 months rehab. And it was a low-strength suture construct, Ethibond with endobuttons. The idea was to limit stress shielding, but in fact, we found that as a bit of a challenge on the retears. The good thing is, in the real world, in the registry, we got now about 300 patients. These data are from 200 patients. Our retear rate is now down to 6.33%. And when we sub-segment between high-strength and low-strength suture, we're seeing that normal 4 to 5% retear rate. So we're really honing in. And as a company, when you study, when you do a study, you're hoping for great results. And but when you get results that make you scratch your head, like a little bit of a higher retear rate, What can you learn from it? And what we learned from it is rehab matters and the surgical technique matters of high-strength suture. And once we get that down, we're seeing retear rates comparable to what's there today, but with all the benefits of having a natural knee and reduction in your post-traumatic osteoarthritis. And I think I'll close with, you know, what are we doing going forward? It's really 5 areas. We have work to do on sales execution. You know, we grew fast and then we kind of contracted on our sales organization. We really have an opportunity to deploy the right people in the right places. And we have a new sales leadership team that is doing just exactly that. I think we have opportunity to double, if not triple, our sales with that alone. And we're putting some focus and effort behind that. Medical education. We've done a great job and the prior team did a great job of educating patients for all the right reasons because This is a great patient story, but our bottleneck right now is surgeons, the trained surgeons who know how to do the technique right and who can understand the mechanism of action and be able to say, okay, I'm going to do something different than 30 years of training maybe have said otherwise, but this is how innovation happens. To that, on the clinical adoption side, we put together a surgeon advisory board that's brand new, will help with peer-to-peer technique and data collection. From a coding access or market access, what matters is obviously pricing. We've done a lot of work there to help the facilities understand how to code.

Yeah.

And then long-term, we think we have a good shot of our own code for reimbursement. And then finally, this is a platform. We've got in our pipeline some delivery devices to make it easier, expanding our indications, different form factors, et cetera. That's a longer-term play. But all of this is, we think if we execute in these 5 areas, we can grow and advance as a standard of care. So that's it. You know, quick, quick 10 slides. Love telling the story, but that's, that's what we're doing. And we're on a mission, not just if you save the ACL, we can save the joint. And that's what we're trying to do. So, Tiger, I'll turn it back over to you.

Yeah, open it up. Who's got the first question?

I'll go.

Great presentation.

Thanks.

Surgeon adoption is the question you kind of had, and I'm wondering, what is the profile of physician? What is the pushback from physicians? Kind of what is that? You know, in early Regenexx days when they launched, stiffness and retear rates was one of the biggest problems they had as well.

Yeah.

And so they had to come up with that, you know, take a step back, pause for a second, and come out with that accelerated rehab protocol, and then you just kind of saw it take off.

Yeah.

So, you know, just curious, you know, those questions.

Yeah, so, uh, again, first during my first 60 days and then ongoing, because I— every time I asked a surgeon, um, I like to talk to 2 different surgeons. Uh, the surgeon who's already, you know, drinking the Kool-Aid, well, how'd you get started? Why did you get started? You know, that, that's kind of the question is why. And then for the surgeons that don't, why not? You know, what, what's holding you back? So those are the 2 areas. So to answer your question, the first bucket the surgeons who already bought in or on their journey. It was really that simple of— they're a little bit contrarian. They're a little bit, you know, they might have been trained at Steadman Hawkins or HSS, you know, very good training programs, but they're curious and they say, why am I looking at this scope and taking out this perfectly good tissue?

Yeah.

So one of the key ones is just an open-minded surgeon who says, I just don't buy that this is the only way to do it is to rip out a perfectly good ACL. A lot of them had followed the early research out of Boston Children's and Dr. Murray and so forth. And a lot of it becomes word of mouth of, hey, you know, Dr. So-and-so is doing this and so forth. I'm curious, right? So that's— they're with anything, early adopters, they're typically curious. They typically think there's a better way to do the mousetrap. Now, one thing we have to keep in mind is Surgeons are— I would say they have to look the parent in the eye or the patient in the eye and say, I'm going to do well for you. And put yourself in the surgeon's shoes. For 40 years, they've been saying reconstruct and you can't regrow the ACL. And I'm going to say, you know, Mr. and Mrs. Smith, I'm going to do something that's going to save this ACL. So they got to feel confident about that. And while we can show them data all day long about the long-term post-traumatic osteoarthritis, what they really care about is Am I going to do right by this patient in the first 6 months? Right? Am I— is that patient going to come back to me in 6 months, say, Doc, it didn't work? And, you know, the thing I like to say is we have to put ourselves in that surgeon's shoes, because if a reconstruction fails, that's just statistics. If a bear fails, well, it's bear's fault, even if it's at the same rate. So we have to understand them, and that's where the peer-to-peer network comes in. That's where making sure we're teaching the right techniques and frankly the right patient selection. You don't want to do a D1 athlete with a mid-substance tear as your first case. You know, you want to, you want to have that confidence build. So there's certain patient criteria. It might be, you know, a patient my age that, you know, followed his son, you know, going down a black, double black diamond that maybe shouldn't be doing that anymore.

Mm-hmm.

You get a nice little proximal pop right off the femoral wall. I'll be a very compliant patient, etc. So really helping that, well, what's the right patient I should start with and how do I do this and so forth? For the patients— excuse me, for the doctors that haven't tried yet, even then when you sit down with them and talk to them, they're open-minded. They're saying, okay, I understand. I like that. I'm going to wait until maybe some more data comes out. I'm going to see what some other people are doing. We have a MOON study. If you know the MOON group, it's a—

Yeah.

Orthopedic Study Group. They're going to be publishing next year, and that's independent from MEOK. We're going to be publishing more registry data. So there'll be an accumulation of data. And at some point, you have a tipping point where you kind of have to defend not doing it. You kind of have to defend, why wouldn't I bring this option to my patient?

Let me ask, there seems to be a movement to preserving tissues. So is that coming from surgeons that are growing a conscience? And learning new techniques, or is it coming from patients saying, you know, are there patients learning about BEAR and asking the doctor about it?

So both.

I would say we did some interesting market research. We did a lot of effort in patient outreach, and I think they did it. I think the team did a great job. And, you know, we had an independent market research firm ask patients, so demographically selected of Either they've had an ACL tear or they're in the demographic window or the parent of a— you're going to have an ACL repair like a soccer player or something like this. And what we found is of that demographic group, the message has already gotten out to 10% of that group. So think about 10% of the entire US population of who might tear or have torn their ACL. 10% of them know about it, which is fantastic. 92% of them said, I would ask my doctor about BEAR now that I'm educated about it. Okay, that's great too. But then the flip question is, well, what would you— what would be your number one factor of what to do? 75% of them, whatever the doctor tells me. 10%— the next 10%, whatever another healthcare provider like the physical therapist tells me. So while we've done a fantastic job of educating patients for all the right reasons, the bottleneck is trained and willing and adoptive surgeons. So that's where we got to focus our efforts.

And it's— and there's no special technique. It's just a different— there's no harvest and it's a slightly different operation. So the learning curve should be really small once they're on board with the clinical data.

You know, you would think that, but it's— I wouldn't underestimate that. And that's actually one of the things that we take very seriously because We have—

we don't—

we're not even in the fellowship programs yet. Now that's going to change. We're going to get earlier into that. But if you come out of a, you know, a Hawkins— Deven Hawkins fellowship out of Colorado, and you know how to do it this way, you've never been trained how to anastomose and bring back the ends of an ACL together. You know, how do you do that? How do you cerclage or properly, you know, secure the stumps and bring them together and sew them together? And how do you get the bare end? So, We, we as a company have an obligation not to take that for granted that they know how to put it in. And that's part of, that's part of what we have to do to educate. You're absolutely right. Once they figure it out, it's pretty easy.

Yeah. Steven.

Yeah, I have a few more coming your way. I apologize. The education part that Tiger kind of said and what you kind of mentioned is very interesting. The Jiffy knee did a very good job at this. Granted, I was pretty much just Facebook ads, but I think you guys have an interesting opportunity to be able to build out essentially like an AI direct-to-patient campaign focused specifically on pediatric patients when patients or mothers or fathers are asking, my patient, my child just tore their ACL.

Yeah.

I'm not sure if you guys have ever gone down that route and how you have to write in specific ways, but it's really if you have all of these physicians that are putting that on their website as well as you guys as resources. You should be the first thing that's being shown on ChatGPT if it's written the proper way and all that. We've been doing it ourselves for certain things, but it's just such an amazing, powerful tool and cost-effective way to go directly to the patients in an educational way, which is really, really interesting. I'm not sure if you've looked down that path at all, but—

You know, to be honest, I don't know. There's been a lot of effort in direct-to-patient. You know, we do metric that we drive patients to our website. We have a find a doctor. We have a patient partner program, kind of a patient I've been through this, you know, what do you think? Reaching more patients cost-effectively is really the trick because this can be very, very expensive. So, you know, you may be right. There's a couple of things we can look into. I will say right now, we're going to continue to educate patients. We think it's very important, but there will be a shift also because our bottleneck is no longer the patients. The bottleneck is really trained doctors.

Yeah.

We've got to get our surgeons trained. That, again, 92% will ask and then 85% will say whatever the clinician says.

There's got to be that tipping point. If enough patients are coming in, then the doc is going to say, well, I've got to train on this.

Yeah, exactly.

Exactly.

Yeah.

Interesting. Mark or Dennis, I know you guys are— yeah, we'll go Kyle first.

So, Steven, Steven, your last comment is interesting, and I think you guys are— that, that's something Jamal, I think, is right to be thinking about, is direct-to-patient stuff. But this is different, right? Like, we can point to models of elective procedures where people are out farming around for ideas and wondering, should I get this bunion fixed, or is my rotator cuff ever going to feel right? Especially in an athlete, an ACL is almost not negotiable. And when you're approaching it from that perspective, most patients are never gonna push back on their doctor. They see someone, they build that trust, and whatever the doctor says goes. And generally speaking, rightfully so, I think across our industry.

Yeah.

So I don't think you should ignore finding a way to get into Snapchat and get these kids talking about having their ACL repaired and not ripped out. But my guess is if you had to prioritize, is your surgeon education is gonna be Yeah, that's exactly, exactly right, Kyle.

In fact, I've had the opposite, um, which is, you know, like I said, ACL and cartilage are special cases because there's so many failures, there's so many, um, things that didn't work or technologies that didn't work. So there's a level that I— we as a company take pretty seriously, which is just credibility, right? We want to make sure it's a credible approach. And I've had some surgeons saying, you know, It's great that you guys are all liking each other on LinkedIn and all this, but this is serious business. I got to be the hero. I had one that just had breakfast with a— or dinner with a surgeon the other day who's not a user, and he said— but very open-minded. And he said, Jamal, I got to tell you, I got to be the hero to this patient's family. That is my job. And being a hero means I'm saving this kid's ACL and he or she gets back to sport next year. That's my job. And so anything that gets in the way of my job, I'm not going to do it. So, you know, they take it very seriously.

Yeah. And that's— that also probably means that I think you were alluding to it before, that that's not the starting point with most of your customers. They're going to develop their confidence somewhere else. And I've had— I've had 3 teenagers within 10 houses of me in the past couple of months blow their ACL, and it devastates the whole family. Like, everybody is wreckage because of it. Because it's just— it's so consequential. I blew out my knee 10 years ago and nobody in my family even gave a shit. Like, it doesn't matter, you know?

Yeah.

So I think, uh, I think you were— you alluded to it earlier, like, it's not your focal point for getting people in the door is a less consequential patient. They build their confidence there, and there is a lot of precedent for that. And I mean, that's where, uh, most minimally invasive surgeries go that way, whether it's open to MIS in the foot and ankle space, I think the new subscap sparing stuff for the shoulder is going to go that route. Anterior hips, I think, demonstrated a lot of that. You picked less consequential patients and then you moved into it. So your marketing tactics there, I think, will be important. And it seems like you've got your arms wrapped around it.

Thank you, Kyle. I appreciate it. And actually, I do want to say one thing is while that's an entry point— and we'll get to Mark next— while that's an entry point, it's also important to know that we've got pediatric surgeons that do nothing but treat 13- to 19-year-old athletes. who do very well, that go— that rehab very quickly, but they've got it nailed. They understand the technique, they understand the rehab protocol, they've trained their PTs, you know, appropriately. So, um, um, and, and by the way, the, the MLS Players Association and the NFL Players Association have invested, you know, into this. So they, they see the long term too. So it actually can be a solution for that aggressive situation. But to your point, we gotta, we gotta Make sure the entry point for a surgeon is correct. Yeah. Mark, how you doing?

Good, good. How are you, Jamal?

I'm well, I'm well.

So, for the benefit of everybody on this call, there are certain people in my constellation of associates that when they talk, I listen, and Jamal is one of those. And there are others on this call in the same, in the same boat. I love the ACL procedure. I've been watching these guys do this, you know, for more years than I care to repeat here. I've always found that the initial fixation stability was incredibly important to the long-term outcome.

Absolutely.

And that the French technique that I'm most familiar with is so stable at fixation that Their proprioception is so high that they actually think they're healed and they have to be like toned down so they don't screw it up. The— you were talking about training the doctors. I know we have here in Atlanta, Dr. Balada, who is probably one of your key users, I think, right? So yeah, next time you come down to see her, gimme a shout.

I will.

I will.

I haven't made it to Atlanta yet with my new job, so that's—

Congratulations.

Actually, you just gave me an idea 'cause I'm gonna head down to Duke next month. So, Swing by, swing by.

So the, uh, the, the concept of training for this procedure, I heard you really hammer on that. Yeah, a little bit, or emphasize it. Um, are you doing any, uh, artificial cadavers technique, uh, training, or is it all actual specimen cadavers?

We do have a, um, um, a foam type of model, and I would say it's kind of a A Sawbones Plus model. I don't know how effective that is. I mean, it's really for the surgeon who just needs a refresher or something or so on. So we, you know, it's a good question. We've got a really good medical education team, but we've been very focused on cadaver specimens.

Okay.

It's been a hard thing to replicate. I mean, even with our prior, you know, life, you know, that's fine for maybe a meniscus repair, but Given, you know, getting— I mean, it's wet, it's a wet procedure, right? You gotta, you gotta bloody collagen piece that you've got to have that art of getting it in. You've got to reapproximate the AC, and the ACL tissue is so unique, like teaching doctors how to sew that ACL tissue. So, so far we haven't really, you know, cracked that wicket, so to speak.

I wouldn't think so either. I have one other thing, and that is, and Dennis would be familiar with this. Dennis and I are associated with this new platform, I'll say. And one of the things that we have at our command is a new procedure from Austria that measures symmetry in the lower anatomy after healing.

Mm-hmm.

So for example, right now, if you have an ACL repair, There's no way for your doctor to say it's okay to return to play. I don't care whether you're a pro or an amateur or return to work, except through their very subjective analysis. How do you walk? How do you look? How you— do you have any pain?

Right.

This new procedure, which is not yet in the US, will give us the ability to quantitatively determine your ability to return to play. So it's something we should talk about in the future because it would give you one more edge, so to speak, because I have a feeling that your, your healing time is probably, uh, pretty good.

Yeah, well, that would be interesting, Mark, because one of the challenges we have with BEAR is because you're not harvesting these tendons and you're not creating all this other pain, yeah, patients feel too good.

And that's what I'm talking about.

You have to pump your brakes and say biology takes some time, right? You've gotta, you've gotta regrow So that would be interesting is how, how do you say not only how you feel, but have you actually healed?

Have you met— yeah, how have you measured? Can we quantitatively measure that your body is back in perfect symmetry? And it only does, it only does that when you're healed. Yeah. So interesting. Thanks a lot. Good to see you.

Oh, you too, Mark.

Yeah.

Dennis, I think you had your hand up next.

Yeah. Hey, Jamal, first of all, excellent presentation. Thank you for getting on with us. My pleasure.

Thank you.

You had a— you talked about, I guess, retooling or reorganizing or redoing the sales force. I mean, everything right now is about execution, right? I mean, if you can't execute— I found that section to be very interesting. I'd like to— if you could elaborate on what, you know, what are the changes or things that you feel need to be done? I'm not worried about what they did in the past because I actually have seen the procedure quite a bit. Yeah. Um, but I'd really be interested in your take on what sales execution in this, uh, in this arena looks like and why and what, you know, what is physically you're going to do or are doing.

Yeah, no, it's, it is really, it's the right question. Um, first of all, I want to say, you know, a shout out to our sales organization. We, and I've said this to them, they know their craft. They know sports medicine. They know what they're looking at when they look at that white circle in scope. They know how to talk a doc through a procedure with Bear or anything else about the ACL. Reps have to add value in the OR well beyond what they sell. And I think we have a group that knows how to do that. So that's great. So to me, when I look at sales productivity, I don't look at people got to work harder. And I give the analogy of, you know, if you— most college athletes are kind of the same.

They're good.

They're really good. That's why they go, they're playing, you know, D1 ball or D2 ball or whatever. But why do they go to one college or another? It's the program, right? The program, the coach, the assistant coach, what program do they put in? And I feel that that's what we have to bring to the sales organization. So, just to give you some specifics, we got reps that get on airplanes, direct reps that get on airplanes to cover cases. They have to drive 5 hours, you know, to get somewhere.

Right.

We've got some buckets of kind of undefined team selling where, while the senior guy or gal may get the credit, what is the junior person actually doing, right? And are they, again, not because they're not doing anything, but are they most effective? Do they really know what you need to do is you need to be in your city, in the hospital all day, every day, catching the doc in the break room if needed, but it's cases per rep, it's cases per rep, right? So that's a mental change that we're going through, um, as opposed— and, and by the way, it's— I just don't really want to talk about the past. We got to a pretty good level, right? Oh, they did. They did a good job. But what gets you from A to B doesn't get you from B to Z.

Correct.

So it's territory design, it's compensation. We're a hybrid, 75% direct, uh, 25% independent in terms of revenue. I, I do believe, um, not just because we have some on the call, that independent agents can be very effective. And that's a great way to supplement. But when you're missionary selling, you know, direct really does matter. So it's all about, you know, individual measurement and accountability, smaller territory sizes so they can actually see this, making sure they understand current levels of education. Continuing education hasn't really been a thing. They're trained and then they go off and the messages are all over the board. And that's on us, right? We have to teach them the talk track. the new data, how can we help them overcome these objections? So that's kind of one thing. And on a very basic level, my average rep does 2 cases a week. There's no reason we can't do 4 cases a week from a capacity point of view, as long as marketing is ahead of demand, but they're too distracted doing some of the things. The other thing is we had— we peaked at 33 direct sales reps back in Q1 of 2025, and then we went down. So you can't be a growth company by cutting your sales reps. And so we just got off a call. We're getting back up to 33 as soon as possible. We're going to grow sales reps. So that's really it, Dennis. There's a whole program around sales productivity to help our great team be more effective, and we got to grow the number of our sales reps.

Thank you. I ran into this very same problem when I talked to— the reason I didn't want to say anything about this, because I talked to them about this when they were launching it, because we ran into this and we were able to solve that problem.

Yep.

But it doesn't mean just because we solved it or I have solved it in the past that somebody doesn't have better ideas. So I'm always looking to add on to that. So thank you for that. And, you know, I mean, it's a great procedure if you've ever seen it. done and seen the patients later on, the physicians that do it really believe in it.

Absolutely.

Absolutely, they do.

Thank you, Dennis.

Excellent. Okay, Sheila, we're going to— you're going to get the PT perspective now, Jamal.

I apologize for my appearance. I was playing pickleball, which, you know, is technically along my lines of research for my company.

We all love pickleball and joint preservation. Yes, we do.

Yes, we do. I just wanted to say, again, I love what you're doing. As you were talking, I felt a level of just angst of getting surgeons who are notoriously a little bit slow to mutate and learn something new. But I was just going to say, as just an experience share, I do think marketing to PTs because— or athletic trainers, as a mother of 3 who had 3 go through sports, an injury happens on site, there's an athletic trainer or a PT. You know, and they kind of tell them where to go and what to do. And the parents trust that situation. And the more I learn about techniques, the more I share with my patients. And it's like you find one PT, you might find 50, you know, plus patients or whatever. And so I just think it's— because I noticed your website, I was looking at it, you know, and it says, hey, if you're a PT, you should click on our link here. But I only knew to go to that because of you right today.

That's right.

So I think it's definitely something the APTA, American Physical Therapy Association, is always looking to learn about new techniques. And you're saying all the things we care about, which is delaying arthritis, delaying a surgery, providing a better avenue for a very, very common injury. So I think PTs and athletic trainers are almost the first line of defense, especially during those first few days of just trying to figure out how serious it is before— I don't think the first go-to is immediately to a surgeon. But, I will tell you, I get calls all the time and I'm a knee replacement girl. I'm not a young sports medicine girl, but they'll be like, hey, my daughter hurt her knee during soccer. They'll tell me the symptoms and they'll be like, the surgeon wants to do surgery immediately.

Yeah.

And, it would be nice to be able to say, hey, you should ask them about if they're a candidate for this approach. And, I'm not saying the surgeon's going to be like, yay, let me learn about a new technique. They're going to probably steer them down to what they know. But enough people start doing that and change happens. So just— but I love what you're doing.

Thank you, Sheila. And actually, super good points. We actually— so when I mentioned the patients, 75% what the doctor says and 10% what other healthcare providers, it's the PT, right? So you're absolutely right. And the more patients we can get to go to prehab and really talk to the PTs— so interesting that you say that. We've been making some efforts in marketing to PTs. I just made a note of going directly And understanding APTA is something I'm gonna look into. We've had some events. I think we actually offer some CME programs, which is good too. But you kind of really reinforce that. I have not spoken with enough PTs, but my sales team tells me that the PTs believe in it a lot more than the surgeons because all the BEAR patients, the PTs are like, these patients are doing great. You should do this.

Yeah.

Well, and I would tell you that it's great that you've done CME. We call it CEUs. I would find a therapist that does a lot of ACL rehab protocol seminars and be like, hey, can I tell you about our product? And I'm telling you, they will immediately adopt because they love to share with their audience, the PTs, anything that's new, latest, and greatest. They want to show cutting edge. They would just incorporate that into their training and education and spread the word for free for your company, right? I would do that too. Yeah.

Thank you. No, absolutely. I'm going to have a chat with Lisa, who's our head of marketing, after this.

Right. Sheila, good one. Sheila, Mark?

Yes. So 2 quick things. Number one, um, Stephen Flutie Davis is one of those people I was talking about when he talks. His work with AI and outreach and information gathering is unparalleled. He's, he's worth a call. Thanks, Mark. Uh, so the, the other thing is, while you were talking, I looked at a 2-year post-op study of the BAER versus, uh, allograft And what was interesting about it was that the— it mentioned specifically that the rate of symmetry at 2 years, which by the way is a fairly new word to me in rehab, but not, I'm sure, to Sheila, but it's 98% plus at 2 years for the BEAR and only 63% for the traditional ACL because of either hamstring or—

Yep.

patellar tendon weakness, which I thought that was incredible. So Dennis and I will probably talk about that one.

Yeah.

Yeah.

And that translates directly to that hamstring strength, right? And not favoring the bad knee and therefore your good knee's not gonna get overstressed. So, yeah, I mean, I hate to predict, but I still go down those diamonds, you know, chasing my son. And, but if and when that time ever happens, I would certainly want one in my knee.

Cool.

Symmetry is a cool thing. That's interesting. Jamal, let's talk about market access fights. I'm sure you're winning new surgeons and you gotta go through their process.

Yep.

What's the tall pole in the tent? Is it coding, contracting, or we've always— we're hamstrings, we always do hamstrings. What's the pushback?

Just like everything else, you go through the VAC committee, and the VAC committee is, um, uh, Byzantine, opaque, and who knows what the right reasons are. So you've got to go— I mean, all of us, I think, understand this. Um, so look, we've got, um, really what we have to do is educate the, the individual accounts. The first thing to know is this is not a Medicare play, right?

None.

I think 99.9% Plus percent are under the age of 65. So this is all commercial pay. So every time they say, well, this only reimburses, you know, $4,000, how can you do this? Like, well, multiply that times 2, first of all, because it's commercial pay. It's not Medicare. That's kind of education number 1. Education number 2 is there's different ways of coding. So we did get feedback that ACL reconstruction arthroscopic is an appropriate way to code. We've got other accounts that are doing, well, I can also do an open repair, and that's a different code. We've got add-on techniques because when you have a complex ACL with a meniscus or an LET procedure, that's a different code. Many of those are actually profitable for the centers. And so there's just a really gap of education that we need to get around. And typically our rule of thumb is we wanna make sure we always price to what the market will bear. No pun intended. If you can stay under 50% of the bucket, you're usually pretty good and we do that. But mostly we're well under that 50%, so we're okay. I think long-term we have an initiative that we have enough data. We have more data than many orthopedic, if not any orthopedic single product I've seen in my career. They've done so much work on short-term and long-term data that I think we have a very legitimate case to be made of our own code. So that's like a 2028, 2030 sort of event, but we will be going for it and seeing what we can get. But in the meantime, it's really about educating the facilities about, you know, the coding options and really to meet them where they're at. And if we're going up against a $1,000, no device, suture only, a button, you know, an off-brand button and a piece of suture, and that's their driver, They're not going to do a BEAR. And, uh, and that's okay because we have 1% of the market, so we've got plenty of ways to go.

Interesting.

Uh, there was a chat question that came through. We're, we're hitting the top of the hour. Does the future of tissue preservation justify the cost, the additional biologic activity, and regulatory complexity of a BMP-12 with the BEAR implant if dose release kinematics, localization, tissue quality, and safety can be optimized.

Yeah.

Cost-benefit question.

Interesting. So I'm not familiar with BMT-12. I'm familiar with some of the FGFs and some of the other ones. And I wonder, is that the B— is that maybe the P-12 from the other company I just highlighted on my slides? Can't remember. So Yeah. When Dr. Murry studied this, because doctors are saying, well, shouldn't I add PRP to this? Shouldn't I add BMAC to this? What about growth factors? And so forth and so on. She actually studied this and she studied it with PRP, not necessarily BMAC. And it was either no difference or worse. And part of the reason is, as many of us know, I think in the industry, PRP is not all the same. And a lot of times you destroy your platelets and your growth factors in the test tube. And you're doing absolutely no, no good. So there's something physiologically about just being natural. Blood has what it needs and you've got the signals of, of what you need and so forth. Would an FGF2 or a BMP12 or something to that enhance? You know, it's an interesting question. I, I guess maybe the question would be, what is that? Does it, can you meaningfully accelerate the time that biology takes to heal?

Yeah.

So we've got all these advantages. But if you can, if you can say you can be back on the football field in 3 months, that could be very interesting, actually. You know, don't know. Don't know.

Interesting.

But I think it'd have to be a materially faster return to activity. That'd be my thought.

Yeah.

Well, we're at the top of the hour. Congratulations. I mean, you got, you know, no pun intended, a tiger by the tail. Yeah. I mean, We didn't talk about other applications, but there's a lot of tendons and ligaments in the body. Yeah, yeah.

Well, you know, orthopedic surgery: see one, do one, teach one, redesign it. And that's the 4-step process. And we got a lot of creative surgeons out there who want, you know, want to find other ways of using this technology.

Well, thanks for your time, Jamal.

Thanks for the opportunity. Great to see some old friends and maybe some new ones.

Yeah, well, uh, we'll definitely have you back for part 2 in a few months and see, see where you are.

Thanks.

All right, cheers guys.

Good luck.

Have a great weekend.