BoneChat #85 - Revolutionizing Hip OA: CytexOrtho's Renew Implant Bridges the Gap for Young Patients

This is Bone Chat number 85. We have Brad Estes, CEO at Scytex Ortho. And Scytex, if you don't know, is treating early hip OA patients who are just too young for a total. And this is really, really near and dear to my heart because there's a, there's a donut hole of patients in hips and knees that don't need hardware and things like what Brad's doing with interpositionals makes so much sense. So he's— I'm handing the slides over to Brad.

Welcome. Great. Well, thanks, Tiger. Thanks for having me on today. And this is one of those, one of those opportunities I couldn't pass up just to interact with this community. I mean, this is a community that, that's in the know, that's been through the trenches. And so I'm excited to have this conversation with you guys today. But, but we really started CyteX Ortho to tackle the problem of osteoarthritis. And I don't need to define it for you guys, but it, it, it's a debilitating disease that affects 1 in 13 globally. And at end stage, joint replacement is the only option. But the more we, we got into it, the more we realized that this isn't a disease of just the elderly. Tiger, as you were alluding to, over half the patients are under the age of 65. And they don't have any good solutions. They're, they're kind of caught in, in limbo is the way I like to say it. They're, they're living too much pain to live a normal life, but, but they're too young for a joint replacement. So what do they end up doing? Most of them end up waiting for 7 or 8 years for that hardware that you're talking about. And, and they just don't want the early replacement and multiple revisions in their lifetime. So, so our, our contention is these patients deserve better. And that's what we're trying to do at Cytec's Ortho is to change their reality, So for us, it's, it's more about joint restoration, not replacement. And so, so that's what motivates us each day. But let me pull up a slide deck and then we can jump in and hope to have a good conversation with you guys today.

Yeah, he's gonna go through a lot of technical stuff real fast. So just raise your hand or yell. You don't even have to raise your hand.

Right, right. So I divided it kind of a motivation, kind of solution, a little bit of the science and. And then kind of segue pretty fast from there to the, the patient population and what they're going through just to, to, to set the stage here. But I always like to start with just talking about, uh, the number of folks that are in, that are, that are really suffering from osteoarthritis. And it affects all of us 'cause we know someone in this category. With over 30 million in the US suffering from the most common form of, of arthritis, which is osteoarthritis, but over half being between the ages of 18 and 64. If we look at the hip population in general though, there are over a million patients under the age of 65 with chronic hip pain, and this is our first targeted indication. And they— but we know that only 20% of that patient population will proceed to a total joint replacement at that young age. You can do the math as well as I can, but that leaves 80% that choose to live with chronic pain and disability for two reasons. One, they want to avoid restrictions on high-impact activities now, but they fear for their future quality of life and what these high revision rates mean for them. And this equates to a $5 billion US market opportunity by 2030. And this slide really highlights that journey even, even better for this patient. And what I've done here is I've plotted treatment complexity on the y-axis and stage of disease on the x-axis. Certainly, first-line treatment options for these patients, they're, they're, they're not curative though. And so what we're looking at is these patients that are still staring at a total hip replacement. In the distant future. And in those intervening years, there are simply no treatment options for that patient. And again, that, that journey from here to this total hip replacement is about 7 years. And 7 years is a long time to live with chronic pain and increasing disability. And this is the reality of these patients. I, I want, we, we just get calls and, and, and messages on social media and emails all the time from these patients. And they, it's a reality for these patients. And this is what we're trying to change right now. There's lots of patients in this category that are trying to to do anything they can to not get that total hip replacement at a young age. So our solution for the active patient is RenewHip. Instead of replacing the entire joint with metals and plastics that are supposed to be permanent or long-lasting, we're just dealing with the damaged areas in the joint. We're restoring the anatomy and we're restoring the contours of the joint, as you can see in those images, but, and then we're designing, we design it to mechanically function from day one so these patients can get back to their active lifestyle. And the cool thing is over 2 to 3 years, the implant is slowly replaced by their own natural functional tissues. And we think this is the only solution they'll need, but we're also not burning any bridges if they need a hip replacement in the future. So we call this a smart osteoarthritis fix because we can restore the anatomy from day one functionally. And it's, and we're working with two components here. This 3D woven textile is our secret sauce and kind of what got us started on our journey when I was at Duke University. And then we marry it to this true 3D printed layer that the combination of which that we, that we integrate during the manufacturing process mimic the native tissues of cartilage and bone. And this is important because whenever you have inflammation in the joint and you have osteoarthritis, that leads to deterioration of the joint surfaces that leads to erosion. And in order to be successful, we have to restore that anatomy. Here you can see a cross-section showing the 3D woven textile, and here's the true 3D printed layers. And these are the differentiators between us and other cartilage repair technologies. One, that we restore the joint contours as I'm showing here, but then I'll show you in a couple of slides here that we integrate with native tissues readily within 30 days of implantation. And then we absorb slowly and transfer that functionality to native tissues. And though this is just showing an image of the implant and how it interacts with the bone, this is a micro CT scan of a goat femur. And this is, this is 3 months post-op, and you can see the implant that is firmly in place, and you can see the contours that have been restored, and you can see how it engages in the axial image of this femur. So here's just a picture of some of our acetabular implants, and I just like to highlight here the bi— the, the, the bicurvature of these implants showing the curvature in two planes to fit the local anatomy. And here's the textile, and here's the 3D printed portion. So just a little bit about the science behind it, and especially the textile portion. This is the loom that was created at, at Duke University when we were there, and this is where the technology was spun out of. But there are 400 fibers going into this textile structure, 400 plus I should say. And then we're weaving this structure that you can see in cartoon form here. These are our X fibers in green, the yellow fibers are in Y, and then we consolidate this whole matrix with this blue, blue, blue fiber. And the idea here is that if you can control the spacing on all three of these axes and choose your material and choose the diameters of these, then you can start to engineer the properties of the tissues you're trying to replace. And that's what we did with articular cartilage. And our first paper was in Nature showing that we could do this. And the, the awesome thing is, is we have this interconnectivity in whatever direction we look, which is really important for nutrients and biological incorporation. And so the other hallmark feature of this structure is the ability to form these complex shapes. Now these aren't super complex, but we can form a condyle, we can form a hip that we published this in PNAS a few years back, showing that we could form this hemisphere or this condyle without losing the mechanical properties and without the ability to, to, to lose, without losing the, the cartilage, the regeneration capabilities as well. And this is a large confocal image. Green is live tissue and the red is the, is the implant. But here you can see the cells and the tissue within our implant. This is just putting cells in from one side. These were fat-derived stem cells, but it doesn't really matter what cells we use. We get complete incorporation and integration with those cells and tissue development. And this is a type 2 immunohistochemical label for, for type 2 collagen showing that we can put cells on one side. They populate this matrix. Here's the Z fiber of our implant showing that it's making the principal collagen found in articular cartilage. So we showed this early on in a lot of our benchtop studies. And then to the textile portion, we married this true 3D printing technology, and we actually borrowed this from the electronics industry. They are— they use these on manufacturing floors for electronics components like, you know, iPhones and, you know, whatever, what piece, anything with a PCB, they use this type of equipment for precise dispensing of liquid. And so we can have tight control of the— of depositing the PCL on the implant. You can see we can get down to 200 microns pretty easily and control that. And here's a, just a picture of, let's see if I can get this to play. You can see that we're printing in 3 dimensions here. So most 3D printers print in 2D and, and index to laminate multiple layers together. I hope you can see that we're, we're printing in 3 dimensions in here. And this is important to get the right contours of the implant for precision because when we go in to replace the, the surfaces of the joint, we need both the 3D printed portion and the textile to match those contours. And here's just a picture of those implants, and you can see the contours, and you can see this 3-dimensional printed lattice. And so just showing you some of the preclinical data and some of the, you know, some of the summaries from that, you know, we, we were able to restore the activities in the animals. This was our 6-month canine study that we published in Science Advances. And we showed that activity levels with RenewHip implant were restored within 3 months, and the osteoarthritis control group remained lame throughout the entire study period. And I could show you the data, and you could look this paper up, but we showed that we restored mobility, motion, and importantly, we got these animals to be pain-free. And we could tell that just by the inventories and how they were interacting with their caregivers. And I'm happy to send this publication to anybody who's interested in taking a look at it. And then after we, we euthanized the animals, we were able to look at histology and the mechanics of these joints and really just showed that, you know, on the control side, nothing surprising here. If we just do some kind of bone marrow stimulation sham type procedure, I mean, you don't have to be a pathologist to understand what's going on here. This is a serious defect that remains at 1 year, and you have fatty fibrous tissue that's nonfunctional. But with RenewHip, We restore this anatomy from day 1, and then that, that anatomy is maintained, that reduction is maintained throughout the 1-year time period. And we also get the differentiation along this cartilage and bone lineage while significant absorption of the implant takes place. So you can see the dotted line of our implant here. And then in these corners here, there was implant here initially. That implant has absorbed, and as that implant is absorbed, we have all this tissue that's filled in here. The polymer matrix is disorganized now, indicating that the tissue that's synthesized is now functioning instead of the polymer from the implant. And these data were critical for FDA as we, as we got our IDE study approved, because they looked at this and realized that, okay, by the 1-year time point, the implant has done its job. And that was the idea. Let the implant do its job and then get out of the way. So you can see the integration with bone and the cartilage. And then I'm not showing you these data, but when we map the compressive properties of the cartilage across the joint surfaces, we show that that's restored too. So that's a little bit of the science, and we'll shift a little bit. If anybody's got any questions on the science, please speak up or, you know, ask any questions here, but I wanna talk about the patient journey a little bit here too.

Yeah, I got 2 quick questions, Brad. What are the materials, and how do you fix it so it doesn't, you know, shear out of the way?

Yeah. So the material for the textile and the 3D print are both polycaprolactone. Okay. So they're, they're both an absorbable polyester. One's in a yarn form and the other's in pellet form that we extrude from our printer. And, and your question about the delamination was one that FDA had too. And, and that was something we had to go to, to, to great lengths to show them that this isn't a problem for our implant. And, and that's, I think that's where kind of our secret sauce is, Tiger, and how we, how we integrate those in the manufacturing process, but we were able to convince FDA unequivocally that's not the weak link of this implant.

Wow, that's, that's strong work.

Yeah.

Thanks.

So, Brad, other than the delamination and the material, how is it attached to the actual defect at the time of surgery?

So, so we create a precise pocket, Eric, for, for the implant. So it's not like we want— we don't want to cut the implant because it's engineered to do its job.. And so if you start cutting and then you could compromise that, and it doesn't cut very well because of the yarns and fraying and that kind of stuff. So we've made the instruments to make precise pockets for the implant. And then we just have an array of implant sizes so that you make the pocket and then you pop the implant in place.

Right.

Cool.

That answers my next question. I was wondering if the 3D printing was patient-specific, but it's not.

And that's good. We get that a lot, and we've tried to avoid that at this point. Just, it's expensive enough to go do this kind of study without doing patient-specific. We can do it, and we've gone from MRI directly to the CAD system to the printer. We can do it, but it's just, I hope we don't have to, but, but that's possible.

Hey, Brad, question for you. When you make that pocket, do you pepper the joint space to increase the blood supply, or is, or is it a microfracture? Um, or do you have a tool that, that makes it— because I've seen variability on belief systems of how, what the best opportunity is. And so making sure that, that you can close that window to protect your implant is really viable.

Yeah, yeah. So our implants are, are almost 4 mil— our smallest, our thinnest implants that we're going into this clinical trial, whether about 4 millimeters tall. So what that means is they're going to get through the cartilage layer, they're going to get through the, the subchondral plate in the, in the joint. So we're going to be into that good bleeding bone bed by that time period. So we, we haven't done anything else in our, in our animal studies to generate more bleeding, but typically when we put these in, the implant wicks that, that blood and marrow in pretty readily, and that, that starts that healing process.

Yeah, that's the, that's the problem that I've seen with these implants is surgeon preference and variability on depth and how that surface is prepped. Um, and so, you know, Joe, uh, what's Tiger— Joe, what's Joe's last name? Um, he was with— no, no, no, Scan SC something. I'll send it to you. He has an interesting, uh, peppering implant that actually creates these.

Oh, Saladino. Yeah, Joseph Saladino.

Yes.

It's a really cool thing because anytime I'm part of these trials, each surgeon has their preference on what they think stimulates and will incorporate the bone, right? And so if you— that's where I think the biggest issue is with regenerative products in general, is getting that baseline and closing the gap for surgeons to go outside of those windows or So, and that's gonna, in my opinion, that will also create the difference in your outcomes, closing that window on how varied the outcomes can be.

Yeah. Yeah. So, so we're trying to control that just by giving them specific instruments to make that pocket right now. And the way those, those instruments work is that, is that we, we're able to make that pocket and put that implant. So it's So it's about 200 microns below the surface of the, of the articular surface.

But if you create those little micro tunnels in 1, 2, and 3, little peppering techniques, that also stimulates the incorporation from what I've, from what I've read and seen personally.

So yeah, we, we've also seen some things we've done and I, I hear you 100%. I've, and I've seen the different preferences for that. When we've tried, when we've tried to be overaggressive in creating some of those tunnels and, you know, maybe we put too many, then you can get, you can get this lytic response from having to deal with that bone too. And so that, that's one of the things that we're, we're a little fearful of. If you, if you're overaggressive there, then you can get these, these lesions, these bone marrow lesions or these cyst formation. And, um, and we haven't seen that as long as we stick to our instruments. If we go beyond that, we've seen some of that.

Before. Nice. Yeah, that's perfect. And then the second thing is, um, I read a new study about how women heal differently. So women naturally have more fibrous tissue. The end goal is— the end result is the same, but initially women have more fibrotic, um, growth. And so, um, I don't know if, um, you're seeing that as well, um, But it's just a commonality in just women in general and our healing responses.

Yeah, that, that's an interesting comment. That's something we haven't been able to study in our preclinical animal models. Um, so, so it'll be interesting to track that.

Yeah. Well, I have a paper for you that defends that if you see it, because the end goal is the same. The end result is the same in bone formation. So you have a way to, um, to, to counter that if there's any issues.

Yeah, send it to me. I'd love to see it.

What about post-op weight-bearing?

So in all the, in all the clinic preclinical trials that we did, we didn't restrict post-op weight-bearing. So we've done goats, we've done 4 GLP studies now, and multiple goat models, and, and so 2 different goat models, and then 2 canine models, and we didn't restrict it.

And it's put in arthroscopically through, like—

No, this is an open procedure right now.

Any open?

Yeah. Yeah. And the first in-human study will be, will be an open procedure. And then, and then our goal is before we get to the pivotal trial to have an arthroscopic, to have the ability to put it in arthroscopically. And that's something we're working on right now.

Brad, is there a certain level of acetabular deterioration that you're comfortable with, or how do you evaluate, like, you know, what, what condition the acetabulum is in that, you know, beyond a certain point is, is sort of considered too damaged?

Yeah, I mean, we, we need to, we need to have some joint space there. You know, typically you're, you're greater than, you know, 2 millimeters of joint space. And then there has to be contained lesion with good cartilage on either side of the lesion. So we can get pretty large with our implants. But there needs to be, be some normal anatomy on the outside of the implant so we can anchor it. If the— if it's like widespread disease and the whole tissue is— the tissue is deteriorating, you're getting to end-stage disease, then we're not comfortable with that. And so that would be, that would be an exclusion criteria for the study. But, but outside of that, we can, we can handle some large lesions. If that— does that answer your question?

Kind of, um, but Like in the study, do you, do you, do you, do you make them like scope it first to assess the condition of the acetabular cartilage?

It's MRI. Uh-huh.

And so, okay. So MRI, a preoperative MRI.

Preoperative MRI.

That's right.

Okay.

And, and we're limiting that this first in-human study is, is femoral head defects only. And yeah, we're seeing stuff like, yeah, femoral acetabular impingement, some slight dysplasia, trauma, osteonecrosis, indications like that. And then, and then we'll open it up to acetabular lesions. That's one clinical study.

Yeah. 'Cause I'm not familiar with any of these studies in the hip, but there's been plenty of similar-ish studies in the knee and there's, right. You know, they're littered with screen failures from people who think sort of they have a femur-only problem and they, they open it up and there's a ti— there's, you know, the tibia is too damaged as well.

Yeah. That, that'll be an interesting part of the study and just to, to see about getting that patient population in, see how many screen failures there are and yeah. And getting it enrolled. But that's, that's a challenge for all these clinical trials. Yeah, yeah, it's a great point. Um, so I can talk a little bit about the patient journey and then, um, you know, and just kind of the things that motivate us day to day. But this is a quote we got recently that I've, that I put on here that some, from a, from a patient that, that contacted us. You know, I'll be first in line to try this if allowed. Everybody's, they want to come in the door and get this implant right now, which is, which is pretty awesome. But it's also a little bit sad because these, these patients are looking for solutions.. And so, and Dr. Vail, who's on our clinical advisory board, who made a living, you guys probably know Dr. Vail pretty well. You know, he, he made a living replacing joints. And, and this, and I'm, and I want to be clear here, I'm not denigrating total joint replacements. I think it's a fantastic procedure for the right patient. I mean, you get to your, your sedentary patients that, that are, you know, 70-plus years old. It's a great operation. And that's not the market that we're going after. We're trying to to solve problems for this younger population. And yet we're pretending in a lot of ways that that total joint replacement's okay for that younger patient. And that's, that's what I'm pushing back against. And that's what we're trying to solve at CyteX Ortho. And we're seeing, and Tiger, I know you've commented on this in some of your blogs too. We're seeing this, this push for total joint arthroplasty in these younger patients. And I just put this slide together to say, is this a good or a bad thing? You know, if you look at the, the Wall Street Journal article that came out about this time last year, we're talking about, you know, patients under the age of 65 getting joint replacements, and the AHRQ put out data saying that this population grew 200% over the last 2 decades. There's no long-term data supporting this trend. There's a high revision rate. And then we know that the AUCAS and AOS recommend no high-impact activities on these patients.. And so we know patients will also push the limits of these prostheses. And so we're, we're gonna run into a problem for these patients where they're gonna, they're gonna cease to be revisable if this trend continues. And this is just a real problem that we're running into with these patients. And, and you see it here in this quote. This was actually in that article, in that Wall Street Journal article. This is a 54-year-old who had seen multiple revisions. And he says, you know, when you're squatting in the gym and running and then get a hip replacement, you can't do it anymore. That's not so great. Again, that's the reality of that patient, and this is why this 20% number is true. Those are the ones that are opting for a total joint replacement right now. And so Bruce Reiter talked about joint preservation being on the rise. And, you know, you can, you can see his quote here, but, you know, one of the biggest stories in orthopedic sports medicine over the first two decades, he, he says it's, it's the growth of hip arthroscopy and associated joint preservation techniques. And I think that's just good timing for us as we're working on some, a way to add to their tool toolbox to treat these patients. And then Dr. Ganz, who, you know, who basically pioneered the Ganz technique for a lot of these hip preservation procedures, you know, he said that most, if not all, hip OA is secondary, often due to subtle but definite and commonly overlooked developmental deformities of the hip. In other words, if we can get these patients early enough, then we can, we can solve some of those problems. And we're just seeing this growing interest. We're seeing growing interest in, in growing, this growing rate of hip preservation centers popping up all around the, the country. And, and, and we're seeing just this great interest in femoroacetabular impingement, lots of RCTs. The ANCHOR Consortium's doing a lot of work to, to put, to put data out there on how to treat these patients. But it's a growing population that's, and, and I'll highlight some of the problems that we're running into here with these patients. So there are limitations. This is a 17-year-old male athlete, and you can see some of his impingement conditions here, um, on this, uh, on this, this femoral cam lesion and causing some problems on this, on this acetabulum. And then you can see the labral repair here, but when you get to the cartilage repair here, it's delaminated and the, the surgeons are looking at this, we don't have tools to address this. So, so this is where where we think Cytex Ortho can come in and start to provide some treatment options for these patients. Allografts are used on the femoral head and also in the acetabulum. But these are difficult procedures. They're difficult to obtain the grafts. They can wait months to get these grafts. It's— there's difficulty shaping the grafts. If you don't match the curvature right, you can have problems with that. It's expensive and the graft survivorship is, is less than— is, is at 5 years is about 80%. And this is some recent data that came out of the Mayo Clinic that I'm quoting from these numbers here. And so this is a 22-year-old with right hip pain. These, and I should say these images are courtesy of, of Jeff Neppl at WashU. And you can see some severe impingement here and, and this, this patient had to get a total joint replacement at the age of 22. And we're seeing too much of this right now and this is what we're trying to solve. So, We know this, we can look at other markers too that this market is growing. I mean, if you look at just the injectable market, $1.3 billion market this year, growing at about 8%, it's growing and it's not reimbursed. I mean, if you look at HA, you look at corticosteroids, you know, these, the, there are a lot of carriers that aren't even paying for these, but it's growing. So these patients are reaching into their pocket, willing to pay $1,600 to get a course of 3 injections to, to start to address their problems. And so, so this is a desperate patient population. And so one of the things that we're having, I'd love, love comments on this from you guys, is obviously we have to improve patient care with ReNu hip implant, and we have to, to lower costs, and we have to have it reimbursed. And so if we have to do all of those things, and so we're starting to get our minds around what that looks like, and we're gonna have to collect these data getting into the clinical trial. But these, especially the pivotal, maybe not the first study, but especially the pivotal trial. So this is the kind of thing that, that, that kind of keeps me up at night is, you know, how do we, how do we walk this tightrope of clinical regulatory funding, getting all this data to get to the market so we can help these patients? And we can do some of that early math to show that it's, it's a, it's favorable from a cost perspective, but there's a lot of studies that we have to put in. To show it. And these data, these numbers don't even take into account the burden of just living with pain over that 5-year period. So this is some work we have to do on that front. So real quickly, just on our— where we've been as a company, you know, we will surpass $22 million this year in funding. I got a couple of grants that are in the hopper that should get funding. And so we've done all this work. And get even to get into a clinical trial on NIH funding. So we have a super clean cap table right now. We're published. We dug in on the science side and did a lot of work on the science front to, to prove out the technology before we started, started getting into some of the animal work. We have breakthrough device designation. We won the Kappa Delta Award in 2021 and the inaugural OrthoPitch competition in 2024. And then we were just named to the MedTech Innovator Cohort this year. So it's a pretty good traction.

And then your, your fundraising is entirely NIH, or was there something else sprinkled in there?

There's about a— so, so our ratio is like 20 to 1 right now. So there's a little bit of dilutive capital in there. We did a crowdfunding raise a couple of years ago, brought in about $500,000 that way. And then I have a couple of SAFEs and we're just shy of $1 million on the dilutive front.

I mean, that's a— That is impressive to raise $20 million in grants.

Thanks. I appreciate that. It's great. And, you know, our team is committed to getting this to the finish line. That's what we felt like we had to do to get it this far. And we'll still leverage grant funding to work on some things because I think we have to. It's just so hard to get funding, institutional capital, angel, family office. It's really hard to get right now. So this is the team. I started at Medtronic, have product development experience. Frank is a resident textiles expert. And then Varsh is— I had the joy of studying under him. And this is where this came from when we were at Duke University. But he's recognized the world over for his work in regenerative medicine and tissue engineering. And then on the business side and the clinical side, this is our team of advisors. Drs. Clohissy and Bolle wrote the book on hip preservation.. They've been kind of guiding our development efforts. And then we got a team and some of these faces at the bottom of the screen that are familiar to this group. And, you know, lots of, lots of education of the major strategics there. So we've, we got, we got guys who've sat on both sides of the M&A table. And then our product timeline looks like this. I mean, we, we, we got an IDE study approved. We're raising a $3 million bridge round right now. We have a lot of clinical studies to do. Coming up over the next few years. And then we've mapped some exit opportunities, but as you guys know, exits are later and later these days, waiting for regulatory approval, not necessarily any recurring revenue, but establishing some sales base. But, you know, we'll see what happens there. And then we have some pipeline development to do in the meantime. And I mentioned some of that on development of the arthroscopic procedure. And that's— those are things that are underway. And there's also other joint applications, and we're working on some of those too right now. So So lots of things to do. It's just a question of bandwidth priority and that funding question. So that's kind of where we are right now. So I will stop talking and let you guys ask some questions and we can have more of a conversation about this.

Great. Good stuff. When do you hit the funding wall? Is it after the pilot? Can you get through the entire pilot without— New funding?

No, we still— we can get through some of the, the pilot study with the grant funding that we have, and it's a, it's a, um, it's funded by NIA, but I can't get it to the finish line just on that funding. So we need to raise some bridge funding, um, before then.

Brad, do you have any idea what the dislocation rate is going to be after post-operative dislocation rate? Because you're going to have to retract?

No. You know, it's, it's when you, that, that's a question we, we've, we've heard some before, Alyssa, but when I talk to the clinicians who do this, they say they don't see it.

Okay.

And they don't even list it as a potential complication. So when we talk to FDA, it doesn't, it doesn't even come up. So I think in the right hands that they call it a safe dislocation procedure or a GONZ procedure. But most, most people refer to it as a safe dislocation, cuz in the right hands it's it's really successful. And it takes about, it's gonna take 3 to 6 months for these patients to get back on their feet from that. So that, that's really good for us 'cause that gives the implant time to kind of incorporate and start to get that tissue developed on it and start to do its job so that when, when they get through that healing of that intertrochanteric fracture from the dislocation, then they should be ready to get back on their feet and start rehabilitating.

So some patients that I've seen are just prone to it. They're just lax. Another revenue stream might be to license a BMAC system and inject like the bone-to-tendon interfaces to strengthen. And then it gives, you know, it gives a better opportunity for those patients. But you mentioned about the compare and contrast. I wouldn't necessarily talk about the total hip cost. I would talk about the revision surgery expenses. Revision surgery is where you're saving the institutions and the insurance companies a ton of money because those patients do not do well. They have chronic dislocations. It's a very expensive procedure, particularly when you go into the custom route. I mean, you're saving not $38,000, you're saving hundreds of thousands of dollars. Um, and infection is significantly higher. Um, that's where I would go because that's the whole point of pushing people out, right? And that's why I don't— I haven't— I need— um, I was a Cartahill candidate, but I didn't want to have it until I necessarily need— absolutely needed to, because I knew once I started, surgery. It's just a ripple effect, the snowball effect afterwards. So if you can push people out instead of having total hips at 60, if you can push them out to 75, then you push out the revision. I mean, I'm preaching to the choir here, but that's where your real bang for your buck is.

That's a good point. I think one of the things that we still need to do is start interviewing the payers because this isn't Medicare. These aren't Medicare patients. So starting to interview the payers and understanding what they're going to want to see for maximizing that reimbursement. And I think that really comes into play. And I haven't thought of it from that angle.

This is—

that's a great point. And that's something we can kind of hone in on. So I like that. But Dr. Vail, I asked him this one time too early on when we were developing this. And I said, you know, so Ted, what How much time do we need to buy these patients in order for it to be worth it? So, okay, you mean is it 5 years? Is it 10 years? Is it 15? What's the answer? And he looked at me and said, it's just 5 years. He said, if you can buy 5 years, it's a win. I think we can do better than 5 years. I think we can do a lot better than 5 years. But I think that kind of underscored the problem for me is they're trying to do anything to get— to listen to your point— get that patient further down the line, and then it's worth it if we can just buy just a little bit of time. Okay, Patrick.

Brad, curious as to why you guys chose the hip. I mean, there's plenty of comparable-ish technologies out there, and they all seem to sort of start with the knee. So pros and cons of, like, why— what was the thought process behind starting with the hip?

Yeah, I mean, when we spun it out of Duke University, we took a dual-pronged approach, and we started working on knee and hip at the same time. And we were— we really struggled with animal models in the knee. And that's just putting my cards on the table. The animal models are really hard for knee. And at the same time, we were working with a veterinary surgeon at NC State whose expertise was, was hips, canine, and pain. And we put together a study and we submitted a grant and got it funded. And to look at longitudinal response to our implant, measuring gait, measuring activity levels, measuring measuring quality of life for these animals. And that was kind of the starting point of walking down that hip, the kind of the hip indication to begin with. Because in that study, and I showed you some of that data in the presentation, if I could draw the, if I could have drawn the graphs ahead of time, what I wanted the study to look like, that's how I would have drawn them. Because we hit on all fronts and knocked it out of the park with that study. And just showed that we could resurface their hip, get them back to normal activity levels, and these dogs acted like they were perfectly normal within 3 months. And that set us on our journey for hip, and we've toyed about doing some other joints, but then when we started talking to Drs. Clohissy, and we talked to Dr. Bolay, and Young-Jo Kim, and, and, and looked at those guys and, and said, why, you know, what do you think? And, and they go, we're just grateful somebody's working on the hip because everybody else is working on the knee. Yeah. And that gave us some real first mover opportunity. And it also coincided with this, this huge, huge kind of growth in the hip preservation market. And I kind of alluded to that too. So, so I love our position and I love where we're going and we're staying out of that crowded knee space. And that's not to say we're not getting the knee because full disclosure, we're working on knee too. But that's, that's not where we're. We're going to begin with. It's just, it's, let's, let's do the hip stuff. And then, and there's other joints too, but, but we'll get there as soon as we can. Mark.

So the, um, a friend of mine sent me a deck a couple of weeks ago about, uh, the, uh, a new device that object— that measures pain, uh, objectively and subjectively in animals. I was curious how you were measuring pain now?

In the animals, how we measured the pain?

Yeah.

So do you— so in, in the, in the canine study, you can— we had an inventory that we use with the caregivers basically scoring their pain levels. You know, you know, does the, does the animal wag its tail when you, when you approach it? Does, uh, do they eat normally? Are they scared of you? Do they, do they They, do they, do they bite at you? You know, if you probe the joint area, do they respond to it? So, so there are ways you can assess pain and we can really understand in our canine friends, you know, if they're, if they're happy or not, you can, you can read them where you can't do that with a goat or a sheep. And so, so that was one part of it. The other part was just, can we measure gait? And I could show you some gait data where we show where we restored their gait, their vertical impulse. Their, you know, their, all the force plate data, the pressure-sensitive walkway became normal again, showed that they're putting the weight on that joint. So by all measures, we relieve pain in those animals.

Okay.

That's how we measured it. We didn't use any specific device though.

I'll, um, I'll make that connection because the ability to measure acute or chronic pain quantitatively, uh, may just be a step up for you. It may help you.

Yeah. I mean, So, so one of the things we're gonna find out pretty soon is these patients, you know, we're getting ready to start our first in-human study. So those patients will be able to tell us too, which is kind of exciting. And we're, we're, we're just so ready to get that, that study started. A long time coming to get there. But yeah, I'd love to see what that device does, Mark.

Yeah, yeah, the quantitative assessment certainly beats PROMs, although that PROMs is better than nothing.

Yeah, yeah, PROMs and, and the MRI data is gonna be really interesting. Longitudinally.

Yeah, cool stuff.

Mark, is that the Dennis McLaughlin one? Yeah.

Who's that? Is that Alyssa? Yeah. Yeah. Yeah. Yeah.

Exactly.

Brad, I'll connect you with, well, or Mark, if you want to connect him with Dennis, um, it'd be interesting for you. It might be interesting.

Yeah.

Yeah.

I'd love to talk to him.

And it's FDA cleared, my understanding, for animals too, or already.

So.

Great.

Kyle.

So, Brian, I'm going to sound like a Tiger acolyte here with my question. But before I ask you, what's interesting about this is you're going to have to go through a clinical trial, which you have to do what you have to do to bring it to market. And certainly, some data will come from that. But given that the consequence of something going wrong largely is we'll just do a total joint anyway, and that's the best we can offer these patients other than deal with pain, I wish that there was just a better pathway to where you didn't have to do so much, but such is the way the world that we live in. Have you at any point, did you guys explore doing some overseas surgeries for your clinical data, Colombia and otherwise? And what stopped you from, from going that route as a, as a parallel pathway or an alternative?

Yeah, I mean, we, we did consider it. I mean, we, we looked at, at the cost for doing studies in Australia. We looked at the cost for doing studies in Bulgaria. And so we thought that was a good idea. But what ended up happening for us is we wrote a grant to do a— to NIH, which is what we do. It's like, you want to do some work? Well, let's write a grant. And so that's what we did. And it got funded. And so NIH isn't interested in funding a study overseas. No. We know the current climate too. We won't get into that, but that wouldn't have been very favorable. So that's really— we kind of got stuck. Stuck. Instead of doing first in man in a land far away, we were doing it here in our own backyard. I mean, that's good and bad though, right? I mean, because now we have more control over it and we can really dial it in with FDA oversight too, which I think that's some positives. But, you know, it's also a lot more expensive. And that's one of the things that concerns me. If I had funding to go to somewhere else and do these studies for different joints, I'm all in. I have no qualms against doing that.

I think a lot of people would take your problem.

Yeah, there you go. Well, so thank you for that. It makes, it makes total sense. Had you been funded differently, do you believe you would have been able to use overseas patients for an FDA clearance, a U.S. clearance?

That's a good question. I— it's tough. I mean, it's, it's, it's all— and I'm probably not the right person to answer that question, having never done a study overseas. Tiger, you could probably answer that question better than I can.

It's, it's a double-edged sword. You know, I, I like the overseas series, you know, just to get early feedback on the device and the procedure. And, you know, did, you know, is it still in there a few months later? Is, you know, their Q scores or whatever gone down? And it's just a, it's just a, it's a sanity check. It's not, it's not for clinical data. It's for the startup to check some boxes. That say, looks like this thing's working before we even start the study.

I, I think it just depends on, does the data look similar across the different surgeons? So, if it correlates with U.S. surgeons, the, the, and it correlates with Japanese, their techniques, their patients, if you're getting the same data, it could be very powerful. But if it's variable and if there's a wide range, then it won't be. It's all about if they— you have the highest skilled trained surgeons and, um, that know how to choose the patients.

I've been in regulatory me— or meetings with regulatory consultants, and they'll tell you that usually FDA accepts like half the study to be enrolled, uh, from abroad. Um, but they don't ever give you like a precise number. It's always like, we don't know the actual answer until the stamp's on the envelope putting the submission in. And at that point, you know, you're, you're so far down the line that if you, if you sort of guess wrong, I mean, they'll, they'll allow some of it, but, uh, not entirely, not entirely abroad. I've never heard of a, of a fully abroad study.

Yeah, I mean, the patient population is different, the criteria is different, the—

yeah, exactly.

It's just so many variables that aren't going to match up with your US pilot, you know.

They like the Western European patients most, for not just sort of like purely like physiological characteristics, but socioeconomic characteristics and, you know, those types of things.

Actually, they're veering away from that. They do not want one type of patient— Caucasian males between 40 and 60. They're actually pushing the diversity because people heal differently and people have different various sizes of anatomical sizes. And so they're actually pushing for more of a diversified strategy, is my understanding.

Yeah, I think, yeah, I should have, I probably said that a little bit incorrectly. More for like, so like they think that like the population character, you know, like if you look at the UK or something like that, the ethnic sort of breakdown is similar enough or France is similar enough that they think if they take a random swath of 10 French people or 10 British people or whatever, that's pretty close as opposed to like, you know, sometimes it's almost like explicitly racist of like you can't take 10 Korean people and like throw them into a US study because that's not representative. But yeah, I have heard the same thing that Alyssa's saying.

Yeah, interesting. So this, I mean, this is a, I mean, let me give you a little history. I mean, I joined Active Implants in 2010 and we had a hip product called TriboFit. And this is exactly what TriboFit was trying to do. It was invented in the early 2000s and it was just a spacer. You went in and you carved a little bit of, you carved a little rim in the acetabulum and then you just stuck the, stuck the head into the polyurethane sleeve basically. And I mean, it screams the need for this. And because they're between 40 and 65, there are no solutions other than HA injections, painkillers, braces, palliative care. It's just, these patients are miserable for, for 20 years. And it's, you know, and then the active implants end up moving into the meniscus area more, but for the same thing, to delay total hips. This is a huge problem and nobody's solving it. And the other thing I, just a comment, but the other thing I want to say is that I think this is going to scare a lot of the total joint companies and we haven't even gotten to that yet, but you know, I mean, Zimmer and Stryker don't want to delay hips and knees. So, there's a chance on the back end that they're gonna buy it and bury it. You know, that's, that is an another strange outcome that could happen.

I don't know. I, I, I, I agree with you, but then I also have a flip side because the regenerative market, they're not capturing, and people are very interested in that. So I think that's your direct competition is the regenerative market where they just— the physicians buy these. And as we get more data, right, we're seeing cartilage regeneration actually occur. And so it allows a device manufacturer to finally compete with the regenerative side where— because you're only getting like the company's only getting about $50 to $100 in revenue in net profit from those centrifuge systems, right? So if I were a device, a big strategic, I would want the regenerative, but I would want this as well, knowing I'm going to lose that market to regenerative if I don't do something.

That's a really good point. That's a really good point.

Wow.

And Alyssa, one of the ways we think about our implants, it's kind of medtech meets regenerative medicine because, because we designed the implant to to basically give way to biologic tissue over time. So, so it's a regenerative play. And so it's, it's uncomfortable for people because of that. And even when we were working on getting this clinical trial off the ground, even dealing with the, these academic centers and hospitals, it's just they can't get their mind around. It's not a joint replacement. What is? I don't understand. You're putting something in the hip and it's not a joint replacement. Believe me. Explain that.

I'm creating the market with you. You know, that's why we can't get funding is we're creating the market.

That's exactly right. It's a different way of thinking. And, you know, in some ways, I can't solve all those problems at once. And so, I just can't. And so, it's just like you. It's just like we got to get just kind of keep one step at a time, you know, advancing our products and what we're doing. And if the data are there, then then we'll, we'll reeducate everybody that way. But that's what we're going to have to do.

Or we just become a Megatron and collectively put 10 of our companies together and then 6 to 10 of our— 6 to 10 companies that are actually have that therapeutic model that regenerates.

I love that.

Yeah.

And then we sell to the company, the strategics, for the multi-billion dollar.

I just said something similar to a friend the other day. I said if there's some private equity company that wants to roll up like 10 different 10, you know, private equity firm that wants to roll up like 10 different companies. There's some sort of great like joint preservation company out there that—

that's what we're doing. This is— I'm telling you, this is what we're doing. This is what I'm working on the side.

So you're totally right. I mean, we just got into that MedTech Innovator cohort, and I had this— I had a similar thought the other day. I was like, if you take, you know, I won't name the companies, but if you take these companies and you put them together and you fund it, you have a quite the product offering for these patients that is, that's totally innovative and treats patients in a different way, which is, which is awesome. You know, early, mid, and late-term developments too. So it's not all, it's not all PMAs. There was some 510 and even Class I devices in, in there. So, um, so it would be a great opportunity. I don't know how you do it, but I love the idea.

I think PE is the way to go, like do a high ridge in spine. Yeah, that's fascinating. What about the direct-to-consumer route? I mean, we're obviously fast forward to the future when you're clear. I mean, is that an avenue? We haven't talked about how to sell it. You know, how do you build a sales force?

You know, but yeah, I mean, I don't want to build a sales force, I can tell you that. But I think, you know, if you look at I mean, if you look at MIAC Orthopedics and what they did with the bear implant, I mean, they were very successful with a direct-to-consumer marketing. And I think that really helped them. And I see similar plays for us. When we did the crowdfunding raise, I think we were successful in that crowdfunding raise because it resonated with so many people. And I think that'll continue to be the case, especially as we show efficacy in these clinical trials. I think we can leverage that. And so, so direct-to-consumer will definitely be part of our marketing campaign. I just got to get some money so I can hire somebody to do the marketing.

Yeah, Patrick, I had a question, but just on the direct consumer thing, you'll get— it, it would work because people know their hip hurts. Um, you'll get so many people though that come in with like way beyond end-stage arthritis that say, I saw this thing, this looks great, why won't you put this into me? And doctors will get frustrated saying like, why did I have to explain to this 72-year-old with horrible arthritis that they're not a good candidate for something like this. But my question was on the typical surgeon, like these hip preservation surgeons by training and background. I should know this, but do they do— they tend to be like people who did sports fellowships? They might have done an extra hip arthroscopy fellowship. What's their background tend to be?

Yeah, I mean, that's a good question. I don't know if I could answer it specifically. It's varied a little bit. Duke, but they have, they have training in sports medicine and they have arthroscopy and they go do some fellowships with, with people that are doing hip arthroscopy. You know, I'm connected with the guys at Duke and, and what I see there is, is these great talented surgeons and then they have fellows coming in learning those procedures. And when you do labs with them, there's, there's a learning curve there. And so that's, that's, that's what I see here locally at Duke. Yeah. That's how they do it.

Yeah.

Something just to like, these are way down the road things, but something to keep there.

They're called hip preservation centers.

I mean, that's— yeah, yeah, I've seen them.

Yeah. And they're popping up all over the place. And it's, but hip, by hip preservation today, we mean injections, acetabuloplasties, femoroplasties, labral repair. And sometimes we'll do an allograft. That's what it means.

So it's kind of everything but metal replacement, basically.

Yeah. Yeah.

Pretty much. Maybe Tag Vale is, is enough, but I would keep like 1 or 2 high-profile hip replacement surgeons close. If for no other reason than like when you get down the road, if you're like trying to get acquired by any of these big companies, like they'll, they'll start asking their own KOL network who is so in, you know, most of them are just so in love with like, let's just replace anyone's joint if they're past puberty. And you don't want them thinking like it's just garbage science and everyone should just get their hip replaced no matter what.

Um, right, you know, yeah, I mean, and I think, I mean, what's really hard for me is when, when I see the, the push from strategics and surgeons, but of why not, why wait, why don't we just go ahead and implant these prostheses in these 35-year-old or 40-year-old? That, that's where I get, uh, that's what, that's what's sad to me is because I, I don't think that's a good procedure for those, those patients. And a lot of times they go into it not even realizing the activity restrictions they're signing up for, and they don't realize even the potential for revision surgeries down the line. And I've asked these, these patients, like, did your— was it disclosed to you what this was going to look like down the line? And they, they tell me no. And, and it's just a— it's an interesting problem. So I'm not sure if people buy the fact that these patients are going to have these implants for 30-plus years. Maybe they are buying that, but we don't have the data to prove any of it right now either. And so, so I think, but, but I get it too at the same time because if that's the only option for these patients or that's the perceived option, then, then we're gonna hit everything with it. And I think that's what's going on right now.

Yeah. And to Alyssa's point, like the difference in moving someone's primary joint replacement from 45 to 65, I mean, that's the difference between having a revision at in your 80s with all the million, you know, right, versus dying with your, your sort of primary implants. And there's a huge, you know, economic and clinical difference there.

That's right. I mean, nobody even wants one, but they certainly don't want more than that.

So, yeah, you're, when you're in your late in life, wound healing issues and bone quality issues and, you know, there's a million, a million issues.

Yeah, that's right.

What's the average, what's the average, uh, revision time for total hip? Is it 15 years?

I mean, it's higher, it's higher than that.

Okay.

Yeah.

Yeah.

I don't know what the latest number is, but it's higher than that. I mean, and a lot of these, you know, with some of these advanced materials, I know Smith Nephew with Oxinium stuff and all these, you know, all these manufacturers have these tri-taper systems and they're, they're putting all these advancements into these. And are they, are they improvements? Sure, they are. But the The, the hypothesis that this will buy 30+ years is— you can't prove it. I mean, it's like, but that's what they're selling right now, and that's just based on benchtop data. But we don't have the long-term data to say that's true. But we, we know the patients are going to push the limits on these prostheses, and then, and they're run— they're playing a game here. The more they use their implant, the more stress and, and cycles they put on it, the less it's going to last. So they're they're trying to balance that so they don't need revisions. And that's a tough balancing act.

Brad, you can look into—

oh, sorry, go ahead.

Go ahead. Brad, at least as it pertains to the knee, I know in the British Joint Replacement Journal— so I suspect they might have the same data on the hip— they bracket patients in 5-year increments at the time that they have their primary joint replacement. And you can tell just on cumulative revision rates in the y-axis you can see that basically from the first day. So, you know, at intervals where people should all be doing well, at 2 years, at 3 years, at 5 years, it's exactly the— it perfectly correlates with the younger someone was that they got their primary joint replacement, the higher cumulative revision rate they have at 2 years, at 5 years, at 7 years, at 9 years. And there's a million reasons to that, but there's the— it does suggest that like certainly in the knee, and I suspect within the hip as well, there's lots of benefits to delay.

Yeah. And, and we know the long-term revision rates. The, the publications that I'm familiar with will quote a 30+ revision rate in patients under 55. And, and that's, um, huge. And should, should we be, should we be satisfied with that? I mean, I don't think we should be satisfied with that, but that's the, that's, those are the current data that we have.

And everybody's spending money on new robots, which makes no sense at all.

Right. And we didn't even talk about the robots, but I mean, You know, with Zimmer Biomet just buying another robot, you know, good for Monogram. But, you know, what I want to see is robots being used to treat new patients in novel, innovative ways. And that's not the way robots are being used right now. Robots are being used to dial in a more precise cut. I mean, for a knee or tibial plateau, whatever it is. Is that a good thing? Sure, it's a good thing. I just, I'm not sure that much money is worth that. And I'd love to see them refocus that, but as long as they're driving revenue with that robot, you're not going to see any differences.

Right.

Yeah.

It's robots don't do anything but add complexity and cost. They don't, they don't improve clinical outcomes.

Yeah. Yeah. We'll see. I mean, I know they say they do, but we'll see if that holds true over time.

Having worked on robots for far too long, for many years, the worst complications I've ever seen were directly correlated with the robots. And that was in knees. And in hips, the acetabular cup placement is really where the value should be, but that's not gotten anywhere. But I think that you have— the Australian registry is the best data that you're going to get. But all of my surgeons have said your prosthesis— and they all the all good ones. And Mark, you tell me if your surgeons say the same thing. Expect your prosthesis to last around 15 years on average. That's, that's what I had always heard. Mark, do you hear the same thing?

Yeah. I mean, the, the survivability rate even at 20 years is like 80%.

Yeah.

Yeah.

15 years is a good number.

And then the surgeon— and here's the other thing, like the hip resurfacing has a higher revision rate because you're just pushing people out more. So if you can go to like regenerative therapy, then you go to your implant, then you go to hip resurfacing, a patient may never even need a total hip.

Yeah.

And that could be very powerful.

That's the other thing that drives me crazy with the joint replacement surgeons sometimes is they, they look only at revision rate. It's like, well, something's very easy to revise. A doctor is much more likely who revise it. So something like Brad's implant could work really well for 10 years, but like, it's, it's not even a revi— you're not even revising it. If you just move to the next, next procedure, a lot of people consider that a success. But like, it shows up as like a revision, you know. The joint replacement surgeons only talking like, did the— was that the last surgery that the person ever had? And anything— if it was not the last surgery the person ever had, then it all of a sudden counts as a, um, as a failure. And this is like, if you put joint surgeons and sports surgeons like next to each other, they're constantly arguing about about this.

And you can even revise it to another one of your implants.

Okay, bigger one. Yeah, really good. Yeah, bigger one. Or, you know, if the other side of the joint starts to get involved, you could put one on the other side of the joint. Either way. Interesting. So yeah, and to get this out, there's no special— if you had to revise it, and we've done so many animal studies, the only, the only time we had one that, that that failed was the animal got an infection. That was the, that was the only one. Because people say, have these ever come out? We've never seen one come out.

What's the— how long before it's totally gone?

FDA really hammered me on that when we were trying to get the IDE study approved, as you might imagine. Our best guess, and we don't know for sure, is 3 to 4 years before it's totally gone. And so that's why it was so critical for us to to look at significant absorption that occurred at that 1-year time point. But then we had enough tissue that's, that's being loaded at that point that FDA was okay once we showed them that.

Hmm. Brad, do you know Tim Ganey?

I don't.

No. Okay. He is, he's a, he's a, he's a PhD with a specialty in regenerative medicine. And he and I were part of a project in 2009, 2010 called Nanospin. Czech Republic and Germany. And basically we were trying to create an artificial ACL, and then we kind of went south after the German government got involved.

I see. Anyway, so electrospinning type technology.

He's a really good guy.

Okay. Yeah, love to meet him.

Well, we've gone overtime. This has been fascinating. I mean, we're all pulling for you, Brad. Anything you do, I mean, we're A lot of us are candidates.

Yeah.

It's true. Yeah, I think one of the things that we run into is that there's the whole vertical for joint replacements. And everybody's just satisfied with the status quo. And I think we— that's where we should push back.

I don't think they are.

Well, I don't think the patients are. But I think a lot of the healthcare systems, and the surgeons, and the strategics, and the payers,. And, you know, they're, they're incentivized to replace your joint. And, and so I think they are though.

I think the only people that are fat and happy are the manufacturers right now, because if you think about it, when a society as big as NASS is teaching surgeons how to invent products and they had 140 attendees, that would've never happened 10 years ago.

Yeah.

And so it shows that the market, not only the patients are pissed off, they want more because they're going to regenerative. They're bypassing the surgeons and going to the regenerative places. But it also shows that the surgeons are pissed off and see room and opportunity for development. I think this is the perfect time. I mean, if you can get funding, it's like, uh, and I say this all the time, it's like when the, the banks collapsed and you had beachfront properties for $300,000. It is the best time to, if you can survive, because all the commodity stuff, all those small startups that are commoditized products, they're gone. It's a great time to invest and it's a great time to try to survive.

Yeah, I hope you're right. We're definitely playing that survival game and we've been around for long enough where I think we'll be able to do it. But it's, yeah, I don't know. I mean, I know the patients want better.. But I'm not convinced that a lot of the surgeons in the healthcare system are motivated. I've talked to surgeons who, who don't get it. I mean, and, and I've talked to a lot who do, but there are some who are just content just replacing joints and only 5%.

Yeah. Only 5% of the surgeons are going, are cowboys.

Yeah.

That's your market. All the rest of them, they're not. They need time to assimilate, assess, and, and see data.

Brilliant. Early adopters. Yeah. Is your target. Yeah. I mean, I, I talk to so many people that are candidates for hip and I say, what did you do? Oh, I had an MRI, x-rays, went in to see my surgeon and they, and the surgeon said you're bone on bone. I mean, they always tell them you're bone on bone, whatever it is. And we could, I could make this pain go away with the total hip. It's like you're not giving them any other tools, you know?

And, and even earlier on in that process, if you have any hip pain, it's almost not worth going in there. You go in there and it's It's, hey, you take an AP x-ray, maybe a frog lateral, and they go, hey, you got some early hip disease. Here's some PT and take some ibuprofen. And then when you can't stand it anymore, we'll replace your joint. And then they come and it's bone on bone 7 years later. And they have an x-ray. That's it. They have no study. They don't know what happens to the joint in that timeframe. And that's the other one of the issues is what does that joint look like over that continuum? We don't know because we don't capture that data.

Well, and coming— being a daughter of a surgeon, okay, I'm, I'm thinking a surgeon's mindset right now. They're miserable with the hospital systems. They're forced to use certain products. They, they're getting paid less and less, and their patients are going away for regenerative products. These surgeons that have had it with the hospital systems, they're starting these regenerative practices, working just 9 to 5, having great lives, making the same amount of money. Yeah, it's a struggle to start up, but once they get going, they're going. And so if you're a physician that works for a hospital institution, you're seeing your patients go away, your workload get higher, and other people thriving. So now you have to find a way to compete to bring those patients back, and you're going to look at different ways. And that's why the Toby Conference in particular has thrived because there's more data now. There's more legitimate people defending the data for 20 years. The data's showing up over and over and over again. And so I think you're in a great place. Just hold on 5 years.

It would be fun to talk about the B2C go-to-market approach and just bypass the traditional way. There's, there's corollaries between what you're doing and what we saw Therese do with the bunion, which was an unresolved, unresolved problem. They didn't do the complete B2C, but I think they could have. Yeah.

Yeah. No, I don't.

Yeah.

We, we gotta get through some of these clinical trials, but those are all good points.

Yeah.

Anyway, good stuff.

Fun talk.

Yeah, this is great.

Good.

Yeah, this has been fascinating. Good. We'll see you again, Brad. We'll, okay, we'll, uh, when your pilot's wrapping up, we'll bring you in again.

Uh, let's do it.

Yeah. Okay.

Thanks. Bone chat 100, maybe.

Let's get it. Bone chat 100 or something.

All right.

One a week. It's easy to do the math.

We'll get there. All right, guys.

Thanks. Thanks for everybody's time.

Enjoyed it, guys.