BoneChat #113 - Anatomic hip stem design reduces dislocations and the Big Orthos are blind.

This is Bone Chat number 113. We've got Dr. Kurt Biggs in Naples who's going to show us how to reduce hip dislocations with a stem design. And this is near and dear to my heart. So take it away.

So you can see the screen that says Xerxes Project. Yes, perfect.

Wonderful. We don't see the full screen mode, we just see the, you know, the slide mode, but that's fine.

Better?

No, that's worse. That's better.

Yeah, okay. So the concept was having that short curved anatomic stem for easier installation and to fill the canal for less incidence of fracture was the, you know, the initial idea. Uh, I was trying to get some biplanar fixation both AP as well as medial lateral. So it was almost like two X's. That's where the X came from, is putting an X in one plane, one, a line in one, and a crossing member in the other side. So it looks like a big X when you look at the design. So you're wedging it both AP and medial lateral and utilizing more of an oval proximal geometry as opposed to a blade geometry to provide more surface area for more hoop fixation or hoop stressing, and the cortical stress is reduced. And so less chance for rotational instability. So where we're sitting at is we have— we actually have, uh, I take this back, it's actually 13 sizes because we have a zero now. And we have— it started at 100mm length and then it increases. It has that highly polished tip, 33% of it is covered with plasma spray, 67% is covered with HA over the top two-thirds, and it has 5 degrees of anteversion. As well as a 10-degree of ante-tilt, and it has both a standard and then a 7mm medialization, and the neck angle stays the same at 129 degrees. I used a fixed neck length throughout, similar to the Coren Trifit. That was one of the stems that I had used for a long time, and in my population down here, with— I have a lot of, a lot of old people. I mean, my average age for patient is 77, so I deal with a lot of type B and C bone. And so we're putting these stems in, we're putting very big size stems and very small cups, you know, 46, 48 to a size 8, 9 stem because of the mismatch. So if you're using a progressive neck length, it gets really out of hand with leg length discrepancies in those older little ladies. So I like the fact that you had one neck size that you could adjust accordingly with your cut height where your stem was placed, or if you could, uh, use your neck offset and neck length on your ball to make up for that. So I was trying to restore the posterior or the anterior offset in the anatomic hip center. So those were the rationale behind the concept. And then started with the drawing. I think the 3 stems that I kind of used as my inspiration, for lack of a better word, is I like the filling size of the Echo Biometric by Biomet. I like the neck length of the TriFit, and I like the curve that was on the Medacta Minimax. The problem with the Medacta is that the proximal body is more of a wedge shape. It's more trapezoidal, and I think there's a lot of femur fractures associated because of that. It also is more wedge-shaped, blade-shaped than the Xerxes, which is more ovoid in shape proximally., and so, and then the curvature of the Xerxes has a built-in helical rotation of 5 degrees that's built into the stem itself. So it fits a little bit different in the proximal geometry, and the bend actually comes back a little bit at the tip compared to the MiniMax. We, you know, looked at these different variables and different points on that. There you can see the curvature of it and how it sits, and it looks like a blade stem when you look at it from the front, but when you look at it from the side, it gives you that that real sense of an anatomic fit and fill. So we looked at CT scans, trying to look and overlay the dynamics of it to see how we were going to fit, what our sizing was. I had a lot of excellent help of trying to get this achieved, and I have to truly thank Signature Orthopedics for working with me on this project. They've been fantastic, kind of thinking you know, talking to one person about one, you know, about an idea and helping to make it work. So they've been great and it's just kind of seized the data as we came along and matching the Sagittal Bow and the, and where it fits in the size range. This all took about 5 years to get through this process because I was self-funded and was paying for this as I went along. So all these parts and manufacturing had to be done piecemeal. We went through a process of 3 different cadaver Fortunately, in my surgery center, we had accessibility that allows us to give us a try and, you know, do it slow, steady. We only had a couple people working. A couple surgeons came in to give it a try to give us some of their ideas. And it's worked out very well. Some of the things that we've noticed is that it's a— you need to— where do you install it? Is you have to take out the lateral trochanteric, cervicotrochanteric area, not the posterior lateral, which you have to do with a straight stem. So you keep the proximal neck intact, essentially, all the way around. You don't interrupt or disrupt the piriformis fossa, and you allow the stem to do its job as far as anteversion, ante-tilt, and putting that head back in its hip center. So these are cadaver lab final implants that we had placed in when we first did this. You can see the date on that is '22. That's how long ago it was. So I can show you some of the other information that we have. I'm going to slip out of here. So this started as a— the process started for me as how I was part of a project called with Next Step Orthopedics that were— there was about 15 design surgeons working in that. It in itself was not something that I felt was— it went along fine, but when we started to have problems, there was a disconnect in communication. And so the surgeons who were involved in this didn't really get a chance or opportunity to make changes. And so it, it would left me very much a poor taste in my mouth as far as what to do forward. And so I figured, what if I just do this by myself and have less chefs in the kitchen and I just foot the bill myself and see where it goes? And started down this process of trying to put things together on a napkin and sit in front of an engineer down here in South Florida, and then made connection with a gentleman, Bede, in Australia at 360, who then put me in contact with Declan Brazil, who— who— they're— they're— part of their repertoire is to help small ideas become big. And we sat down and started working this process out. They helped me with my my, uh, final engineering. They helped me with my testing, and my— they helped me write my 510 that I, you know, submitted to the FDA. And, um, we signed a licensing agreement with them, and so they've been manufacturing. We now have about 300 stems on site, and 94 have been installed. So we're making, we're making good progress.

Good.

Who works with your IP, uh, Kurt?

Uh, I had a— my attorney was Cozen O'Connor. Out of South Florida, and so they helped me with my patented process so that I was able to get— I just recently received my, my most recent one was in Australia that we just received here in the last couple weeks for that.

So it's actually the algorithm for the patent family, right? Pardon me, you only have one patent family on, on the entire thing?

That's correct, you are correct, yes.

Are you planning on filing more?

I don't, I don't know. It just, it would be helpful to have protection. But I'd have to tell you that the, the, the cost as an individual is prohibitive. It has cost me more to patent this, and I think it has a lot to do with my, my attorneys, you know, and being very naive going into this and not having a lot of great knowledge. I was— it was much more expensive for me to do that than the design, the paying for testing, the paying for the 510, the paying for the FDA registration. Those were all cheaper than the IP patent attorney fees. So it frightens me.

Yeah, that shouldn't be— it shouldn't be that way.

And that way, Andrea— Andrea can help you. She's our patent expert on BoneChat. She's really good.

Oh yeah, I mean, I see you have— thank you, Tiger— you have Hong Kong application and Japan applications, and it's not— yeah, not necessarily in the big scheme of things. Like, maybe prioritize them differently would have been a good, good way to go. And, and freedom to operate is also a big, big deal. Have you done anything with that? No. Yeah, that's really important. Probably even before filing all of those patent applications to know for sure that you're not infringing on anyone else's because—

Well, I think that part was as far as the patent search to see if we have anything that was infringing on another patent. Is that what you mean by that?

Yeah.

So that was done.

Okay, great.

Yeah.

That's awesome.

Good.

Yeah.

That was part of the fee.

All right. All right. And, and yeah, as long as it was done properly, then that, that is fantastic.

Yeah. Yeah. But I would love to have a conversation another time with you about what you feel like could be done else to protect me. Um, because I, I do have interested parties already that are very, very interested. And, um, you know, we're having manufacturing issues as far as I'm the only one putting it in. And so we've been slow as far as building what repertoire. We have a few surgeons that would like to be using it. Tim Keating in Rush and Tony Carter and Adrian Badder, Steve Cummings. These are guys that are all interested in it. We have a collared version, which is, it's just going through kind of like the final checkoffs before we make metal. And hopefully that would be something that could be brought into market probably by middle of the year, if potential, or by quarter 3. And we have a— I think that opens up a much bigger door because it's such a bigger market right now, is the colored version of everything. Um, it just wasn't a thing in '19 when I was drawing this on a napkin.

But so, so, Kurt, what are your goals? I mean, uh, what are you— what do you want out of this?

What I think in the end, it was really just to build a device that, that works and makes a difference. That was the, the whole nice warm fuzzy feeling of it was I'm going to make something that's better. And in the end it became, well, what do we do with this now that you have it? And I think the idea is to sell the idea, sell the patent, sell the, the concept to a bigger and larger distribution network. And I think Signature would like to keep hands somehow on the manufacturing portion. So, uh, I think that's where both of our goals. If we were to look at it that— if we were both to sit at a table and say, what do you want to do with this? I don't know if I have the capability that I have to make it into its own company, to have your own sales force and your own distribution. I think that's some— you're going up against a 3,000-pound gorilla out there, and I'd rather have somebody else make it, sell it, and, and be compensated for it on the back side.

Got it. And you own, you own 100% of the company?

100%. Yeah. And the patent and the FDA, the 510, they're all—

Got it. Yeah. The, the, I mean, I, the, it's, it's an age-old problem where you have a better mousetrap, but you don't have, you can't personally fund it.

Yeah.

To make a big dent in the market. It's a really common tale. And then with hips also, as you know, you gotta have years and years of clinical results to before you know you're out of the woods or not.

Right.

So right now we're at, I think, 36 or 37 today in clinic came in for 1-year follow-up.

Okay.

So we're slowly building that side, and I'm trying to collect that data in a very, very scientific manner from who scores the HS, you know, Harris Hip Scores to the pain levels and radiographs on time and recovered and recorded. You know, it's, it's a, as a private practitioner, it's always, it's always fun to try to keep track of all this stuff.

But these are all your patients too, Dr. Biggs?

Yeah, I'm the only surgeon to have installed at this point. So we have people that are interested and we have the brooches now, but we don't have the inventory of stem. And so, and then we're talking about going to a colored version. And so Signature is a little bit hesitant of like, okay, if we're going to switch gears here, Do we hold off and just make the switch to collar and go, which I'm not opposed to? It's just I think it's going to delay the next movement.

Yeah, you probably want both as part of your portfolio though, right? What do you— just curiosity, out of curiosity, all right, does this— is this able to work through any surgical approach?

Yes.

Okay, and then on the acetabular side, you're— do you have your own cup?

No, I don't. I just— I— it's, uh, FDA approved with, uh, the Logical Cup at this point because they helped me with that process. So no, it's a— the system is, is— they manufacture it for me through Signature, but it's to be married with a Signature cup.

I have used it with another cup in certain situations as far as bone quality, but yeah, the surgeons can use their favorite cup as long as it's compatible, right?

So absolutely, yeah, it's not dedicated to one, right? Yeah.

So you, you've used a lot of imaging to design this. I'm, I'm wondering how hard it would be for a company to do patient-specific Right.

Good question.

I think getting, you know, this going from ideation to commercialization is one of the hardest things to do. But then adding in the additional, you know, to Tiger's point, what do you want out of this? You know, you're capturing a strategic's attention. You know, they have to most of the time, unfortunately, they have to feel a threat. In order for them to act upon this. And so, you know, some of that data though that you're going to need, I think you capturing that attention is going to require other users.

Yeah.

You know, in order to get at least some groundswell of, you know, discussion point on that.

So, yeah. So with HIPPS, we got—

That's the hard part about it. We have the broaches. For the other surgeons. It's just getting the inventory, and I'm willing to give up my inventory to, to take it to the surgeon to—

let's, let's go.

I guess what you're saying is you need, you know, to be capitalized though, right?

Yeah. Well, it's— I've offered that to Signature, you know, like I'm, I'm willing to come up with more cash to, to, to make devices. I don't know if they're— they have the capacity. I'm on the low end of their spectrum. That's nothing negative to them because they've got they've got bigger fish to fry, they have bigger parts that need to be made. So, uh, you know, filling in for me is understandably slow.

So is it, is it a 100% requirement to have it manufactured with them though?

Uh, no, they just have the licensing agreement right now, and, but it's not— I don't have a— that licensing agreement is not, um, exclusive, right?

Interesting. Um, So, you know, the problem— I'm not a physician obviously, but the problems with hips are infection, loosening, but dislocation is one that happens in the first few months usually. So out of your 36, I think you said you had 36 at 1 year, have you had any dislocations?

We have had no dislocations. We've had 1 calcar fracture at time of installation that was cabled. I've had 1 subsidence and I relate that to me. I think I could have upsized the implant, and that subsidence happened at 5 weeks post-op. And I've had one periprosthetic fracture at 6 weeks after a fall. Those are my only negatives of the first 90 so far at this point. My films, the projections have been great. I mean, images have been very spectacular, and scores have been great. Everything's been what it's supposed to be. There's not been any outliers in that sense. It's been really quite happily satisfying as far as what we're getting across.

And what's the standard rate of dislocation for symmetric hips and knees? I mean, hip stems.

I have to say, I bet you David has that answer like off the top of his head, like—

Well, it's a target, depends on approach. Kurt, your stem will dislocate less than the standard ones. And people always say the posterior approach dislocates more, which it does, but The posterior approach gets a bad rap because of the stem. The stem is what makes the posterior approach vulnerable to dislocation. Or to put it another way, the stem makes the anterior approach even safer to prevent dislocation. But if you use a stem like, like the Xerces, that asymmetry between anterior and posterior approach will diminish, it will reduce. So the stem's just going to cause less dislocations and Curt, those other early complications you had, absolutely expected with a new stem, but a lot of those would not happen, I suspect, with the collared version. I'd go straight to collared.

I agree, that's what I want to get to. I think you're absolutely right.

Well, you've done your own without collared and they're not supporting you adequately with inventory, so I'd be switching over. I mean, run out some of the stock you've got already while they're switching over, but I'd get them to start manufacturing the Collard one. If they don't wanna do it, 'cause they've got too many other projects, then if they don't have an exclusive licence, get someone else to do it. But I'd go straight for Collard because your subsidence won't happen. Your intraoperative fracture won't happen. Your fall at 6 weeks probably won't fracture if you've got a Collard. So I'd go straight for Collard. Having said all of that, they're not collars. That's a little pet hate of mine. They're not collars. Collars are what you put on a priest or a dog. They're circumferential. These things are a landing plate or a landing pad, and they stop subsidence and they give you axial loading on the cow-cow in standing and walking anyway. They give you axial loading, grow in zone 7 of the cow-cow, so they're very protective for the bone and prevent lysis up there, give nice proximal loading. But it's not a collar, but everyone calls them a collar. But a lot of surgeons won't touch it if it hasn't got a collar anyway, so you're probably better off just going straight to a collar and get rid of those problems. And your stem's not the only one that's done that. The Symbios, you know, the Europeans are big on that. The Swiss company Symbios have got a side-specific stem that's got some curve built into it or anti-tilt built into it. And when they first started using it, they had quite a lot of intraoperative fractures and revisions within the first 3 months. And That was learning curve. It's a different operation. It's a different— it loads bone differently, just as yours does. And if you whack that thing in the same as you do with a Korai, it's going to cause problems. It's going to cause fractures because it loads the bone very differently. Much higher hoop stresses, as you've already pointed out, but less of the fouling of the 3-point fixation, PAP fixation, which kind of loads the femur up like a spring over a long distance. So you get away with that, hitting it really hard. If you, if you have a better fitting stem, you hit it hard, you're going to cause fractures. And they had that, but the really good thing is 10 years out, their survival figures were better. So they had a steeper revision curve on their registry in the first 3 months, and after that it flattened out. And the non-side-specific stems were having higher revisions. Over subsequent years. So I actually think you're on the right thing. I mean, it's a really good advent that you've got there. It's an improvement on what's out there. And getting back to Tiger's point, they did that. I mean, Striga Hamedica had side-specific stems while the PCA primary was side-specific. The ABG, sadly, that had other problems, but the ABG was side-specific. They didn't stop them because they were side-specific. They stopped them because they wanted to save money because their competitors were saving money. Their competitors weren't doing it. J&J weren't doing size-specific, so they're making half the inventory, making a better profit. Stryker just switched over and copied. They all do the same. And to chance to get back to your point, the hospital cannot buy a size-specific stem because they don't exist. All the companies do the same thing. They all make Z1s or Insignias, or what's the other one, the Actus. So they all make the same stem now. They all copy each other. No one's got a side-specific stem. And, um, Kurt, I think you've got to stick to your guns. I love the stem. I think it's going to be great. You're already noticing no dislocations. It's designed to do that. The other thing it will do in the long term is late periprosthetic fractures. If that's 1%, and it looks like it is now around that figure, 1%, if I put it to you that that 1% is on the surgeon, then the hotshot surgeons who are doing 500 hips a year That's on them. They're getting 5 fractures a year later on. That's on them because they chose the stem. If you choose the stem, you put it in, and that fractures 10 years later, that's on you as a surgeon. You might be retired by then, but those figures belong to you, and they belong to the company that makes it. And you're going to have a lower periprosthetic fracture rate, no question about it, later on. So, uh, that's a good thing to do. And, um, We don't have to wait quite as long for all data. Yes, we do for clinical follow-up data, but today with really good software, range of motion to impingement software, which is a big part of pre-op planning software nowadays, lots of companies have got that. You will show that you've got— you'll get an extra 10-15 degrees of flexion before anterior bony impingement occurs. And anterior bony impingement is what causes posterior dislocation. I believe it's what causes intertrochanteric fractures in the elderly, unreplaced hips, the commonest hip fracture we see. And it's what causes Vancouver fractures in replaced hips. If you fall and suddenly into deep flexion, if you extend your lumbar spine, then your proximal femur hits the pelvis. The hip's tethered, so it breaks either the unreplaced bone or around the prosthesis. It's the same mechanism. It's what little old ladies do. It's why we see fractures. So your stem is going to impinge at the front of the hip to cause those two problems, dislocation, or if it's a, you know, if it's sudden, a fracture. It's gonna bend another 15 degrees before that phenomenon occurs. It's protective. And we can show that on range of motion to impingement software now. We don't need to wait 10, 15 years for that. So that data, the companies have got it. I mean, they've got it all with their robotic software. They just don't wanna look at it. I mean, you think—

I've got a company who's gonna take a look at it.

I beg your pardon?

I've got a company that's going to take a look at it. So I've got Jim Pierpont at, at Coren. They're going to take the data files and put it into HipX.

Very good. Very good. I can tell you what the results are now. Jim doesn't have to do the work. The results are going to be just fine. Yeah.

Well, I'm excited that we're heading that direction as far as getting some, you know, data from software that's technology that we can do this now and not wait 10 years to see.

I, I'll be surprised if they share the data with you because they're going to compare it with their own stems and they're going to find out that your stem's better than all of theirs.

So, uh, then they won't— they'll just suddenly go radio silent on me.

They could.

Did, uh, Kurt, did you, did you talk to Corin before the acquisition or after? Because that, that may affect things?

Um, I have— we've been in conversation for probably a year.

Okay.

As a big Korn user, you know, they're— they, they know of this project, as my distributor knows of it, because they're— he actually carries Korn and he covers Signature because of this project. He picked up the Signature line so that he could have this in his bag to help me. And so Korn has been in— I've been talking with them prior to the acquisition, and and after.

Got it. Well, you're in a great place. I mean, you're in the world headquarters of, of Arthrex. Yes. And right down the street.

And I'm crossing my fingers. Yeah.

So how, so what, what percentage, what reduction of dislocations is meaningful? I mean, you're getting an extra 15 degrees of non-impingement, but how does that Is that, you know, 1 out of 100 goes to 1 out of 300?

I mean, yeah, I think we have to, you know, we're not going to eliminate dislocation. It's not going to happen. But if we could go from, you know, 1 in 100 to 1 in 3 or 1 in 4, or that's, that's significant because the, the things that happen after that is recurrent dislocations because of the, the, you know, the pseudocapsule is torn and things are unstable. We can avoid those reoperations, not just the closed reduction. It becomes then when's the revision happen.

Yeah, I mean, it's, uh, man, we're all pulling for you. What, what can we do for you? Uh, other than just—

I like hearing the, the ideas of, you know, stick with the collar, which, uh, Signature is in support of, because as we've talked, they've been, they've been wonderful about it. And in this process, because it's been slow for them because I'm the guy that's like, okay, I can afford more, let's do this, or let's, let's do this change and let's move this way. And they understand that that's where things are. So we've kind of pulled back on trying to reach out to these other surgeons until we have some collared stems. So I think we're going to sit for a little bit, build, work on the collar side. I'll dig down on the inventory of the 290 stems that I currently have in my possession. And then I think we have to— I have to— I think I'm gonna have to have a conversation with Andrea about what other options that I look at as far as protection goes. And continue to build on. Hopefully by September I'll have— that'll be 2 years for my first group of people. And so by the end of this year, I should have 22-year follow-ups by the end of this calendar year. And hopefully by the end of the year, I could have other surgeons installing collared versions of this stem.

Is the stem— is it cast or machined?

It's cast.

Cast. So it's cobalt chrome then?

It's titanium, actually.

Titanium. Cast titanium. Oh, that's interesting.

No, I'm sorry, I apologize.

Yeah, okay.

It's fully forged, is it, Kurt?

Yes. Good, good.

Super strong. But then there, there's tooling. There's a huge tooling investment. That's why—

did you buy the tooling?

Did you buy the tooling or did they buy the tooling?

They bought the— they have the tooling as part of the licensing agreement.

They got it.

So they— that's the, the part about the inventory argument for these companies is you've got 200 hips. Well, I have 100 lefts and 100 rights. You have 200 straights. So it's the same inventory number. The brooches are where the inventory is, and then the, then the machining is. So that's where their cost is. Um, that's, that's where the difference in the brooches. It's $15,000 for a brooch. For a broach set to make that. So, uh, is it worth it to have that better outcome for the patient? I, I think it is.

That's probably not at scale though, right?

That's a smaller version, right? That's definitely a smaller version.

Yeah.

Yeah.

I mean, yeah, Kurt and I were talking yesterday and he made a great point. There's, there's— you don't have to make any more extra inventory because you know the patient's a right or left, you already know that. So you already, you just ship them the right or the left implants. Yeah, but you still have to have, you have to have brooches, you have to have sterile brooches for rights and lefts, and that, that's the bigger challenge, I think. Yeah, yeah, interesting. Have you thought about raising money? Have you talked to any venture people?

I have not, I haven't had that enter, but, um, what's been the— I mean, I don't have any experience in that. Does anybody here have that Oh yeah, it's a sore subject.

Here you go. Well, I'll turn it over to Chance.

I was going to say, I mean, it becomes a sore subject, especially if you only have a me-too product, which I don't think that you have, which is unique. So there are, not to do, in a sense, a shameful plug, but at the end of the day, there are organizations, a small number of them, that can actually help you go from, you know, idea to commercialization and then, you know, try to create the outcome that you want. I mean, your essence, like all of us, everybody's climbing Mount Everest, right? And I think you're halfway up the mountain, at least at this point in time. And I commend you for the tremendous amount of work that you have gotten to at this point in time, especially investing in it yourself, because it is very, very costly. But you're getting to a point, I think, where you need force multiplier. And that means resources in order to help you get up the last 10,000, 12,000 feet of Mount Everest, which is the hardest. And the resource requirements are very different. And so to Tiger's point, you're raising capital at this point in time. You've, you've done all the seed and friends and family round yourself. And so I'm doing that with my company, Genesis Innovation Group. You know, this is in essence what we do is we help entrepreneurs and early stage companies move through this process and then get to an outcome that's desired. And let's say there's others that do that, that a lot of not having everything in-house, and for some of these other organizations, they only want to go really to a certain point, but you're at a major inflection point, at least from my perspective, in where you can add kind of, you know, fire in a sense of the campfire that you've created to get to a bonfire. And hence meaning you need to put this in other people's hands to establish the credibility and value proposition of your STEM and why it's going to make a clinical impact and then be able to have it, you know, not just coming in a sense, the data coming from one surgeon who is the founder.

Right. Yeah, it's very biased, admittedly, you know.

Yeah, I mean, it's not a bad thing. Like I say, you've done a great amount of work, but now can you, can you take this and put together, you know, because really you're at a bit of a commercialization plan at this point in time strategically, and where to go to with a, you know, group of surgeons who will do the work, do the follow-up, you know, get the data, you know, not just, you know, the short period of time, but You know, can you get 5 other surgeons, to your point, that are doing follow-up for a year or 2 and then create value, right? You're creating enterprise value in a, in a company here. And so, you know, it's always going to kind of depend on what the exclusivity agreement looks like with, you know, Signature Companies doing manufacturing. But those things can be, can be addressed.

Yeah, well said. Steven?

So 2 questions. One, have you talked to Max, Max Orthopedics yet? I know they're looking to make some acquisitions here very soon.

Well, I'm actually a Max ortho surgeon for their, on their knee side. I use their device. I'm also one of the design surgeons for their medial congruent poly. And they're, and I've, I think that they would like to see more data collection and more time after talking to the guys and, Ashesh. And so it's, um, I think that's to the point of, you can have a couple surgeons, we've got a 2 years worth of data that includes more than one, more than one guy. I think then that would light the fire because I don't think their hip, um, line lineup is that, uh, amazing. Although they're going to have an Actis copy coming out here.

Yeah, I think Varzan's a great guy.

Yeah.

Oh, he's awesome.

Yeah, yeah, he's a client.

That's great too.

Yeah, yeah. The other is, I don't think— I don't know if a lot of people— Chance, if you know this either, but distributors have become such an amazing source of investment. And we've raised a couple million dollars ourselves just from distributors.

Oh, really?

You have some that are working with you already?

I would—

no, talk to them. So this is what you're looking to do and expand. Yeah, it becomes such a great source of capital, especially since venture money is still a little tight at the time being. So definitely go that route. And if you need help with that, I'm happy to. And help you connect you with some individuals.

So the— as far as the— with the capitalization, it would be then money that goes towards the manufacturing side at this point. Correct.

I think it's, you know, several different points in a sense. You know, you need to look at how many people that you would put into, you know, a group of surgeons to do X number of cases in a defined period of time, you know, and then you need to raise enough obviously to do, you know, those number of cases and put the number of sets there and things like that. It's just, you know, kind of putting all the data together at the end of the day.

Yeah, there's some great sophisticated distributor groups that have come up with some fun investment opportunities and allowing their physicians to get on board via SPV and LLCs. So it's definitely out there and it's a great source of capital.

I don't know. You already created an organization just out of curiosity of your company, or is it just on the, on the stem?

No, it's just— well, it's the stem. I mean, the stem is itself, but it's owned by the company.

Okay. And is it, is it an LLC or an Inc., if you don't mind me asking?

It's an LLC. Okay.

So there's a— I don't know if you go way back in time, remember Joint Medical Products in Connecticut? I don't know if you guys are.

Yeah.

Anyway, they had a really clever kind of revision hip stem. Anyway, they used a local supplier in Connecticut and they never paid them. They gave them equity in lieu of cash. And so when J&J bought Joint Medical Products, that supplier made a fortune. So you— there is— there may be a pathway to give equity instead of cash to build more inventory. It's got to— just depends on the supplier. I would talk to Signature about it.

Just—

yeah, yeah, they've been very, very helpful. I can't say enough positive things. They've been really— they've been great.

Tag Medical is also interested in doing some investments for companies that would— that they could do the manufacturing for as well. Okay, well, that Tag Medical, T-A-G. They make everyone's instrumentation pretty much for, for sports med, all of Arthrex's instrumentation. Um, they're Israeli-based, but I can give you a contact and introduction there afterwards if you, if you'd like.

I would love it. I just, I've got to get information so I know what the, how to keep this.

Just curious though, from, from, from the group's perspective, um, you know, given Given the amount of work that has already been accomplished, you know, going from Phase 0 to Phase 1 and, you know, in Phase 2, I mean, wouldn't you all— what would be you all's perspective, though, on actually doing, as I say, having more cases completed by other, in a sense, independent surgeons who will take part in doing the work to follow these patients that they're already going to do anyway. But there's a close relationship and they— because they believe in the technology, but creating some considerable enterprise value at this point in time, you know, over the next 2 years before having these discussions with midco and big co companies.

What are your thoughts, Steve, about getting just more data rather than going and having some of these manufacturing? I think that'd be better if you— the best thing you can. I'm all, I'm all for raising the least amount of possible. And, you know, funding via revenue, so that'd be phenomenal, especially if you can get more physicians using the product, different variety of physicians using the product. I think that's one of the best things you could possibly do if you have the capital to fund it. Um, you know, that's, that's the hard, the hard side of it. But if you, if you can revenue fund, that'd be the best.

We're doing a, a raise now with, you know, just convertible notes. And I mean, that's, it's a great vehicle. And when, when people believe, you know, in it. But most of the entities when they're looking at you are going to want kind of some, some, some real data that's not coming, you know, really from only one source.

Yeah. A biased source potentially.

Yeah.

It creates, it creates a bias and they look at you and like, yeah, you know, this is great, but.

Or they'll be a little bit malicious, if you will. You know, they'll try to take a little too much if you can. Yeah, yeah, we've raised everything on SAFEs as well, and, and it's been a great instrument. But something you want, you want, you want a little bit of variety there for what you're trying to do now.

I think you need to get out a piece of paper and just say, start with the end in mind. What would be de-risk enough for the big orthopedic companies to be interested? How many surgeons? How many, how many patients? How many years follow-up? I think, and that's, that's your starting point. Um, yeah.

And are you really—

are—

do you, do you want to be in it for the long haul as well? We— everybody knows this is your baby, you know. Yeah. And you want to see that baby grow up and, uh, move out, get out into life. But everybody on this call knows the long haul of it. Um, and it's, it's, it's certainly a passionate thing. Um, and I think everybody has a tremendous appreciation, probably can, can give a lot of information, but I think strategically you're at a point now where you've passed some of the, you know, challenging milestones to get through. And there's certainly more, but now it's more about creating credibility and penetration and visibility to, you know, what you ultimately want outcome-wise.

Great. I think, uh, um, I think the next step is to— it sounds like it would be best for me to get our collared stems rolling and get multiple surgeons who are— who have already voiced their desire to do, to get them involved in the process.

Yep, makes sense. Mark, did you have a question, comment?

So, I'm a huge fan of any founder led-owned entrepreneurial self-funded venture like this. So certainly, you know, I'm passionate about that. I think it's fantastic. Um, this particular vehicle, BoneChat, talks about 3 things over and over again. Number 1 is raising money, and then after that probably comes, you know, where's all the good— where's the good sales force, the distribution? Why can't anybody sell anything? And number 3 is probably, how do I get my products in the hospitals? And so now we have value analysis committee. I don't know, I call virtue signaling committees. Um, and so you've hit something. I, I would look at, because of the nature of your particular passion, I would look at family office money, which are more almost European in their patience. They're very long-term. And if you find somebody that has had problems with hips, you know, which you might, because a lot of the family offices have older people in them, you might, uh, might stumble on a, you know, an unexpected source.

Yeah, especially where I am here.

Yeah, especially where you are in, you know, Heaven's Waiting Lab, or Florida.

Yeah, it's, it truly is.

Yeah. That's a great idea. You, you, for very little money, Curt, you could hire a researcher to go out and find every famous person in the world that's had a hip, hip revision, hip dislocation, and, and then reach out to their family office. Say, I heard, you know, your grand— I, I read that your son, you know, had a dislocation.

Yeah.

Whatever, we've got the solution. We'd love to talk to you.

Yeah.

The, the guy that I had coffee with this morning who's had the hip replacement and now still has more pain than he did before, who's a very, you know, very fit bicyclist, is actually moving to your neck of the woods. Oh yeah. It's really, it's kind of intriguing in a way. I have a couple of questions 'cause my career has been mostly about making new markets, early markets. Specifically into, uh, you know, the medical device surgeon market. Is this a— is this procedure harder or easier?

Easier.

Okay.

Because of the curve, you actually enter in anterolateral, not straight lateral. So you actually go around the corner as opposed to trying to roughen it out to that post lateral corner. It's actually easier, and it works really well on stiff stiff muscular men.

One of my, one of my tattoos is easy always sells. So that's, that's a very good, that's a very good thing. What about, what about for revisions? Great question. While you were talking earlier, I consulted my guru ChatGPT and Claude and a couple of others. And I said, tell me all you know about, you know, the anatomic hip replacements going back to the '70s. And my career, you know, I go back to the Charlie times, so I've been in this a long time. And one of the things is that anatomic hips were difficult to revise. Is that interestingly true or what?

I think that's interestingly true. And since we'll never have to revise these, I'm not worried.

That's true.

That's a fast story.

No, it is.

And that's a question that came up on LinkedIn and okay. I don't have an answer other than the flexible blades because the Watson's not gonna work well with this. Um, you know, those extracting, uh, it's, it's going to be, uh, and it seems to be my year follow-ups are getting a lot of fixation. I mean, it goes, it is fixed and you can see it all the way down to the where it gets polished.

Wow. So you have to, because you have to take it out curved instead of straight out, right?

Well, it's trying to get the, the release from the bone and you're hitting the osteotomes down as it curves. You can go on the concave side, got to shear the bone. Yeah, yeah. But the convex side, it's hard. Yeah, and the third thing, the color will make it worse.

The, the third thing was that although the tide has gone in and out a couple of times on this particular, uh, design, it did at the end of a couple of analysis say that there is a quiet return to this particular design. Which was interesting. Of course, that's sometimes, that's sometimes part of the, sycophantic trend of the AI trying to tell you what you wanna hear.

Yeah.

What it thinks you wanna hear.

Well, I, I, you know, you can feel that kind of tide and, you know, Dr. Kirwan has made it very prevalent as far as conversations on LinkedIn about the, the necessity for considering this as an option to return to my national, natural function of the hip by getting the center back where it should be.

Well, obviously that's true, and Dr. Kerwin is obviously an early riser being in Australia.

Yeah, yeah, today I am anyway, Mark. Thanks. Um, I've made a lot of noise on LinkedIn. It's been a great platform for that. And, um, I think that's part of the disruption we'll see. And, uh, Kurt, you'll see it with, uh, if Jim Pierpont starts modeling it on, you know, 50, 100 hips, he's gonna get some really good data, solid data, and it's gonna be very supportive of your design. That sort of software is disruptive. LinkedIn as a platform is very disruptive compared to, say, publishing something in the Journal of Bone and Joint Surgery, which takes you about 2 years to get up. No one ever reads it. If they do, they read it once, they forget about it. But LinkedIn's just amazing where you've got surgeons, engineers, company people from all over the planet buying in on things. If you put something up there that's wrong, they're going to tell you. So it's— I think it's very valid. It's a very peer-reviewed environment. I mean, you don't have room to have great long lists of data, so they've got to be kind of pretty punchy points. But if you make a point and it's original, people like it, it spreads. It's so quick compared to, say, the traditional journal thing where every article has to be peer-reviewed by 7 retired professors who'll all disagree anyway. So that whole, uh, the traditional academic structure is very structured And it's all happening much quicker now. Software is quicker, AI is quicker, social media is quicker. I don't think we're going to have to wait. I think the progress Kurt's made already is amazing and that's going to accelerate. Stand back. I mean, you're on your way.

You just—

we just don't know what's around the corner yet. But if Archtrex has bought Coren and Jim Pierpont and Co are looking at your stem with their impingement software, and it's some of the best planning software in the world. Um, it's on its way. And now that the world, via Tiger's, uh, bone chat today, has found out that Arthrex is looking at your stem, you watch the other big companies suddenly wake up and sweat with fear of missing out. And, uh, they're going to be looking at stuff as well.

So, um, I'm hopeful I didn't make anybody mad by mentioning it. So I don't have a non-disclosure agreement signed, so I can, I can talk about my progress.

So good for you. You just woke up 5 big American companies today. That's big news. I mean, if your stem, which is totally out of the box, it's completely different to all the actresses— everyone's copied the actress, they're all the same, they're all actresses, there's not a scary originality in any of it. Your stem is original, it's different to all of those. And Arthrex are looking at it because Qorin are looking at it. Arthrex are looking at it and Arthrex are big, they're wealthy, they're hungry, they're new on the block. They're going to want to make an impression. What do you think the other 5 companies are going to do now that you are looking— you are looking at a stem that is completely different. It's 50 years ahead, 60 years ahead of the Actis. Sorry, Mark, but the Charnley, the Kauri and the Actis are all the same. They're geometrically, they're identical. So nothing's improved in over 6 decades, not a thing. We don't put the same shoe on our right foot that we put on the left foot, and there's a reason for that. Yet we do it in the hip. We don't do it in the knee replacement, we do it in hip replacement to save money. It's not good enough. Now I get Charlie did it, he had to do it because he would have had funding problems as well. He wouldn't have had seed capital or whatever. Manufacturing would have been incredibly expensive back then, and it was experimental, so they started off with a right equals left set. 6.5 decades later, a couple of, you know, $500 billion companies out there, Stryker's turning over, what, $25 billion, was it, Tiger? They turn over $25 billion and they still don't have a different hip for the right side compared to the left side. Come off it. No surgeon in the world will operate with gloves that are not side-specific. All our knee replacement components are side-specific, but our hips are not. Why? Because they've always been that way. For 6 and a half years, 6 and a half decades, I'm sorry, no one's ever thought of a better way out of it. Well, Curt has, and I think you're on your way. This, this, it's going to disrupt and it's going to happen quicker and quicker. And if ChatGPT and Claude are both telling you this stuff, Mark, it's because it's happening. Curt's stuff's out there, Tiger Buford's out there. I've been out there. It's happening on LinkedIn. There's great appetite for it. So I think it's gonna take off. It has to happen.

It has to happen.

Dr. Biggs, I think you found your pitchman.

Yeah. Well, we need to talk more because we've had some discussions already. It's been great and I'm a big fan of what you're doing. So we need to talk more. We need to join forces a bit because this is gonna happen.

I would love it.

If you just check your, I just sent you a link that has about 60 family offices on there, all in healthcare space.

Oh, it's in the chat for everyone.

Wow, thank you, Stephen.

That's disruption. That's disruption.

You're welcome. Also, if you're looking for distributors, I've got an AI natural search distributor tool, so I'll give you free access for that as well. So let me know if you need help with that.

That is fantastic. Steve, that's a great idea because that's sophisticated money that actually knows the industry. I mean, those distributors know a lot about it. So unlike your standard private equity bankers who know nothing about the health space, This is a, you've just introduced a very sophisticated source of finance, you know, technically sophisticated in terms of the HIPAA space. So that's a great idea.

I would tell you also too, that any of your peers that want to invest early like this, you know, certainly they'll be considered part of the, you know, the adopters that are fast, but many acquirers like to see that people, especially with the type of knowledge and, educational training and practices, they're going to want to see those on the cap table.

Yeah.

Okay.

Okay. Well, awesome.

Tiger, I got to hop off. Thank you, Dr. Buford. Thank you, everybody. And thank you, Steve. I'm actually looking for family offices right now for a Canadian company that I'm on the board of. Yeah. And if you—

let's connect up—

new ideas, you need, you need new money.

Yeah, let's connect after. I've got a list of 2,000.

Yeah. And last thing, the best thing that happened to you today is you met Andrea.

No, thank you so much.

Thank you, Mark.

Yeah, good catching up. Thank you.

Congratulations.

Thank you, Mark.

Yeah. Well, Kurt, this is great. I mean, we're all pulling for you, so, yeah. And, you know, we just reach out to me if you need anybody's contact information. I put your contact in the chat if anybody wants to grab it before it goes over.

I'll be reaching out to you if you don't mind. I've got a couple tools that I think that can help you pretty quickly.

That's awesome.

Thank you. Good. I'd like to have a close look at your slides, your PowerPoint. Are you happy to share that? Because we raced through it really quickly. I'd like to have a look at that in detail.

That's an older one. I've got some newer ones that have some post-op pictures and, and follow-ups on it. So I, I can definitely send that. I gotta see if I can find it. I can, I can email it to you.

Yeah, convert it to a PDF if you don't mind. That way the email will take it, otherwise it'll crunch, it'll be too much data. But if you could, happy to send it as an email PDF, that'd be great.

Yeah, I'll send, I'll send everything I've got your way for sure.

And we'll, we'll stay in touch. And Tiger, thanks so much for, uh, for doing this, for facilitating it. It's a really good platform.

Yeah, it's just better. It's a better product and the big companies are ignoring it. And I'm gonna be a, I'm gonna be a mouthpiece. Say, I mean, if patients, if patients were to know that if you get an anatomic hip, your dislocation rate is lower, everybody would want one.

Yeah.

Well, periprosthetic fractures are nasty thing that kills, that kills people. The fixation kills people, the revisions kill people, and they're elderly and they're frail, and we can stop that. And no one's taking responsibility for it. So I kind of love making a bit of noise about that because someone's got to step up and say, hey, we could have prevented this, and that'll make it happen. But Tiger, if you're mentioning that Corin and Corin OPS and Arthrex are looking at Kurt Stem, if you, you, I mean, you won't believe what that's gonna do to the big companies that Kurt and I have already spoken to, have sort of go, ah, yeah, yeah, bit hard, or we don't know and we'll think about it, whatever. That, that those big companies are gonna wake up.

Yeah.

You're gonna, you're gonna provide a wonderful service there.

I promise you. The timing's perfect. Arthrex has a chance to come out with a differentiated total hip for the, you know, yeah. That the other, the other, the big boys don't want to do. They literally— and you're right about OPS. OPS was great technology that just never got any traction in the US. But OPS is a great planning software.

It is, it is. And that's probably what's best about it. The spinal pelvic side of it's important, but it's just good pre-op planning. It's good templating. And none of the companies looking at templating in 3 dimensions. It's all 2-dimensional, uniplanar, 2 dimensions. It's, it's very deficient. So I mean, can you believe you've got robotic platforms with all their software, but they don't look in the sagittal plane? They're not looking at it. And we know the reason. Henry knows the reason they're not looking at it, because they don't want us to see the results.

Yeah. Yes, you're right. All right, well, thanks. This has been terrific.

Thanks.

Question real quick. Sorry, Andrea, quick question for you. Do you do IP work? On tech, like, like, um, algorithms, AI stuff, things of that nature, outside of just devices?

Yeah, yeah, absolutely.

Love to touch base.

Yeah, yeah, let's, let's touch base.

Awesome, appreciate it. Thanks everyone.

Thank you again, Tiger.

Bye, Tiger. Thanks so much.

Bye.