BoneChat #92 - Absorbable metal implants are here. Blake Helm shares the technology.

Okay, so this is Bone Chat number 92. Just can't believe we're at 92 now. Um, yeah, and Blake Helm's going to, uh, walk us through the Bioretic, um, kind of technology, business, and clinicals. He's, he's one of their new sales leaders, and BioRetic has got a really cool technology where they have magnesium implants that resorb into bone. And I'll just hand it over to Blake and throw up your slides. It's all yours.

Yeah.

All right. Thanks, Tiger. So it's BioRetic. Um, Bio-Retic sounds better, but it's—

Yeah, it does. Bio-Retic. Okay.

Um, yeah, so thanks for having me. Just wanted to kind of share a high-level view of what Bio-Retic's all about. Um, trying to keep this to 10 minutes. I'll go through a lot of these pretty quick, but I've been doing this for, I think, going on 34 years. Um, my brother Corey's in the audience here, and he and I were Arthrex distributors for most of that time, and we're both kind of in the startup world now. And I came from Artelon, so we had a successful run with them, got them sold to Stryker. And a good friend of mine who I used to work with at Stryker Endo back in the mid-'90s went to work for BioReTech about a year ago, and he pulled me in to help him launch into the US. So we're kind of relaunching. They did a soft launch about a year ago, but, you know, the Finns don't really understand the US very well, and they kind of, they hired a company called Spartan Medical. Which is really more of a, you know, DOD and VA type, type company to get into those places. But, and then they hired Orthopediatrics for the, for the peds market for our Activa product line. So we're kind of hitting the reset button. We're rebranding, we're re-messaging, and we're hiring, you know, independent distributors to get the ball rolling here. So I just started in July. I'm by no means an expert on this, but I'll kind of go over, um, what I understand of it. I think what's really important to understand is, um, you know, Bio-Retech, these absorbable polymers, really the birthplace is all in Finland and they've been around for 20+ years. But you know, most of it can be traced back to Tampere, Finland and some couple different individuals, uh, specifically who kind of pioneered this whole world. Um, the magnesium actually comes out of Graz, Austria. And so we've partnered with them. But if you look at BioReTech, so back in the— and Corey and I sold Bionics back in the day. And they were the first ones that had kind of a bioabsorbable polymer, a pin. And they sold that to, to ConMed. But the people who started Bionics are the same people who are with BioReTech. And so over the years, they've developed all these different types of polymers, and, and we feel like we've really got the best newest, greatest version now. But we've had it in Europe for 10 years, had over 400,000 implants with no problems. And so we're, we're just launching that in the US and then along comes Remios, which is our bioabsorbable metal. It's the US, it's the first US bioabsorbable metal made out of magnesium, calcium, and zinc. So they really launched that about a year ago, beginning of '24. And I kind of happened how I told you, but so now we're kind of re hitting the reset button. We're waiting on FDA approval for a bunch more, um, additions to that family of products, which I'll show you. But, you know, obviously challenges with metal, um, second surgeries, taking things out, infection risk with biofilm, you know, stress risers, um, you know, things like that, loosening, breakage, hardware irritation. We know all the limitations. Of metals, but we've been using them for decades and decades. You know, it scatters the x-rays and all that stuff. So, you know, I think Osseo has done a really good job for, for bringing awareness to the world of, of absorbables. And if, if you can do an absorbable instead of a metal, why wouldn't you? So we're kind of going to come in right behind them with that same philosophy. Um, but we feel like we've got a very different product than what they have. And then obviously nobody has magnesium. So the first, you know, there's really two product lines. The first one is Activa, and then Remios is the magnesium. Activa has been around, it's a PLGA, so it's a lot different than what's come before it were PLLAs and PLDLAs and different forms of bioabsorbable polymers. This is an 85/15. There's some really unique characteristics to it. Um, most importantly, we, we call it the self-locking auto-compression technology. And, uh, it's really linear reinforced. So in a nutshell, the, the way it's manufactured is we, we line up the polymer chains linearly and it's actually manufactured in a CMC machine. This is injected molded like everything else. And so when we do that, it lines up the polymers linearly. And so when you put it into the bone, it actually shrinks about 2% and it grows about 2%. So it locks into the bone. We don't see it spitting out of the bone, and then it's gonna be gone without a trace in 2 years. So we don't have any of those cystic formations some of the other absorbable implants are gonna have. So, you know, it's a really robust line. And I think to Tiger's point, everyone has— we were talking before— everyone has some kind of bioabsorbable pin. You know, Arthrex has got the Trim-It pin, and Acumen's got a pin. They have a, a polymer product here and there. This is a full line of products. And it, you know, the Activa is full body indication. We can really go anywhere. There's a lot of different indications for it. But when you talk about, you know, absorbables versus metals, really what you want to do is get to where this green dot is. And that's the, you know, modulus of bone. Obviously titanium and stainless are way up here in the stress shielding zone. The Remios, the teal circle, is much closer, and then the polymers are are, are just on the other side. So, you know, we just want to get closer and closer to the modulus of elasticity of bone without creating stress shielding and, and some other things. And so, you know, the generations of materials have kind of come through here, and now we're, now we're at the magnesium and the hybrid, the hybrid composites. So we've, we've come a long way, we feel like. And so this is an example of kind of when we, when we, uh, have this linear reinforcement of our polymers on the left. On the right is really the market leader right now and some of the other absorbables that have come before us. It's more of a, you know, it's more of a latticework where we're really linear, and I'll show you why that's important. This is kind of the degradation of what happens, and this is, you know, a big issue with the early polymers because they had no controlled degradation. Some would, would would resorb faster than others based on metabolisms. And, and so this is kind of, um, the market leader here. You know, it's, it's a high in crystallinity. Um, it's gonna degrade from the inside out, which the polymers do, but, um, because of its, its crystallinity, you know, you're gonna end up with, with kind of a burst regener— a reverse degradation towards the end. And it kind of takes a while to get there. Um, and so with, with the PLGA, you have a much more controlled degradation that's really engineered to coincide with the healing of the bone. So as the bone heals, we're transferring the load to the bone, and it's engineered that way because it's amorphous. It's this 85/15 polylactic acid to glycolic. So there's no crystallinity in there, and when it goes away, there's no cystic formations. It's replaced by bone.

This—

I'm not going to go through this. This is kind of, you know, the degradation profile, the phases. But key advantages for Activa: self-reinforced. Obviously, we're, you know, we have the auto-compression, self-locking. We maintain 90% strength at 16 weeks, so well beyond the healing cascade, and then we're going to fully go away in 2 years where you can't even see what was left behind if you look at an X-ray. So super excited. I'll show you a couple. This is just an example of how strong our bite is. So that's a reindeer femur because we're from Finland, so we use reindeer for some of our things. But they're just screwing a, I think that's a 4.5, Activa screw. And that's one of our old engineers. So I don't know, we've been selling screws a long time. I'm not sure I've seen a lot of screws that have that kind of pullout, especially for, for an absorbable product. So if you look at pullout, this is us versus a Synthes 6.5. This is our 4.5 lag., we're actually better in the pullout and our 4.5 is pretty close to the Synthes 6.5, in the regular screw, not the lag. And same with compression. So, you know, we feel like we have really, really good strength, really good pullout. Um, this kind of highlights the, you know, as the bone starts to, as the bone starts to heal and our implant starts to go away and those lines cross at about 15, 16 weeks. So we, we like that profile. This is quick on, uh, you know, the patented self-locking auto compression. Um, you know, as it, as it, you know, hydrolyzes, whatever, you know, goes into the warm environment of the body, it's gonna grow a little bit and it's gonna shrink a little bit because when it's manufactured, it's, it's kind of stretched. So it, when it, when it feels the body heat wants to go back to that, to that original state. And this is a pretty bizarre, um, video, but this is a piece of Activa. That's just warm water. We're going to deform it as, as to the max as we can, um, deform it. And then he's just going to put it right back into the warm water.

Wow.

And this are those, those polymer chain veins lining up to be straight again linearly. So it'll go all the way back.

It has a memory. It almost has a memory like Nitinol. That's fascinating. Yeah.

It does have a memory. Yeah. And I was gonna say it's like Nitinol. So that's, it's pretty bizarre when we show doctors and, and people that slide. It's, it's pretty cool. So the compression, I'm not gonna spend a lot of time on that. So, you know, benefits of Activa, we, we, we have a full, you know, robust product line that this is all we do is absorbable technologies. We're not just doing one-offs. We've been doing it for a long time. Like I said, we have, it's probably closer to half a million cases now worldwide. No adverse events. We're not seeing the cystic formations. And we got, you know, at least 10 years of clinical follow-up.

And what, and Blake, what are those cases? Are they small bone fixation, osteotomies, things like that, or?

Everything. Yeah, small fractures, osteotomy corrections, a lot of peds. This is really, really good in peds, obviously, where you don't want to have to go back in and take hardware out.

Yeah.

So now to the next kind of— this is the shiny nickel that every doctor I talk to just gets really excited about. And I think that— I don't know if Tiger agrees with me, but I think we're going to see a lot of magnesium in the coming years, and I think it's going to change orthopedics big time. But we just happen to be the first ones to market, which is good and bad. I mean, it's great, but we got to do it right, the right way. So REMEOS is our platform. This is a magnesium. We added calcium and zinc to it because magnesium wants to go away really quick. And the magnesium and the zinc actually make it stronger and it tempers the degradation. So they did, you know, obviously a ton of research on that. It's the, it's not the, well, it's probably the world's first. It's definitely the first in the US. Right now, all we have is this screw. And it's a 3.5 lag that's not even cannulated. That's our only approved device right now, and the indication is for medial malleol fractures. This, um, kind of a threaded Steinmann pin we're probably going to have by the end of the year, where fingers are crossed. That'll be a game changer. You can zip it into like a hammertoe, cut it off flush with the bone, and you're done. You never have to go back. So lots of advantages with, with Remios. Um,, you know, proprietary magnesium alloy. It's, it's got the perfect ratio to, to match the degradation to the healing cascade. It doesn't scatter an image. You can't really see it on X-ray. I'll show you some X-rays. You can see it, but not really.

Right now you said proprietary, Blake. Does that mean there's trade secrets or are there patents that—

Yeah, that's all patented with our—

You can't patent magnesium, but you can patent Yeah.

Our secret sauce is patented. It's all, it's all protected.

Got it.

One of the coolest things that, that we can say with, with Remios is that it's osteopromotive. And there's no other product in the US, probably in the world, that can claim we're osteopromotive. So as this degrades, it's replaced by bone. It actually promotes bony ingrowth and it degrades from the outside in. Remember, the polymers degrade inside out. This degrades outside in, and as it degrades, there's a thin layer of bioactive hydroxyapatite that forms around the implant. So obviously HA is telling the body we need to turn this into bone, right? So that's how, uh, the FDA said you can make that claim, which is a really, really big deal.

Wow.

That's big. So this is the full family that's being sold right now in Europe. Uh, when I show this to doctors, this Remios screw FT is immediately they go to. This is a fully threaded headless compression screw that's going to go from 2 to 4 in diameter. That will be a game changer for so many things. Traumatologists want it. I mean, foot and ankle, hand and wrist, elbow, everywhere are going to want this. We're going to have a headless like a Whipple Herbert screw, and then the headed lag will, will have cannulated. But right now, This is all we got and we're using it in the medial now. Yeah.

So those other products are pending FDA or they're pending manufacturing.

Okay.

Yeah. You know, typical FDA that, that, you know, so we got the, the de novo pathway for this, which is, as you guys know, is really, really hard to get. The burden of proof you have to show is, is mountainous to get this approval cuz there's no predicate. And so we got that breakthrough designation de novo pathway from the FDA. And so we were pretty pumped thinking, well, all of our other products are going to just be 510s and we're good to go. Well, that guy that had our file left the FDA and somebody else came in and they're like, well, wait a minute, what if you put a hole in this? Does it change everything? And they're making us jump through all these hoops. So, you know, again, we're hoping on that, that threaded K-wire will probably be first. I'm thinking, you know, the FTs will be first of the year. But, you know, having the De Novo pathway is a pretty big deal. And in addition, we're about to make an announcement. We're going to have a CMS pass-through that's going to last for 3 years. So that's going to be really cool. And it's going to help us in terms of VAC approvals. I see Mark on the line here. You know, I think being able to say, look, you know, the delta between, you know, what you're going to pay and whatever that delta is, is Medicare is gonna, is gonna reimburse you. So they're not gonna lose money on these products. And that's gonna be good for 3 years. I don't understand the CMS pathway, so don't ask me a lot of questions on it, but that's what I understand. So one of the things that, that is really important when you're talking about magnesium is the natural degradation. A natural byproduct is, is, is promotes hydrogen gas. Okay, so you're gonna see it, and if you don't know what you're looking for, they're gonna think this is an infected, it's an infected joint. But if you look right, right here, let me see if I can. So here's the fracture. Here's our Romeo screw. You can see that, but you see this little bubble at the distal part of the screw? That's hydrogen gas. And you can see a little pocket of it here, and you start to see it around the screw. At 6 weeks, you see this fine line around the screw. That's actually the HA that is, that is kind of forming because of this hydrogen gas. And, um, but by 12 weeks, it's still there. 24 weeks, it's pretty much gone. If you— and I'll show you one at 52, you can't even tell. But at 6 weeks, it's fully healed. So it's a completely harmless gas that it doesn't elevate any kind of anything in the body. The patient doesn't feel it, doesn't create pressure. It's just kind of there. A lot of times it'll settle right here in the soft tissues. Because it's the least path of resistance to just kind of get out of there. But it's a natural byproduct. We need to do a really good job making sure that everyone understands this because it's already happened where some of the early adopters put, put, put one in the medial malleolus and then the patient goes to another doctor 2 weeks later because they fell down. They take an X-ray and they see this and they say, we're going to prep you for surgery. We're going in. This is infected. You know, so. Luckily, we've— they've called the original surgeon. The guy's like, don't do anything, it's fine. Take an X-ray in 6 weeks, you won't even see it. So this is just a little study on, you know, 90%— oops, 90% of the medial malleus were healed in 6 weeks. You know, osteopromotive properties were verified, normal, normal healing, no swelling, no, no nothing, but no, no elevated levels of magnesium, calcium in the blood, no pain. So we've got some, you know, mountains and mountains of data. This is kind of another set of slides that I'll just show you real quick because— so this middle one here, you can see the screw here. And pretty soon, this is 52 weeks, is all the way at the end here. So it's like nothing ever happened. It's pretty wild. Here you can see it 24 weeks. You can see that screw still there. But at 52, it's all gone. Wow. This was the study that, that created, or that prompted the FDA to say, you know, y'all are really, you're really osteopromotive because this was a pullout study and we put our screws in next to titanium. But at 6 weeks, if you can see that red circle there, there's bone growing over the head of the screw. And at 12 weeks, it's fully encased in bone. And that's, you know, outside of the, of the, of the bones, so to speak. So the, the, the FDA said, listen, man, you guys are growing bone. This is promoting bone growth as it goes away. And we said, yeah, we know that. So they said, well, you can say then that it's osteopromotive.

So pretty cool.

If you guys want to get into the chemistry, I didn't do, I took chemistry in college and I think I barely passed, but, but this is kind of showing the HA layer., that forms as the, you know, as this, as this whole thing starts to degrade and the chemistry that happens. I've got surgeons who actually want to, they try and read through that and I'm like, don't tell me you understand that because I know you don't, but they pretend they do. Um, just another, uh, large animal study here showing kind of the outside-in degradation for the magnesium alloy. And then another study of just pullouts and, and strength of the material. So hopefully that was 10 minutes, Tiger.

Yeah, that's a little more than 10. That's good. Normally when you have bone growing over the head of a screw, it's a, it's a problem cuz you have to take it out later. But this one, it's not a problem because it's gone. That's really cool.

Yeah.

Wow.

Yeah.

So that's, that's Bio-Retec. Like I said, we kind of push the reset button. I'm, I'm working most of, mostly the, western half of the US. So I think I've signed on 8 distributors in the last 2 weeks, and I've got distributors calling me, which is always fun. We're putting together a really badass KOL board. We do have a surgeon advisory board. A lot of them are European. But we just added Dr. D. Giovanni from Mass General Harvard. Him and his team are now on our surgeon advisory board. And so we're gonna— one of my jobs is to create a really badass KOL team, which I've already well on my way with. But, um, you know, the biggest barrier to entry, as everybody on this call knows, is approvals. And so I've got all— hiring all these guys, and they're— we're sending them all the back information, and they're going to town for trying to get approvals. And that's kind of where we're at. Wow.

Yeah, if you have kids, I mean, this is kind of a no-brainer. Or if foot and ankle where you don't, what, 45% of metal has to come out in the foot and ankle, you know, of like titanium and stainless.

Mm-hmm.

Yeah.

How does it compare cost-wise? To what? Well, to anything else that's, they're, they're using in, in a, that's absorbable in fracture management. Well, we're, we're right there with Osseo. Obviously a hell of a lot more than stainless or metal, but, but Osseo is really the only one out there that's, that's, that's really making a difference with absorbables and our, our prices are right there with them.

Alright, Alyssa's up and then Mark.

Hey Blake, I am a big advocate for magnesium and I have a paper coming out with a neurosurgeon and a neurointensivist. So I am all for magnesium and I've been studying magnesium and metals for for a few years now because I do see the benefit. However, all of the data that I'm seeing show high non-union— there's a Scafoyd paper that just came out that showed 40% non-union rates. I've heard the one manufacturer said that they have issues with cyst formation and the gas formation. How are you getting around that?

Um, you know, I haven't heard of any of that with ours. It might be our alloy. And Alyssa, I'm no scientist. I'm pretty new to the company, actually. So, I mean, if you wanted to talk to, to, uh, one of our engineers, I'm happy to arrange that. Um, but, you know, we just launched this in Europe. We've been, you know, obviously going through all the approvals and everything else. We're not seeing cystic formation because of the the osteopromotion. I think that's a really big deal. You know, the other magnesiums don't have what we have in terms of the calcium and the zinc. So maybe that's it. I've heard nothing about nonunion, but I'll have to look that scaphoid paper up. You know, what are they putting? What was that scaphoid paper? Was it a, was it a pin? Was it a screw? Like, how big was it?

I don't, you know, what's the name of your product?

It's called Remios.

Okay, this is the Mag Something. Um, here, I'll share the paper with you.

Thanks. Yeah, there's a bunch of companies that are coming. I think we've got probably a 2 to 3 year head start on anyone else before they hit the US market. Um, but they're, they're gonna be varying degrees of, of, you know, of elements in the magnesium. You know, with ours, it's, they're all rare earth elements and they're all available in your body already. So, you know, magnesium, calcium, and zinc are already in your body. So we don't have any issues with rejections or anything like that. But in terms, yeah, I can't answer your question.

It's probably, could be a different alloy, but that's, it's a really good question.

Wow.

No, I made a note of it.

Yeah. Yeah. It's magnesium and zinc. There's, there's quite a few papers about it. And yeah, there's, there's several companies coming out with product, um, but compress it. Are you doing F2193? Is the FDA making you like fatigue the screw mid-shaft?

I have no idea. I'm sure they made us do all that. Yeah, yeah, never heard of F2391 or whatever.

That's an ASTM mechanical test.

I'm a sales guy. I'm just showing what you got. I want you to buy it.

Yeah. So, but there is, um, a benefit. Magnesium helps with the regeneration of the myelin sheath surrounding nerves. And so there's actually a definitive benefit from a nerve pain standpoint to put magnesium in it. From an osteogenesis and like a VEGF formation, um, it's not— I think you have more of a selling feature for nerve issues and diabetic. If you can get the fatigue to where the screws don't break in areas where there's load, that, that could be valuable. But I mean, scaphoid nonunions are a perfect indication because it's low blood supply and there's not a lot of pressure and it's not a weight-bearing joint.

Yeah, that's why they gave us the medial malleolus. You know, that's not really weight-bearing. Yeah.

All right, Maloney.

Let me lower my hand. So I always, I always love Alyssa's questions. They're so hard. If you, if you were, if, if you were my biology teacher, I would go, oh no, I'm, I'm, I'm transferring.

I'm out of here.

So, uh, I think Blake, of course I know Corey and I can't remember you if I, if you guys were Orthologic dealers back in the '90s or not. But anyway, I've got in my hand, I think, so in addition to VenOps, which is where I spend most of my time, I've got an orthotecnic small distributorship. One of my reps brought me these the other day. These are BioReTech in my hand.

Blake, stop sharing your screen so we can see a little bigger.

Sorry.

Yeah, they're, they're, they're clear, right?

Well, here's a clear pen. This is the magnesium.

Milky. I can't tell. I can't see them.

This is the Activa.

Yeah. Yeah. That's Activa. Yeah.

Yeah. Yeah.

That inserter, that, that metal inserter on the back of it.

Anyway, so when Carlos brought me these in my office, I'm going, bioretec. I said, we got some of that in the warehouse. We had that like years ago.

So you had a couple years ago?

Oh, years ago.

Yeah.

Yeah.

And we didn't really do much with it. We, we, we ran into almost, we ran into some anti-inflammatory stories, blah, blah, blah. And it was, I think it was early on, it was way before you guys got involved.

Interesting.

Yeah, it's got a, but you know, this is, this, this with this magnesium, I think you're onto something. By the way, so I put in the chat your, your marketing campaign. It says our implants give your patients gas and, but they'll thank you for it.

I like that. I'm gonna make a note of it.

Yeah. Oh, it's free.

Geez, free market.

I love it.

It's free.

All right, Andrea is up and then Mauricio.

Yes, I was looking at your IP. You said that you have IP coverage and I don't know if with the name change, if everything got reassigned. It looks like there's, you know, a patent portfolio about 29 inventions, but 20 of them are dead, like from an IP perspective, either abandoned or maintenance fees haven't been paid. Paid. So I was wondering what— why that is.

No idea. Sorry, I don't know.

Yeah, yeah, I mean, yeah. And looking like a lot of them were filed, you know, 20, 15, 20 years ago, and there hasn't been much happening since then. So I was wondering if there's anything— are they going to do anything with the portfolio? Are they gonna— are they working on anything new, or is this sort of one invention or one, you know, a handful of inventions that were done in the past, and that's kind of what they're riding on.

Yeah, I don't know. I know that we, in the pipeline, there's some pretty, pretty cool things. Yeah, you know, maybe some plates. We're going to— we're looking at a spine cage, which would be really cool in the magnesium. But yeah, I don't— I've never looked up the patents like that or anything. I'm just assuming that we have protection. I hope we do.

Okay.

But I'm gonna ask, I'm gonna be actually, we're going to AOFS next week and in Savannah and actually Timu, our CTO who really invented all this stuff is gonna be there. So we've got a couple days worth of meetings there, but I'll bring that up.

Thank you.

Yeah.

Yeah. Cool.

Appreciate it. Blake, I would just from the peanut gallery, I would seriously stay away from a spine cage when it's next to the central nervous system, you have hydrogen gas creation, you have cyst formation and an inflammatory response that might get you into a world of hurt and really hurt your, your brand. Because I think you definitively have a brand, um, particularly in trauma. But you do one product and it causes inflammation and it causes a degradation in the spinal cord, and, and you're in trouble.

Yeah, no, I hear you. I, I I've stayed out of spine my career on purpose. I don't like spine.

I would say in bone, in bone and vascularization, VEGF formation, you know, like nutrient supply protection of the nerve endings within the bone. That's a— I honestly think if I were you, the myelin sheath is a big deal because there's a lot of nerve and vascularity that occur inside bone. Particularly in diabetic patients.

And you—

if you're— the magnesium helps regenerate that myelin sheath surrounding the nerve. And it's a much better campaign, in my opinion, because nobody discusses it.

Yeah, that's, that's a really good point. I'm going to talk to Timo about that next week for sure. Yeah, and in terms of the spine cage, I mean, I think they're just trying— they're looking at proof of concept. I don't think they're anywhere near a product, you know.

Yeah.

And, and I don't think that BioReTech wants to be in spine. I think it's something if they could prove concept, they'd probably spin it out or something.

Plates are cool. You know, plates are really cool.

We'll have staples. We'll, we'll have some of that other stuff. Yeah. Yeah. Because the magnesium obviously can't touch metal. It causes corrosion and it affects the degradation profile. So if you're gonna have a plate, it's gotta be magnesium with magnesium screws.

It's wise words from Melissa there. And the other thing is you don't wanna deal with multiple sales channels. You know, I mean, that's insane, you know?

No, no.

All right. Mauricio's up.

He's gone.

I was just gonna say, I love this. I've been following magnesium for a long time. Since I got into fixation, I've been trying to 3D print it and find the right alloys. And I've been, I've burned my eyelashes on this for a long time. Never have been able to get the right alloy. There's, I've been following you guys and I've been following a German company, Syntellix, I think it's their name, or there's a German company that is doing magnesium screws. It feels like both of you guys have the right alloys and have the right resorption rates. So I look forward to seeing you guys do well in the extremities market. And again, I'm with Alyssa and Tiger. Extremities are beautiful for this, you know, and it's probably like those headless compression screws. That's enough of a business to keep you guys happy for a very long time.

I agree. I'd be happy with that.

And you know, what would be cool is curve effects. The hip fracture system, that might be a cool partnership too if you want to get into the larger. I don't know, there's a lot of forces, so I don't know if you can, but it's one rod that bends for hip fracture. It's hip fracture, is it pelvic fracture?

Pelvic, it's a fragility pelvic fractures.

Okay. So would that be too much of a load, Tiger?

I, you know, the patients are 70, 80 years old. And so I, it's the, I don't think you, you need bioresorbable stuff, it, you know, for that patient demographic.

But yeah.

Yeah. But yeah, there's, but I love the thinking. I mean, everybody's wheels are turning. Where's this— where could— what's the next application that we're not seeing?

Reverse total shoulders? Well, no, no, you need that. There's, there's so much hardware that goes in the glenoid. It's really sad. Like, I mean, it's just, it, it makes me uncomfortable with the amount of hardware that goes into the glenoid for reverse shoulder, total shoulder. I'd love to see a new prosthesis developed for the glenoid.

I don't know how the osteopromotion aspect of it would work if it's like osteoconductive or something, because you could theoretically find a way to make something that will stick even if it's made in another metal or plastic or something. That would be interesting to explore.

Mauricio, what about CMF? Are there things in the CMF that you want to disappear over time?

Oh, everything in the face, everything that stays there is a problem. Like, I, I'm immediately thinking orthognathic surgery, mandible recon, all of those plates you need, you want them gone because the mucosa is very thin and it ends up, uh, you end up seeing many of those plates again, which you don't want. So if the plate will disappear, that's, that's actually great. I, I, that, that's the application we had been, we've been pondering around for a long time. It's patient-specific 3D-printed mandible plates and maxilla plates.

Hey Mauricio, so how hard would it be to use this material for like a custom glenoid for revision?

I mean, the problem with the custom glenoid is that you don't, you don't want the glenoid to disappear over time because you, you need it to, to hold for— you need it to hold long. So I was thinking something like what they're doing with like with those porous chips that you use to generate bone around the glenoid to like recover the bone.

What about this? Having a total— this is a little out there, right? Sorry, Blake, we're kind of, uh, we're taking over. I apologize.

No, y'all go for it. I have a hard stop here in about 10 minutes, that's all.

Total shoulders.

It—

you take a total shoulder, it grows into bone in the glenoid, and it turns it into basically a bipolar. Uh, well, no, no, because you'd need cartilage, wouldn't you? Would you need cartilage? Because it's just a poly that it buttresses up against for a total shoulder. And then it gives you bone growth, bone regeneration. So it turns in a total shoulder, it reverses back in time, right? It goes from a total shoulder to a bipolar, and you have the rotator cuff in place. And then if you need to go to a reverse total shoulder, now you have bone to put all your hardware in, and you don't have to take the glenoid out.

Well, I think that, like I said, I think magnesium is going to come at us pretty hard. And I'm, you know, I've already got several companies who've called me and said, hey, can we make our product out of your material? You know, so that's gonna be another decision BioReTech needs to make. Do they want to do some of that, you know, manufacture different products?

I would strongly suggest you want to own your customers and you want to control your brand. I, I hate it when companies become suppliers like Syntex. Yeah. You know, they lose control. They lose control of pricing. They lose control of their brand. They lose control. They don't even know who their customers are. It's, It's a sad thing.

Yeah, I, I think we're, we're, you know, we, we gotta get going here in the US and establish a market here before we can really look at some of that stuff. But, but yeah, there's, there's a whole company called Magnesium Development Company that's coming. There's a, there's at least 3 or 4 that I've read about. So magnesium is gonna come.

Yeah.

This is where you, you wanna make sure your, your IP is, you know, in order cuz you could potentially license license it if it is truly strong and, and alive, right?

And active.

Yeah.

Or, or not. Then you have, you know, you have to make sure that you're not stepping on anyone's toes.

Yeah. No, I mean, this is, this is a Finnish publicly traded company, so they're on, they're on like their version of the NASDAQ in Finland. So, um, I'm sure that they've got all the IP buttoned up if they're a public company. But I'll ask.

You have a good question. The other advice is you gotta be different. So, you don't want to be a magnesium company. You want to, I just, I don't know how you brand it, but I tried to help Ossio when they came out like 5 or 6 years ago. You know, don't, you know, don't be a foot and ankle company, be a non-metal company. So think about being different. You don't wanna be put in the category with all the magnesium companies. They're gonna, oh, another magnesium. I like that osteo, osteopromotive thing is huge. You could run with that. And I don't know if you could trademark it or brand that.

Yeah, I think so.

Yeah.

The De Novo approval, the osteopromotion, the CMS pass-through. I mean, there's some really good, good headwinds for our tailwinds for us.

Yeah, that also promotion to, to bridge bone gaps, like if you have critical defects in the lower extremity from a comminutia or something, that you can put something in there and have that implant promote the bone and then disappear. That, that would be incredible.

You got guys talking already about Chevrons and bunions and lapidus using the product for the—

using our product in those.

Yeah.

Yeah.

I mean, it's, it's so compelling. You can see the group here. As soon as everybody understands, it's like, wow, where else can that be used? You know, you're, I'm sure surgeons' wheels are turning too. Wow. Where else can that be used? And the other, you may run into the same thing Osseo ran into where they had, they had to focus. 'Cause they could have, they could have tried to boil the ocean with, with ACL tunnel screws. They could have done everything at once, but instead they, they focused foot and ankle only, bunions only, and then staples. They added staples, they added compression. So focus is focus on the markets you want. Blake, and like Andrea said, maybe license the other stuff.

Yeah, I think, you know, and that was the same way at Arlon. You know, Aaron decided we were going to be a foot and ankle company even though I was a sports guy and most of my team were all sports guys. We're like, we want to sell into sports. And no, no, no, we're going to focus on foot and ankle. And 25% of our revenue came out of sports just because guys heard about the material and got our friends we talked to about it. But I do believe I learned a valuable lesson that You know, when Aaron said we're gonna focus on foot and ankle, we're gonna own the lateral ankle reconstruction, he was very, very clear what he wanted. So his vision was there, and I really like that. So right now we are focused on foot and ankle primarily because our only indication for Remios is the medial malleolus, right? And so we've gotta sell Activa because all we have is one screw for one indication on Remios right now, and we, we need sales. So we've gotta sell Activa. We can sell that all over the place, but there's enough in the foot and ankle that could keep us very busy. And then it'll be interesting, you know, when we get the full line out with Remios. Do everyone, do they stop using Activa and go all Remios? Or, you know, what's that gonna look like? We're almost selling against each other a little bit. So it'll be interesting. But yeah, I mean, you know, upper extremity, hand, we're not gonna do a ton of the hand, but elbow is great for some of these Activa products and even Remios products if they want to go there, but that's their decision. We can't market it.

Focus is, is really important. I mean, the whole Treece story, you know, I talk to John Treece every year. When are you guys gonna do a full bag of products? The board won't let me. It's world domination of bunions. That's all we're, that's all I'm allowed to do. World domination of bunions.

Well, that makes a lot of sense because, you know, we were, We built the Trees business here before we sold it back to him, and the rep that brought this to me was the Trees regional manager who works for me now. So obviously whoever's doing it here is a foot and ankle guy.

Is that Jonathan?

I don't know. Oh no, I mean the rep was Carlos.

Oh, okay.

Carlos Cuevas. Yeah, he left Trees, uh, 2 and a half months ago and came back to the mothership.

Hmm. It's a different company now. They're big.

Hey, y'all, I gotta hop. Thanks for letting me share my story.

Uh, this is great. Thanks.

Really appreciate the feedback. I got some notes here, and I got a lot to talk to them about next week when I see them in Atlanta. Good luck to Gunnar this weekend. Hey, thank you, man. We watching. Hopefully he catches a couple balls. I told him if he scores a touchdown, he's got to do the Mile High Salute. All right, thank you guys.

Thanks, Blake. Yeah, you guys want to stick around, talk about anything, or, or jump on our next call?

I got to get—

we've got Joe Colonna next week, Mark.

You got what?

We got Joe Colonna next week.

Oh, is that next week?

Next week, September 11th.

Yeah.

Give everybody an overview of, of who this guy is and kind of, why it's gonna be interesting.

All right. So Joe is the senior guy of supply and logistics for the biggest hospital system in Georgia, Piedmont Healthcare. And about 4 years ago, I started noticing a lot of investment money going into logistics for the margin. And so I deliberately set out to make, create a relationship with him and his counterpart at WellStar with the other big system in Southeast here, Michael McCullough. And it turned out Joe actually was a Navy veteran. So when I was starting up a veterans nonprofit in 2018, a couple of years later, I hit him up to be, for Piedmont to be a sponsor. So we became friends and I, I meet with him coffee for coffee about once every 3 months. And I'm not trying to really sell him anything. I'm just trying to learn how the game on their side works. And in the last meeting I had, I was taught, I brought it back. I think I had talked to Mark Copeland a day or two before and I was, I couldn't decide whether I was gonna kill myself over it or, or try to get better at it. So I talked to Joe, I said, Joe, What the hell? And, uh, he said, this value analysis, it's killing us. We can't get new products in. The doctors are pissed at us. And he said, well, first of all, Mark, he said, most of the doctors work for us now, so screw them. I don't care.

And he said, if you think it's bad now, it's going to get worse.

I said, oh man. But then he got a little, he softened a little bit, and that's when I invited him on. To ruin your day.

So he'll be— so Joe will be here next week to— we'll look behind the curtain of how big hospitals think. Raymond's got a question or a comment.

Well, it's a question, totally off the subject, but you published an article about the High Ridge acquisition of the two uh, Accelis products, but I didn't get the information I was hoping you'd give me. And so it may obviously probably not be available, but I wanted to ask, uh, any information on the terms that were associated?

No, the terms were not made public, I don't think, Raymond. It's— and Hybridge doesn't have to do that, I'm sure. So the Hybridge sales are like $400 million, and Accelis's sales are like $30 million. And Accelis is barely hanging in there. And they sold their, you know, couple of their flagship products. I think just to— I think it was a desperation thing, just like the article said, you know, the, the, the strong and spine eat the weak. And that's what happened this week.

They, um, yeah, I mean, I figured as much. Um, now just about a year ago at NAS, uh, High Ridge was uh, showing those implants on the— on in their, uh, booth. So I'm guessing that they had some type of distribution agreement for a year or so. But my guess is— I, I don't know what's going on with Axellis other than the problems they had a year or two ago when they had to sell the robot, but I'm guessing it wasn't pretty with regard to that situation, the more recent situation.

I mean, I don't have any inside information, but they're probably circling the drain and they're, they're desperate. They're selling all the good stuff, which is crazy, and good for Hyridge for picking up things like that. Does anybody know what Hyridge's sales force looks like? Is it, is it the old K2M? Is it, what are they doing? Are they building it from scratch? They gotta have a, a collage of sales reps from different companies. Alissa probably has a note on that.

Yeah, they, they have partnerships with some big, big distributors like Frank over in New York, and that can just pull in surgeons quick. Frank is— I think Frank owns 5% of VorWeb as well. And so, yeah. I think he's the biggest shareholder for, for Web. So it's a good complement to what they're doing.

Interesting. Yeah, the Highbridge will probably acquire here things here and there and then eventually spin out and go public when the IPO market is robust again.

But I think we're seeing a lot of early movement on investment. Um, We went, we had zero as of June. There was not even $1 billion investment based off of PitchBooks. And it's probably, there was probably more that was unaccounted for. But PitchBooks said in 2018 there was $152 billion invested in medtech. And then as of June of 2025, this year, that this year they, there hadn't even been $1 billion. And now it's hit $4 billion in one quarter. So it, it's coming in, it's starting, the movement's starting to come. I don't know, and I'm feeling it on our end as well, um, we're getting a lot more people looking and talking investment, but I think that that will end very quickly as we get into the holiday season. So we, we need to grab it quickly.

Interesting.

Are there Are there particular groups that you are finding more interesting or interested? Yes. Um, and what type?

Yeah, a small percentage of investment firms actually invest in orthopedics and spine because there's been traditionally very low returns, if any returns, and they've been holding on. And because there were so many commodity companies out there, they're only interested in non-commodity products, companies that are producing non-commoditized product, and which is— which luckily, because the only ones that have been able to survive up to this point over the last few years are companies that are unique. Bye, Mark.

See you, Mark. In this, another notable thing that happened, there's a SI fusion company called PainTech. Do you guys see that?

They just—

I mean, I'll put it— I'll put their website in the chat, but they just raised like $35 million out of nowhere with 2 investors. And it— for— there's 50 SI fusion companies, you know. So, and they don't— and their, their offering looks more like a spine cage, looks like a you know, an inner body wedge. It doesn't look like a screw. Um, but that was— I considered that as kind of a canary in the coal mine, that if, if there's— if investors are actually bringing in $35 million into an SI Fusion company, you know, then that, that's a good sign for everybody.

Tiger, what was the name of that company?

The SI company?

Yeah, let's put, I just put it in the chat. It's P-A-I-N, Pain Tech, Pain Tech. And it's owned by, I think, a surgeon, the interventional specialist in Tampa. And they've done like thousands of cases. But I mean, my gosh. I mean, there's 50 SI fusion companies now. You know, SI Bone taught everybody about it and then everybody ran run into that anatomy.

Yes.

Yeah. Simplicity just developed a couple of new SI fusion products that they just got approved and they look pretty good.

It must be that it must be an easy $5-10K because everybody, I'm thinking about doing an SI fusion. I mean, it's gotta be easy compared to, you know, compared to, you know, $5-10Ks with clinicals.

I mean, as long as you don't, as long as it's not different. Exactly. It's an interesting time being in the FTM community.

Yeah.

Yeah. I mean, it's a bone, it's basically a fixation device, right? That goes across bone, cartilage, and then into the other bone. And some of them scrape away the cartilage, others don't. But it's almost like an osteotomy screw, you know, for a lot of these companies. Anyway, I thought that was interesting. A MeToo company got a lot of funding all the last week.

Good news.

It's interesting. Yeah, you know, it— I think it's a lot easier for surgeons to find funding, um, than it is for because they have the credentials, right?

Yeah, well, they can certainly tell the clinical story very well.

Yeah, investors like it because they feel like there's credibility there. The problem is, is you only get one viewpoint, and whereas, you know, people that go in and have worked with hundreds of different surgeons, they have a very different viewpoint a lot of times.

But yep.

How— Raymond, how's your fundraising going? I know you're, you're talking to people all the time.

Next subject. I mean, I could be— I could lie. Would you like me to lie?

No, tell us what's going on. Alyssa's in the same boat, but she's pre-revenue.

Um, I went to Hawaii for a week And I'm still on Hawaiian time, so that's my excuse. But I'm ramping up again. But it's hard. It's hard. I was just looking up. I was out of the loop for a bit. Carl's Med continues to decline and the impact that may have on what Alissa had just said. I don't know whether that's going to be negative or positive. Our, as it turns out, our sales are going great guns. I mean, it's just blowing up. And so we're in this weird position of— some might call our product, uh, commoditized, but it's differentiated enough to where surgeons are saying, I want it. Um, but we gotta keep up with demand. So it's a weird, hard place to be, if that is perhaps too transparent. But Yeah, I'm looking for investors.

We had a person— we were talking with a funding specialist. Every state has— a lot of states, I should say. I don't know for sure of every state, but a lot of states have hundreds of millions of dollars in grant money for AI. And if you can find a way to build AI into your company or in a product, you can get funding. And I think that might be the path of least resistance. Even if you use the money to buy, to acquire an AI company.

That's interesting.

You can say you use AI in your design, Raymond, and probably tap into that.

I had a cool trademark until I let it lapse. This was like 5 years ago. It was AIgorhythm. All one word.

Oh, well.

Wow. That would have been a good one to have.

Yeah, no kidding. That was— you were a little early.

I should have saved it just for the funding grant. I love it. Thanks for the advice.

And Raymond's in a big state. He's in Florida. So there's— I mean, there's got to be— Florida is a massive state. There's got to be a lot of grant money in Florida.

I was just in Florida yesterday speaking in Destin.

Okay, hope you got to the beach.

That's my hometown.

Okay, and no shark attacks this time?

Yeah, not this time.

Alyssa witnessed a real shark attack, uh, Yeah, I was on the Discovery Channel.

Did you know that? It's on HBO Max now. I was interviewed. Wow. Yeah, really weird. It actually, uh, the woman that was attacked by the shark, Elizabeth Foley, she, uh, got a prosthesis from a company that had been on here. We're work— I'm working with her to get their prosthesis attached to the muscle with Brian McLaughlin's firm. What's his company?

Oh yeah, ALM.

Yeah. Yeah.

That's cool, man. That is a cool area. The osteointegrative, I don't know what you call it, but it's basically a peg that sticks out of your tibia or femur that holds the socket way better than skin sockets.

It's the muscle attachment functionality, the muscle and nerve functionality within the prosthesis. A prosthetic device is really cool.

Wow, cool. All right, we hit an hour. That was, uh, that was really interesting. Can't wait to see what BioReTech, uh, when they come out with more magnesium options, it's going to be a buzz. And Blake knows how to build sales forces, man. He helped build Artilon and did an incredible job. So All right, thanks guys. Next week, uh, we've got Joe Colonna, uh, he's gonna take us behind the curtain in large hospitals, so that'll be fascinating. Okay, thanks.

Bye.

Bye-bye.