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

Foreign.

Okay, so this is bone shots number 92. Just can't believe we're at 92 now. Yeah. And Blake Helm's going to walk us through the Biuretic kind of technology business and clinicals. He's, he's one of their new sales leaders. And Biuretic 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 Bioretech. Biuretic sounds better, but it's.

Yeah, it does. Okay.

Yeah. So thanks for having me. Just wanted to kind of share a high level view of what bioretech's all about. 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. 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 Ardalon, so we had a successful run with them, got them sold to Stryker and a good friend of mine who I, I used worked with at Stryker Endo back in the mid mid 90s, went to work for Bioretech about a year ago and he, he pulled me in to, 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 what I understand of it. I think what's really important to understand is, you know, bioretech, these absorbable polymers, really, the birthplace is all in Finland and they've been around for 20 plus years. But you know, most of it can be traced back to Tampa, Finland and some couple different individuals specifically who kind of pioneered this whole world. The Magnesiums actually comes out of Graz, Austria. And so we've partnered with them. But if you look at bioretech, so back in, and Corey and I sold Bionics back in the day and they were the first ones that had kind of a Vibes orbital 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. The US 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 additions to that family of products, which I'll show you. But you know, obviously challenges with metal, second surgeries, taking things out, infection risk with biofilm, you know, stress risers, 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 absorbables. And 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, 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 8515. There's some really unique characteristics to it. Most importantly we call it the self locking auto compression technology and it's really linear reinforced. So in a nutshell, the way it's manufactured is 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 going to be gone without a trace in two years. So we don't have any of those cystic formations some of the other absorbable implants are going to 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 biosobal pen. You know, Arthrex has got the trim, it pen and Acumen's got a pen. They have a polymer product here and there. This is a full line of, of, of products. And it, you know, the Activa's 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, the polymers 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 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 come a long way, we feel like. And so this is an example of kind of when we, when we have this linear reinforcement of our polymers on the left, on the right are, 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 lattice work 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 control degradation. Some would, would, would resorb faster than others based on metabolisms. And, and so this is kind of the market know, it's, it's a high in crystallinity. It's going to degradate from the inside out, which the polymers do. But because of its, its crystallinity, you know, you're going to end up with, with kind of a burst, regenerate, reverse degradation towards the end and it kind of takes a while to get there. 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 8515 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, we're, you know, we have the auto compression self locking. We maintain 90% strength of 16 weeks so well beyond the healing cascade and then we're going to fully go away in two 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 four or five 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 pull out especially for, for an absorbable product. So if you look at pull out this is us versus versus a synthes six five. This is our four five lag. We're actually better in the pullout and our four five is pretty close to synthes six five 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 pull out. 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, you know, the patented self locking auto compression. You know as it high, as it you know, hydrolysizes whatever, you know, goes into the warm environment of the body it's going to grow a little bit and it's going to shrink a little bit because when it's manufactured it's, it's kind of stretched. So when it, when it feels the body heats, wants to go back to that, to that original state. And this is a pretty bizarre video, but this is a piece of Activa that's just warm water. We're going to deform it is to the max as we can deform it. And then he's just going to put it right back into the warm water.

Wow.

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

Has a memory. It almost has a memory like nitinol. That's fascinating.

It does have a memory. Yeah. And I was going to say it's like nitinol. So that's, it's pretty bizarre when we show doctors and people that slide. It's pretty cool. So the compression, I'm not going to spend a lot of time on that. So, you know, benefits of Activa, we, we have a full, you know, robust product line and 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, 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, is good and bad. I mean it's great, but we got to do it right the right way. So REMIOS 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 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 mal fractures. This kind of a threaded stymon 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 hammer toe, cut it off flush with the bone and you're done. You never have to go back. So lots of advantages with, with Remios and know proprietary magnesium alloy. 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.

When you said proprietary Blake, does that mean there's trade secrets or are there patents that.

Yeah, it'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 osteoporomotive and there's no other product in the US probably in the world that can claim we're osteoporomotive. 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 the FDA said you can make that claim, which is a really, really big deal. So this is the full family that's being sold right now in Europe. When I show this to doctors, this Remio screw FT is immediately they go to. This is a fully threaded headless compression screw that's going to go from 2 to 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. We'll have cannulated. But right now this is all we got and we're using it in the Medial mouth.

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

Yeah, you know, typical FDA 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 because 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 will be 5, 10ks 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's threaded K wire will probably be first. I'm thinking, you know, the FTS will be first of the year. Um, 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 three years. So that's going to be really cool and it's going to help 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 going to, is going to reimburse you, so they're not going to lose money on these products. And that's going to be good for three 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 promotes hydrogen gas. Okay? So you're gonna see it. And if you don't know what you're looking for, they're going to 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 Remeo 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 six 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. 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 six 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 one in the medial mal and then the patient goes to another doctor two 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. 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 six weeks, you won't even see it. So this is just a little study on, you know, 90%, oops, 9% of the medial males were healed in six weeks. You know, osteoporotive properties were verified normal. Normal healing, no swelling, no, no nothing. But no, no elevated levels of magnesium, calcium in the blood. No. 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 oops, real quick because, so this, this middle one here, you can see, 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 osteoporotive because this was a pull out study and we put our screws in next to titanium. But at six 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 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 osteoporomotive. 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 in 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. Just another large animal study here showing kind of the outside in degradation for the magnesium alloy and then another study of just pull outs and, and strength of the material. So hopefully that was 10 minutes tiger. Yeah.

That's a little more intense. That's good. Normally when you have bone growing over the head of a screw, it's a problem because 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 bioretech. Like I said, we kind of push the reset button. I'm. I'm working most, mostly the western half of the US So I think I've signed on eight distributors in the last two 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 going to. One of my jobs is to create a really badass KOL team, which I've already well on my way with. But you know, the biggest Barrett entry is everybody on this call knows is approvals. And so I've got hiring all these guys and they're. We're sending them all the VAC 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. Yeah.

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

All right, list is 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 neuro intensivist. So I am all for magnesium and I've been studying mag, magnesium and metals for a few years now because I do see the benefit. However, all of the data that I'm seeing show high non. There's a scaphoid paper that just came out that showed 40% nonunion 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?

You know, I haven't heard of any of that. With ours, it might, 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 one of our engineers, I'm happy to arrange that. 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 Osteo promotion. 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 non union, but I'll have to look that scaphoid paper up. You know, what are they putting. What was that scapegoat 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. 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 two to three year head start on anyone else before they hit the US market. But they're going to be varying degrees 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 alley. 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, but compressor. 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 F 2391 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 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. 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 non unions 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, maybe that's why they gave us the medial mal. You know, that's not really weight bearing.

Yeah.

All right, Melonia.

Let me lower my hand. So I always, I always love Alyssa's questions. They're so hard. If you, if you were, if you were my biology teacher, I would go, oh, no, I'm. I'm transferring. I'm out of here. So 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 Vinops, which is where I spend most of my time, I've got a orthotechnic 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 pin. This is the magnesium milky I can't tell.

I can't see.

This is the Activa.

Yeah, yeah, that's Activa.

Yeah, yeah.

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

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

So you had a couple years ago.

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.

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, but they'll thank you for it.

I like that. I'm making notice.

Yeah. Oh, yeah, it's free.

Jeez, I love it.

It's free.

All right. Andrea's up and then Mauricio.

Yes. I was looking at your ip. You said that you, 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. 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, handful of inventions that were done in the past and that's kind of what they're writing on.

Yeah, I don't know. I know that we. In the pipeline, there's some pretty, pretty cool things. 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 going to ask. I'm going to be. Actually, we're going to AOFAs next week and in Savannah and actually Timu, our CTO, who really invented all this stuff, is going to 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, particularly in trauma, but you do one product, and it causes inflammation and it causes a degradation in the spinal cord, and you're in trouble.

Yeah, no, I hear you. I. Well, I've stayed out of spine. My career, Chris. I don't like spine.

I would say in bone. In bone and vascularization, VEGF formation, you know, like nutrient supply, protection of the. The nerve endings within the bone. That's a my. 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. 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.

Love staples. 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 got to be magnesium with magnesium screws.

It's a wise words from Melissa there. And the other thing is, you don't want to deal with multiple sales channels. 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 burned my eyelashes on this for a long time. Never have been able to get the right alloy. I've been following you guys. And I've been following a German company, Syntellix, I think is their name. 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, 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 is. That bends for hip fracture. It's hip fracture. Is it pelvic fracture?

It's fragility. Pelvic fractures.

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

I. You know, the. The patients are 70, 80 years old, and so I. It's the. I don't think you. You need biores. Orbital 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 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. 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'm immediately thinking orthognathic surgery, mandible recon. All of those plates, you want them gone because the mucosa is very thin. And it ends up. You end up seeing many of those plates again, which you don't want. So if the plate will disappear, that's actually great. That's the application we've been pondering around for a long time. It's patient specific.3D printed mandible plate 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 want the glenoid to disappear over time because you need it to hold for. You need it to hold long. So I was thinking something like what they're doing with, like, with those. Those porous. Porous chips that you use to. To generate bone around the glenoid to, like, recover the bone.

What about this? Having a total. This is. This is in. This is a little out there, right? Sorry, Blake, we're kind of. 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. 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 cup 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 going to 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, yeah. 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. That's a sad thing.

Yeah, I think we're. We're, you know, we got to 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 Co. That's coming. There's a, there's at least three or four that I've read about. So Magnesium is going to come.

Yeah.

This is where you want to make sure your, your IP is, you know, in order because 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 finished, publicly traded company. So they're on, they're on like their version of the NASDAQ in Finland. So I'm sure that they've got all the IP buttoned up if they're a public company. But I'll ask. You're a good question.

The other advice is you got to 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 Osseo when they came out like five or six 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 want to be put in the category with all the Magnesium companies. They go, oh, another Magnesium. I like that Osteo. Osteo promotive thing is huge. You could run with that. And I don't know if you could trademark it or brand that.

Yeah, I think, yeah, the de novo approval, the Osteo promotion, 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 communutia 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 lepidus using the product for the.

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 to focus because they could have tried to boil the ocean with ACL tunnel screws. They could have Done everything at once. But instead 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, we're 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. I learned a valuable lesson that, you know, when Aaron said, we're going to focus on foot and ankle, we're going to 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 mouth. Right. And so we've got to sell Activa because all we have is one screw for one indication on Remios right now, and we. We need sales. So we've got to 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 going to 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, we're not going to 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 tree story, you know, I talk to John Trees every year. When are you guys going to do a full bag of products? The board won't let me. It's world domination of bunions. That's all. We're 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.

I mean, the rep was Carlos.

Oh, okay.

Carlos Cuevas.

Yeah.

He left treece 2 1/2 months ago and came back to the mothership.

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

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

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 him in. Good luck to Gunner this weekend. Hey, thank you, man. We watching. Hopefully you get 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? We've got Joe Colonna next week.

Mark, you got what?

We got Joe Colona next week.

Oh, is that next week?

Next week. September 11th. Yeah. Give everybody an overview of who this guy is and kind of why it's going to 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 four 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 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 three 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 up vac, I think I talked to Mark Copeland a day or two before, and I was. I couldn't decide whether I was going to kill myself over it or. Or try to get better at it. So I talked to Joe. I said, joe, what the hell? And he says, 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. The. Totally off the subject, but you published an article about the High Ridge acquisition of the two Axcelis 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 any information on the terms that were.

No, the terms were not made public. I don't think Raymond, it's. And High Ridge doesn't have to do that, I'm sure. So the High Ridge sales are like 400 million and a Cellus sales are like 30 million and a Cell is barely hanging in there. And they sold their, you know, a couple. Their flagship products. I think just. 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.

Yeah, I mean, I figured as much. Now, just about a year ago at nass, High Ridge was showing those implants on the. On in their 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 Axcelis 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 sell and all the good stuff, which is crazy. And good for hybrids, for picking up things like that. Does anybody know what High Ridge'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 got to have a. A collage of sales reps from different companies. Alyssa probably has a note on that.

Yeah, 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 4Web as well. And so, yeah, I think he's the biggest shareholder for Webb. So it's a good complement to what they're doing.

Interesting. You know, the High Ridge will probably acquire 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. 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 PitchBook 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'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. 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 need to grab it quickly.

Interesting.

Are there, are there particular groups that you are finding more interesting or interested?

Yes, 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 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 Mark in this, the another notable thing that happened there's a SI fusion company called Paint Tech. 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 two 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. 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. I just put it in the chat. It's P A I N Pain Teq Pain Tech and it's owned by I think a surgeon, 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. SI Bone taught everybody about it and then everybody ran. Ran to that anatomy.

Yes, I know. Simplicity. Just developed a couple of new SI fusion products that they just got approved and they look pretty good.

It must be the. It must be an easy 510k because everybody. I'm thinking about doing an SI fusion. I mean, it's got to be easy compared to, you know, compared to, you know, five 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 f. 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 me too company got a lot of funding all the last week. Good news.

It's interesting. Yeah. You know, I think it's a lot easier for surgeons to find funding than it is for. Because they have the credentials. Right?

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 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. I could do the same book, but she's pre revenue.

I went to Hawaii for a week and I'm. When 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. CarlsMed continues to decline and the impact that may have on what Alyssa 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 just blowing up. And so we're in this weird position of. Some might call our product commoditized, but it's a differentiated enough to where surgeons are saying, I want it, but we got to 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 the funding specialists. 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. Say you use AI in your design. Raymond and probably.

Cool trademark until I let it lapse. This was like five years ago. It was a Igorhythm, all one word. Oh, well, wow.

That would have been a good one to have.

Yeah, no kidding. That was. You're. 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.

No shark attacks this time.

Yeah.

Not this time.

Alyssa witnessed a real shark attack.

Yeah, I was on the Discovery Channel. Did you know that it's on HBO Max now? It was interviewed.

Wow.

Yeah, really weird, actually. The woman that was attacked by the shark, Elizabeth Foley, she got a prosthesis from a company that had been on here. I'm working with her to get their prosthesis attached to the muscle with Brian McLaughlin's firm. What's his company?

Yeah. Alm.

Yeah.

Yeah. That's cool, man. That is a cool area. The Osteo Integrative. 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.

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. That was really interesting. Can't wait to see what Bioretech. When they come out with more magnesium options, it's going to be a buzz. And Blake knows how to build Salesforce as man, he helped build Ardalon and did an incredible job. So. All right, thanks, guys. Next week we've got Joe Colonna. He's going to take us behind the curtain in large hospitals. So that'll be fascinating. Okay, thanks.

Bye.