Inside Orthopedics Podcast #40: Anatomy of a startup - Q&A with the Founding CEO of OSSIO

Brought to you by Tiger Buford. Welcome back to Inside Orthopedics. This is Tiger, your orthopedic industry insider and retained recruiter for early-stage companies. This is episode number 40. I have a real treat for you today. An inside interview with the founding CEO of Osseo, Oren Price Bloom. Osseo is a newly disruptive biomaterials company that is positioned to change orthopedics forever. As you know, surgeons have been implanting metal plates, metal screws, metal nails for decades. And these permanent implants can cause long-term clinical issues and often have to come out. So what if a surgeon had an implant with the fixation strength of metal, but the implant would disappear over time and turn into new bone or tissue? Well, it's here. So I'm live with Oren Price Bloom at Osseo. Welcome, Oren.

Thanks, Tiger. Thanks for having me.

Yeah, so where are you? Are you somewhere in Israel?

Uh, yeah, our Israeli offices are located in Caesarea, which is a little bit to the north in Israel, about half an hour north of Tel Aviv.

Yeah, the tech town. Yeah. Yeah. So that's great. So thanks for your time. I know that listeners are going to want to get into the technology and the company, but first, can you kind of tell us about your background and kind of education and where you came from?

Sure. Yeah. No, thanks, Tiger. And I also wanted to thank you for really being a voice for the orthopedic startup. I think it's a really important thing for us entrepreneurs to have out there, so thank you. So, yeah, so basically I grew up in New York. I studied biomedical engineering over at Columbia University, and that took me into orthopedic research, which I did for a few years at the Department of Orthopedic Surgery over there at Columbia, mainly biomechanics. And then came to Israel for graduate school to study biomaterials. And that really brought me down this road of trying to figure out how novel biomaterials can help solve clinical problems.

And what was that impetus? Do you remember a course or a professor or something that said, hey, here's a big problem in orthopedics?

So it's actually, I started studying computer engineering and then I joined the water polo team. And unfortunately, while I was playing water polo, I started to have some real serious problems with my knees and I was forced to stop playing. I found that to be very frustrating and so I started looking into the difficulties that are in the field of orthopedics. And just at that time, another good friend of mine was injured pretty badly in an orthopedic way. He was a professional basketball player, and it basically ended his career. And so it just, you know, these things coming all at the same time just drove me to want to help people who wanted to engage in certain activities that were being held back by their physical limitations.

Interesting, interesting. Okay, so, and so what was— so you studied graduate school in Israel, so then what was the— take us to the founding of the company. I know the listeners will want to get into, you know, where did Osteo come from, where was the original idea, and so on.

Sure, so Osseo is actually the second company I founded. Right out of grad school, I started a company called Lifebond in the field of soft tissue fixation. Then a couple years ago, that was acquired by Bard, who has an excellent biosurgery group. And when I was thinking back to my orthopedic research days, I basically remembered one of the things that had most frustrated me in biomechanics research, which was in any of these systems where you're loading bone again and again and again with a metal implant, over time you will see an effect on that surrounding bone. So we would do all these types of constructs where we would evaluate the effect of the metal implant over time on the bone, and you'd see loosening, you'd see stress concentration, you'd see various types of damage to the surrounding bone.. And that's something that has always really bothered me. And so I thought perhaps there was a way that we could address this. Perhaps there was a new set of materials that we could use that would have the strength that we need to fixate bones and soft tissues in the orthopedic system, but that would actually quite instantly go away over time. So that started the process of looking into potential solutions for addressing this problem.

Interesting. So were you trying to fix the modulus mismatch, or were you trying to fix the permanency of the implant, or both?

Yeah, so that's a great question. I really— for me as an engineer, I was definitely looking at the modulus impact. And I know you come from an engineering background as well, so that's very logical to people who come I come from an engineering background. But I also reached the conclusion that that might not be enough for people to really convince them to make a switch. I mean, that is a— any biomechanics engineer would fall in love with that company, but I was in doubt of whether that would be sufficient to really transition the field into something that was new and different. To me, it felt like you needed to give something extra. Just having a more ideal modulus for fixation wasn't enough. It also needed to be something that was going to have a better bone friendliness, a better bone response, because without being able to provide the full package, I wasn't sure that it would catch on.

Got it. And was there a surgeon in Israel that was— guiding you with sort of clinical needs, long-term clinical needs?

Yes, that's a great question. I met with a couple of surgeons who were very generous with their time early on in the process. I actually remember the first conversation was actually with Dr. Steve Schwartz out in LA many, many years ago about talking about this. And as we started just to think about how this could actually turn into a company, turn into a commercial enterprise. I started to get more focused and then started speaking to people specifically in the foot and ankle space. Dr. Bob Barovarian, also in the LA area, Dr. Meir Niska here in Israel. So there are definitely a number of surgeons who are very generous with with their time and who were able to confirm the overall need for this in the field. And that's something that's just built upon itself since then.

Interesting. Yeah, it's really interesting. Yeah, it's amazing how the best startups have a great technical idea and guidance from a surgeon. You have to have both. One without—

Yeah, definitely.

—yeah, you miss the target if you just focus on the technology. Alone. Well, interesting. So take us back to the beginning. How was the company founded? What was the early team? And how did you guys get started?

Yeah, great. So actually, one of my colleagues from graduate school, Tali Lindner, had just come back to Israel from her postdoc at Caltech.. And she invited me out to coffee one day and we went and she said, "Hey, Oron, are you working on anything interesting?" And so I told her about OSSEO. I told her it's something that I kind of had in the back of my mind. I'd kind of been thinking about a couple different ideas. And she was very interested. I actually hired her pretty much on the spot to be Ostia's first employee and to start running feasibility tests with the technology. Again, this is quite early stage. It took— we didn't even have the raw materials that we needed. We had to work for several months even with the raw material suppliers to get anything to even work with. And we got those materials in, so the first time we found— kind of a garage-looking operation up in the north of Israel that were making soccer balls out of polyurethane. But they were— exactly, the furthest thing you can imagine. And they were producing these balls and some other things out of foam. But they were a bright couple of guys, very hands-on, and they cobbled together kind of a mold for us where we could just do some very basic testing of these materials. And we saw that there was something there that we could actually get something that was very strong. And as we'll discuss maybe a little bit more in depth in a few minutes, we had a sense that the bone response would be good based on the types of materials we were using. And once we had that feasibility data, and that took probably about a year where we were just bootstrapping and funding it out of basically family or personal money, we were able then to get a group of angels involved led by the current chairman, Udi Gilboa, who had a background in in life science investment banking. And that actually worked out to be a really good fit. Again, I think this is something you've written about, but when you take on angels, what the additional value and additional skills that they bring to the table are extremely important. So Udi's skill set as an investment banker and my skill set as a biomaterial engineer are obviously very complementary. Complementary and we both know how to do very different things, but we had very much a shared vision for company building. Actually wanting to build a company, not a flash in the pan you're just building to sell off to somebody, but a company that would develop a proper production system, quality system, be out in the field learning from the customers, developing more products. And so that really got us going. And we were fortunate enough that Following that, there were a couple of other rounds of angel financing, and we were really able to get to quite an advanced state before looking at any institutional money.

And you attracted the angels with just raw prototypes and no animal data and a vision? Did you have animal work?

Yeah, now you're making it sound crazy. Yeah, so again, I think the idea behind the technology— there's kind of parallel stories here, so maybe we'll kind of jump back and forth. There's really a technology story and then there's a company building story, and so we can talk about both of those. But on the technology side, we very intentionally started with materials that have been out there for a while. We did not create a new chemistry. We had, you know, half of our products were made out of mineral compositions that came directly from bone filler type products. So it didn't take a genius to consider that if a product is 50% bone filler, there's a good chance that it could have a positive bone response. That is, you know, it's a very intuitive argument. And as I said, we had kind of the mechanics, so it seemed like a good argument. That first group though, I would say, really had faith that, again, they were investing in the team, which were myself who had done this once before and Polly who just had a very strong academic background, as well as Udi, the chairman's previous business records. So I think at the end of the day, angels will look at the team, I would say, more than anything else. And so that was, I think, what enabled them to come in. And then the subsequent angels were really actually from the field, and so they did want to see more data, but by then we already had a good amount of initial data. Which showed some of the really exciting things about osseo. For example, the fact that we get bone ingrowth already after a couple of weeks into the implant, which is something that's very unusual with a fixation implant, obviously. So that was a great—

sorry, go ahead. So when was the first animal study? Because the mechanical You can't really test the resorption profile until you're in animals. Correct.

Correct. Yeah, that's absolutely true. So that— let's see, we got started in 2014, so those first angels came in in 2015, and later that year we actually already had material in animals for pilot testing. So I think we started to go several months out already based on that data, so we're probably talking about early 2016. And then later in 2016, we actually got into our longer-term animal studies that ended up supporting FDA several years later. So it was a pretty quick turnaround. We were very fortunate that the initial data looked so good, and there was not a need for a lot of reformulating and rethinking the project, because that would have definitely cost a lot and set us back significantly.

So you didn't have to do a lot of iterations with the composition. You sort of either thought it out really well or got lucky with one of those 3 rounds.

How many times? Yeah. So it's interesting for me because this was not the case in my first company where we had to iterate quite a few times. Here we basically started with the types of— they call them sometimes bioglass type bone filler. We started basically with a bone filler type composition and we took the— we kind of had to triangulate between what existed as bone filler and what could be manufactured as a fiber as a continuous fiber that would have integrity. And we triangulated those two things and we got to the formulation that is still the formulation today. Now, you know, if we would have had to go further away from the bone filler formulation to get manufacturability, I guess that probably would have been the likely iteration, but fortunately our our raw material suppliers did a good job and have and continue to do a good job and are able to reliably produce what we need to manufacture. And so we were just able to run. But yeah, I would— to anybody listening, I would not assume that that's always going to be the case. It was a fairly— a combination of decent intuition but also obviously a certain amount of fortuitousness.

For twisting it. Right. And so part of the code that you cracked was, I think it's creating long silica fibers that can be manufactured that hold their integrity?

Yeah, no, so that's— so yeah, so basically the underlying engineering principles of Osseo are derivative really of the aerospace industry or other industries that use a lot of composite materials. So the engineers with whom we worked way in the beginning were people who had gotten their experience making the wings of unmanned aircraft. And they had experience with using carbon fibers. And the way they use carbon fibers are these continuous carbon fibers with a resin that give you the strength for the wings. Obviously, we did not want to use carbon fibers since that doesn't have the benefit, the bone benefit.. And so that's why we wanted a fiber that would also have the mineral benefit. And so for those familiar with composite materials, so glass fibers are what's commonly used in composite materials. And so taking bone filler materials that had a certain amount of silica and increasing that enough that you could produce a fiber seems like a fairly natural fit, a fit that could let you use that in the same way that carbon fibers are used. Now, that's where then perhaps some of the more iterations were necessary. I mean, you cannot use— if you just try to use a glass fiber like you use a carbon fiber, it wouldn't work well. Because these are non-permanent products, you need a lot more redundancy in the design. We ended up on a very nice layered design with these fibers structured in multi-directional layers, and that basically built upon these principles but adapted them appropriately to the material platform.

Got it. Got it. Yeah, so I actually had the chance to work with carbon fiber peak like 35 years ago. Sure. Yeah. And it's amazing. Yeah. What's amazing is you can dial in the strength, the torsion, the flexibility in any direction just by changing the angle of fibers. It's really incredible. From a design standpoint.

Yeah, yeah, yeah, yeah, no, it's fabulous. And that's something that we— a benefit we also have with the platform in terms of how we design and are able to design a number of different types of implants. The big difference being that we really have to plan also for the degradation or biointegrative process, which by we mean the going away of the polymer component of the of the implant as the surrounding cells and tissue grow into and onto those nice fibers.

Got it. Got it. And the bone always has to heal before the implant loses its integrity, I guess?

Right. Right. So that's what's nice. You never end up here with a void. You end up with bone healing that basically replaces the implant, which is— very much in line with some of the ideas of tissue engineering or tissue regeneration, which is actually kind of exactly what I studied in graduate school.

Interesting. So what is— fast forward to today, what does the team look like in the U.S. and Israel?

Yeah, so I'll take you back one more second back to 2016 because in terms of the company building, Basically, in 2016, we were able to bring on a couple of great board members who had a lot of experience in the industry, including Ken Reilly and Joe Darling, who unfortunately passed away recently. And then, most importantly, Brian Barrier. Brian had been head of a division at the business unit at Covidien. And I think he was running a $1.2 billion business or something like that. And then of course they were acquired by Medtronic and Brian had become available to be on our board, which was great. But we definitely had a vision for expanding his role. And fortunately about a year later, maybe a little more, we were able to— convince Brian, or Brian was kind enough to join the company as CEO. And that is, for a young startup just a couple years out of the gate, getting a world-class CEO like that is a huge boost of confidence. It's fairly unusual to get that level of talent at that early stage. And frankly, that I think took the organization just to a whole different level. About a year ago. It's a smart move.

Most tech founders hold on to the reins way too long and they don't bring in adult supervision, people that know how to build companies, financing, sales and marketing, all that, until it's too late. That was a really smart move early.

Yeah, so I can't— as the founding CEO of the company, this is perhaps a good time to mention to all other founders out there, taking a step back from being a CEO to staying in an organization in a different role, it's not the easiest thing to do from an ego perspective. Being the boss is always great. But at the end of the day, you want the company to succeed. You want the company not just to succeed, but to be a world-class organization, to really, truly take it to the next level. And obviously, I learn every day from Brian. And it's a whole different set of skills than being an expert, whether it be in technology or regulatory or any of the specific disciplines. But really being a leader in that way, it's been a fantastic experience for me, honestly. So I think it's something that I would definitely recommend. But it depends on having the right person. And Brian also came to it without any ego, just believing in a great technology, saw something in us that he could work with us to blow up into something really really huge. And really, I think when you find that right person to build that partnership with, it just makes a difference. It's the difference between having a company that becomes hugely important contributor to the field and not. So I think that was a really meaningful step in the growth of the company. And Udi had actually known Brian from before, so he made that connection, and so that worked out really nicely for the company. And then a year later, after Brian became CEO, actually Brennan Murillo, who's today the Chief Commercial Officer of the company, joined as well. And they had worked together for decades going back, and so they have a great dynamic. And Brennan, again, brings a world-class ability to commercialize a product. So basically Brian Heidi and Brennan are based in the Boston area. They drive all the commercial aspects from there. They only have about 6 people over there in Boston, another 5 spread out around the US. And here in Israel, we're about 40, and here we do the development, the manufacturing, and actually the CFO, Moshe Schneor, also sits here. We also— so we basically have the executive team split 2 and 2, and that's— it's been a really, really great dynamic, and it's fairly unusual to have such an even split like that, but it's worked out really nicely. Yeah, yeah, interesting.

So let's talk— let's get into the first products. So, well, first of all, I assume you're only targeting the US to start. Is that— tell me about your market strategy and then talk about the first products. Sure, sure.

So, yeah, so the US was our first market. Obviously, the US is by far the most attractive orthopedic market in the world. And so we started there. But right now actually we're just at the stage where we're starting to move into some other markets. But, you know, nothing is going to replace the US as the most important market and we'll continue to put the majority of our focus there. So, yes, so we did— we launched actually I'll go back a second. So it took a while to get our first FDA clearance. FDA, rightly so, has a lot of concerns about new biomaterial technology. They want to be absolutely sure beyond a shadow of a doubt that this is not going to come back to haunt them in terms of adverse events down the line. And so it took us until— 2019, which is again about 5 years since from the get-go to get over the goal line with FDA. And that was a very, very extensive process. And that allowed us to have our limited release of our Hammer Toe Implants in 2019. But we really only were able to get the full release approved in 2020. So it took quite a long time to get the ball rolling, but 2020, despite all the craziness and the difficulties faced by every company because of COVID was actually a pretty excellent first full commercial year for us where we were selling mostly our Hammer Toe Implants, which is where we started, but also some Trimable Fixation Nails, which is kind of a new type of product that we came up with together with a couple of surgeons to use in a number of different fixation situations. It's almost like a beam that you would put that has unbelievable bending support and great pull-out strength. You can really just kind of stick it in and just get this fantastic bridging support. So those were just released kind of in the latter half of last year. And this year we're just getting ready for our biggest release today, which is going to be the— 4mm compression screws, which are coming just about a month from now.

Got it. So, and so the first FDA clearance was Hammer Toe. Correct. You started with something simple or you started with something that was easy to make?

What was the thought around Hammer Toe? Yeah, so that's a great question. So yeah, so we did, we thought Hammer Toe was a good place to start because it was fairly straightforward from a review standpoint. It basically let SBA focus on the material question without challenging them with any novelty of— yeah, it wasn't an overly novel product that would be more complicated like a suture anchor or something that had multiple components. And that I think was a good strategy to get that, to get it started with the hammertoe. And also, it's a fairly attractive market. Obviously, surgeons have— there's a lot of surgeon preference that goes into that market. But we thought it was an area, it's an elective surgery, that having something new and exciting could be a real benefit to the surgeons in communicating the surgery to their patients where Surgery for teens, should I get it, should I not get it? All of a sudden you have this new technology that is a lot, feels a lot less invasive in that you're not going to see it on the x-ray, you're, you know, it's going to go away. We thought that that could have a, be a good way to start explaining the technology to people.

Got it. So for the listeners, explain the strength of the implant because most People have familiarity with the graveyard of resorbables in the past made out of PLA, and that you could snap a pin like a potato chip. Explain the difference with Osseo.

Sure, sure, yeah. So actually one of our favorite things to do is to have people come by a booth or whatever when we're out and show people the implants and let them bend them because this is several times as strong as any non-permanent implant that's been out there. So it's not a small jump over where we were as a field, it's a huge jump. In fact, these are about twice as strong as PEEK off the bat and that's a pretty great place to start. In terms of cortical bone, again, these are the first non-permanent implants ever to be stronger than cortical bone.— and they're about 50% stronger than cortical bone. So that actually allows you, for the first time, to do proper bone fixation with a non-permanent implant. So on the strength perspective, you know, that was a major jump, and that was a jump that we felt was really necessary to be able to take non-permanent implants out of the realm of soft tissue fixation. Where today about two-thirds of the soft tissue fixation market has moved to non-permanent, and bring them into bone fixation as well. And that's why we were able— we really look at this as a new category because you're able to address this whole additional set of indications which previously have not been able to be addressed by non-permanent implants. So that's why we call this new category biointegratives. It's a biointegrative implant, so it's an implant that will accomplish a fixation up front but over time will integrate.

Got it. So you can impact a pin, no problem. It'll handle bending stresses and you can torque a screw, no problem. Right, exactly.

So that's really the jump we were able to make here. And yeah, I think it's been really exciting, honestly, to be able to— every time we go out to a cadaver lab or to a surgery and you see people kind of being surprised by the implant strength, that's certainly always fun for me. Yeah.

It's fun to surprise surgeons with something they've never seen before. So how many cases have been done so far with the hammertoe and trimmable nails?

Sure. So we're up above 1,500 combined. I'm not up on exactly the breakdown, but it's been more than 1,000 hammertoe. For sure by now and several hundred now. So we've definitely gotten over that initial hump of kind of early adoption where people have used it, people now have long-term results from some early clinical work we did in Europe. We now have 2-year results which look fantastic. So for people who had issues with bioabsorbable implants back in the day, 20 years ago or whenever, we now have the 2-year data to show that there have been no inflammatory events, just really nice bone response throughout this entire degradation period. So that's been really important data to be able to collect, to be able to show that this is just so different, not just in terms of the strength, which we just talked about,, but also in terms of the bone response and that you don't have any of these fluid accumulation or other signs of inflammation that you might have seen with older generations of non-permanent implant.

Yeah, I'm familiar with a lot. I worked at Wright Medical and Biologics and familiar with large bolus of calcium sulfate or TCP and, and you just can't, you know, it can't melt away fast enough, and it creates a fluid and inflammation, and because it melts from the outside in like an M&M. So, so with those 1,500 cases, um, kind of walk us through kind of what the average— what's going on in day 1, you know, week 1, and so on, um, as, you know, walk us through the resorption profile as the bone heals.

Sure, now obviously we have more, we have a better idea of what's going on with, in some of the animal models where we actually can sacrifice the animals and do proper histology. So based on what we know from the animals, I'll start there because that's where we started, is you have Full degradation is by about 1.5 to 2 years. Really by 2 years, you're— nothing's left. By half a year to 1 year, you'll have substantial degradation of the polymer component. As I mentioned, what happens first is the polymer starts getting eaten away by the macrophages, and then into those spaces grow cells, grow mesenchymal cells., and then that whole area starts to calcify, and that's where you get the bone reformation remodeling. So by about a year, you'll start to see a fair amount of that bone remodeling along the edges of the implant, and from a year to a year and a half, that just expands so that by a year and a half, you no longer have the full implant there. It's already— it's kind of half-half, and again, as I said, by about 2 years it's going to be gone. And that's what we've seen so far, both in our early rabbit models and subsequent sheep models. Right now we are starting to look into the human patients with different imaging modalities, which gives you a sense of what's going on, obviously not to the cellular resolution, but gives you a sense. And what we're seeing is that timeline is is roughly equivalent. Obviously, there is some amount of difference depending on the physiological location. So if you're in a hammer toe, it might be a few months slower. If you're more proximal, it might be, you know, that same year and a half timeline. But generally, 2 years is about when you'll be back to native anatomy. So it's been pretty consistent from the animal models into the humans.

Yes, so that's— so the way I understand it is the binder is about half of the material and the bioglass fibers are about half of the material, and the binder absorbs first, and then the— But the strength is retained by the fibers in different orientations. And that's what takes a year and a half to 2 years is the bioglass to go away. And what you see at the end is just cortical bone and cancellous bone left? Yeah, yeah, pretty much.

Obviously everything is dictated by Wolff's law to some extent, meaning where you need bone regrowth, you'll have bone regrowth. So if you have something that's a totally non-weight-bearing area, you might have a different type of remodeling. But yeah, generally once it's done, you're not going to have a void there. You'll have whatever is physiologically appropriate for that area. Amazing. You're not going to get bone where you didn't have bone previously. It's not going to suddenly sprout out in a funny way.

That's just something we tested as well. Amazing. So, um, you know, I've heard as much as 25% of all metal foot and ankle implants have to be taken out because of issues— pain, inflammation, rubbing against tendons and ligaments. Um, I mean, that's amazing just to do away with that problem on day one.

Yeah, it's actually, it's really, it's like, it's really deeply meaningful to me honestly. I just actually since the last time I spoke to you, there was a woman who reached out to me after a meeting we'd had and she just kind of told me about a surgery she'd had 6 years before where she had a metal screw and plate construct put into her foot. And the words that she used to explain to me what she's been feeling since then were crippled, disabled, you know, just it's been a nightmare. And, you know, and I wish this is the only time that I had heard something like that, but it wasn't. It's something that I hear all too frequently. And really, it's when you hear these cases, you say, well, you know, it's not a joke. These are real people, people who have these terrible complications down the road from metal. These are people that we need to help. We just really need to get the product out to them so that they don't have to deal with that. And I'm not saying that there's not going to be a place for metal in some cases, you know, I'm not, but it just, right now there's just too many patients who we hear from who have had such severe issues down the line that it almost breaks your heart. And so it's really meaningful for me to be able to be doing what we're doing right now.

I used to work with a vice president of operations. He was a tough guy. He was a hockey player. And one day he announced in the morning, he goes, oh, I've got to go have this screw taken out of my foot. He goes, I'll be back this afternoon. And he comes back and he— I mean, he's moaning like a lion. I mean, he's— he was totally wiped out for 2 weeks. He was on crutches, taking pain pills. Um, he's— he couldn't believe how painful it was just to remove— remove a screw. Yeah, so it's amazing. So where do you see the future products going? You know, obviously, anytime you repair bone, compress something, fix an osteotomy, I mean, gee whiz, the sky's the limit. So where do you guys see the next products?

Sure, yeah, it's absolutely true. So one of the biggest challenges with Altea has actually been staying focused. Every time we meet with a new surgeon, they would come back at us with, all kinds of really exciting ideas that we can, you know, explore with our material. But, you know, I think in terms of having the discipline, we really started out in distal extremities, which is where we're predominantly developing products into right now. But the other two big spaces we have on our radar where we should be moving in within about a year would be Sports medicine, which has historically been the domain of non-permanent implants, and actually we've been doing some testing against the market leaders in the field, and so we'll have some really exciting data to share on that later in the year. And then pediatrics, again coming back to that kind of humanitarian approach. There's nothing more heart-wrenching than seeing hardware removal surgery in a kid, and so if that's an area that you can potentially replace even though, you know, it doesn't have the— on a business side, it doesn't have the volume numbers that you'll see in distal extremity and sports. Just from a kind of contribution to surgery side, I think there's a lot of really important things that we can do there.

Yeah, kids are special because their musculoskeletal system grows and it just, you know, it outgrows the implant. Yeah. Yeah, that almost has to come— I think 100% has to come out in kids almost. So yeah, that's an interesting market. So what— are there any limitations? IM nails, you know, femoral nails, tibial nails, cages, is there anything that— Sure. Yeah.

Yeah, so obviously we're not going to get into implants that are supposed to stay there. For example, you know, with knee implants or hip implants, you know, that's a little bit out of our scope right now. We have explored ways of potentially incorporating ourselves into some of those implants, but in terms of making the entire implant, that's something that's out of our scope right now. We haven't gone into spine. It's a little bit also out of our scope right now. I think on a technology level, it would be fantastic, but it's kind of its whole own pathway from regulatory, from a number of perspectives. On a pure strength level, I think we can get, you know, pretty much anywhere you would need to get in the body. So I don't think that's going to be a limitation. It's really just a matter of, as you said before, a proper design. You have to really design for the indication, and that's a big difference when, from an engineering perspective, in terms of osseo versus metal. You know, metal, you just have the geometry. But in osteo, you have this whole microarchitecture. So for each and every product, we have to build a microarchitecture for that product. So in terms of fixation products for bone fusion, for fracture fixation, I think that whole field is fairly open to us. Again, just in terms of working with FDA, so we keep providing more and more data to get the agency comfortable with the different sizes of implants, different mechanisms of implants. So, you know, it doesn't all happen in one day, but certainly there's a nice roadmap ahead of additional places that we're planning on taking this. Got it.

And bone plates, that seems like a natural— have you done animal work with bone plates and screws?

JASON SCHMIDT] Yeah, so we just— yeah, we're just wrapping up 2.5 years on a study on plates. Again, there was a big underlying question there on, okay, so you put the nail, you put the screw in the bone, then the bone will regrow through the implant. What happens if you put it on the bone? Again, we don't necessarily want bone growing out of the bone. That could have potential issues. And so we were actually pleased to see that as the product goes away, it actually remodels down when it's outside the bone, when it's on top of the bone. And that's something that, you know, again, we can't really take credit for. It's just really good bioengineering of the body that it really knows where bone is supposed to be and where it's not supposed to be. So in these areas where it's outside of the normal skeleton, it actually remodels down rather than remodeling back into bone. Interesting. That was a really interesting finding. Yeah.

What flow actually works? I know there's been companies that have actually made bone plates out of cortex before, cadaver cortex. Right. And implant those. And there's always a hump there because the cortex doesn't turn over after a while. Right.

So it sounds like it doesn't happen overnight. It takes about 2 years for it to be totally gone there. But yeah, definitely we just— so this study opens up the road to this plate and screw system. So we're working on those now, but it's a little further down the line than this year. As I say, we're doing all these screws and nails and stuff, and next year moving into soft tissue. But we're a fairly small company, as we just talked about, so you can't do everything all at once.

Focus is important. Yeah. Defocus will kill a startup real fast. I used to work for a company and we had a technology that was the same boat. Everything looked good and our CEO always said, "I feel like a mosquito in a nudist colony." He goes, "Everything looks good." And it created a big problem for us because if we didn't focus. Interesting. So what else— I want to be cognizant of your time. What else would listeners want to know about Osseo, and where can they go for more information?

Sure, yeah, look, I think for us at this stage of the company, we kind of got over those initial humps. We were able to bring this technology to market, really the first new biomaterial platform in decades, and that's a really, really, really exciting place to be in right now. At this stage in the game, what we're super excited about is collaborating with the surgical field and just expanding our relationships and finding all those really exciting indications to which we can bring the benefits of our platform. I think as people hear this, certainly they can reach out to us through our website at ossio.io, O-S-S-I-O. Io.io or through LinkedIn. Those are both great ways to get in touch with us. And we're pretty much located almost anywhere across the US right now. And as I said, later this year starting to expand outside of the US as well. So it's certainly the next frontier, I think, will be clinical. You know, clinical research and clinical design, and that's, you know, that's of course from a guy who loves innovation and loves bringing clinical outcome benefits. Those are both very exciting directions.

Excellent. And, wow, so that's— thanks for your time. This has been great. I love disruptive companies that have a chance to change the world in orthopedics, and Oscio is certainly set up to do that with both the team and the technology. So thanks again for your time, Oren.

And, uh, well, thank you, Tiger.

Yeah, listeners, go to oscio.io to learn more.

Thanks a lot. All right, thanks, Tiger. Appreciate it.