The Irish VC ep29: Fireside chat with Brian Thornes, from orthopaedic surgeon to Inventor!

Hello and welcome to the Irish VC. In this episode, Mark Farley brings you a fireside chat with Brian Thorns, orthopedic surgeon, turned inventor and CEO of X-Bald Orthopedics. It's a short punchy episode packed with insight, and if you're an angel investor listening in, there might just be a compelling opportunity in store. So without further ado, let's dive straight in. (upbeat music) - So Brian's background is actually an orthopedic surgeon. He's best known for being the inventor of the original tightrope, an advanced ankle stabilization device. He developed during his orthopedic residency. Tightrope has become so ubiquitous in the industry that one is implanted every 12 minutes, which is pretty insane. Personally, I think it's cool that you can be described as an inventor, rather than just an entrepreneur. That's just really cool. Recently, Brian has also made significant strides in hip fracture treatment with the invention of the X-Bald hip fracture system, and following FDA clearance in 2023, Brian managed the US commercialization of the X-Bald Pro X-1 in 2024. So we will definitely talk a little bit about that, but we're also probably talk about as Brian himself is an angel investor as well. So if we have time in the med tech community, we might talk a little bit about that too. But first Brian, I suppose I just want to, that was a very, very brief synopsis of your career. So I just want to give you an opportunity to talk about, a little bit more about what you're doing with X-Bald as well. - Okay, okay. Well, where does it start? Where does it start? - I'm starting at X-Bald, really? - Yeah, I think so at X-Bald. - Yeah, I can start at the, where we're at now. So X-Bald is a 15 year startup. We are now just commercializing in the US where a med tech product company, so X-Bald comes from the word expanding bolt. Like we're very simple, we're a very simple folk, so X-Bald is an expanding bolt. Like think of a role plug, they put into a wall, but that was actually the inspiration behind between, for X-Bald. So I've been a surgeon for 11 years, and I started off wanting to be a trauma surgeon, and you think trauma is like road traffic accidents or sports injuries and you know, kind of hot trauma like that. But actually when you go into the hospitals about three quarters of the trauma is geriatric trauma. It's old people in their usually 80s and 90s who have like low energy falls, and they fall over and obviously break bones. But the bone itself is so soft, it's very hard to treat. And on orthopedic surgeries is a bit like carpentry in a way. So the screws that are used for putting bones back together again are just not up to the task of fixing these, and clearly you want to fix them as best as possible, get them mobilized, get them out of hospital, and reduce the overall cost to the health service. So that's essentially what X-Bald does. It's an expandable bolt that fits into the sort of the spherical part of the ball and socket joint that's your hip joint. So it's about the size of a snooker ball cue. But if you put a screw into that, if you think of putting a screw into that, it can actually, if it grips, it'll spin around. If it doesn't grip, it might just cut out of the bone. So, but an X-Bald has, it sort of ticks every box in that. It's easy to put in, you get a little bit of tactile feedback when you open it up and it crushes into the bone, and it gives a good outcome for the patients. So I think it's going to be transformative for hip fractures. And can you tell us a little bit more like it's going to be? So where are you exactly are you at? You got FDA clearance, it talks a little bit through that, because I know there's definitely some angels in the room here who've invested in companies struggling with the FDA clearance. Yeah, we've gone through kind of a long journey. So at the beginning, right at the very beginning of X-Bald, I wanted to recreate what I did with tight rope, which was kind of get the proof of concept out first, get a regulatory approval. And there you're first sort of major stepping stones. So we actually, it was way back, we got a CMARC and we were able to then run a clinical trial in the UK. And the big thing back then was try to get FDA approval. So we ran successful clinical trials in the UK. And we got FDA clearance for our first generation product in 2018. It was a bit of a journey we started actually interacting with the FDA in 2012. So it took like six years to get that first approval. We went through kind of a, I'll tell you a few things that went wrong with that. We're not went wrong, but with the hurdles that they put up. So one of the technical issues was that there was too much friction within the boat. And we used a compound called Parlean. It's like a teflon. But it's medical grade and it's been used everywhere around the body except in the bone. And the FDA wanted to have an animal study for proving that it was safe. So 66 rabbits unfortunately met their demise, proving that it's safe. Well, yeah, like it absolutely was safe. So that was one of the things. And then they came up with another technical thing and another technical thing. So it was quite a while getting through that first FDA journey. And then we got approval in 2018. But by that stage, we realized that we couldn't really market it in stainless steel, yet to market it in titanium. So we sort of pivoted. But it's easy to pivot when you're a small company, I guess. That's probably one of the advantages of where we're at at the moment. And actually, even if you look back from before 2018, we had all that clinical data. So we'd quite, we have garnered a lot of evidence on our journey and our knowledge is way, way better than it has been in previous years. And maybe touching a little bit more with the FDA approval. And I suppose access to the US, going into the US market, I know some of your team was over for the whole, say, Patrick's Day, Palava that goes on over in the States and all the kind of the kissing hands, shaking babies sort of things. Do you think that the American market is definitely the way forward for you or do you think that with trumps and the tariffs that things are going to change? Yeah, there's been, I guess it's, what, five, six years ago, there was a big change in terms of MDR. It actually stemmed from, there was a breast implant scandal in France where the company ended up using industrial silicone rather than medical grade silicone. And then the European Commission then decided that they'd up the rules in terms of getting regulatory approval. But for a young company like ours, we just take the path of least resistance. So previous to that, C-Mark was the easiest path to take. And we had actually taken that back then. And FDA was tougher. Where now FDA is the easiest route to go. And what makes it doubly worse is that the US is obviously the most lucrative market. So most companies will just look to the US and know where else. So it's to the detriment of Europe that we have. We're in this situation that you have a number of companies that just get their FDA and they'll have no interest in marketing whatsoever in Europe. So European and Irish patients are missing out on innovative technologies because of the regulatory environment that we're in. OK. Yeah. I mean, and regardless of the tariffs, it's still just the margins are still there. Obviously, the tariffs is a new thing. It's not coming in for Medtech yet, but it's something we're keeping alive. I mean, it's like another of these things. Yeah. Well, I mean, as you said, you're a young or nimble. You can adjust if needed. We're actually quite lucky. So yeah, so we got our FDA clearance in 2023, late 2023, 80 months now, for our US product. So the immediate things we did after is we were incorporating the US. Most of our suppliers are US-based anyway. So we're actually quite well insulated if we have to just become in the eyes of the authorities that were US company. And the advances-- I mean, I hope the advances of being an Irish company with the tax advances and all the R&D stuff you get here are still going to hold true. We can be nimble. We can-- Yeah. We can Irish. Yeah, exactly. Exactly. Well, we'll play the film, make sure we get it our way. All right. And in terms of funding, you obviously talk about what I think the last round was BVP, 3.5 million. And that was further commercialization. So couldn't you tell us a little bit more about the angel investors that came in? You have a lot of angel investors that are in the round. And what makes a good angel investor in my tech, I suppose? Oh, gosh. So yeah, we've had a probably different journey than a lot of startups. So I'm still the majority investor. I've played a lot of the tightrope royalties that I got back into the company. I've invested in every single round. So but as we've grown, I've become less and less able to obviously to support the company myself. We got our first angel investors through the MedTech angel group in 2013. And they're still with us. And they still invest, including the chairman of our board as well. He came in in 2013. Then the next big round we obviously did with yourselves in BVP in 2022, 2023. 2023. And yes, we've got a few angel investors in and along the way. They've been very helpful for us in terms of just the additional support that they bring. We also actually, I guess I'm lucky to have a surge in network as well. So we've got 50 shareholders in total now. And about 10 of them are. or speed excursions, two of which are put in very significant amounts of money into the company as well. So for me, that's a great support that I'm not the only sort of scientist or the only dark that I think this is a great idea. We actually have other people that are willing to put their hands in their pockets and support us. And do that encourage the other angels that maybe don't know, go, well, you know, there's three doctors going in, they know what to do. I think so, yeah, I mean, it's all symbiotic. So they're actually, it's funny when you talk to the darks, they say it was great that these business people think to the business. So it's all in the round. Yeah, it's crazy. It can always be a little bit of form of first move. Once someone takes the plunge, everyone's willing to follow. And for those angels, obviously you're doing an incredible amount of good and there's so many benefits for an aging population as well. So is there, was there a case of, was it a distribution of so many angels are like, I'm going to go into that because it makes an impact or was it commercially, mostly commercially focused? And how do you balance that in a business? You want to do good for people, but you also want to make money. I think, like, maybe I look at it like myself. I mean, I'm pitching for investors. But also I'm an investor myself. I see the things that I would particularly be interested in. So I think we're disruptive technology. I mean, there's nothing like it in orthopedics at the moment. It's a simple thing. I mean, simple as always best as well. So people can kind of get their heads around what the proposition is. So yeah, it's, it is tough business to go out and pitch to everybody else. But I think that we have, we have something that's disruptive. We have a great sort of plan of action of what we're going to do and to actually execute our plan in a timely manner as well. And so that's what you're saying. That's what you look for as a med tech investor yourself. That's also what you look for. Yeah, I think the number one, if it's not, if it's not disruptive, if like if a Chinese company or something could reproduce what you have and flood it in the world, then there's no point in going there. If another company can take it on and be a faster route to market, there's quite a lot of things that would become commonplace. I think very, very quickly. I mean, even now actually looking back at my tightrope. So there's a ton of companies. It's come off patent last year. And there's nearly every, well, actually every major orthopedic company now has a tightrope-like product. So you have, you have first mover advantage being, you know, the, the innovative one, but you've got to basically seize on that. So that's the first thing. And always even like in the business now, everything we do is done with a, you know, time is the major, major currency. So if I'm looking at an investment myself, a med tech investment self, you want to see what time it's going to take to the next milestone or the exit or whatever it is. Because your capital is tied up for that. I mean, you know, people who invested in us in 2013, the money is still in with the company. It's quite a long while to keep your capital tied up. And I'm conscious of that as well. But obviously when BVP invested, you know, you have your exit horizon as well. And that's obviously on my mind as well that we have to do something within that time frame to actually get an exit or to get a significant milestone. And just maybe a final question for the med tech investors that are in the room that maybe don't have the same expertise and don't have your background. How should they follow up in terms of our, how should they do their due diligence? Do they need to lean on experts music? As you said, how do they know that it's not going to be something that can be replicated so easily but the Chinese? Yeah, I think, I mean, like the investments that I've done, you know, few of them haven't got well as well. And you kind of think, oh, if only knew this, only that. So, yeah, people are obviously going to be comfortable with their own level of due diligence on certain things. And we've obviously had due diligence done on us as well. Like, I'm a technical person and if I didn't know something on the medical side, I would ask a buddy, a friend or a colleague, whatever, like say if it was interventional radiology, I'd ask an interventional radiologist, is this going to be a good thing or not or an ENT surgeon? Is this going to be a good thing or not? And, yeah, so I mean, everybody has their networks. And I think it's leveraging them to get the most information you can that you trust and can work with. But you'll never, nothing will ever be complete. So you'll always have to make decisions based on the best available information you have at a particular time. Okay. And I look, I know we could go on. We did yesterday for about 45 minutes when you're planning this. So I know we can go on and talk and go down many different routes. So I know we do have to wrap up. But this was the last thing to just talk about is, you obviously have raised investment. You're talking about next exit, just maybe for anyone who's in the room who might be interested. When are you going to raise next and what are you looking for? Yeah, maybe just to sum up where we are in the company. So like I said, we're commercialized in the states. We are increasing our distributor network. We have been here last week there. We just sort of signed up a distributor that will cover most of California for us. The week before, the month before, as in Singapore, and we have Singapore distribution and surgeons all essentially signed up. There is a regulatory thing to go through there as well. In terms of our fundraising. So we have, like our model is a very limited launch moment. So we're obviously working really tight on our capital. We have 20 instrument sets. You know, these are the toolkits to do the operations. In order for us to scale, we need to be up at 100 plus of instrument sets, each one costs about $20,000. So, like we need, you know, we need 10 million plus as our next round. And we're talking to a number of investors. I mean, we do all the time in terms of doing that. But I guess anyone in the audience as well, if they had big enough checks to go in, we did take in the last round, we did take two or three angels in with significant check sizes as well. So, if people were interested, sure. Got in touch? Absolutely. And I know obviously Medtech might be talking and there is some Medtech investors in the room as well. Okay, perfect, Brian. That was fantastic. Thank you so much for that. Really appreciate that. We're going to move on to the next round. Thank you. Thank you. [Music]