Philip Kemp, X-Bolt Trauma Orthopedics - Expanding Bolt Design for Orthopedics | LSI USA '24

Philip Kemp  0:04  
So in health care, orthopedic surgeons are very often compared to carpenters. They repair bones, they replace joints, they reconstruct our bony anatomy, much like a carpenter might repair a wall or replace a joint or reconstruct the anatomy of our homes. So it makes a lot of sense that a lot of orthopedic innovation comes from some of the simplest ideas in carpentry. Which also makes sense that when one day our founder Brian thorns was one day mounting a TV into some drywall using one of those little wall anchor Molly bolts that you use. And he had this revelation that we need something like this for osteo, product bone in orthopedics. And that's the genesis of export orthopedics. I'm Phil    Kemp, the president and CEO with X-Bolt, we're a company proudly based in Dublin, Ireland, as I'm sure it's pretty evident by my authentic New York accent. So if you're gonna take anything away from this presentation today, just take away these few things. We're an orthopedic trauma company, we're laser focused in the the increasing increasingly elderly demographic that we serve. We've got an FDA cleared, hip fracture nail with our first US surgery is imminent. And as a company, we've raised $14 million to date, including a four and a half million dollar series A last year. And we're targeting a circuit that 20 to $25 million, Series B in 2024. So I want to take us a little bit on the journey that we've been on. And I think it starts by appreciating the hip fracture problem that we have. In the United States over 250,000 hip fracture procedures are performed every year. And there's a one in six lifetime incidents in these in these hip fractures occurring in women. And that's compared to one to nine lifetime incidence of being diagnosed with breast cancer. And the nature of these patients is that they're often quite elderly, frail, highly osteoporotic, and over 80% of hip fractures occur in patients that are over 75 years old. The number one mode of failure in hip fractures is a phenomenon known as cut out. And the cut and these cutouts occur as a consequence of poor implant fixation and rotational instability. And when one of these hip fractures fail, we're adding over $40,000 in episode of cost to our health care system. And we're completely taking away the independence of our patients. So after we've conceived after conceiving the first version of this implant, we went to work to establish clinical data in partnership with Oxford University. So through two randomized controlled trials, we took a look at our cut out rates with this, with this expanding both technology. And in the largest ever, hip fracture trial conducted of over 1000 patients a result in cut out rate was 0.8%, which was the lowest reported rate for a study of that nature. And in our modern years, we've positioned the port the product in the portfolio for the US market and for global markets. And we haven't FDA cleared trochanteric nail here that you see on the right, and we've we've invested in expanding the pipeline of our indications in applications of our expanding bolt technology. So as we position ourselves enter the US market, we're entering a market that's that's rapidly approaching $8 billion, with an historical CAGR of over 6%. And what you'll note here is that pretty much every solution that exists on the market today uses some version of screw fixation. Now what happens when you put a screw into some drywall and you put some load on it, or you over torque to screw in drywall, a lot of times these screws fail, they break, you strip the threads, and osteo product bone is not too dissimilar to this phenomenon we see in drywall. So we're well positioned to win in the marketplace. And it starts with how we line up with our customers, namely our surgeons and our health systems. We provide a unique combination of novelty and familiarity for our surgeons. We're not reinventing how hip fracture procedures are performed, we're only improving the mechanism for which these are fixed. And the consequence of that is there's effectively zero learning curve to using an export. If a surgeon has been trained on any trochanteric nailing system. They are effectively trained on an export. Because we're able to come to the market with robust clinical data. Our hospitals and our hospitals are reassured with the with the data that we have and we are in a good position to win hospital contracts and getting back approvals. And we've got the we've got the right team to do it. Our US team is led by our VP of sales, Nick Suquet, who's and spent who spent his entire career in orthopedics after a brief stint in the NFL, and we provide a very attractive product to our distributors who have deeply embedded orthopedic relationships. When they add a hip fracture nail to their portfolio, they're bringing on high volume, high ASP product with cases that often last 15 Under 20 minutes from in terms of their coverage. And for our initial our initial launch here, we're deploying a limited number of sets to about 10 states and with our series B will have the capital to expand our market access. And as a as a company, we've raised $14 million over 15 years. So we know something we know a thing or two about being a little bit efficient with the capital we have. And we want to make sure that we're deploying some of those those lessons in our commercial strategy. So because there's effectively zero learning curve, we we partnered with Oso vr Virtual Reality education platform to make sure that we can actually scale our medical education efforts, while avoiding some of the the the UPS the startup costs that are associated with traditional training methods. And look, were founded by the inventor of the tight rope, which is arguably one of the most ubiquitous products in our industry today, which which means for us are actually the Quiddity, we can be pretty lean with our Kol base. And we don't have to over invest in consulting activities to realize some of our business objectives, unlike a lot of a lot of companies in the position that we're in. And as I said, We're based in Ireland, which means that we can be be efficient with the capital, we have to develop a pipeline, we can move at a fast pace while also taking advantage of a lot of the r&d grants and programs that are available to us as an Irish company. And as a European company. city decided to play. So a lot of that efficiency and our focus on on specifically serving the indications that are best suited for expanding bold technology. We become cashflow, positive and 2025. And as we get our footing into the US market will then start to activate some of the global relationships that we have, including in the EU. So just looking ahead as an organization, as I started with here, we're cleared for takeoff, we've gotten FDA approved product or first surgeries are coming in, in just a matter of weeks. We've got distributors in place, we've got back approvals, we've got customers lined up, we're just shoring up some final inventory to align with our demand. And with our series B will continue to invest in the engine of our r&d pipeline to expand on indications of this patented technology. And we'll use the capital to expand our market access to as I said, grow our portfolio and to grow the team accordingly. So thank you all it's been, it's been a it's been a really enjoyable experience here at LSI. I want to thank LSI as well for for giving us the platform. If anybody wants to join us and learn more about the expo journey. Or if you want to put a headset on and become a surgeon for 20 minutes. Just reach out. So thank you