Maxwell Munford, OSSTEC - Additive Manufactured Bone Healing Platform | LSI USA '24

Maxwell Munford  0:05  
Thanks very much. And thank you, everyone for having me here today. It's a pleasure to be here. Although the time difference is a killer, I'll be honest. So my name is Max. I'm the co founder of OSSTEC, where we've developed two platform technologies for use in orthopedics. We're using these in our in our first product, which I'll go into to improve patient lives and keep patients more active for longer. If you look at the orthopedic market, there's a growing trend to treat patients earlier treat patients younger, and also to move patients from an inpatient setting to an ASC or an outpatient hospital setting. There are many good reasons for this, it's more cost effective for patients and providers, and also it achieves better outcomes. So if you dive within orthopedics, if you dive into the knee replacement market, there are currently 1.3 million knee replacement procedures performed every year. And for patients under the age of 65, which is about half of them at the minute actually, they experienced a failure rate of up to 35%. There are good reasons for this the most, the most common cause of failure is loss of fixation between the implant itself and the bone surrounding the joint. And there are also complications from cement, which is the most common, most common method of accessing these implants, if you look at our stack for a second, so our background, our core technologies have been developed for the past 10 years at Imperial College London. And we have seven patents governing our two pillars of technology. These are 3d printed articulating surfaces, effectively using metal to replace cartilage, and also printing the bone, bone fixing element of the implant using metal to replace bone. We're applying this technology. And we're ideally suited in the middle of this market at the minute in our first product, which is a fully 3d printed cementless, partial knee or UK for short. So if you look at the market for a second, 3d printing within orthopedics is currently growing more than 20% year on year. And there are good reasons for this, it helps reduce costs, and surgeons increasingly want to move away from using cement in the joints. Our first product is a partial knee replacement. And these well we know from literature that a partial knee replacement achieves better patient outcomes is more cost effective in the short term, and is more cost effective in the long term. And yet, currently, only 10% of knee replacement procedures are partial knee surgeries. Where which is strange considering 50% of patients are actually indicated for partial knee surgeries. Now, if you contextualize this a bit, that what you've got here is a technology and the products, which are both high growth and which are ideal for addressing the problems in terms of moving to early intervention, and moving to robotic surgery and moving to an outpatient surgical setting. So in terms of our underlying technology, this will be the first device in the world which has a 3d printed femoral component. So a 3d printed articulating surface. There are many, many reasons why that hasn't been done yet. It's extremely difficult to do with 3d printing. And that's where our rich heritage of research and publications on the 3d printing side comes in. And also we are using our our core technology, which we refer to as stiffness matching. So it's interesting lots of people when they talk about 3d printing, I haven't even said the word yet. But people think personalization. And when people think about that, they think and they talk a lot about in in orthopedics, about making a geometry, which better matches patient's anatomy. What people don't ever talk about is making mechanical properties that better the better the patient's been. So some of our core IP that we've patented, means that we are able to print titanium in a way that directly mimics how bone works and help naturally grows. No one else can do this. Essentially, we can combine the strength of titanium and the flexibility and bone growth of a more compliant material. Just going back to the femoral component for a second. We've shown the another advantage of this as well as making a simpler supply chain as well as reducing costs. It directly eliminates a key failure mode that other implants see. So, a core failure mode the other attempts at porous coated implants and you see is delamination of sprayed on porous coating. Without device it's simply not possible. And the final benefit in our technology is that we directly save in costs, our cost of goods are lower than other people's devices and the surgery is much faster. So again, this is ideal for an ASC setting setting where typically surgeries might take 4550 minutes an hour outside Please take anywhere between 20 and 30 minutes. So just to summarize that we have two core pillars of technology, 3d printing the articulating surface and making implants which directly stimulate long term bone growth. I've only spoken about the new market here today. But what we're really excited about here is that these market these technologies are applicable across Orthopaedics. And we already have a pipeline of products to follow these two devices. We're also uniquely uniquely placed in terms of the technology position, the product position, and our regulatory approval process. So with this will be submitted for FDA approval later on this year. And as I said, this is all built on 10 years of research heritage at Imperial College London, including animal data and human cadaver data. In terms of launching later this year, we'll be launching with our core clinical advisory board. These are six surgeons spanning the UK, and the majority of them in the US. They are high volume and key opinion leaders, they will be part of our post market studies and UK clinical trial, which will help us generate the value and evidence that we need to progress further. Beyond that we have plans to scale with a distribution partner. And we already have strong progressor. And as I've said, this is an ideal first product, but we do have plans for a pipeline product beyond this. In terms of where we are today, we close our two and a half million million dollar seed round last year. And to date, we've been able to progress through multiple regulatory milestones, collect animal data, and undergo significant usability work with our clinical advisory board. We've also built a very robust portfolio of patents. We're currently in the middle of our $5 million dollar series a raise, which will enable us to achieve our 510 K launch in the US which will be q4 or q1 of next year. And and move ahead without clinical trial in the UK and post market studies here in the US. Beyond that, as I say there's a pipeline of products that we would love to set in motion. And we already have prototypes. In terms of the core team, we actually all met at Imperial College, where we were working on the core technology here 3d printing and knee replacements. Our CTO, Professor Jonathan Jeffers, he's successfully exited multiple companies in the orthopedic space previously. Alex Liddell is our Chief Clinical Officer. He's a key opinion leader and prominent surgeon in knee surgery, particularly in less invasive surgery. And our chair has been there and done all of this previously, including multiple axes. One of the things I'm most proud of is our team. And we've managed to bring skills from the forefront of academia, engineering industry, and quality and regulatory as well. Looking into our clinical advisory board, we have we have six high volume surgeons for in the US to in the UK. And beyond that we have other advisors on the commercial side of us tech as well. As I said, we're currently raising our 5 million Series A, this will enable us to progress through 510 K commercial launch in the US and clinical studies in the UK. Yeah, I always love to talk money, and we'd love to answer any questions that you may have. Thank you very much for your time.