David Kirschman Presents Orthomod at LSI USA '24

David Kirschman  0:03  
My name is David    Kirschman and I am the CEO of Orthomod. So we all know about the importance of orthopedics we all know about the importance of orthopedic implants is matter of fact one in two Americans have a diagnosable musculoskeletal condition 10,000 orthopedic implants are placed in bodies every day in the United States, and over 77% of Americans over 50 have an orthopedic implant. There might even be a few people in this room that do. And that number is growing rapidly as we have an aging population and people want to stay active longer. This is a huge market. We're all very familiar with the size of the global orthopaedic market somewhere in the $47 billion range and you know, growing at about a 5% CAGR. And sub markets, verticals of joint spine, cranial maxillofacial, dental, and trauma are also significant verticals in this space. There's two basic functions of orthopedic implants. Okay, well, what do they do? Well, there's fixation which basically holds bones together. And there's fusion, which heals bones together. Okay, so you have one stuff that supports bones, stuff that heals bones, and they're different. So these are two different categories of products. So you have structural materials, like titanium and peak on one side that support the skeleton. And then you have fusion products like bone substitutes, including calcium sulfate, calcium phosphates, bioglass, you have one side of the coin, which is load bearing, you have the other side of the bone, which is bone healing, or osteo active, which basically means promoting bone healing. And with this duality, you have a problem, because you're using multiple implants and procedures, this increased costs, increase complexity, increases in efficiency, even creates poor outcomes. And right now, it's, for instance, in the spine market, we have a duopoly of two choices out of this entire industry. There's two choices peak and titanium, peak polymer and titanium. The joke is there's there's three choices for materials, there's peak, there's titanium, and then there's peak mixed with titanium. And and that's basically what it is. So what is the missing link? And this was our mission, how do we cross this bridge and create a new type of implant that does both that is fully structural, and functions as an osteo active bone substitute? How can we do that? And break this duopoly? A little bit about me. I was a neurosurgeon, a spine surgeon and a former life have been, you know, through for companies now and for successful exits over the last 20 years, worked with a great team of operational experts of scientific experts, and clinical experts that are really driving driving us forward and really exciting. So this new solution needs a new material. And what is that new material. It's called Camp, calcium acrylic modified polymer. It's an all new orthopedic biomaterial, it's permanent, it's synthetic, and it will be an alternative to Pekan titanium for the first time in about 20 years. It combines the osteo active properties for fusion and the mechanical properties of fixation. We've undergone extensive testing, and will have first in human by the end of this year. And this will be the first in spine. This will be the first new structural spinal biomaterial in over two decades. Why has nobody done this before? Well, very few materials can withstand FDA requirements, for instance, in spine greater than 5 million cycles of greater than 5000 Newtons without failure. Well, it's not a lot of materials that can do that. Hence only titanium and Pete Well, we were able to do that. This material has high compressive strength actually exceeding the market leader of peak and it has microporosity It has long term biocompatibility and low cost rapid manufacturing much cheaper than peak and titanium. It's ideal for patient specific applications. And we use a rapid molding technique where the where the product is actually injection molded into individual disposable molds, which are 3d printed. And this makes the amount of and variety of implants we can make practically limitless. Does it heal bone? There's the mechanical side. Well, what about the biologic side? Absolutely. We just present into the state of actually about three weeks ago at the oars orthopedic Research Society showing superior fusion with our product compared to peak and titanium you can see the, the high level of bone growth around and within the implant this is a 12 week sheep study that was done down in Australia. And you can also see the, the staining on the calcium containing areas of the implant. In these micrographs you can see extensive bony ingrowth into the surface of the implant, which you will never see in the other materials. You also see strong osteoblastic activity around the implant but no inflammation but no inflammation. There's no inflammatory cells, lymphocytes, white blood cells, PMS that have come in the microporosity is visible on electron microscopy. This allows for the diffusion of cytokines and BMPs compared to peak and titanium and can also be used for drug release, excellent rated graphic visualization and multiple applications sports medicine, bone void filling, surface modification of IP surface modified drug and implants drug delivery, and even can be co implanted with peak if that's your, if that's your game. Very strong competitive benefits over our competitors promoting bone healing visible on X ray Hi cyclical loading capability, very similar modulus to cortical bone micro porous low cost and it looks and feels like bone and I actually have some samples with me if you'd like to, if you'd like to see it. And you know, it kind of looks and feels like bone unlike unlike a piece of plastic or a piece of metal. We have very extensive intellectual property around the material itself around the manufacturing process and around the implants themselves. Our technology roadmap we've already completed many significant milestone ins and derisk. This we've completed ISO 10 993 chemical characterization, genotoxicity cytotoxicity, animal studies, as well as mechanical studies all the way to packaging aging and sterilization. In preparation for marketing. We are looking to do two 510 ks this year, one for the cervical spine indication the other one for cranial maxillofacial indications. And then after that a production ramp up and then adding the additional verticals, the lumbar spine, the suture anchors and and also dental which is a very exciting market for this material. Our funding roadmap, we've right now got about 3.5 million in the company, we're looking for to raise a Series A of five to 7 million to support our initial launch and clinical experience for the first two products and then looking for a larger round thereafter, bridging to a strategic exit the strategics also already have a significant amount of interest in this material, they can see the benefits of the competitive benefits of finally bringing new material. So why orthopod as we as we conclude this is a disruptive technology this is a very definition of disruptive. It is the first new structural biomaterial orthopedics in over two decades, it is addressing critical needs of healing of cost and complexity. And key de risking validations and technology validations have been completed. And the platform technology is scalable over multiple sub markets and verticals and orthopedics. We've got a strong team with a history of successful outcomes for investors and stakeholders. This is a large and rapidly growing industry. we're uniquely positioned to improve patient outcomes surgical experience and and reduce costs and multiple strategic options for exits and collaboration. So with that, I'll conclude and I'll be here if anybody has any questions or wants to see some of these implants themselves.