Zygmunt Porada Presents DirectSync Surgical at LSI USA '23

Transcription

Thank you, in the spirit of McGinley Orthopedics and Locate Bio, let's all just stand up and kind of feel your spine, relax a little bit and kind of get get yourself loosened up a little bit. We've been sitting for a long time listen to people talk. So while you're doing that, I'll give you a little bit of background on why I'm with direct sync surgical and feel free to sit down or stand up whenever you want. But ultimately, my background, my dad had a car accident back in the early 90s. And he's had three subsequent fusion surgeries, two of which failed, and he's still in back pain. So he's had a lot of failures with those spinal surgery. And he's ultimately the last one took using infuse, so there's a place for biologics, but certainly, certainly still in pain. And so we've got to do better. And with that there we go. Oops, thank you. Alright, so today, we've got what you heard earlier was that with infuse, you had a very high success rate with patients who heal really well. And so what we're trying to do is deal with those patients who have diabetes, who are morbidly obese, who don't heal as well, who've got diabetes, and we're trying to help enhance their healing. And so what we see here is a pictograph of what the traditional single level fusion surgery is, you got an interbody device, where you place that's placed after you evacuate the disk, you also have the rods and screws that are posterior located to immobilize those vertebral bodies above and below the inner body. And so ultimately, what you also have is, is not very visible as packing a valid graft or those biologics inside that inner body, or in that side, that disk space. So what we're doing at directing surgical is we're taking electrical stimulation, and placing it inside that interbody device. And as the patient walks around compression relaxation, generates a charge that we're able to harvest and turn around and stimulate the bones above and below that disk. So what we're looking for is over time, that electrical stimulation has been demonstrated in our comparative animal studies to help grow bone. And we also are in the process of adding diagnostics to this device. Ultimately, we've fully integrated it into a form factor that spinal surgeons use today. So there's no change to their approach to doing spine surgery, we've got to be collecting that data. So there's an opportunity for big data opportunities. So we got to collect that data first. So we're laying the track right now, to be able to be in a position to digitize what we're doing with these patients over time. All of that, and all that microcircuitry surgeries contained within the device. And ultimately, you get a sense for the form factor size. So what we're looking for, and why do we care about this. So from a business perspective, TL antibodies make up about 343,000 procedures a year, and about 288,000 of those are T lift, which is the first form factor that we're going to go into our product can go across the entire platform, all the interbody fusion products. And so we're starting with T lift, but we're going to expand into these other approaches as well. And this translates into $1.45 billion market, it's growing, the T lift market is $750 million market, it's growing, we got a good opportunity to capitalize on what we're doing and stabilization, by integrating both that's stem electro stimulation market into that stabilization market. So what you see up here is today, patients might have to wear this external brace, in order to get some sort of therapeutic benefit from their electrical stimulation. Or in the case where they're not using an inner body device, they might actually have a product implanted, like a pacemaker, where those leads are placed, and then left in and around the vertebral bodies to promote bone growth. And so what you end up there with is resident content that's never extracted, you'd have to have a second surgery after placement of that pacemaker like device to remove that battery when it's depleted six months later. So we've got a self contained solution, it takes both best of both worlds into one product, and there's still a place for biologics, we think that with our product plus biologics, we actually have an opportunity to expand the market, expand the number of patients who can be treated, and so wanted to underline that fact. And with the recent integrations going on, you know, the top five, maybe top four now achieve the top 75% market share for both biologics as well as the hardware. So this slide is intended to give you a sense for the left third is kind of the intellectual development side got our IP established. The middle third is about getting just the stimulation circuit, miniaturized and working. And the far right is feedback from FDA showing that we need to do a PMA to get this product approved with just electrical stimulation. And the decision was made to add diagnostics to that so that we've got a pretty compelling I think argument for the recent breakthrough designation that we submitted, that we're currently in the first 60 days of. And looking forward to leveraging the current SBIR grant that we have $250 phase one, that two and $50,000 phase one grant to integrate that sensor functionality with the stimulation circuit that we have already developed. So there's some 2014, we did a proof of concept study 2021, we ended up using eight more animals with that integrated circuit, fully formed factor design. We randomized placement, superior inferior on the sheet that we used. And what you see on the right, farthest right is good for speculation, you've got great bone growth through that fusion site. Whereas in the control on the left, that histology shows that gap that still formed at four months. So we're getting some good evidence, look forward to talking to anybody who's got questions around what that looks like. From that latest animal study, it gave us a couple of different insights. So what you see here is the distribution of loads that the human normally sees, as well as what the sheep would normally see. And so with our Gen one product line, we had most humans in terms of the loads that they see, with our gen two product line, we're going to get all humans and most cheap loads. So we expect to have even better outcomes. As well as when it comes time to commercialize. We're hitting all humans and all the loads that they would expect. So even slight patients would benefit from this product. In short, we've got a good group, a lot of experience in the medical device, as well as orthopedic spine space, myself, engineer biomed Hopkins, MBA Loyola University 20 plus years at Medtronic and Boston sigh, working in and fuse with medical affairs, as well as the clinical evidence generation dissemination for a pacemaker defibrillator product line. For majority of those years at Medtronic Leighton hlep. Here, the previous CEO is our CEO. And he comes with some startup experience, as well as good marketing and product development background. And then the original founders Chief Technology Officer, at least Afrese is the Department Chair of Mechanical Engineering at the University of Kansas. And Dr. Paul Arnold is the chief medical officer and is currently out of the University of Illinois, working as a neurosurgeon there. And so we've got advisors, people, literally written letters of support, and are currently in the process of getting ready for this current funding round. So we're raising 3 million, and we're looking with to use a convertible note 0% interest $50 million cap just kind of offered for the first 2 million. We've got 500,000 so far and soft commitments, looking for lead investors and follow on investors who are interested, so interested also in discussing how we get there, maybe a convertible note isn't your thing. Let's talk. Ultimately, the milestones are to get us through the next two years. And I'll be happy to answer any other questions people might have. So in summary, great company, good team, great product, look into bring diagnostics and granularity to the follow up that these patients have with the diagnostics that will offer so trending fusion over time, gives doctors not the three month visit or the six month visit, you get it in between and every every week if the design holds true to what we plan. So feel free to reach out call me I'm here all week. I look forward to talking to anybody who wants to go deeper. Appreciate the time