Ben Hertzog Presents Intelligent Implants at LSI USA ‘23

Transcription

Ben Hertzog  0:05  

Good afternoon, everybody. I'm glad there are still some people out there in the audience. I understand orthopedic people are tough. So that's why we're all still here at the end of the last session on the last day. I'm continuing on a theme a little bit here. I think this is an exciting time in medtech when we're using electrical signals to do things with the body. And so intelligent implants is a company operating at the intersection of digital medicine and orthopedics. And what we've done is developed an electro therapeutic technology that we can embed in orthopedic implants that uses electrical signals to accelerate control and then remotely measure bone growth. So what does that mean? It means we're developing a portfolio of products with electronics embedded in them that have some distinct features, which are one a therapeutic benefit, accelerate bone growth, you know, reduce healing times be able to reduce failures and some complicated orthopedic clinical situations. But we also have a diagnostic piece of that we can measure that bone growth, we can track the healing of the patient, we can do it all remotely and send that information through the cloud, and get it in the hands of the physician for the first time giving real time data to support clinical decision making. So this is applicable across a wide array of implants in orthopedics. But we're starting in spine, our first product called the Smart fuse cage. It's an antibody spacer with our technology embedded in it. And our goal here is to address the unacceptably high rates of failures in spinal fusion procedures. So the spine fusion story really starts with chronic back pain. This is one of the most common and debilitating conditions worldwide. In the US we talk about 3 million productive life years lost every year and $50 billion of spend every year addressing chronic back pain. Now usually treated medically generally resolves. But when it doesn't, a large number of patients undergo a invasive surgical procedure called spinal fusion. This is where we take the disc out, we replace it with a piece of metal or plastic called an inner body spacer. And then we encourage the adjacent vertebrae to grow together and to fuse. And the goal here is to reduce motion, reduce nerve impingement, and eliminate the pain, very common procedure done almost a million and a half times a year worldwide. It's a very invasive and expensive procedure. It's often cited as one of the most expensive procedures in the US. And the problem with this is it still fails at an alarming rate. So non union is when those two vertebrae don't grow together. And when you look in the literature, you see non union rates of 20 to 50%, depending on the patient population. And that leads to revision rates somewhere between nine and 45%. And this is expensive surgery revision rates have outcomes even worse than the primary surgery. This is a big problem. And as you can imagine, the financial impact of these revision surgeries is significant to the providers and the payers who are footing the bill for this. Of course, it's the patient that pays the highest price. So chronic back pain, excruciating, long recovery times chronic quality of life impairment, opioid use, this is a big problem and we believe we can do something about it. If you look at the spine market, the device market overall it's a $10 billion market and it's dominated by four product categories fixation devices, rods, screws, plates, biologics, bone stimulators, the technology has been on the market a long time, it's old technology, it's external contraptions that the patient have to wear and then inner body spacers and intelligent implants. We said, well, what if we could take the bone stimulator technology that's been well proven, and we could apply modern electronic design to it, take a page out of the neuro stem playbook, miniaturize that technology, put it in the inner body spacer, and then deliver that stimulation exactly where you want the bone to grow. And therefore, it's kind of like the local drug delivery version of electrical stimulation. And so that's what we've done. And by combining those and creating new product category, then you ask the question, do you need all these biologics? Or potentially is this complementary to those biologics and make some work even better. So that's what we've done, we call the technology smart fuse. With miniaturized the bone growth stimulator down to less than one cc of volume. So we can put it in almost any orthopedic implant, we deliver our electrical signals across an array of electrodes, and that allows us to have a lot of control over the stimulation so we can activate those electrodes independently, we can steer the stimulation. In essence, we can get the body to 3d print bone insight to exactly where we want it to accelerate healing all that can be done remotely. Now on the diagnostic side as because bones and electrical insulator as the new bone grows in, we can see that across those same electrodes and we can actually spatially resolve where the bone is. And so we have this therapeutic and a pair diagnostic and you put them together and now sudden you can start with Thinking about closing the loop on these things, no batteries in this we power wirelessly well protected. We've got 16 issued patents across nine families. And the implant is just one component of our system. So the implant is then powered by an external wearable that we call the e cap. So the patient wears the EEG cap when they're getting therapy, it wirelessly sends power to the implant activates it stimulates. And then when we collect data from the implant, all that data transmits wirelessly to the EEG cap. And then that's backup to the cloud. And the smart fuse cloud is a third component of our system. And this is where the clinician and the patient get to interact with the Smart View system. So the gold standard animal model in our field is the O vine model, we've done over three dozen chronic Oban studies now. And we typically do an L two L three fusion and l 405. Fusion same implant in both levels. But we only activate one of those implants. So we're able to isolate in each animal the difference between stimulation versus no stimulation, and what we see three is three times the amount of bone. And that bone is better quality, we see a 70% increase in trabecular thickness. And all of this happens at early time point. So a lot more bone, better quality bone, and it happens in about half the time. On the diagnostic side, we use those same electrodes again, and we measure this bone growth and it's a very sensitive measurement to the presence of bone. And there's a lot of information stored in there. So not only can we detect the presence of bone, but we can actually make measurements on the quality of that bone. And we can see the difference between new bone that's grown in versus synthetic bone graft material or autologous bone chips, the surgeon might have used pear procedurally. So we believe this is going to give us in the surgeon unprecedent visibility into the progress of healing. Over time remotely, all this data goes to the cloud and to the physician portal. So now all of a sudden, we have this ability to track patients, we have this ability to have data that's actionable. Because we have a therapeutic tied into it, you can make adjustments to therapy, ultimately, you can look at patients identify a type of patient by the curves, and personalize that therapy to that patient to further improve outcomes. So as an entrepreneur, I get really excited about this because I think this is the future medical devices we've been talking about a therapeutic a pair diagnostic, it's all done wirelessly. patient doesn't have to come in can be done from home, no CTS, no X rays, any of that. So we've created a new product category, if you will, by combining some of the things that are out there already. And we believe we can compete as a better safer solution with data addressing a significant unmet clinical need and a massive market with really poor outcomes. And so will with the spine fusion device be competing in segments that are now worth $4.7 billion. And we're going to start in lumbar spine. This translates easily to other parts of the spine, but it also translates them to major joints, trauma extremities, all of these and so we believe our technology can play competitively in markets that are worth over $40 billion now. So quickly a little bit about the company. Founded by Swedish Irish team, we've got operations in Gothenburg, Sweden, Houston, Texas, and Cork, Ireland. We received FDA breakthrough designation raised 6 million and cumulative seed financing. So far, we were the recipient of an European Innovation Council accelerator award. And now everything we're doing is focused on getting the first in human we're going to do a first in human study in lumbar spinal fusion and really be able to demonstrate the impact of our therapy, but also collect the data and compare it to diagnostic imaging CTs, Xrays and be able to connect the dots and show the power of that diagnostic. So we're currently raising a seven and a half million euro Series A round to fund that first in human study. And I've got a dedicated team of entrepreneurs and we're on a mission to improve outcomes across orthopedics with these smart implants. Thank you very much