Ben Hertzog Presents Intelligent Implants at LSI Europe '23

Transcription

Ben Hertzog  0:04  
Good afternoon, everybody. Glad to see so many familiar faces out there. I think if you have sat in any of the panel discussions this week or sat through any of these sessions, you'll know that it's a very exciting time to be in medical devices, we're clearly on the precipice, or maybe we're in the middle of it already, it's hard to tell the digital or data era of medical devices, and a lot of us are convinced that every implant in the future is going to be smart, or maybe even intelligent. So at our company, Intelligent Implants, we're operating at the intersection of digital medicine and orthopedics. If you look at the orthopedics device market, $50 billion market, it's massive. And all of those devices or implants, with very few exceptions are designed to heal bone. Or alternatively, they need bone healing to work properly. And the problem is we have very few therapeutic strategies to impact that bone healing to accelerate that bone healing to improve outcomes. So many decades ago, researchers discovered that electrical signals play a key role in the signaling pathways that impact bone growth in our body. And what we've done intelligent implants is developed cloud connected bio electronics that we embed in orthopedic implants that mimic these electrical signals at the surface of the implant exactly where we want the bone to grow. And then we use those same electronics to gather data about the healing and other critical pieces of data and all that gets transmitted to the cloud and presented to the clinician in real time. So this is a technology platform that could be applied broadly across orthopedics, almost any orthopedic implant, where you want to accelerate healing and be able to track that healing. But we're starting in spine. And so our first product is called the Smart Fuse cage. It's an inner body spacer with our smart fuse technology embedded in it. And our goal here is to address the unacceptably high rate of failures in spinal fusion procedures. Now our spine fusion story really starts with chronic back pain. I think you've heard this a couple times already this week. one of the most debilitating and common conditions worldwide. In the US we talk about 3 million productive life years lost and 50 billion of spend annually chasing chronic back pain, usually treated medically usually resolves. But when it doesn't, a large number of patients are subjected to an invasive surgical procedure called spinal fusion. This is where we take out the disc, we encourage the two adjacent vertebrae to grow together. The goal here is to stabilize the joint, reduce nerve impingement and alleviate the pain, pretty common procedure done about a million and a half times around the world. Also very invasive and expensive. This is often cited as one of the most expensive surgical procedures in the US. The problem with it is it fails at an alarming rate. Some of the best data we have now came out very recently, it was the fusion arm of the Topps us clinical trial 44% of the patients had a non union, 44% failure rate. In fact, if you looked at a composite score of overall clinical success of fusion, the success rate was 24%. It's abysmal, it's really bad. And this is really just starting to come into light with clinical trials. Because it's such a expensive invasive procedure, you can imagine the economic impact of these failed fusions is massive to the payers and the providers. Of course, it's the patient that pays the highest cost for these failed fusions and revision surgeries and long recovery times. So why do they fail? Well, insufficient bone growth is the short answer. And why do we have insufficient bone growth? Well, if you're 10 year old child and you break your arm, your bone grows very quickly, it heals. It's no, it's not a problem. But based on risk factors like age and diabetes, and obesity, and smoking, or complex clinical scenarios, like trauma, or osteoporosis osteopenia. There are a lot of situations where bone growth isn't a given, and it's very hard to get bone to grow. The other piece of the puzzle, it's very, we don't have good objective measures of fusion or bone growth or healing without bringing patients in and doing CT. So we believe new technologies are needed to address these issues. And that's what we've done. So we call the smart fuse technology. We've miniaturize, we've taken a technology page out of the neuro stem playbook, and we've miniaturized everything, we're putting it in the implant. We're delivering the electrical signals across an array of electrodes on the surface of the implant that allow us very precise control allow us to steer the stimulation. So in a sense, we can get the body to 3d print bone inside to exactly where we want it to improve healing. Then we use those same electrodes to take measurements because bone is an electrical insulator as that bone grows in we can see that in the electrodes and we can spatially is all where that bone is. So there's a therapeutic component to this. But there's also a paired diagnostics. For the first time, we can present that information to clinician in real time track, close the loop, make adjustments to therapy, personalize the therapy to improve outcomes. So our core technology platforms well protected, we have 22 issued patents so far, and we have achieved breakthrough designation with the FDA. Now the implants just the peace of our system, we've decided not to embed a battery in our implant, we power it wirelessly. So when a patient's receiving therapy, they were an external medical wearable, we call the ecap, the ecap sends power to the implant wirelessly activates, it provides stimulation. And then when we collect data, that data flows back to the EEG cap and then is transmitted to the cloud. And the smart fuse cloud is the third component of our system. And this is where the physician can track patients in real time remotely, and patients can interact with our system as well. Now in our field, the accepted animal models, the bovine model, we've done over three dozen chronic large animal studies, we typically do two levels like an L2 L3 and an L4 L5, we will put the same implant, same time same procedure in both levels, but will only activate one of the implants. And this allows us to isolate that variable of therapy. And so excuse me, what we see is three times the amount of bone growth. And not only do we get a lot more bone, but we get better quality bone, we see a 70% increase in trabecular thickness. And all of this happens in about half the time. So a lot more bone, better quality bone, and it all happens a lot faster. On the diagnostic side, we're measuring impedance again, as the bone grows in, we can sense that on these electrodes. And because again, we have an array of electrodes, we can tell you where the bone is, is anterior posterior inside the cage outside the cage. And the electrical properties of the bone are a function of its its structure. So not only can we detect bone, we can actually differentiate between autologous bone grafts synthetic bone grafts and real natural bone that's grown in all of that data flows to the cloud along with other important data. So we're able to not only measure our core bone growth measurement, we measure a temperature we can, you know, look for onset of infection, we can know if the patient is using the system and when and if they're using it correctly. So we can track patient compliance, we're also able to detect micro motions to look at the stability of the fusion of their joint. And we're working on a prototype now that has strain gauges in it. So we can actually measure the loading forces on the implant. So all of a sudden, you have this very complete clinical picture of the patient that's transmitted in real time remotely without that patient having to come in and sit in the waiting room or have diagnostic imaging. We think this is a game changer. And we think this really allows us to have this vision where you can then close the loop and make adjustments to therapy. So in our niche, we're competing against bone stimulators, biologics, interbody, spacers, we replace all of them, we say we have a better safer solution to compete in this market and the markets enormous. So at our expected ASP on spine fusion, it's $12 billion market, we're going after lumbar first to $6 billion opportunity. And our initial market launch will be US and Europe. That's a 3 billion opportunity. And then we have this vision that it's this is bigger than just lumbar spine, we can go to other segments of the spine. And then our technology is applicable to arthroplasty, major joints, trauma, all these other major segments that can benefit from this therapeutic plus diagnostic play. I've got the obligatory best team ever slide and the greatest minds and medicine that are helping us navigate. We are all focused right nowon doing a first in human clinical study. And we're currently raising an 8 million euro series A to do that. Thank you very much.