Chris Kaufmann 0:04
Yeah, thanks for having me. I'm excited to be here and introduce y'all Iota to really show you how we're doing surgical robotics differently. So we're out of the University of Iowa, which is one of the leading cochlear implant centers in the country. We've been fortunate to work alongside KOLs, as well as surgical expertise in our development and also have international cochlear implant manufacturer partnerships that sort of culminated into our FDA approval, the first ever in the US in the world, robotic assisted Cochlear Implant System for electrode array insertion. And so, in general, a cochlear implant is really indicated for patients with severe hearing loss, if you're not a candidate for hearing aid, or for patients who aren't really getting a benefit from the hearing aid. They're candidates for us, there's over 60 million people globally, who are experiencing severe hearing loss two and a half million over the age of 60. In the US alone, it's a significant public health problem. And one of the most surprising things that actually sort of led me to start it is this is profoundly under penetrated, market, less than 5% of patients who are eligible for a cochlear implant by Medicare, very objective criteria, are getting an implant. And so when I started looking at this as when I was at the University of Iowa and spinning this off, it's really why was that and, and one of the main factors is really the variability and the uncertainty of hearing outcomes that patients are getting with their cochlear implant. So what that is leading to is really a lack of confidence by both the patient in order to undergo the surgery just from fear of hearing loss and undergoing that surgery as well as the surgeon in their comfort level of performing the cochlear implant insertion itself. And so you can see here on the left, this is just, it's currently inserted manually with a pair of forceps by hand, on the left is the sort of the the forces that cochlea experiences when a surgeon is doing it manually. And you can see is there lots of variability, there's outliers. And so when we were looking at this, he was like, Well, this is a perfect solution for robotics, robotics can bring that precision and that control and in constant electrode insertion that we can now really start to standardize cochlear implant insertion. These are just some videos on the left, it's just the cochlea on roofed This is a surgeon trying to insert an implant very slow, even stabilized. And we're talking, you know, five millimeter insertion or under microscope, this is a millimeter or 10 millimeter, cochlea size. And then on the right, you can just see the stop and go when they're trying to go slow. And it's sort of beyond the ability of human kinetics. So on the right is 100 micron per second insertion, and really just a drastic difference in controlling and decreasing the variability compared to a manual insertion. And so like I said, we're the first and only FDA cleared, robotic associa insertion system. And I think this picture sort of speaks to, I think, what we're trying to do and how we're doing robotics so differently. So as you can see that the robot is a miniature tiny right there alongside the surgeon, the surgeon is still has its manual instrumentation and doing what they're sort of trained to do. But at the same time, you have the robot there sort of collaborative right there, right along their side, at the surgical site, we're not taking up a giant or we have, we have nurses and assistants that can get in there and still do surgery. And so that's what we're really excited about, it's kind of changing the way that surgical robotics is thought about. It's a miniature system. It's a single use micro robotic system, it's fits right there, mounted on the patient at the surgical site. One of the advantages of our system is it's an open architecture, implant agnostic school. So we can work with all three leading cochlear implant manufacturer, and that gives the patients and the surgeons sort of the freedom to choose what implant type they want, and they can get robotics benefit from it. And again, that that micro level insertion control that you can't physically get with human capability that has shown in studies and literature to improve outcomes. So here's just a video of sort of a quick overview of the system. There's a capital component that comes with the system, and then the single use Drive Unit, it's controlled with the foot pedal, it's designed to fit on various anatomies based on the surgeons variability in their approach locks the flexibility and degrees of freedom. And then I think the most elegant feature of the system is the ability to hear it is screaming onto the surgical site, same exact approach that we use, but kind of flip on and off two implants without significant change in their approach. So 30 seconds to implant to screw the screws down 1020 To load the implant, and then you're sort of ready to go. And you have the benefits of robotics, without all the hassle and the setup time. And so now they're under the microscope, they're advancing with the foot pedal hands free and stable few 100 microns a second which minimizing trauma. And so once they're done, again, a simple removal, take the device and dispose of it. And hopefully their outcomes are optimized and they have confidence in the surgery. So not to overkill here. But this is a live session on left of a surgeon manually performing them on a right just to demonstrate what we were showing and clinically is the stability and control sets. Now they're sort of going in slow motion given the surge of time to react and optimize their insertion procedures. We've shown a reduction in insertion force variation, but I have to say have an 8% and maximum insertion forces by up to 51%. And really again, removing that variability. So we're currently ongoing a limited market release rollout with following our approval, we've 20 Plus clinical cases to date. Again, this is to show just the implant compatibility and the agnostic nature of it. And one of the things we're excited about is just one, the surge of excitement. And also from the patient perspective, I think we're seeing, you know, patients are now saying that some of the key sites are out there waiting for the rollout to be available to other sites. Before they want to undergo cochlear implantation, you're seeing, you know, patients coming from other centers asking to now go to the site that has the robotic system. So we're starting to see an early impact just in the few couple of weeks that we've been launching. And so, again, it's that comfort that surgeons that patients have to undergo surgery that that question of whether you want you or your loved one to undergo surgery, you want the best, you want to optimize it. And then for the surgeons, it's just the confidence to help standardize it, maybe you don't do 120 Or maybe do 10 to 20. But that's the power of robotics to kind of standardize your procedure, from the hospitals. It's the patient volume that they're seeing growth from sort of the Billboard effects as well as the standardizing the procedure results. And then for the implant manufacturers that we're working closely with, it's really almost a tool and a mechanism to help catalyze their market growth, increase their market share and differentiate. And so this is just a slide to just demonstrate how we think Iota robotic solutions can really catalyze the the cochlear implant market and open breakthrough, that really stagnant utilization rate that we've seen over the last 30 years that cochlear implant has been around. Since they're a team we've strong core team, I think we have Eric Timko is our chairman comes from a surgical robotics background at blue belts and Smith and Nephew. Marlins, the chair at the University of Iowa, co founder and I and then Chris Smith helps us he was the former CEO of cochlear helps us with kind of the working with the partnerships. And again, our our clinical advisors have just been phenomenal to really make a solution that fits in with the current approach. So like I said, ongoing LMR really Kalos driving our adoption, collecting market data product feedback at different hospitals sites on the value side. And then in parallel, that we're still sort of developing this product pipelines that I think I had a soft is really central to enabling all these other added features being the center of it. So we have a real time monitoring system that detects cellular trauma and real time Now feeds back to the robotic system and can stop automatically, you can couple in some analytics and insights now that we're able to capture what the surgeon is actually doing and or an in the case and couple that with preoperative postoperative data that's out there, and really start to potentially make an impact on outcomes. So beyond cochlear implants, we're sort of looking to the future as well, where precision accuracy and consistency really matters, to do crease side effects and improve efficacy of other other implant types. And so we're excited about this, but keeping our heads down focused on the cochlear implant space, like I said here, getting commercial traction, expanding our indications, to the pediatric population that's ongoing. And then expanding electrode compatible. There's a range of variety of arrays. And so we're adding that as well. And happy to talk more about this or strategic funding directions following on to the here. So yeah, just in summary, I hope you kind of can see how we're approaching robotics a little bit differently. We're first and only FDA approved a micro robotic electrode array insertion system for cochlear implants. Really hoping that it can catalyze and improve access, patient access to cochlear implants and increase utilization, as well as kind of see it in the future is like really a compelling central hub technology that is still driving the spokes on the value for all the stakeholders involved, not only in cochlear implant, but sort of beyond as well. So I just want to say thanks, and happy to talk more afterwards.
Join us at the next LSI Emerging Medtech Summit
LSI's global events attract top innovators, active investors, and deal-making strategics.GET INFO