Steffen Hovard, Neuspera - Ultra-Miniaturized Implantable Neuromodulation Devices | LSI USA '24

Steffen Hovard  0:00  
I thank you very much for the opportunity to present to you today. Thanks to both LSI for giving us the opportunity and for all of you for being here, we appreciate it. Gusberg medical has been dedicated over the past 10 years to progressing a micro, invasive, battery free neuromodulation platform. We have our first application in overactive bladder. We have promising clinical results. We have a massive market opportunity in front of us. We see a very large opportunity for value creation. This situation, phone respiratory is quite unique. We are in a field where everybody is pretty well aligned, that there is about a 5% market penetration with the current solution. The current solutions from exonics and Medtronic typical can and lead requires a relatively large incision, a big bulk on the back and then an implant in the sacral. Nusrah solution is a, as I said before, battery free wireless solution. So we have a significantly less invasive procedure. The therapy has been around for 25 years, so very well documented that we can see from our clinical results, from our feasibility trial, that we are performing right in line with what is known out there? We have a unique, truly unique technology platform that is well proven. As I mentioned, it's been around for about 10 years. So we know that it works, and we know that it works well. We are well advanced from a clinical standpoint. As I mentioned, we completed feasibility studies back in 2021 and we have recently completed the last implant in our pivotal trial in December of 23 we have positive situation on reimbursement. So we know what that looks like. We have our own code, so we have a very clear path for market access perspective, and we're well progressed from a regulatory submission as well. As mentioned, no battery, which is a really, really big deal. Actually. What you see between the fingers up here, that's the entirety of the nusbera implant. We use a wireless transmitter that can stimulate up to 10 centimeters deep in the body, through skin, tissue, bone, whatever it may be, and by not having a battery in the body, we eliminate the pocket and we eliminate the tunneling, which is at the same time where most of the issues occur with the current solutions. From a patient perspective, it means that the implant cannot be filled, cannot be observed, and only do the patient interact with the system the two hours a day where they take the wireless transmitter, put it in the belt, over the implant, and take the stimulation. So I mentioned the results before that are in line with axonics and Medtronic for sacral neuromodulation. We just do it with just two hours daily stimulation. It has a benefit on the short term, because it means that the patient has a lot less stimulation, obviously, and there are theories, at least, that it may reduce the risk of adaptation over time. What's also great about the technology, and makes it truly unique, is that the patient can go about his or her daily life. The wireless transmitter that I mentioned does not have to be glued to the skin. It fits in a belt underneath the jacket. So for all you know, I could be stimulating right now, and I could go about doing my thing. I can twist and I can turn. I can do all those different things, and that has to do with the technology, both in the wireless transmitter and the implant. May be small, but I can promise you, there is a lot of thought gone into how do you design an ASIC that one fits in about a two millimeter can and gives that freedom of movement, which is so essential for the patient, because the two hours per day does not require that the patient is lying down, sitting still, whatever it may be they can go about their daily lives. So it's a wonderful combination of technology enabled patient liberating technology that we think will will significantly change how the world sees neuromodulation, saql, for many, many years to come. This is our sort of, our bragging slide when it comes to size. I mentioned the small implant. It's a 0.03 CC. It's very, very small, and you can see how that compares to other solutions on the market, going over tibial and to the sacral solutions. And one thing is the size of the electronics, which may, for engineers and business people, be interesting, but from a patient perspective, if you look at the bottom graphic, and apologies for the graphic pictures, it makes a real difference. When we say micro invasive, that is really true, we leave about a two millimeter puncture behind, and that is the entirety of the procedure. It is done in the OR, but could over time, which is our vision. Obviously, we want to take it out of the or we want to take it into the office. We want to. Do it on the local and eventually we want to skip the trialing system. When we do all of that, we can come a lot closer to realizing the full not just the value of potential of the market, but serving all of those patients out there that are not currently getting the optimal treatment. And looking at the market, there is pretty good alignment that that we are about a 5% penetration. There are about 30 to 40 million Americans that suffer from varying degrees of overactive bladder and just fast progression. To the right of my little arrow chart here, there are about 55 to 60,000 sacral implants per year, and that's after 25 years. And the question is, why is that? Our theory is that is because there has been very little innovation, real innovation, and we think the market is ripe for true disruption, which is, which is our intent. So when we think about the future, of course, we want a nice share of the 55, 60,000 which I think will take. But more importantly, we are thinking about the millions that are not currently being treated, and what does it take to get to those? So we see an opportunity for significantly expanding the market. We think we are set up very well to do that from a clinical standpoint, as I mentioned, we completed feasibility studies in 2021 34 patients, 89% responder rate, which is right in line with the best studies we've seen from the accumbens in this space. What's interesting is that we saw a 52% dry rate. So 52% of subjects were 100% dry at their 12 months follow up with about 16% points higher than other sacral solutions and about 25 27% higher than any tibial solution. So really promising. Feasibility results we just completed, as I mentioned, the last implant in our pivotal trial in December last year, which puts us on path for PMA submission, last module, sort of q3 of this year and then commercialization. Call it mid of 25 that timeline is pretty much unchanged from from the past couple of years. We see, we see a launch strategy that will build on, as I said, clear site on reimbursement. We will have a soft launch to begin with. We'll build on sensors of excellence. We want to see repeat purchases. We want to see that that the physicians get it. We're not concerned because placing a new spare device the electrode is just like placing an exonics or a Medtronic electrode. So if they know that, they know the new spare system, which means that we build an existing therapy, existing procedure, and then we'll accelerate the launch from there. We've done it before. It's a very predictable space, high concentration, and we know exactly which physicians to go to. And here is the chart as we see, the positioning high level of efficacy, efficacy and level of best in the industry, and then the absolute least invasive procedure of anything out there. And then, oh yeah, by the way, we can, with our patent, actually document that nobody else will be able to get to the centimeters deep stimulation. So we feel really good about the position, because getting to the sacrum, you need to be somewhere between four and eight and a half centimeters, which nobody else, as far as we can see, will be able to do. And the team is a wonderful combination of science, clinical business and what's really important in our industry and the stage of the company, a wonderful combination of entrepreneurship and those that have been around the block a few times, and with that, I appreciate your attention, and thank you very much for your time. Applause.