Tim Miller Presents Stimdia Medical at LSI USA '23

Transcription

Well, thank you. And good afternoon, everybody, you know, we all recognize we're playing in a team sport here. It's not easy. It takes grit to take a concept into building a product, to get a product that's capable of doing great things within a clinical study, a clinical study that's capable of getting something to market. And I appreciate your time, your attention, as you consider collaborating with us as we walk through this process. And I'm anxious to introduce you to our product that we've got here. My name is Tim Miller. I've been with the company for two and a half years, incredibly excited about this. You know, I think, as you'll see here, and you know, with our solution COVID garnered a ton of attention in this area. But this is a product that stands the test of time, it was something that was needed before it's going to be needed now is well here we go the wrong way. There we go. Alrighty, so this is a flyover on what we're going to be talking about today. Our technology applies in a minimally invasive manner, neuro stimulation, to be able to pick up a diaphragm, the primary muscle that's utilized in breathing to awaken it and begin reconditioning it in patients who are on mechanical ventilators. There's a lot of work that's been done on mechanical ventilation, it's an incredible therapy. However, there are consequences with this. In a number of cases, you can do damage to lungs. There's a lot of things now for lung protective ventilation that's being talked about and technology implemented on that. And then recently, you'll start hearing more about diaphragm protection. And that's what we're targeting. With our solution that we've got here as well. Let's make sure I can get this. from a market perspective. The CAGR is on this are just under 10%. Markets increasing primarily due to an aging population increasing COVID. And it is still yet to be determined with long COVID. How many patients are going to be candidates for this type of therapy in the long run as well. We've got a deep portfolio on our IP, we've gone deep on a number of we've got five issued patents, we've got another a number of them in works. We're blanketing you know the globe in a very constructive manner. That gets expensive. As you all know, we're entering phase, our clinical phase or pivotal study phase where we've been working with the agency. And we're looking to integrate that in June of this year. And we're looking to cap our series B round, which I'll talk a little bit about here as well. Keep going backwards here. Sorry about that. There we go. Okay, I think I'm getting help from back. Thank you. All right. So from a, you know, market perspective was, we take a look at this today, these numbers are representative of before COVID. And we're starting to kind of settle down into this again, as well. We all heard about ICUs being flooded, trying to get patients shifted out of beds to free up beds on that, in a normal situation or run rate we're at about a little over 5 million patients a year are admitted into just the EU into ICUs. In the US here, of those about 20% of those are mechanically ventilated, a little higher than that, actually. And And again, as I talked about mechanical ventilation is a very effective therapy. But you've got high mortality rates, it's a number one area where the source of hospital acquired pneumonia. As you take a look at the lower part of this slide as well here, the pain point for clinicians on this is after they've taken care of the underlying disease, they still spend considerable amount of time trying to get these patients off a ventilator. And it's a little over 40% of the time. So almost half the time a patient is intubated, taken up ICU space, they've got the intubation tube in them. So our goal is to be able to get these patients off again, allow these physicians to be successful in an area where they haven't had the luxury of having success over the last number of years here. Keep hitting the wrong one here. Can you advance me here? Thank you. Okay. So this use on the diaphragm when a patient gets intubated, that diaphragm just lays there in a fasted state. And it breaks down very quickly. As you can see here in this clinical study that was done, where they were using ultrasound to measure the thickness of the diaphragm, you can see, after five days, they've lost 30% of the bulk on that diaphragm bulk on the diaphragm leads to decreased strength. decreased strength means that these patients can't breathe independently here, and there is no physical therapy that's really provided these patients, because they're knocked out. So we've got a method now to be able to do it in a non volitional manner atrophy sets. And if you take a look at that first tick on here, atrophy sets in within 24 hours, and you can already see a decrease in that muscle thickness on those patients their next slide then if we could, okay, so neuro stimulation has been around for a long time, this isn't anything new, it's used in many applications out there, it's been very successful. As you can see here, what we're doing is is connecting between the brain and the diaphragm through a phrenic nerve, that phrenic nerve essentially goes numb on these patients, it loses some of its neuro elasticity, if you think of it that way. So by triggering will implant leads in the neck. And we'll talk a little bit more about that one on next slide here. But to just pick up that diaphragm, again, you can see it's like a piston. Right? When you activate it, it contracts it moves down into the abdominal cavity, increasing volume in the thoracic cavity, which again, creates a larger pressure differential and creates more physiologic breathing than having a tube and then forcing pressure down in that tube itself. Next slide. Thank you. So here's our solution, PD stem, you can see it's really got three components here, we've got leads minimally invasively placed, they're in for a maximum of 30 days, we're hoping to get patients off these ventilators in a shorter period of time, that runs up into think of this as an external stimulator or pacemaker with a UI interface on it. And then what makes our system unique is, is we've got an integrated flow and pressure transducer. So we're agnostic to any ventilator out there we maintain synchrony in this is what allows us to maintain synchrony with the patient and the ventilator itself. Next slide. Here is our first in human study we did 12 patients over in Europe. The goal of this study was to determine can we safely implant leads are they able to actually coordinate with the ventilator and the patient for their breathing for therapy success. And then these were only for 48 hours. So it was a pretty quick case that we did. But even within that 48 hours, we saw a 15% increase in diaphragm thickness on those patients. Next slide, please. One of the physicians that was involved in on that trial, took the cohort. So if you take a look at our treatment group who's non randomized, so the one on the right hand side for you here is the cohort that we had in the clinical study. The one on the left hand side was a control group that enrolled after our study was complete, and did the same protocol on those patients, they had similar demographics to our treated group. And as you can see, here, there's a trend in the negative direction that we've got in the control group in the treatment group, the trend is in the positive direction here. So that's consistent with the data that we saw from the previous slide, that would suggest that these diaphragm are getting thinner over time losing some of its strength. Next slide, please. We're moving into a our pivotal study here 400 patients, our patient population, our patients who have been on event for four days, they've had one failed weaning attempt, this is a real sweet spot so that we know over time, we're almost 30% of that integrity that diaphragm has already lost at this point. And we'll be able to pick these patients up. primary endpoint is time to when we're looking at reducing length of stay in hospital. And again, secondary on increasing the maximal inspiratory. Pressure is strength on that. Next slide, please. Target Population, again, very large population of patients. Again, we hear this through COVID. Here, were targeted on that patient population. On the left hand side. There's a lot opportunity here over on the right for minimally invasive ventilation on these patients where we could replace the intubation tube with forensic stimulation. Think of it that way more natural breathing, and put a CPAP or BiPAP on Next slide, please. So here's the asset we've got on this. So our we've raised 24 million to date last June, we closed on our series B first tranche for our series B $16 million. We're looking to cap that within the term sheet that we identified here with an additional five If and what that will do, let's go to the next slide here. What that does is gets us to an analysis point within our pivotal trial that we've got. So looking at this, as we roll this out, we've got, again, 400 patients that will be enrolled, we're starting that in June of this year, by third quarter of 2024. We've got written in the protocol where we can do an analysis on those patients. Take a look, confirm that we've got all the mechanisms of action triggering on this thing, and then take down that second tranche. Here's the team that we've got lined up here. We've got over a century of experience on this. But truly, it's the aptitude that we've got on the on this team to be able to keep driving this thing through to conclusion here, an incredible Board of Directors Soulless bio ventures letter last round, they've been an incredible partner. We've got some familiar names up there as well. Let me just go back here real quick. So in conclusion here, just to wrap this thing up, we've got you know, large unmet need here. We've got a solution. We've got parts on the shelf, we're ready to go into our clinical trial here, and strong interest from corporate partners as well, which is a positive thing to have. We had two of them come in on our last round. We've been very capital efficient. And again, we're just looking for those partners to help us out here on capping our Series B. So thank you for your time.