Tim Miller, Stimdia Medical - Temporary Pacing Stimulation for Ventilation | LSI USA '24

Tim Miller  0:04  
I imagine for a moment how disheartening it is for critical care clinicians who are working in the ICU. They've spent an inordinate amount of time with a patient, they've prescribed therapy, they've done diagnoses, and they finally crack the code and get the patient resolved. They've got the underlying disease resolved, and yet that patient remains tethered to the ICU because they can't liberate them from the mechanical ventilator, and by that they can't get the patient to breathe on their own. My name is Tim Miller. I have the opportunity to lead a tremendous team in Minneapolis that are highly motivated, very experienced, and we all share a passion to put a winning card in the hands of these clinicians who these are post covid Doc, so they're suffering a little PTSD, yet they're looking for that winning card to get in their hands, and then for patients to ensure that we get the patients off these ventilators and so they can communicate verbally again with their loved ones and their care providers. How do we accomplish what we're doing here, we're utilizing leveraging neurostimulation that's been around for a number of years, decades, for neuromuscular stimulation. What we're doing is stimulating the diaphragm muscles, so we're essentially awakening and reconditioning a muscle that has begun to atrophy due to these patients being placed on a mechanical ventilator. Ventilation has taken over the physiologic side of breathing in a non physiologic manner. From a market perspective, there's a significant unmet need on this one here, and those unmet clinical needs result in substantial market opportunities here, and that's been calculated out to over $2 billion from a market perspective, from a phase perspective, we've got FDA approval to initiate our clinical trial here in the US, and we'll talk a little bit more about that. To digress a little bit, 10 million patients a year are placed on Mechanical ventilators throughout the world, 5 million here in the US, 40% of those patients are placed on Mechanical ventilators, and have a challenge on being liberated from those as you take a look at it again. This is a garnered a lot of attention during covid, but there was a clinical need that existed before, and it exists today. There hasn't been a lot of change on the mechanical ventilator side of things in decades, actually, on this and you can see up here one of the things on the right hand side of this slide here, that a number of these patients present with diaphragmatic dysfunction. So you've got a diaphragm, our primary muscle utilized in breathing that's essentially lying there flaccid and is not exercising over the period of time that the patients are on mechanical ventilation, and again, we're there to awaken and recondition that muscle. High mortality rates are associated with this, and there's a high correlation between the amount of time a patient is on a ventilator and the modalities that are associated with that, one of those being ventilator induced pneumonia. So that increases the amount of time and dollars consumed in our healthcare system. Here's an example of a just one study that was conducted as we take a look at what is a compromise that were is happening to the diaphragm itself. So again, it's laying there in a flacity, essentially position here, the x axis a little hard to read here day zero through day five. The y axis is the thickness of the diaphragm itself. And you can see here on day one, you're already seeing a compromise on that diaphragm. You're seeing thinning of that muscle tissue. By day five, that muscle is about 30% gone already, which is pretty surprising when we when we think of other muscles that we've got in here. But atrophy is a is a real thing. It happens in quads as well, on patients, and they assign muscle stimulation on those as well. So our goal is to be able to reverse this. We're really paying attention to what's on the right hand side here. So by neural muscle stimulation, we're really applying physical therapy in a non volitional manner. So in patients that are non responsive, we can provide physical therapy and get that muscle up and moving so that they have enough reserve to get off these ventilators when the time arrives. One of our physician advisors came up with this term training the entire respiratory circuit. So we know here, it's a rather complicated circuit I've. Have summarized it in four key points here. Chemo receptors throughout the body are really defining the amount of o2 CO two and blood acidity levels that will go back to the nervous system itself and adjust the depth and rate of breathing that a patient has. And then that circles back down here through the diaphragm, muscle activating, and then the lungs as well. Okay. How do we solve this problem? So again, we're playing neuro muscle stimulation. What we do is we place leads bilaterally. It's at less than three French each of the leads so one millimeter in diameter. They're placed percutaneously through an access point that clinicians are very familiar with. These leads are connected to an external stimulator, which you can see the council here, and then also attached to that council is an integrated flow and pressure transducer, which you can see here that goes in the ventilatory circuit itself. Our components are the lead, which we have manufactured, and then the council itself, the flow pressure transducer, are off the shelf components. The reason that we've got those in line here is so that we can be agnostic to any ventilator that's out there. And what this allows us to do is trigger our therapy within milliseconds of detection of inspiration, and then we stop our therapy at expiration, which is important because dyssynchrony and asynchronous events are a common problem with respiratory therapists out there. Okay, so some of the key milestones that we've accomplished here, we've completed a feasibility study, we've received breakthrough device designation, and again, we've got our FDA, FDA IDE approval. Our study is a randomized trial enrolling 350 patients. We've got the patients that we've identified this are patients who have been on a ventilator for for four days and have at least had one failed weaning attempt. So these are patients who have a compromised diaphragm. We always position ourselves right for opportunity to success on these trials. Our control arm is standard of care, so treatment arm stimulation. These patients will be stimulated for up to 30 days, and then the leads would be removed, and we'd continue to follow those patients for another 30 days, just for adverse events. The endpoint that we've got is time to wean. Time to wean is defined once they extubate the patient. They've been extubated for 48 hours, that's considered a success, and then the leads would be removed at that time, we've got secondary endpoints as well here that contain some metrics here that are common to respiratory therapists critical care. Doctors will also use this data in our data science program to be able to be more prescriptive and predictive on our therapy itself. We've got a marvelous national pi here, Dr Steven Conrad, obviously here, one of the most educated individuals I've ever met. And we've got 12 sites that are active throughout the United States. We've got 14 more that we're working through contracts on. And we'll enroll up to 35 sites in the US, and we'll get some in in Europe here as well. From a timeline perspective, we've got, we're looking at completing our study at the end of 2025 again, enrolling 350 patients. We'll do the data clean, do modules into the FDA, get a submission in midq Two of 2026, and then we're looking to be postured for a nine month approval from the FDA itself. The take home message is on that bottom line there. We've been really frugal with our finances. To date, less than 25 million spent to date to accomplish feasibility study. We've got all the product on the shelf to support the clinical trial. We're going to be identifying another 5 million with a round internal here that will take us to the end of the year, and then we're looking and seeking for a partner for another $20 million to help us complete the clinical trial here, these are all the opportunity highlights we've talked about, again, large unmet market here. One that I'd like to point out is a compelling value proposition. There is a CPT code for physicians to implant this device that's always helpful out there, in our in our system that we've got today, and the economics work out very favorably under a current DRG. But we are going to pursue another DRG in a carve out on that one as well. So again, we're looking for partners out there to be able to for us to complete the trial. Please give me a call. I met with a lot of terrific people already and help us put that winning card in our clinicians hands. Thank you. Applause.