Kirt Gill Presents NeuraStasis at LSI USA ‘23

Transcription

Kirt Gill  0:05  

Thank you. My name is Kirt Gill. I'm the CEO and co founder of Neurostasis where our mission is to press pause and ischemic stroke using non invasive nerve stimulation. So I'm a clinician by training. But I'm also one of the many people around the world who's had a loved one that suffered from an ischemic stroke. For me, it was one of my best friends and old college roommate who suffered a stroke in his 20s and was robbed up so much. So there's 7.6 million people each year there are going to suffer an ischemic stroke, and half of them are going to be left dead or disabled. That really doesn't need to be the case, however, because in 2016, a new procedure called mechanical thrombectomy, allowed neurosurgeons to go into the blood vessels themselves and remove the blockage. This is a game changer in stroke. And it really increases the odds of that patient walking out of that hospital, going back to their loved ones without disability. But there's still some discrepancies that we need to solve. So first, mechanical thrombectomy has a very high revascularization rate. But the outcomes still lag. One of the issues related to that, and I think everyone's really heard this throughout this conference is that time is brain. This requires specialty care. And it takes a long time sometimes to get to that care. In the United States, it varies drastically based off geography. So median times for patients that have to be transferred can go up to four hours depending on where you're at. And during that time, that brain tissue just continues to die. The New York Times actually just talked about this in a recent article this month, mechanical thrombectomy. It's billed as this miracle, but it's a miracle the vast majority of the world just cannot get to. And Logistics is not something you can figure out overnight. So within the field, there has been a renewed interest and push towards neuro protection as a way to break through the ceiling of outcomes that mechanical thrombectomy has allowed. So neuro protection is a way to preserve tissue. And that's exactly what we're doing with blue stem near stasis intends to slow down ischemic progression using non invasive nerve stimulation, we use electrical currents to stimulate the trigeminal and vagus nerves around the eye, and in the ear to jumpstart brainstem and neurovascular reflexes. So one of the mechanisms we're utilizing as collateral augmentation. So think of it as the highway is clogged up, but maybe we can open up a side street to provide additional blood flow. And we can inhibit excessive excitotoxicity. So once these neurons start going down cell that cell death pathways, there's massive neurotransmitter releases depolarizations and neurostimulation has been shown in preclinical models to put a stopper on that, what we're doing is packaging this into an easy to use device that can be applied early and quickly by non physician personnel, because it's all about time. So the vision for what this device could be is the ad for stroke, we're first going to start off by in our studies within the emergency room. But our mission is to get this into the pre hospital into the community to allow patients a Chance of early protection and allowing them to get to reperfusion treatments that already exist. So what we're building on our neuro stimulation principles have been building over the last 10 years. So first off, we did animal labs that are looking at perfusion. So my backgrounds in radiology, so I tend to geek out over some of these images. But what I want to show you here is the general principle of what we're talking about. So I'm going to play a video that is taken from one of our animals a permanent inclusion model, we've clipped the middle cerebral artery, so that blood is not going to get through but what you start seeing is a dramatic increase in blood flow through adjacent vessels. So here's the anterior circulation, where this blood flow continues to rise. So I'm going to walk through this really quickly here. So that dark blue region without reperfusion, that's all tissue that's just going to die. There's no getting that back. So when we turn on our stimulation, what we're seeing is a rise in the ACA, the anterior circulation, circulation. And this is then causing and rise that kind of resets the autonomics and sets a new baseline for what this perfusion is set to. And what's important is that in a stroke, there's a region of tissue that can be saved called the penumbra. And it's kind of like a rising tide. So after our stimulation, we're seeing an increase of almost 22% That shows that that tissue can now be preserved up until the point of view profusion but for our technology to work, it has to be utilized non invasively. And that's what we focused on. We in healthy volunteer work, we're using transcranial Doppler, measuring flow at the middle cerebral arteries and looking for patterns of downstream blood flow increase. We've done this work, we've seen it and now we're actually moving into our first clinical studies where we're done illustrating safety and tolerability in volunteers that have significant risk factors for stroke. So imagine a 70 year old with high blood pressure AFib maybe had a past history of so we're looking to see how we affect that vasculature. And whether that lines up with what we've seen already. This the stroke field has been changing ever since mechanical thrombectomy was approved. Part of the most recent advancements have been pushing towards earlier and earlier diagnostics, using tele neurology as well as AI based tools. Though there are all these technological improvements moving towards early diagnosis, there's no other device like ours that can be utilized as an early therapeutic that can actually utilize once that diagnosis is made. As a as our first indication, we're going to be selling into the emergency rooms at selling to hospital networks that have strict certifications. Everything's organized in a hub and spoke model funneling patients towards these comprehensive centers where they're actually doing these procedures. We met with FDA, we expect to be a class II De Novo the device and there are reimbursement pathways that we will be filing for incremental reimbursement. This market it really attached to mechanical thrombectomy in the large vessel occlusion market, which is growing dramatically and has since its approval, scoring 400% since 2016. But an important fact is that there's significant tailwinds for further growth. Part of that is going to be coming through continued device improvements that are going for smaller and smaller vessels, as well as improvements in technologies for perfusion that allow Windows to be extended with the applicable across the board. My background is clinical, my co founder comes from a background in engineering and business around ourselves. We're a small but dedicated team, we've focused on clinical and regulatory risk. We know ischemic stroke requires trials that are well thought out to find the right patients that are going to be right patients for our therapy to be utilized. So we have physicians here who have run massive acute stroke studies, know which outcomes to look for and how to recruit for them. On the regulatory side, we have people that will get us through FDA. In addition, we have gotten grant funding and through that we've gotten experience or gotten mentorship through industry, contacts that just clarify as well. So over this next three years, our goal is to prepare for an ID submission and get to treat get to get to using our device within the mechanical thrombectomy patient population. We've been collecting our current data with an off the shelf benchtop unit that allows us get into clinics early, but we will be furthering our developmental testing and de risking safety over these next three years. We have significant non diluted opportunities as well as follow on funding from our current grant. What I do want to focus on is that we have the opportunity to utilize our current bench current prototypes to test within the acute stroke patient population, focusing on a patient population that has a large vessel occlusion but has mild clinical symptoms, these patients aren't necessarily going for thrombectomy and allow us to use CT perfusion exactly like we did in animals to capture a treatment effect. This is what we're seeking funding for to be able to bring this, bring this technology and test it within the patients that actually can use it. We're very passionate group. All the founders have been affected, have had loved ones who have been affected by stroke. And we're looking for passionate partners and investors who are also looking to make a difference with this patient population. So I want to thank you