Richard Foust Presents MicroTransponder at LSI USA '24

Richard Foust  0:04  
My name is Richard Foust, CEO of microtransponder. Today we're going to talk about vivistem, which is neuro restoration for chronic stroke care. Just to give you a little bit of an update of the company, we're grounded in 29 patents, our mechanism of action was published in Nature in 2011 in 2021 we have our pivotal data published in Lancet, breakthrough device designation, FDA, approval, ntap, and pass through as of 2023 our technology is in a huge market that's underserved and underdeveloped, and we have a CPT code, 64568, that has been used for over 25 years. There's 850 physicians that are doing this procedure, and it is something that for us doesn't become a training issue. The tam for our technology and our market that we're going after in the United States is large. The incidence population is over 200,000 per year, and the prevalence population mostly driven by the fact that we've shown that our pivotal study had the same results in someone who was six weeks, six months after stroke versus 10 years. Leads us to 3 million patients that we have access to. So a tam of over 65 billion just in the United States, is something that we don't take lightly. The team that has really helped us put this together that we've in our last findings around the 73 million was led by usvp, OUP vertical group, as well as action potential play an important role in us really being able to be successful. Right now, we're in the process of bringing on really seasoned people that have done this before, and obviously at the heart of a technology that is elective is building a patient funnel and getting access and educating people about this. And we have someone who's best in class at that. So what is the problem that we're trying to solve for? Well, chronic stroke survivors have very few treatment options. The you know, the entire society of stroke treatment has focused on acute stroke care and getting to survival. What we're focusing on is what happens next for these people who have impairments. 60% of stroke survivors have upper limb impairments. This keeps them from having being able to do activities of daily living, or, in fact, be independent. And frankly, that's unacceptable. Today we are really focusing on these patients and asking them, are they interested in new options? 78 of these. Percent of patients have not lost hope. They are actively looking for options to improve themselves, until our intervention happened. It's a little bit sad. So here comes vivistem. Vivistem is an implantable class three device. You have an IPG that goes into a chest pocket, you tunnel up to the vagus nerve and implant a lead around the vagus nerve. It's then controlled by computer with specific software and a wireless transmitter. The therapist uses that technology to pair the stimulation with the therapy. So the mechanism of action this is all about paired VNS plus rehab induces neuroplasticity, so task specific practice stimulation increases neuromodulators in the brain by six fold. This creates a motor learning environment that allows for the neurons around the affected area actually to take over the function that was lost, so we are actually restoring function in the brain. All of this was proven out going from preclinical to clinical in our randomized, triple, blinded, Sham, controlled crossover study that shows statistical significance in the therapeutic group, not versus standard of care, but versus intensive rehab, 90 minutes, 300 touches per patient, as we went into the sham controlled side, the therapy also showed the very same, two to three times improvement. This was published in The Lancet in 2021, most recently, at the International Stroke Conference, we presented our one year data. And this was really about, is this therapeutic benefit, this change that you're undergoing in the brain of all of these individuals durable? And so the answer is, both from an impairment as well as from a functional standpoint, the answer is yes. This was not a surprise to us. We had already published our pilot data out to three years, and it showed this durability lasting until one year. And in fact, an uptick happening in year two and year three. What's most important about this therapy is that it's not a destination to do six weeks of therapy or eight weeks of therapy, or even one year of therapy. This is a. Therapy for life, patients are going to leave their sessions do therapy at home by swiping the IPG and come back every single year to get more therapy. So what's a departure from our pivotal study is the fact that these patients are continuing therapy over time. So what I'd like to talk about today is a patient story. So this is Don. Don, unlike many stroke survivors, has a lot of distal function issues. You can see that he has some movement in his upper arm and his elbow, and right now he's trying to pick up Legos. What's most important in regaining independence is actually not all of the benefit that you gain from the proximal part of your arm. It's actually your finger extension your ability to capture small things and grasp them. What you see is purposely Don asked for a bag of candy to be used as something that he could grab. And then, you know, actually you can see by his face, every time I see this, I laugh. He is so incredibly impressed by something that for seven years he didn't have the ability to do, and now he does. And so that does obviously translate into activities of daily living that are really important for him. And today, that's not the destination. The second story I'd like to tell you about is Kathy, and it's another, you know, just amazing woman who, after with a very vibrant life, had a stroke three years ago, and her Why was really being able to write letters to her grandchildren, and so one of the things that she practiced the most was handwriting. And of course, you have to grasp a pen. You have to write things over and over, and this is the progression of what her handwriting looked like week after week after week, and obviously she continues to do lots more. So what does that all mean? So we are a commercial company. We've been commercial for 18 months now. We're capitalized for quite some time, and like many companies that are entering a new space, this is not about taking market share. This is about building a market. This is creating new referral pathways between physicians that some haven't talked before. So when you do that, you start with your clinical trial sites. You need people who believe in you. Over time, you figure out the referral pathways and where we are today is in 2023 we eventually got to about 35 hospitals. We're in about 45 hospitals today. We haven't had any churn. Our largest hospital does 8% of our revenue and and so it's a very durable commercial experience today. Our goal is to get to 40 more hospitals and build this business as if we're going to be around forever. We believe everyone deserves this therapy. Scaling will happen in 2025 we have capital to do that, but we will obviously be spending some time working with people who can help accelerate that if we find the right recipe. That's all I have for you today. Hopefully that gives you a couple minutes back. And thank you very much for your attention. You.