Yeah, we have 28 people on the line right now. Looks like, yeah, I see 30, 32. 32 in the park. So I'm gonna go ahead and get started. Thank you, everybody, for joining us, and, in the run-up to the holiday season here. My name is Dan Goldberger. I'm the CEO of electroCore, and I'm joined by my distinguished colleague, Dr. Peter Staats. We're here to talk about the core technology around electroCore that's being commercialized by electroCore, and a little bit about how we see the future evolution of the company. We're so very, very fortunate to have Dr. Peter Staats. He's had a very distinguished academic career, trained in anesthesiology. Co-founder of this company almost 20 years ago, continues as our Chief Medical Officer, is in parallel to all of the important activities he has on the academic side as well. This is being recorded. We've got the participants muted, but you should have access to the chat box, and so if you have, if you do have questions, please put them in the chat box and we will do our best to answer in real time or near real time, and if not, then we will get back to you. This presentation is being recorded, and the materials will be available on our website, probably after the holiday. Because we're a public company, we have the usual disclaimers about forward-looking statements. With that, I'm gonna turn it over to Peter. We're gonna talk about the vagus nerve, the history and science of vagus nerve stimulation and clinical progress, and then Peter's gonna turn it over to me to talk about the product pipeline and commercialization. So the vagus nerve, Dr. Staats. Well, thanks very much, Dan. It's a pleasure to be here, and it's a pleasure to still be working on this after so many years at this, this important area. I sometimes think of the vagus nerve as the next frontier in medicine because of the profound impact it has on bodily functions, and the fact that it's been completely or partially undiscovered until the last 15 or 20 years, where we've been working on it, I think, in part. Just to level set everybody in the audience, I know people come at this with a slightly different background, and I wanted to just take a moment and say what the vagus nerve is and where it fits into your body. Your body has two sets of nervous systems, effectively, what's called your autonomic nervous system and what's called the somatic nervous system. Now, everybody's familiar with what the somatic nervous system does. That allows you to touch and feel your world, allows you to walk, it allows the motor nerves to fire, and that aspect, I think, is what we typically think about. The other aspect is the autonomic nervous system, and that's broken up into two separate parts. The first part is, in fact, the sympathetic nerves or the fight or flight nerves, and the second part that is incredibly important is the parasympathetic system, and the main branch of the parasympathetic nervous system is the vagus nerve. Now, when I was an anesthesia resident, oh, so many years ago, what I really knew about the vagus nerve was, "Don't touch it when I'm placing a central line." But it turns out the vagus nerve is incredibly important. It provides all of the information from your visceral structures. You see here the liver, the kidney, the small intestines, the lungs, the heart. You see these various structures. They give the information up to the brain about what's the state of the body. It tells you that you're hungry. It may tell you that you've got inflammation going on in your body. And in return, the brain gives information back to these structures. It's the command and control, so to speak, about how to function. Now, on the left side here, you see various different functions, and I'm going to highlight a couple for you here today. First, the brain function. I mean, the brain function is incredibly important. It is the counterbalance to the sympathetic nervous system or that fight or flight. It's what I call the rest and relaxation and recovery sets of nerves that your body is craving all the time. I became interested in this very early on, because of the importance in bronchodilation. My son had peanut allergies, and we were looking for a way to bronchodilate it when the lungs start to collapse. Other areas that you'll be hearing about in the future is gluconeogenesis with these GLP-1 inhibitors that you've been hearing about. You're gonna be hearing more about that down the road. Gastrointestinal import is clear. And then I would also draw your attention to the last bullet point, which has been underappreciated until 20 years ago, is that your body can control inflammation via the nervous system. It's kind of a strange concept to many, but it is the command and control of inflammation in the body. It controls the systemic inflammation. So this vagus nerve does an awful lot, and a lot of good throughout the body. Next slide, please. Now, people have been studying the vagus nerve for quite some time. Really since the 1880s, people started to have very crude approaches to stimulating the vagus nerve in people with epilepsy. This was developed further in the 1940s in an animal model of giving toxins to the dog in particular. They were able to block seizures from happening with vagus nerve stimulation. I fast-forward to the 1980s, where they started doing human studies with implanted devices, and in 1997, the first approval or clearance for FDA implanted device for epilepsy was obtained by Cyberonics, which is now LivaNova. 2002, it was noted that in some of these patients with severe epilepsy, their headaches went away. So that was, you know, it's about a 20-year history that we've known that this can control migraines. 2004, Tom Erica, JP Erica, Charles Theofilos, myself, and a few others started to work on this in a more, I don't know, targeted way. 2005 brought us the implanted clearance for depression, which we're gonna see is gonna be relevant in what we're gonna be talking about today. 2017 brought electroCore its first FDA clearance for acute treatment of episodic cluster, and subsequently, we've have 6 different clearances in primary headache disorders, including migraine, cluster, paroxysmal hemicrania, hemicrania continua, adolescent migraine, all today. Yeah. Now, this is kind of an interesting topic here, so I'm gonna spend a few minutes talking about the mechanism of action. And I know that we're not all scientists out here, but this mechanism of action is something that leads us and drives us, directs us towards our new therapeutic targets. I've outlined for you a couple of the things that the vagus nerve that vagus nerve controls and vagus nerve stimulation does. Number one on my list is neuroprotection and modulation of inflammation. It does it in the periphery, as I said earlier, with the control of the spleen, but it also does it in the brain with the microglial cells in the brain. It can control inflammation. It can mitigate pain responses, and we've shown that in both animal and human models. It affects cortical spreading depression. That's waves of hyperactivity or electrical hypersensitivity of the brain. It can dampen it back down to a normal state. It affects neurotransmitter balance, so we tend to think about drugs in many of the different diseases we treat. That occurs typically through neurotransmitter modulation, and the vagus nerve controls neurotransmitters, notably serotonin, which you've heard about before. Noradrenaline, norepinephrine, and glutamate are some of the ones that we hear about all of the time. And as we start to talk about disease states today that we're gonna cover, it controls the autonomic nervous system, blood flow, and that's gonna turn out to be relevant to disorders such as PTSD, opioid use disorder. Now, another way of looking at this problem is that the parasympathetic is simply the counterbalance to the sympathetic nervous system. A quick search will note that many of our psychological colleagues are starting to really tune in to the impact of the vagus nerve on controlling both health, wellness, and disease. My good friend Steve Porges came up with the polyvagal theory, and this basically suggests that the body can't heal itself if it's in a state of constant threat, and we need to optimize our parasympathetic tone by activating what's called the dorsal vagus. And so this is an area where I do see many different areas of medicine and study are somewhat coming together and alighting on the vagus nerve. Next slide. Okay, so here is a diagram of the mechanism of action as it relates to post-traumatic stress disorder. I gonna start over here on my right side and say, yes, we know about inflammation. We've talked about inflammation and how important that is to me in studying different disorders. Doug Bremner has done some really seminal work in studying post-traumatic stress disorder in humans and showing that in a stressful environment, you can mitigate the inflammatory response that occurs, yes, with post-traumatic stress disorder. So IL-6 is dampened, and normally there's a spike in patients with PTSD who are exposed to stressful environments, like a traumatic script, and we're able to mitigate that bump that we see in inflammation. We also know about changes in other neurotransmitters, such as serotonin, acetylcholine, and norepinephrine. All of these ironically help with relaxation. We think about norepinephrine as an excitatory, but in the brain, it functions to relax the individual. It modulates circuits and fear. So specifically, there are fear circuits that occur in the amygdala, insula, and other areas of the brain that has been shown with PET imaging studies to modulate those responses. And of course, will alter neuroplasticity, which was originally shown in our, some of our original headache work. So, the mechanism of action leads to improvement in outcome, and in, you know, his first study, Doug Bremner showed improvement in what's called the PTSD Checklist scores. So how anxious, how debilitated people are, are significantly improved in as a result, I believe, of these various mechanisms of action. Next slide. So we also have, you know, this somewhat built on our original work in headaches, where we were looking at trigeminal allodynia, an animal model, and we showed that we could modulate glutamate. The most prominent excitatory neurotransmitter in the brain gets upregulated in diseases such as migraines, and we were able to show a really kind of a reversal back to normal that correlates with improvement in trigeminal allodynia. We also were shown in humans that we could modulate the pain response in the trigeminal distribution, and these effects last for an extended period of time. I have here up to 3 hours after stimulation. It's actually longer than that. In some of the animal models, it's 6 or 8 hours, and it's partly just we don't know because we haven't studied them out far enough. But people can report a reversal of the sensitization and blocking of headaches, in fact. And we've also found that you can stimulate the vagus nerve on one side and get bilateral relief, and that's partly the way that the nervous system works, with the branches going up to the nucleus tractus solitarius. Branching out from there, it crosses bilaterally. So we don't need to stimulate on both sides to get a bilateral effect, and this can be done with as little as two two-minute stimulations with the gammaCore device for cluster and migraine as well. Next slide. Now, cortical spreading depression is kind of a new concept to some people, and I think it's important to stop and think about what that is. These are waves of abnormal electrical activity that course across the brain, and we think about our patients with epilepsy, right? Our epileptic patients, you may note that they start to have waves of activity. It's starting in their right hand, then it goes up their arm, and it courses across the brain, and your body basically sees this in these abnormal electrical signals. We also see that with migraines. Migraines, you may feel, a sensation in your arm, or a visual hallucination, or have an aura of a certain type of smell that occurs, and over time, you get these electrical activity changes that course across the brain. Now, what Dr. Ayata did up at Harvard was he stimulated an animal who he elicited a cortical spreading depression. He did it in different ways, but was able to block that cortical spreading depression, this abnormal electrical activity, and this appears to be related to both inflammation as well as some of these neurotransmitters that we've been talking about, norepinephrine and serotonin, and it's likely due to a central effect at the nucleus tractus solitarius. Next slide. Now, one of the areas that I, you know, I think have been really important is the realization that vagus nerve stimulation blocks neuroinflammation. This is somewhat built on some of the work that Kevin Tracey did more than 20 years ago, and he identified what's called the cholinergic anti-inflammatory pathway. Now, he identified this in the periphery, really at the spleen, where that the vagus nerve, if you stimulate the vagus nerve, it activates the celiac ganglion, which releases norepinephrine on T cells. T cells... Excuse me. T cells then release acetylcholine, which can modulate the production of pro-inflammatory cytokines. I know that's a mouthful. If I want to just break it down for you, vagus nerve stimulation blocks, via a couple of pathways, the production of these pro-inflammatory cytokines: TNF alpha, IL-6, IL-1 beta, HMGB. These are pro-inflammatory associated with inflammation, and we can block that with vagus nerve stimulation. And there's a number of studies going on with implanted devices now for rheumatoid arthritis and other types of problems as well, with this recognition that this does some of the same things that TNF blockers can do, we can do with vagus nerve stimulation. We upregulate norepinephrine and acetylcholine, which is really important in things like memory, laying down new memory, and serotonin, which is important in sleep, as you know. Because of these mechanisms of action, we're looking at a variety of different areas of interest: ischemic and hemorrhagic brain injury, traumatic brain injury. We're looking at long COVID, and the impact. Some of the theories around long COVID is that there's persistent inflammation, which of course, we've talked about why that would be helpful, but it's also thought that one of the other main theories is that there's damage to the vagus nerve. So there's lots of reasons to think that this might be part of the solution for us. Next slide. Okay, so in summary here, what I hope to, you know, in a very short period of time, explain a few mechanisms of action, and these mechanisms of action drive the area of interest of, clinical areas to study. Modulation of autonomic nervous system, and that's gonna lead us down the road of looking at things like anxiety and stress, post-traumatic stress disorder, opioid use disorder, the autonomics and other areas that abnormal electrical activity or input could come in, and we're not gonna talk too much about some of those other areas. But what we did find is that we do in a headache model, it takes several weeks for topiramate or Topamax to modulate the cortical spreading depressions. We do the same thing that we can do get to eventually with drugs in 30 minutes, where it takes several weeks to do that with topiramate. Modulation of inflammation, we talked about the pro-inflammatory cytokines. We actually showed in an acute study with acute COVID modulation of C-reactive protein and some other changes in IL-6 in particular. Then finally, modulation of pain has been noted with vagus nerve stimulation as well. Next slide. So, we are a small company, but we are punching above our weight, I would say, so to speak. I'll defer to Dan on that. But we're looking at a lot of different things right now, and fortunately, we're not paying for most of them. We're looking at post-traumatic stress disorder, as mentioned. Studies are going on at both the Emory VA, as well as the San Diego VA, and looking at different physiological states, looking at memory, looking at stress response, quality of life metrics in our veterans with PTSD. Another area of interest is opioid use disorder. Opioid use disorder is, you know, one of the big problems we're facing in America. I had the fortune of serving on the Health and Human Services Task Force, looking at best practices around opioids. Opioid withdrawal is a major problem when we stop patients from opioids or patients with true opioid use disorder. Mechanistically, I've explained to you some of the autonomic dysfunction that can occur, and it makes sense that this will work as well, and there's some preliminary work that's been published on that as well. Alcohol use disorders, work going on at the San Diego VA, and then, in animal models, looking at how TBI can relate to post-traumatic stress disorder, and addiction, and how VNS may potentially modulate this. So there's a lot of work going on across the neuropsychiatric domain. Next slide. Again, here, I guess I'm summarizing here. There are currently nine studies that mostly came out of Emory, looking at PTSD, the PTSD checklist scores, modulation of the autonomic and neurobiologic response. It's not just that these patients are anxious, there are actually brain changes that can appear to be reversed or mitigated with V- vagus nerve stimulation in patients with PTSD. In a recent publication, declarative and working memory was improved, modulations of heart rate variability have been noted. And this all occurs because it modulates brain activity through the nucleus tractus solitarius to critical structures in the brain, including the cingulate, hypothalamus, insula, and amygdala, all get up or modulated during a fear response that can be mitigated with VNS. So all of these are in critical, critical, ways of actually treating the underlying cause of PTSD and not just treating a symptom. Next slide. Now, some of the work that I just mentioned was presented to the FDA. The FDA did grant a breakthrough designation back in January 2022, and there's ongoing discussions with the FDA around the pathway forward for a full clearance on this device. Next slide. Substance abuse disorder, I mentioned, is incredibly important. It's a we can believe that we can modify withdrawal, shorten the detoxification period, and potentially lead to an easier path forward to a Revia trial or another drug such as that. We believe, and there's, you know, data in both animal and human models, that we can decrease the behavioral and physiological response of withdrawal to opioids with VNS as well. Next slide. How about, so I mentioned at the outset, we're not paying for much of this, not at the NIH, through its branch called NIDA, the National Institute on Drug Abuse, has given Emory a large grant of $6 million to study this more thoroughly in humans, and those studies are ongoing right now. Now, some of you might be thinking, "Okay, Dr. Stutz talked a little bit about modulation of inflammation in the brain. What are the other areas that are associated with inflammation?" Well, one is Parkinson's disease, and the first of a few studies rolled out a couple of years ago now in Nature Parkinson's, and they looked at freezing gait. Now, freezing gait is a critically important problem, and the gait problems associated in Parkinson's is what can be lethal. Patients with Parkinson's ambulate, they don't turn quickly, they don't have good balance, they have more of a shuffling gait. They fall, they can break their hip, and that is what can be lethal for them. So and this was Mark Baker's group, but it was performed in India, looked at 33 subjects in a double-blind crossover trial, looking at patients with Parkinson's gait, and what they found was an improvement, and if I go to the next slide, Dan, on the left bar graphs here, you'll see they had an improvement in ambulation velocity, step length, and stance time. All of those are really important in Parkinsonian gait. Now, what was also noted, and you get one of the themes of my presentation here, is that there was a decrease in the pro-inflammatory cytokine TNF alpha, and those seem to correlate with improvement in function. There was an upregulation of glutathione, and you can think of glutathione as somewhat of a scavenger for some of these pro-inflammatory states, and improvement in BDNF, which is like, like a nerve growth factor, and so that can potentially take us down the road of are there things that we can do long-term? Now, this is very, very early, but these are some very intriguing early steps. If I go take you back to the last slide, Dan, I'm sorry to make you do this, but the last slide, my last bullet point is there is another study enrolling at the University of Newcastle, 40 patient subjects looking at gait mobility and some of these same metrics that we've been very interested in, to replicate, see if this can replicate an improvement in Parkinsonian gait, which frankly creates a new option for people beyond a deep brain stimulator, which is probably the state-of-the-art. Next slide. Peter, I'm gonna interrupt you here. There are a couple of questions I'd like you to address. Sure, sure. The first one, and I'm paraphrasing a little bit, is, can VNS harm a perfectly healthy person that doesn't have any of these medical conditions? And can we prevent or reduce inflammation and other maladies in a healthy person? So the answer to both of those questions are no and yes, and I won't tell you which are. No, I'm kidding. Yes. The first answer is, we don't know. There has not been any sign anywhere that stimulation of the vagus nerve can be dangerous, and in fact, some of those early studies that I mentioned with the epileptic patients with an implanted device. Actually, they take an electrode, coil it around the vagus nerve, and they stimulate 30 seconds on, 5 minutes off, throughout a 24-hour period. And they've not shown, over the extensive period of time, that that can be dangerous on any other organ system, et cetera. So the first answer is, we don't really have a sense that stimulation of the parasympathetics is bad, in the vast, vast majority of patients who have been treated with our therapies. So the short answer is, I don't think so. I think this is something that we can optimize and potentially help with. Now, a second part of the question is, can you modulate inflammation in healthy people and potentially lead to some good long-term benefits? Well, I certainly hope so, and Emmanuel Lerman has done a study on taking normal human healthy patients, subjecting the blood to lipopolysaccharide and some other types of inflammatory mediators, and then taking that same patient population and stimulating the vagus nerve before they subject the blood to that, and they were able to show a decrease in some of those same pro-inflammatory cytokines. So the answer to that is, in a healthy person, it appears to dampen any inflammatory response that you're gonna see from any minor injury, or bacterial infection, or viral infection, or leaky gut, or any other of these areas. I believe, personally, that inflammation is central in a lot of different disorders, and if we control inflammation by whatever means possible, by using an anti-inflammatory diet, that's important, sometimes that's not enough, and things like vagus nerve stimulation potentially could be helpful in that population. So thank you, doctor, and there's a second question: If stimulating the vagus nerve can impact multiple tissues, how do you ensure that we're not impacting any off-target tissues? Well, that's, that's actually a really great question, and one of the top questions that I get, and, you know, the NIH is actually funding a large grant to tease apart the vagus nerve in animal models and see if we can isolate specific fibers to go into the pancreas, that goes to the liver, that goes to the colon, et cetera. My view is actually a little bit different. We've known a beneficial effect on glucagon and insulin, and colon, you know, constipation, and mood, and anxiety. All of the benefits that we see with this, let me just reiterate, rest, relaxation, and recovery nerve, all of the different structures that you're stimulating actually tend to benefit from this. We've not seen downside by going to an off-target area, and to me, I'm not even worried about that. If a patient comes in and getting treated with, for, you know, severe migraines, and lo and behold, their headaches get, lo and behold, their anxiety or anxiousness or mood improves or their sleep improves, hey, you know, that's not so bad. That's a positive benefit. It's unlike some of the other drugs, where we really do have to be worried about developing the tuberculosis if we do something. We've not seen that here at all. Thank you, Doctor. I'm gonna skip over, there's a question about intellectual property that I'll deal with later on in the talk, but- Yep ... skipping ahead, there's a question here: any help with celiac and/or Alzheimer's? No, those are, great questions. Dan, you'll have to increase my budget to answer those questions on Alzheimer's- Moving right along. 'Cause I do think there are, there are possibilities, particularly with that, and, and celiac maybe. You know, that, that one is associated with inflammation. There's a fair amount of data out there on inflammatory bowel disease. Bruno Bonaz actually did some of the original work on that with an implanted device, and, and I think he studied seven patients who... and he implanted a vagus nerve stimulator on, and I think all seven of them went into remission of their IBD. So, the cholinergic anti-inflammatory pathway that I discussed in the spleen and I mentioned in the brain also exists in the gut, and it can mitigate or modulate that inflammatory response in the gut. And since there is some inflammation going on with celiac, the answer is maybe. It doesn't get to the underlying cause, but the answer is maybe. All right, I'll let you return to the NFL Players Association grant. Sure. So, post-concussion problems, it's actually got the news again lately of the CTE that's occurring in professional athletes, high school athletes, and post-concussion problems remain a significant problem. We've had a number of conversations over the years with the NFL about this, but most recently, the American Society of Pain and Neuroscience, which I'm a member, submitted a grant to the NFL that was interested in things like cannabinoids and other novel strategies for NFL players and elite athletes. And they submitted a grant that's going to take a look at both syn- cannabinoids, standard of care, and vagus nerve stimulation in C- in patients with post-concussion. That study hasn't gotten started yet, but it's a funded study, and it will probably get started in January, February of 2024. Starting to take a look at elite athletes, men and women, who are suffering with post-concussion headaches. So they're starting to understand the impact of that chronic trauma causing inflammatory processes. Another area that's really exciting to me, and is probably a talk in and of itself, is the what happens after a stroke. There have been hundreds of drugs that have been tried for this, and for the most part, failed. In the animal models, a group up at Harvard started to look at this about more than 10 or 15 years ago, and they showed that in an animal model, you could create an occlusion of the blood supply to an area of the brain, and that causes an injury, as you would suspect. What's less clear to the non-physicians on the group here is that injury grows over the next 24 hours. That area is called the penumbra, the area at risk around the original area of injury. What was found in the first study, it was about 40 patients, showed that if you stimulated the vagus nerve in... In animals, if you stimulate the vagus nerve in an animal model, you can decrease the growth of that penumbra dramatically, and that's associated with modification and modulation of that inflammatory cytokine. In humans, in the first study that was done, published about a year or so ago, they were able to show that vagus nerve stimulation, again, modified the growth of that penumbra really dramatically. So it's a really interesting finding, and there is a subsequent study, being done in Leiden, in the Netherlands, and they're nearing enrollment with about 150 patients. So that's gonna be an exciting avenue for somebody, you know, for patients who are having an acute stroke, to see if there's something that we can do to keep the stroke from being as damaging, as we all know stroke can be. It's really a tremendous problem, and this is potentially a new treatment strategy. Again, you understand that this is... I'm not advocating you do this today, but this is part of this process that we're using to figure out what's the best treatment strategy out there for patients with an evolving stroke. Next slide. Okay, switching gears, you know, as Dan will talk about a little bit more in more detail, we're interested in wellness as well. There has been information about depression, anxiety in implanted devices for some time, and we're switching gears to take a look at how does this work in wellness. The first study with non-invasive cervical VNS showed, and I'm just gonna, you know, highlight over on the right side, that patients had improvement in focus, energy, general mood, sleep, stress, a sense of well-being, such as anxiety, and they went from a 1-10. They showed how much improved they were, and it really comes up pretty close to 7-8. Significant improvement in an open-label study. This is on the left side, you see what they were looking to get, but on the right side, they actually had really significant improvements in all of these different domains you see here. Next slide. Another area that's extraordinarily exciting to me, and if you, some of you look around, you'll see that I have some wounded warrior paraphernalia here. I'm a fan of trying to help our returning soldiers, but also, we're very devoted to our veterans and current soldiers. And unbeknownst to some of us, the U.S. government is also very interested in vagus nerve stimulation for slightly different reasons. They've been looking at TacStim enhancing responses in basically the drone operators. They've looked improvement in cognitive skills, in sleep after sleep deprivation, and they've also showed improvement in mood with some of these sleep deprivation tools, and they did very exquisite studies. They're looking at improvement in language recall, and these are all really, really important things. I wish I had this when I was a medical student to improve my new language of understanding microbiology, as well as improving my mood, as well as helping me make good decisions after sleep deprivation. You can see the applicability of this really very robustly beyond just the military. I don't have all of the details to tell you all this. They've been working on this for some time. They're sometimes a little, as you would suspect, secretive, and keep some of their cards close to their chest. But every time they roll out a new study on the importance of VNS in helping our athletes... I mean, not our athletes, our warriors, VNS it's turning out to be a very powerful tool in making our super soldiers even more super. This is really an exciting area for us as well. So, thank you, Peter, and just to be clear on this slide, we are aware confidentially of quite a bit of human performance work that Air Force Special Forces and Army Special Forces are doing. Very little of it is in the public domain, and so we're not able to talk about it publicly as much as we perhaps would like to. But it's very exciting work under the banner of human performance for otherwise healthy individuals, which is very different from your experience and mine going back many years in disease states. Yeah. There were two other questions here that I am going to not answer because they get into proprietary trade secrets information. But one of the questions is, "Do you program gammaCore to stimulate with different frequencies or for different time periods for headache versus PTSD?" That's in the trade secret and ultimately patent domain. So no, I'm not gonna answer that. And then another question here: "Do you see changes in the dynamics of stimulation, amplitude, or frequency changing the efficacy?" Again, that wanders into proprietary information that we appreciate the question, but I'm gonna respectfully duck the question. So Peter, thank you very, very much, and stay on the line because I expect there will be more questions. I'm going to... Sorry, maybe... So, there's a follow-up question: "Is the human performance data from the Air Force and Army something that we can access, or do we need to perform those experiments independently?" There's absolutely, positively no way we will repeat those experiments. They're scary, and what the Army and Navy Special Forces are willing to do in training, I'm not willing to do personally, so I'm not gonna ask my colleagues to do that. Is it something that we can access? Probably not commercially, but within the armed services community, and that seems to be expanding to NATO as well, there is awareness of the benefits to human performance, primarily cognitive performance. And so they talk about it amongst themselves, but we are obligated by our confidentiality, and we want to respect that as Yeah, and just to add, they are slowly- For so many reasons. Just to add, they are slowly publishing some of these papers, and we have some of those papers that they have published and what's in the public domain that we can share. So I'm gonna move on to some of the more mundane commercialization tactics, and Peter will stay with us in case there are additional science questions. By way of review, this is our flagship product that we call gammaCore Sapphire. We currently have six FDA clearances for a variety of headache conditions. What I think the audience is more interested in is, how do we commercialize the really fascinating science that Peter has just been talking about? So we talked a lot about PTSD, post-traumatic stress disorder. We are working with the FDA as we speak on a 510(k) de novo submission to expand our label to treat the symptoms of PTSD with non-invasive vagus nerve stimulation. Everything that I've ever done with the FDA, the timing is uncertain, but we've had a couple of rounds of questions, and the questions are—I put them in the category of looking for reasons to say yes. So I think, this is not a question of if, but it's a question of when we'll be able to say more publicly, what the timeline is to getting an explicit, label extension to treating the symptoms of PTSD... post-traumatic stress disorder. Peter talked about, the NIDA NIH grant around, financing a pivotal trial on the use of vagus nerve stimulation to treat the symptoms of withdrawal from opioid addiction. We think that data will read out in 2025, and then based on that data, I presume, and we've kind of previewed this with the FDA somewhat, that it'll be a regular 510(k) pathway with the FDA. And so that's something to look for in 2025. The Parkinson's trial that Peter talked about, that is on track to complete enrollment in 2024. Again, based on those results, we will enter into discussions with the FDA about a regulatory pathway. And that 40-person, 40-subject trial may be enough data, I can't tell for sure right now. Similarly, with the stroke trial that is enrolling in Leiden, we'll see some of that data in early 2025 as they complete their follow-ups, and we'll have a similar conversation with the FDA. Wish I could be more specific about those timelines, but as you know, the regulatory authorities are not always forthcoming, nor do they stick to a strict calendar. So just to summarize, you should be looking for an announcement about PTSD in the first half of next year, and then announcements about opioid use disorder as we roll into 2025. In parallel, we have dramatically expanded our product offerings. A vast majority of our business is prescription headache right now with our flagship product, the gammaCore Sapphire. And gammaCore will continue to be the brand that we talk about for all of our prescription medical indications. Many of you, if not all of you, are aware that we launched a direct-to-consumer general wellness product under the Truvaga brand. This is the product that we are currently selling, and in human performance, a lot of the work to date has been done with a modified version of the gammaCore Sapphire. Going forward, we've hinted in some of our public conversations about this product configuration that we're now calling Truvaga Plus. This is a streamlined, direct-to-consumer general wellness device that communicates to a mobile phone app. And so not only are we going to have a more competitive, more contemporary-looking, general wellness device, we're now explicitly entering the digital health, digital wellness, community, and we think the sky is the limit for that combination of a vagus nerve stimulator and a digital health application. On the prescription side, you will see an evolution of gammaCore Sapphire into a more streamlined, more flexible format, and we're also working on wearable implementations of our prescription therapy. Not so. Not that the wearable formulation is not so important for personal use devices like headache, but as you get into Parkinson's, as you get into stroke, where the patient is less able to self-administer the therapy, that wearable opportunity becomes more and more important. On the human performance side, Air Force Research Laboratories helped us design a mil spec version of the gammaCore Sapphire. This is in prototype form now. We are working towards commercialization, and we expect that this heavy duty, mil spec version of the gammaCore Sapphire that we call TacStim, will supersede what we're currently selling to the Air Force and Army today. So there were several questions around intellectual property. We have really two pillars in our intellectual property platform. The first is around non-invasive stimulation of the vagus nerve at the neck. And the reason I emphasize non-invasive is that there is a pretty large right to practice that stems from the fact that implanted vagus nerve stimulators became available in the late 1980s and were commercialized in the 1990s. So, we have a broad field around intellectual property in vagus nerve stimulation that's available to us because it's an old technology, but the new piece, and the protectable piece of this technology, is the non-invasive transdermal treatment method. The second pillar of our intellectual property is around digital health. We were early filing intellectual property about connecting a medical device to a mobile accessory, to a mobile phone. We are tracking a surprisingly large group of potential infringers of that intellectual property portfolio. For the time being, we've chosen not to be aggressive, but as the company gets stronger in the future, you may see us taking some steps to assert our digital health portfolio. We continue to file for additional patents, both as standalone patents and continuations to the matters that we have pending as we explore additional disease states, and as Peter and his colleagues uncover more detail around the methods of action. So how do we monetize some of this? The headache market, you've heard me talk about this quite a bit. Sorry, I'm gonna jump back to some of the questions. There's a question here about: "Is the design of the Parkinson's and stroke trials publicly available?" Yes, those trials are posted to ClinicalTrials.gov. And if you contact me after the talk, I can point you in the right direction, or you can search for them directly. Then there's a question here about price point in our different channels, and again, I'm gonna hide behind the trade secrets notion that yes, we have different pricing strategies in our different channels. But our direct-to-consumer channel, you can go to our website, truvaga.com, and see what our current pricing is. We may or may not be doing a Black Friday offering on truvaga.com. The headache market, the patient advocacy groups will tell you that there are tens of millions of Americans that suffer from headaches and specifically migraine. In practice, about 2.5 million Americans have a prescription therapy, and so I really see that as our total addressable market in headache. Triptans are the first line of therapy in prescription headache, followed by the injectables, and for the time being, especially in migraine, neurostimulation remains a distant third in sort of the continuum of care. That said, in cluster headache, which is about 400,000 patients in the US, non-invasive vagus nerve stimulation, specifically gammaCore Sapphire, has been identified as a first-line therapy in cluster, because there are very few pharmaceutical options, and the ones that are available are expensive and difficult to administer. One of our big channels, you know, for those of you who've been following the company for a long time, one of our big challenges has been the competition with Big Pharma in headache. But in the VA hospital system, which is our single largest customer, there are about 600,000 headache patients. We've treated not quite 4,000, so we're less than 1% penetrated within the VA hospital system, our primary revenue generator. So we have plenty of room to run within headache, and I'm very much looking forward to expanding our horizons beyond headache in the future. Post-traumatic stress disorder, as I mentioned, is next up for extended indications on our prescription brand, gammaCore. Roughly 8 million Americans, we often think about PTSD associated with military service, but unfortunately, there's an even larger cohort of PTSD sufferers related to domestic violence. So it's a shame that that's part of our society today. 46 million Americans, I don't know, but that's in the literature. 8 million Americans currently diagnosed. Opioid use disorder, three million diagnosed right now. Unfortunately, as everybody is aware, that's a growing category. The launch market, if and when we do get a label in opioid use disorder, will be as using vagus nerve stimulation as a bridge to Revia therapy, initially, at least in residential treatment programs. So again, because we already have a channel in the VA hospital system, launching PTSD in the VA hospital system makes all kinds of sense. Launching opioid use disorder in the VA hospital system makes all kinds of sense. Parkinson's disease, fortunately, it's a much lower prevalence, but we think we have a very interesting targeted therapy there. So, I'm optimistic that if the data continues to come in in a positive way, that we've got a commercialization path for Parkinson's, especially in rehab medicine, in the continuum of care, as well as some of the other indications that Peter was talking about. Let me pause here to take a look at some of the additional questions. "Are you going to partner with any large, established medical device distributors to accelerate the ramp of sales?" There is nothing imminent in the way of partnering. We do believe strategically that some of these markets that are available to us, concussion, stroke, might be better served by a distribution partner. Outside the United States, we have a distribution agreement with Teijin Pharmaceuticals for Japan. We have distributors in Australia, and in parts of Western Europe for our current products that we would extend to our future products as well. All right. Moving on to our direct-to-consumer initiative. For those of you who've been following the company, we've been surprised to the upside with the efficiency and the metrics of our direct-to-consumer launch. All very small numbers right now, but the digital health and wellness market is huge and getting bigger every day. We have a very unique offering, and we have quite a bit of intellectual property in this space. With the budgeting process that we're going through with our board right now, the launch of Truvaga Plus sometime next year, I think you're going to see this become a larger revenue and more an accelerating revenue contributor to our long-term business. So the summary that I'd like you all to take away, we're gonna continue to grow our prescription non-invasive vagus nerve stimulation. The VA hospital system in the US is our largest customer. The NHS, National Health Services in the United Kingdom, is our second largest customer. We've talked about the distribution agreement we launched with Journeys Healthcare. That gives us access to another 12.5 million covered lives beyond the 9 million VA hospital covered lives. So slowly but surely, we are increasing the number of covered lives that have access to our therapy, and we're gonna continue to work towards broader indications and broader insurance coverage for our prescription business model. The Truvaga direct-to-consumer business, please go to truvaga.com and take a look at what we're doing there. That business in the short term is going to scale with our advertising and promotional spend. Look for us to launch Truvaga Plus, our first app-enabled vagus nerve stimulator, in the first half of 2024. We're very excited about continuing to work with our champions at Air Force Research Laboratories, Air Force Special Operations Command, United States Army Special Operations Command, where we've been upside surprised by some of the pilot deployment orders and the feedback that we're getting about human performance. Longer term, and, and I think some of the questions were heading this way, we think there's a large opportunity, for civilian crossover in, in our human performance product line to first responders, to elite athletes, to, transportation, healthcare shift workers, on and on. And then, you know, those of you who are following the company, you know, know that, we improved, added to our, our balance sheet, over the summer, and, we really believe, that we've got adequate financial resources, to execute on this plan, through 2024 into 2025, and, and growing the business and the cash flow that comes from that business. There's a question here, that just came in about, timing of the opportunity with Journeys Healthcare to becoming more meaningful We did report a small amount of revenue in the third quarter. The current quarter will again be a small amount of revenue. It's gonna be very similar to the first year of our work with the VA hospital system in 2020. Which was our first full year of sales in the VA. We did roughly $1.5 million of revenue, and so I'd like to see us meet or exceed that in 2024, which would be our first full year of working with the Journeys Healthcare system. That concludes our prepared remarks, and shocking Peter, we're more or less on time. I hope this was useful and great to get some meaty questions from the audience. Peter and I, and the rest of the management team, we all try to be available to the investment community and our existing shareholders and prospective shareholders. So, please don't hesitate to reach out to either one of us or through the investor relations email that's available on our website. We'll do our best to be responsive. I wish you all a very happy and healthy holiday season that's coming at us very, very quickly. And I wanna thank all of our customers and physician supporters, and our supporters in the Armed Forces. Thank you all, and have a great day. Happy Thanksgiving!