Go ahead. All right. Good to go. All right, great. We'll get started. My name is Brent Lucas. I'm the CEO of Envoy Medical. We are listed on the NASDAQ under COCH. Forward-looking statements, a quick snapshot of where we are as a company, get into our investor highlights. Throughout this presentation, we'll touch on all these, so I'm not going to spend too much time here. Envoy Medical, if you're not familiar with us, is a hearing health company. We are essentially positioning ourselves to disrupt the cochlear implant market, but we make fully implanted hearing devices. We have two devices. One is a fully implanted active middle ear implant, and the other is a fully implanted cochlear implant that is an investigational device. The world is really excited about that second device, about the ACLAIM CI. We are positioning ourselves with that fully implanted cochlear implant to go after the existing players in the market. We have a large TAM, which I'll get into in a second, also significant differentiation. It's pretty obvious, I think, when you learn about this, if you're not familiar with cochlear implants, to see the difference between our device today and the existing devices on the market. It's also important for you to realize our differentiation going forward, and we'll talk about that as well. We do have a validated technology in our device in that we have a sensor, a piezoelectric sensor, that was part of our first product. Our first product, the Esteem, had this sensor, and everybody had told us over the years, "Take that sensor and put it with a cochlear implant." We ignored them for the first 20 years of the company, but when I took over as CEO, we did that. We took that sensor, and we've put it with a cochlear implant, and now I think we're in an incredibly good position. It's a mature and it's a concentrated market. The CI space, if you're not familiar, has three main players. They've been the same players for about three decades. They have pretty much the same products. This is an industry ripe for disruption, and I think we have the product to do it. Then, as you'll see later, we have multiple milestones, a lot of good things going on to be excited about. This is a large market. Hearing loss in general is a massive market and really, quite frankly, an untapped market in the U.S. Here, the CI market is a very specific market and is a very exciting market in my mind. We are geared towards adults. Let's focus on just the adult market in the U.S. You have 2.8 million adults in the U.S. that could get a cochlear implant. The good news for us is only about 5% of people who could get a cochlear implant have gotten one. That's despite the fact that these products have been around for about three decades already. Now, if you ask people why is that, if you ask patients, if you ask surgeons and audiologists, why is that these devices, which provide hearing to people that don't have it, why are they not getting one? It's because these traditional devices have these big, large external components on the side of their head, and people don't want to deal with that. The manufacturers, of course, that have the products won't admit that. They don't talk about that in publications, but that's reality if you get on the floor and actually talk to people. We project our price somewhere around $30,000 when we get commercial, so that's how we get the TAM of $84 billion. That's just the U.S. I think this is a relatively conservative number, quite frankly, because of a couple of factors. One, we might end up charging more for the device than $30,000. The other reality is that everybody has two ears, not one. So that 2.8 million is a smaller number. About 30% of people get both of their ears done, so that TAM could be larger. As people live longer, as they age, as more drugs are introduced into the world, such as COVID, right? That's not a drug, but the COVID pandemic. You have ototoxicity from certain cancer treatments. There's going to be a rise in hearing loss. It's not going to be something that goes down. This is going to be something that goes up. This slide here highlights just sort of the overall size of the hearing market. I'm not going to spend too much time on it because everybody knows somebody with hearing loss. You know this is a big market. You know it's probably an untouched market. If you look at the large strategics in the U.S. and throughout the world, there's not a traditional medical device company that has yet gotten into this space. This is white space for the large strategics. What I do want to pull your attention to is the last bullet talking about dementia and cognitive decline. There is a growing body of evidence that there is a strong connection between untreated hearing loss and dementia and cognitive decline. This is growing. This is getting a lot of attention in a lot of different circles. As you can see, the healthcare economics of an intervention like a cochlear implant will only get stronger, and I think that's an important thing when we start thinking about reimbursement, and we start thinking about how this can grow as we get further along. A little bit of a kindergarten slide here, so I apologize for that. If you're not familiar with hearing loss, the important thing I think for us to make clear on this slide is we don't compete with hearing aids. We are not a hearing aid manufacturer. I'm not interested in hearing aids. I don't ever want to be a hearing aid company. I'm glad we're not one because as Apple, Google, Meta, and all these other people start coming into the hearing loss space, the hearing aid is going to be a very crowded market. We are interested in the hearing implant space, and on this slide, that's that red dashed line and below. I think from an investor standpoint, from my perspective as an operator, I love that we are a therapy of last resort for these people. These are people who have tried hearing aids, and hearing aids no longer work for them. We are below that line, and they need something different. Right now, the only thing that they can get that's different is electrical stimulation. In the future, maybe there'll be a magic drug to reverse hearing loss. That's not even on the horizon right now. All the drugs and the therapeutics that are being discussed are talking about very specific genetic mutations in children, and I'm talking about noise-induced hearing loss over the course of somebody's life. We are below that dotted line. It's a market that is specific to cochlear implants, and I think one of the things that I would suggest is once you get past that dotted line, it's either us, a fully implanted, or it is a partially implanted, where you have everything on the side of your head. Let's talk a little bit about what traditional cochlear implants of today look like. If you're not familiar, this is what they look like. There is a large sound processor on the side of your head tethered to a magnet that is then connected to a magnet on the inside of your head. You have an implanted portion, and you have an external portion. These are very large. They're very visible. Oh, by the way, if it gets knocked off and breaks, that's going to cost you about $8,000-$10,000 to replace it. If it gets knocked off, you can't hear. You need the external portion to hear with the internal portion. Any time that magnet comes off, is dislodged, whether it's because you're sleeping or you're around water and you can't wear it, you're now deaf. You can't hear. We've decided to take the good parts of cochlear implants, which is electrical stimulation does work. You electrically stimulate the cochlea, you are going to have a perception of sound. We took what works with these traditional devices, and again, here's a couple more pictures before I move on. Importantly on this, I would just point out that pretty much the three manufacturers, they have about the same form, fit, and function. There's not a lot of difference between the existing manufacturers and their device. They're about the same. Maybe the plastic mold's a little bit different. Maybe the colors are different. You have different choices. Essentially, they're exactly the same. They have the same drawbacks, and they work exactly the same. What we did is we took what works, which is electrical stimulation, putting an electrode array in the cochlea, and we made everything fully implanted. We have the fully implanted Acclaim Cochlear Implant. Again, I'm going to foreshadow to our differentiation. There's two other companies in this space that are talking about a fully implanted solution. None of them have our design. Our design is unique in that we use that sensor, which is in that circle there. That's our piezoelectric sensor. We are the only ones that were smart enough to put the battery pack in the chest, which is going to be a huge differentiator for us, in my opinion. This is a first-of-its-kind device, and it will be the first that only has the sensor and the battery pack in the chest. This is a unique device across the board. We are in a pivotal study. I'm going to get to that a little bit later. We're in a pivotal clinical study. This is an investigational device. We are now fully through enrollment, and we are just in the data collection phase. We are in the final stage of our device's journey. Let's see if this works. This is an animation. There's no sound. Don't worry about that. It's a little easier for me to talk about it if this is working. Let me see if I pause it, if that screws up. Okay, you can see you have the battery pack in the chest with our design. If you're familiar with Inspire Medical, the sleep apnea device, very similar. There's a battery pack in the chest. Pacemakers, deep brain stimulators, vagal nerve stimulators. This is a very common thing for implantable medical devices to have the battery pack in the chest. It is connected with a wire that we call the power lead. The power lead is also completely underneath the skin and invisible. Everything you see here is invisible. It's underneath the skin. You cannot see it. You have the processor, which is in the head. This would be located behind the ear in a very similar location to where the magnet is located in the other cochlear implant devices. It's about the width of two quarters if you stack them on top of each other. It's not very big. Again, it's underneath your skin, and you cannot see it. One of the hardest things about having a fully implanted device is trying to visualize it for folks. This is the beauty of our device. I'm going to spend a little bit of time here. When you're hearing me right now, what's happening is that sound waves are vibrating in this room. Your pinna, which is the big floppy thing on the side of your head, is helping collect those sounds and funnel them down your ear canal. Once they're in your ear canal, it actually works to make the sound stronger before it hits your eardrum. When your eardrum vibrates, it then engages these three tiny bones behind your eardrum, which are called the ossicles. That is the key to your hearing organ, and then it gets to the cochlea. Once in the cochlea, there's these. It's about a 20th of the size of your eyeball. Inside of that cochlea, which is a bony structure, there is fluid, and then within that fluid, there's these little tiny hair cells, which are nerve endings. It then takes the signal to the brain. That's how natural hearing works. What happens for most of us, about 85% of us, maybe even 90% of us, is those hair cells inside the cochlea begin to die off or get damaged over time. Whether you took the wrong drug, it's genetic, too many rock concerts, whatever, those hair cells start to die off, and you start to lose your hearing. What we do is we electrically stimulate it by putting an electrode array in there to basically directly stimulate the nerve. What the beauty of our device is we have this sensor, and we're the only ones that have this sensor, and that's in the middle of your screen here. That sensor is picking up the vibrations off of the bone. We're leveraging the natural anatomy. We're picking those vibrations up and using that as the sound input. We're essentially using your ear as nature's microphone. We do not have an artificial microphone in our system. We're the only hearing company on the planet that does not have a microphone in our system. It will pick up those vibrations. That's how the signal gets sent to the processor, and then it'll go down, it'll get processed, and come back down to the electrode array, which sits in the cochlea. Again, that's just delivering electricity to the cochlea. I will tell you that between all the manufacturers, the cochlear electrode arrays are pretty similar. This gets a little scary here. It looks like it's in the brain. It's not. It's just a bad animation. That processor sits on the outside of your skull and beneath your skin. On somebody like me who's bald, you might see a little bump. On somebody with even a little bit of hair, you're really not going to notice it. Again, I think the benefits of a fully implanted device are pretty obvious, right? It's discreet. Nobody has to see it. We've trademarked Invisible Hearing because we are really the only company that can say we have invisible hearing. Nothing is outside the body whatsoever. This is dependable. You can wear this 24/7. I mentioned earlier, you cannot wear a traditional cochlear implant at night because the device will come off. You put it on a pillow, it'll come off. Plus, you need to charge it, or you need to change the battery. In addition, if you're wearing that all the time and the magnet starts to compress the skin, you actually can have wound issues. You can start to have abrasions that will start to fester and become something else. The fact that our device is fully implanted and you can wear it 24/7, I believe will be a game changer. I would ask you to look to the sleep apnea industry, with Inspire Medical Systems, Inc. Everybody thought they had a device nobody would be interested in because you could just wear an external CPAP at night, they've obviously proved everybody wrong. It's very easy device to use. We have a rechargeable battery in the chest, I'm going to get to the why that's a big deal in a second. Because that's in the chest, we can have a nice large battery, which allows for multiple days between recharge. That is going to be also an industry standard going forward. I don't want to spend too much time on the Esteem, which is our first product, because it's not covered by insurance, it was not a commercially viable product. We had to pivot away from this product. I will say that's a lottery ticket in a way. If I can get insurance covered for it, that is going to be quite a significant deal because that is an FDA-approved product, and we're essentially working on reimbursement behind the scenes. A key for somebody who's just looking at a PowerPoint, taking my word for it, I think, is you look at that sensor. That sensor was with our first device. We got FDA approval with that sensor with one product already. It bears repeating that we're using essentially that same sensor for our current product. It is a validated idea. It's something that we've proven can work. Here is the race for fully implanted cochlear implants. As I mentioned, there's three main players in this space, Cochlear, MED-EL, and Advanced Bionics. I'm going to talk about them in a second here, I want you to know that we are the furthest along in the journey when it comes to the race to fully implanted cochlear implants. We are the only one that received Breakthrough Device Designation from the FDA. We got that in 2019. We were the first ones to get an IDE for a U.S. study. We were the first ones to start implanting patients, we're definitely the first ones to get all the way through enrollment of the 56 patients. We are by far the furthest along in this race. I'm also going to show you that Cochlear and MED-EL have a different type of device, which I'm not worried about in the long run. I think a very important point on this slide is that Advanced Bionics, which is the third player in the market, does not have a fully implanted product. Maybe they're considering M&A activity or maybe they're just going to be willing to give up their market share as time goes on. I don't quite know. Durable differentiation. It's pretty obvious that we have a different product from what's on the market today, right? We don't have anything externally. We don't use a microphone. That's pretty obvious. I want you to really understand that we also built a product that will be different going forward. Envoy Medical has a superior design, in my opinion. The architecture that we picked is different fundamentally from the other players. That also will help us because we have IP around that, but we also have regulatory moat around that. One of the things that you need to internalize if you're not familiar with medical devices is that the timeline that it takes to get an idea to a market is easily 12-15 years. We're at about year 11 right now. It gives you an idea that if somebody says, "Oh, Envoy has the proper design. The sensor really makes a lot of sense. The battery in the chest makes a lot of sense." They're going to have to go back to the starting board. We should have multiple years of being the only one on the market with this type of device because the regulatory hurdle is actually a bigger barrier than IP, in my opinion. Here are some important design differences. This is Cochlear's Tiki, which is from their publication. This picture came straight out of one of the doctors who published a paper on their feasibility study. MED-EL, this is a graphic that was put in a publication talking about their device. Both of these products have a subcutaneous microphone. They do not have our sensor. They have a subcutaneous microphone. Essentially, they just put a microphone like I'm speaking into right now underneath the skin. There's problems with that. Cochlear and MED-EL both have talked about body noise problems, people picking up body noise with that microphone. Also, you're not using the natural ear. You don't have the benefit then of having the natural ear be your sound pickup, okay? I'm a big AirPod user. I wear AirPods all the time. Our patients will be able to just pop an AirPod in and still get the benefit of using their device. The other companies, if you're picking up sound back here, you can't put an AirPod in and get that benefit. As AI moves forward and as connectivity gets different and different phones come out, it's going to be a benefit of our patients that they can just use their ear, which is going to be a huge thing in wearables. They call them hearables, but it's kind of tacky. I think wearables will be a huge thing with the Meta glasses. There's all sorts of examples of new technology coming out where you want to be able to use your ear. Our device will be compatible with those because we use the natural ear. A couple of big differences. The subcutaneous microphone. These both also still have magnets within them. Our device does not. These both also rely on an external part of the device for part of the day to do two things. One, to provide better hearing, and two, to charge the internal battery. These patients will have to wear an external thing for part of the day, kind of defeating the purpose of a fully implanted cochlear implant. In addition, they both made the very poor design choice, in my opinion, of putting the battery in the head. By putting the battery in the head, that means you have to have a smaller battery, right? I could put a much larger battery in my chest than I can put in my head. Skin is tight up here. There's very little room. By the way, the skin up here doesn't revascularize well, so once you go in there once or twice, it starts to break down more easily. There's all sorts of problems with doing that. Because they put the small battery in the head, that means there's so much capacity. Cochlear implants use a tremendous amount of energy. They're electrical stimulators that are firing all day long. You know from your cell phone, if you have to charge once a day, at about three years, you start to lose capacity where you can no longer get a full day of charge. That's just chemistry. Over time, battery capacity diminishes the more you recharge it, right? As you go through this, you'll realize that the fact that they have a small battery in the head is a problem, in my opinion. The other big problem with their battery, not replaceable. To replace their battery, you have to replace the entire system. Our battery pack in the chest can be replaced with a simple incision. You unplug, you plug it back in. Again, we will be the only cochlear implant that uses the ear, the only cochlear implant that has the sensor, the only cochlear implant with a battery in the chest, and the only cochlear implant with a replaceable battery. All of these should point to very positive things. I have a limited amount of time, so I'm going to quickly go over this. Cochlear is our largest competitor, COH. Look at them on the ASX. Their market cap's been cut in half since we started our pivotal study. Don't know if it's just us. It's just reality. Could be a coincidence. Who knows? Sonova owns Advanced Bionics. That's the other company I was talking about. MED-EL is privately held. These have been the same three companies that have been in this industry for the last 30 years. There has not been disruption in this industry. This is ripe for it. I mentioned we're in a clinical trial. This is a little bit more detail. If you're interested, obviously, you can go to clinicaltrials.gov and also find out more information. 56 patients, seven sites, all U.S.-based. Top-tier sites in our study. All 56 patients have been implanted. We are now through one-month visits for all of them, and we're getting to three-month visits for all of them. Again, top-tier sites. Mayo Clinic, Cleveland Clinic, University of Florida, Medical University of South Carolina. These are not cowboy centers. These are legit practices that are very interested in what we're doing. Our timeline to commercialization. I made this slide, first version of this 10 years ago. We're now all the way on the right. This is a great time for folks to get interested in this product. A lot of blood, sweat, and tears, and capital have gone into getting us to this point. With our market cap where it is today and our share price, I think this is a great opportunity for you to buy into this story. We are now in a phase where we're data collecting. I will be giving updates as we go through the various milestones. As patient number 56 goes through the process, we'll be giving updates. As we look forward, we will be submitting our PMA to the FDA in May or June of next year, hopefully FDA approval by the end of the year. I am hoping to get a lot more excitement, a lot more momentum behind us over the next 18 months. Once we get commercial, I am quite certain this will be a big deal. Real high level, I just say that we have a plan of a very targeted approach for commercialization. This is not something where I need to raise $100 million and commercialize the product. This is something where I already have these 35 sites picked out, and we are going to slowly but surely go deep with them. If I can get 10 of these to implant 50 to 60, we are already talking about $30 million-$40 million with a very limited amount of surgical sites. It is a great commercial opportunity. Very importantly, it is already covered by insurance. Our first product was not. This is going to be covered by insurance. It is a cochlear implant, it has to be covered by insurance. That is the National Coverage Determination 50.3 that says Medicare has to cover cochlear implants for FDA-approved products as long as it is within indications. This is our team. Advisory board members. We have a very good group of advisory board. Again, I want to point you to the fact that these are top-tier centers. These are KOLs. These are people that are going to be at podiums just like this, talking at conferences just like this to the group. This is a very good advisory board for a young startup company. Again, here are some recent milestones as well as some upcoming milestones. With that, I guess I got two minutes. If anybody has any questions, I am happy to answer them. Yes, sir. First of all, I thought that VR comment about Invisible Hearing is absolutely spectacular. Yeah. It's a great selling proposition. Yes. $30,000. Does that include just the device, or does that include the surgery? The device covered by insurance, that would be our ASP. That would be the device. Traditional cochlear implant sells for about $25,000 right now. All in surgically, it's going to be somewhere between $45,000 and $50,000. Is that all covered insurance? It should be covered by insurance. It depends on your insurance. Maybe sometimes there's co-pays. You guys are planning to get to FDA. You can immediately begin to sell. Yes. We can immediately begin to. Yes. There are existing codes. I will tell you, there is an honest debate going on right now about whether or not we want our own set of codes. Because if we get our own set of codes, we can charge significantly more money over time. The good news about that is whether you have a Category I or a Category III code, if you have an NCD, which we do for cochlear implants, Medicare has to cover you right away. It might be a little bit more of a fight with private insurers, but it won't be an issue with public insurers. For the medical breakdown, it's about 60%-65% Medicare in this space, and 35%-40%. We'll have plenty of people that can get it. Yes. Can you speak a little bit on the fidelity of the product? Is it the same as hearing versus a submerged microphone? The cochlear implants sound a little bit, nobody likes when I say this, they sound like drunk Donald Duck at a techno concert. There's an electrical sound that is very different. You have to learn that hearing. In terms of, has a higher level of fidelity than traditional cochlear implants, that remains to be seen. I can tell you with our first product, the Esteem, we got a lot of people talking about it being a more natural sound because you're using your ear. I don't have data to say affirmatively if that's the case with this, though. Yes, sir. Can you talk about the evidence you're generating at Cochlear? Where's the risk? Is it safety risk or is there some medical risk? We anticipate our cochlear implant to have about the same adverse events as other cochlear implants. Nausea, maybe some wound breakdown here and there. It's a medical device, you got that kind of stuff. The data we're collecting is really what you're focused on is word scores. We're going to focus on word scores just like our competition does. To give you an idea of the benefit of that, it's about a 40-point improvement over your baseline. If you come in at a zero and you go up to 40%, that's considered an above average score. If you get to 60%, 70%, you're doing great. That's the kind of data. We're also a lot of quality of life. We're doing a patient preference study. We're doing a lot of things to show that once we get the full picture, this will be the device patients will want. If you need a cochlear implant, you've made that decision, you'll get that. There's no control arm? No control. No control, not blinded. You're- You're basically comparing to your baseline. You know that data as it rolls in? Yes, I do. Yep. Thank you.