All right. Thank you, everybody. Let's get started. We don't have a ton of time, and we have a fair amount to get through. My name is Randy Mills. I am the Co-Founder, President, and Chief Executive Officer of Elutia. I'll be talking to you today about one of my favorite topics, which is forward-looking statements. No. What we're great at Elutia is something called the drug-eluting biologic, and this is where we take a biological material, a biomatrix, and we add to it a powerful antibiotic that's released locally over an extended period of time, and it prevents the number one issue that surgeons face during any surgery, which is postoperative infection. The biological matrix, what's that's good at doing, it's good at regenerating and repairing and strengthening soft tissue. These are used in any kind of soft tissue surgery. You might see these in abdominal wall repair. You might see these in hernia. You might see these in different kinds of reconstructive procedures. This is what we're really great at. We actually have done this now. We started and created a product last year called EluPro. This was a biological matrix antibiotic solution that we used for pacemakers. When somebody gets a pacemaker implanted into their body, that pacemaker can actually slide down the chest wall. That's a bad thing if you have a pacemaker. We made an envelope that actually would stabilize it and hold it in place. You don't want an infection if you're getting a pacemaker put in, we added the powerful antibiotics. We launched that product in January. It took off like a rocket. By October, we were at $18 million run rate. Boston Scientific swooped in, bought that product from us for $88 million. We're now taking the same technology, we're applying it to our project named NXT-41x, which is the same basic drug delivery technology, biological matrix technology for breast reconstruction, that's really what we'll be focusing on today. Why does this matter? Because surgical site infection is such a big problem, in United States and everywhere. These are United States numbers, 300,000 cases of postoperative surgical site infection a year. If you're a patient, this adds 9.7 days to your hospital stay for every one of these infections. If you're a hospital, $3.3 billion in uncovered cost in order to mitigate that infection. It destroys hospital margins at an alarming rate. We have a whole lot of very interested parties in finding ways of solving postoperative infections. Just a little bit of a high-level investment highlight. 1, we have a validated technology platform. We've done this before. We're not making this up. This isn't something we hope works out. Our first shot at this was EluPro. We showed that we could get it through FDA, that once we got it through FDA, surgeons loved it. They would buy it, most importantly, it worked. When we implemented EluPro, our physicians that were using EluPro in pacemaker surgeries just didn't see postoperative infection anymore. That was sold to Boston Scientific. We're now moving it into breast reconstruction. Breast reconstruction is a $1.5 billion market in United States. When I say breast reconstruction throughout this presentation, what I am referring to is a woman who has been diagnosed with breast cancer, who has had a mastectomy, needs her breast reconstructed. They have a different set of risk factors that makes this not only a very large market, but a market with a really significant unmet medical need. Lastly, kind of surprising for a microcap conference, we have everything we need. We have a proven team that's really excellent at what they do. We have the GMP manufacturing facility up and running. We have $36.5 million on our balance sheet to get it from here to there. Why do we love this breast reconstruction market so much? Because it combines three things that really matter to us. 1, it's a large market, as I said before, a $1.5 billion market in breast reconstruction, United States alone. It's also a really enormous problem. When we went into pacemakers, postoperative infection rates in pacemakers was 3%, we couldn't make that stuff fast enough for the electrophysiologist that was putting in that pacemaker. In breast reconstruction, it's 15%-20%. One in six women that go through a mastectomy and a reconstruction procedure will develop a postoperative infection. It's a hard number to believe. Most people don't at first. I'll actually explain to you why that number is so high, and punchline, it's not because you have bad surgeons. Lastly, the thing we really like about this is, this big market with a big problem is actually one that our technology perfectly addresses. That's sort of the strategy there. Just peeling back the onion a little bit more as we go through here. A big market. This isn't like some crazy making it up TAM. This is a very real established $1.5 billion market. 320,000 cases in the United States. We're only talking about U.S. here. 320,000 new cases of invasive breast cancer diagnosed each year. In United States, that leads to 162,000 breast reconstruction procedures performed, about two-thirds of which are bilateral, meaning it involves both breasts. A biological mesh, which means the base matrix that we use, is already used as standard of care in 85% of these reconstructions. Essentially, almost never done without already using a biological mesh. The surgeons are already putting the biological part of what we do in there. Lastly, that mesh is really, really expensive. Right. The established market for this, that mesh that's used, has an ASP of something like $8,000-$9,000 per breast. Right. That's already used. You do that math to get together, somewhere between a, we'll call it, $1.4 billion-$1.7 billion established market where the mesh is already standard of care. The problem is the outcomes suck. This isn't because, by the way, the biological mesh is bad either. Doesn't help the problem, but it doesn't cause the problem. You end up with this 15%-20% developing a really serious infection. If you're a woman that's going through breast cancer, okay, this is a real big problem, because your number one goal for having the surgery in the first place was to deal with the cancer. The mastectomy was the first part in that journey. Right. It usually gets followed up with things like radiation, chest wall radiation, and almost assuredly, chemotherapy. When you develop a postoperative infection, all of that stops. Right. You can't be taking a woman into immunosuppressive chemotherapy if they're fighting a really serious infection. That's what happens in these cases. Right? This is a really bad experience for the woman. The hospital doesn't like it either, though. The cost of mitigating these infections, $48,000, not covered by anything. Right? A surgical site infection that's covered under a DRG that happens within the first 30 days is the hospital's problem as far as the payer is concerned, and by the way, as far as CMS is concerned. We have, again, we have a whole lot of interested parties in fixing this problem. The question is then, how? How in the world is this problem actually this bad? It's worth sort of unpacking here. It's a little bit of a lesson in anatomy, physiology, and pharmacology. I'm going to try to make it fun and use a cartoon. First thing to understand is the first thing that happens in this whole process is a mastectomy. Right? This is the removal of the entirety of the breast. You cannot leave breast tissue behind. If you leave breast tissue behind, you leave behind the residual opportunity for the woman to have recurrence of breast cancer, and that is bad. All of the breast tissue needs to be removed. That's done by an oncologic surgeon. That's surgeon one in this procedure. The problem is when you do that, you see all those blood vessels? All of the blood flow for the anterior or the nipple side of the breast passes through the breast. When you perform a successful mastectomy, you effectively remove the entire vasculature for the anterior side of the breast. The problem with that is normally what we do after surgery, right, to prevent postoperative infection, is give the person antibiotics. That just sort of makes sense. In this case, when you go to give somebody antibiotics, and it doesn't matter if it's IV or if it's oral, all of that goes through the bloodstream until it finds its home where it needs to be at the source of infection. Well, we've blocked that. We've effectively cut off that pathway by removing all of those blood vessels. You end up with a site that cannot be adequately perfused with blood and your immune system, and it can't be adequately addressed with antibiotics. That's part one of the story. Part two of the story is that was only the 1st surgeon in this really long surgery. 2nd surgeon comes in, that's the plastic surgeon, and that's the reconstructive part of this procedure. A plastic surgeon comes in and places this giant implant into that cavity. Foreign body, right, it's made with a foreign body material. Your body does not like that. We then wrap it, as I said, remember a biological matrix is used, right? That biological matrix is actually used to hold this implant in place and surgical drains are put. Two surgical drains per breast are these big giant tubes that go to the outside, and they stay in for 17 days. Right? 17 days you have a big tube to the outside going into this breast cavity that doesn't have any blood supply, has a giant foreign body in it. When you think about, you put all this together, it's a four to six hour surgery, two surgical teams, large foreign body, external drain, and no blood supply, and no antibiotics to get there. The question isn't how do you end up with a 15%-20% infection rate. The question is how do you only end up with a 15%-20% postoperative infection rate? Our team asked the question: Well, if you can't get antibiotics into the breast cavity systemically, what if you just put them there? You're already using this mesh. That's what we've come up with, and that's what 41X is. Again, on the left, that's the biological matrix that's used in almost every single breast reconstruction procedure today. On the right is 41X. It's exactly the same thing, except when you look underneath it, you see this orange coating, and that orange coating is a sustained release mechanism of rifampin and minocycline, two very powerful bactericidal antibiotics that fully cover the pathogens that you see in breast reconstruction. Why do surgeons love it? They love it because it's local. The patient doesn't experience systemic effects from this. The antibiotics that are in here don't affect the patient systemically. It's easy to use. They're doing exactly the same surgical procedure, just has antibiotics on it. For the hospital, it's cost neutral. From their standpoint, they were going to buy a biological mesh. Now they're buying a biological mesh with antibiotic attached to it. Except their huge infection burn goes away. That's what we're in our process of doing. The path we're going down to do it on, we've already been down. We like to, in biotech, if you can keep things the same that are successful, keep them the same. Really that's what we're doing. When we launched EluPro, we actually didn't start by taking EluPro through FDA. We actually started by taking a product called CanGaroo through FDA, which was just the base biological envelope without any antibiotic on it. Got that through the FDA, got FDA comfortable with that, got that approved, got it on the market. We turned around and we submitted EluPro, and then we were able to get that successfully through FDA because they had already digested the envelope part of this approval. We're doing the same thing right now. We have actually already submitted for the base matrix. We call it 41 when we don't have the drug on it, sort of think of the X as like Rx, prescription. We've already filed for approval for 41. We expect approval for that in the fourth quarter of this year and are then immediately turning around and filing for approval of 41X, and we would actually expect that approval around this time next year. For us, we are in a very busy time going on at Elutia. A little bit about manufacturing, because why not? We own the entire manufacturing process, and the product, and the formulation, and everything else end to end. We have it in-house in our GMP manufacturing facility. We don't have any contract manufacturers or key single source suppliers. The formulation for the release of this product is proprietary. That is ours and very difficult to develop. Something people don't think about, we also developed the QC tests in order to get it released and through FDA. Not easy either. Those are ours. Lastly, this is a real upgrade over what we did with EluPro, we now actually have robots that do all of this, it's a fully automated process. Gross margin, even if we price this thing really competitively, gross margin on this process is going to be greater than 80% with really beautiful lot-to-lot consistency. Last thing I just want to touch on is as we get closer to commercialization, this becomes more and more of an issue, is how does a little company like Elutia commercialize it? The first thing I'd say is we did a really good job with EluPro. If you wanted a reason to have confidence in us is we've done this before. This market's actually better for us, the reason is, with EluPro, pacemakers are put in everywhere across the country. Breast reconstruction is actually really specialized. Out of the 7,000 plastic surgeons in the United States, only 3,200 actually perform breast reconstruction. When you pare that down, if you just go to the top 50 centers, 38,000 cases of breast reconstruction are performed at the top 50 centers. That's a $300 million opportunity in and of itself. We don't need to go out and actually try to boil the ocean here and just randomly start throwing sales reps. If we just picked off the top 50, we would be in good shape. I threw over here some historical data for EluPro. What you're seeing on the right is that's the actual VAC approval data that we generated from EluPro. What that means, VAC is something called the Value Analysis Committee. That is the thing that the hospital puts in place to keep new products from flooding their shelves. You have to go through the Value Analysis Committee if you want to sell a product. It is the thing that governs adoption of a product. You can't sell a product in a hospital until it gets approved by VACs. That's our VAC adoption curve for EluPro. If you go to 50 occurs in our third month of launch with regards to EluPro. The other thing that's going on is we're getting more and more sophisticated with how we do this. Right? We're not just saying, "Oh, I bet L.A. is a big city. We should put somebody in L.A." "I bet Phoenix is really big. We should put somebody in big." We actually have case-level data that we've paired up with AI that lets us drill down. This is actually real data. I've anonymized the hospital name here and the surgeon names, those aren't actually the correct, but the numbers are real. This is very real data. For example, we say we want to go into the Midwest. Show me the biggest hospitals in the Midwest. Okay. Midwestern Hospital has 431 patients of breast reconstruction. Hmm. What are the surgeons like at that hospital? Dr. Whitfield, that's their top surgeon. Right? She has 175 cases of specific breast reconstruction procedures last year. How did those cases go for Dr. Whitfield? Well, out of the 175 cases, 74 had complications. By the way, if you're judging, and I can feel you judging Dr. Whitfield, if you're judging Dr. Whitfield, don't. When you see complications in breast reconstruction, what you're seeing is a surgeon dealing with a very difficult, complicated case, not poor surgical technique. Right? That's actually what drives the risk factors. She had 74 complications, we can say, well, what were those complications like? Actually, 30 of those cases were postoperative infection or sepsis. By the way, Dr. Whitfield's not real, but all of those numbers are real. That's actually from a real surgeon we pulled out of this. This is real typical data. The thing I want to point out is this number 30, because we talked about what it's like for the woman, we talked about what it's like for the hospital, but what this number 30 means for Dr. Whitfield, it means 30 times a year in 2024, she got called back to the emergency room and had to take a patient urgently into the operating room to solve this problem. Right? Only the breast surgeon can do that, only the plastic and reconstructive surgeon. That's one out of every 12 days a surgeon is going through and doing that. It's a really significant problem. We've got this launch planned with real surgical precision. We know where to go. We know who to target with regards to which surgeons are actually driving the relevant case volume. We know what to show and what to say to the value analysis committee. We're walking into the value analysis committee saying, "Hey, you want to know about your postoperative infection data? Because we're about to show it to you." What all that means for us and why it matters, it means faster adoption with lower spend on marketing. We got a whole lot of good stuff coming up, 2026. This year, we have some legacy businesses that we're going to be selling, actually it'll bolster our balance sheet, which is kind of cool. We expect a clearance of the base matrix in the fourth quarter, submission of the full product in the fourth quarter as well, clearance next year, then full launch in the second half of next year. I talked about all this stuff, so I don't want to belabor it. We've already done this. We're going after now a really big market with a really big need, we have the team and resources in order to enable us to get from here to there. It has been wonderful talking with you. I think we have a minute or two if you have any questions, but thanks so much. Current burn. Current operations. Actually, this is a great time for our CFO not to be here, right? Like, ask the CEO a question. Quarterly burn rate, I think from operations is right around, I think $4 million mark. Yeah. Related question, that $36 million cash. 36, for us, that is cash on hand. One thing that also is in there, though, is a receivable from Boston Scientific of $8 million. It's in escrow, and it just gets released on October 1st. Cool. Thank you guys so much. I appreciate it