Hello, everyone. Thank you so much for being with us. It is my pleasure to introduce to you Randy Mills, the Chief Executive Officer of Elutia.
Thank you all. It is absolutely my honor and pleasure to be with you today. Hopefully, we're going to have some fun and learn about Elutia and exactly what we do. Before we get into that, of course, because we're a publicly traded company, I've got to read every word on the forward-looking statement slide. I will not do that. Please consult our SEC filings for any risks associated with making an investment in Elutia. I like to be pretty explicit and clear. In that vein, I want to tell you about Elutia's mission. We exist as a company to humanize medicine so that patients can thrive without compromise. What does that mean? We believe in this idea of biologics. That's why we use the word humanizing biological materials combined with actual medicine, humanizing medicine.
We work in the field of drug-eluting biologics, and we do that so that patients can thrive. Our strategy is pretty simple. Biological materials, biomaterials, is a multi-billion dollar industry in the United States and around the world. They're pretty expensive. They're pretty pervasive. They're reasonably effective, but over time, they've become quite stagnant. As a result, they've also become commoditized. We see that as a real opportunity because we can take biological scaffolds and biological materials, and we can add effective active pharmaceutical substances to them and get them to do things that a biologic implant otherwise wouldn't be able to do, and therefore offer superior outcomes for patients and significant clinical differentiation. We're starting with that in breast reconstruction. We're doing that better, and we're doing that faster than anyone else out there. What are we great at as a company?
This is sort of an important thing for us to understand. We're great at this idea of developing really good biological scaffolds that you can implant into the body that will regenerate into the patient's own active living tissue, and then combining that with powerful antibiotics that deliver into the patient locally over a protracted period of time, thus really reducing or almost completely eliminating the opportunity for a post-operative infection. We haven't just started. The first one of these that we created was our EluPro product. This is on the left here. You can see this is a biological envelope that stabilizes a pacemaker in place. That's a biological envelope holding a pacemaker, so it doesn't slide down the patient's chest wall, so it doesn't erode through the patient's skin. We impregnated into that rifampin and minocycline, two powerful antibiotics that deliver over a protracted period of time.
That's a product that we got approved. Actually, we had very good early commercial success with it. Boston Scientific just bought that product from us for $88 million. We just closed on that transaction October 1. NXT41 is a product that's been in development since 2023, and that is our next major product. It's the same technology, the same antibiotics, and a little bit more of an advanced state. We're using that for breast reconstruction. The post-operative infection rates in pacemakers are 3%. The post-operative infection rate in breast reconstruction is 15% to 21%. There's a very, very significant unmet medical need when a woman has breast cancer and has to go through a mastectomy and have her breast reconstructed. It significantly increases the likelihood of a post-operative infection, and that's something that we're able to take care of with this technology. A little bit from an investor highlight standpoint.
Why invest in Elutia? Our technology platform isn't theoretical. It's validated. We developed and got FDA approval for the first drug-eluting biological envelope. We were able to monetize that with Boston Scientific for $88 million. It's about eight times revenue. It's a known proven technology platform. We are now taking that same technology, those same drugs, and biologics into the $1.5 billion breast reconstruction market. It's a much larger market for us to go after, and it has a much, much more significant unmet medical need with post-operative complications rates approaching 30%. Lastly, and the thing that probably differentiates us from a lot of companies at LD Microcap, is we're the company here that doesn't need any money. We are fully resourced. We have a team. We have a GMP manufacturing facility. We have a commercial platform.
We already have a number of biological products on the market in the space. We do about $12 million in revenue a year. More importantly, we have the cash to fund us not just through development, but all the way through launch and commercialization of this technology, thanks in large part to the success of our first product, EluPro. This is where we're going, and this is what we're doing. This is really why we exist as a company. In 2025, 316,950 women will be diagnosed with an invasive form of breast cancer in the United States alone. Many of those women obviously have to go on and have mastectomy as a treatment for that. One in three of them that gets reconstructed will suffer a serious complication, almost all of those arising from contamination and bacterial colonization. That is what we aim to change.
Here's why this is really such a transformational opportunity for us as a company, because a couple of really interesting things come together and collide here. One, breast reconstruction is a really, really big market. It's a $1.5 billion market in the reconstruction space alone. That obviously, from an investor standpoint, makes it a very attractive market. It's also one of these markets that has an unusually high unmet medical need associated with it. One in three women going through breast reconstruction will face a serious complication. One in seven women will just face a flat-out infection that will often lead to the complete failure of the reconstruction. You sort of imagine that. That's bad in a lot of conditions. The reason that you're having a mastectomy in the first place is because you have cancer. The mastectomy was only one part of your treatment for cancer.
You also have radiation that goes along with that. You also have adjunctive chemotherapy that goes along with that. When you develop an infection from the mastectomy, all of that has to come to a stop, and the infection has to get cleared. This is a really, really significant unmet medical need that we're talking about. The thing that really makes this such a great opportunity for us and for Elutia is that this really big unmet medical need in this really big market is something that is directly addressed and solved by our proven technology platform. The same technology, the same drugs that we used to solve this problem in pacemaker implantation, we're now able to take directly into breast reconstruction and solve it in this much larger market with this much greater unmet medical need. That's what we're off to doing.
To sort of dive into some of this a little bit about the breast reconstruction market, there's 317,000 women, right? They're going to be diagnosed with this. Only about 40% of the women that go through mastectomy, only about 40% of those actually will be candidates for reconstruction. One of the major reasons that women aren't able to be reconstructed after mastectomy is post-operative infection. There is just too much tissue. There's not enough vascularity left. They know if they go ahead and do the reconstruction procedure, the likelihood, the strong likelihood is that they're going to actually have an infection that's going to lead to the whole procedure failing, and it's actually going to place the woman in greater danger.
Said differently, if there were an effective treatment for post-operative infection and prevention in mastectomy and reconstruction, a whole lot more women would be having their breasts reconstructed after mastectomy. This is a very, very serious unmet medical need. Digging into this market a little bit more. How do we get to a $1.5 billion market? There's 160,000 breasts that are reconstructed after mastectomy annually each year. About 90% of those will use some form of biological mesh, and that's primarily used to stabilize the implant. Without the use of a biological mesh, generally what happens is that the implant will move around. It can literally slide down the woman or slide over. You need something that actually stabilizes and holds the implant in place. That's where these biological meshes come from, why they exist in this market. They are very expensive.
Even though they're the standard of care, the mesh itself that holds the implant in place on average costs somewhere between $7,500 and $9,500 per breast. Compare that to the implant's only cost about $1,000. The vast majority of the cost of breast reconstruction procedure is borne by this mesh that stabilizes the implant in place. Why is that important? Because it doesn't work really well. I'm not saying that the biological meshes are causing the problem. They're not causing the problem. We know why women get post-operative infections in breast reconstruction. It has to do with when you remove all of the breast tissue, you also remove all of the vasculature. Removing that vasculature creates a real problem. If you don't have any blood flow, you can't get any antibiotics there taken systemically, and you can't get your immune system there.
Any bacteria that are put in during this procedure have just free rein to grow and run wild. That is why you have these really high post-operative infection rates. The biological meshes that they're putting in there aren't helping. One in three patients will suffer serious complications. One in seven will experience a flat-out infection, which is a medical emergency. About one in five will actually have to have the entire implant removed and the whole thing taken out. Treatment stops. Everything comes to a grinding halt. From a hospital standpoint, if you're on the hospital side of this, you don't like any of this either because the incremental cost of an infection is $48,000. If it happens in the first 30 days after the surgery, guess who gets to pay for it? The hospital has to pay for it all by itself because it's viewed as a preventable cause.
They don't get any extra money for it. This is a significant health problem. This is a significant economic problem. The standard of care, just frankly, is failing women today. The good news is that we know that local antibiotic delivery fixes this problem, or at least very significantly addresses this problem. The other side of this is if you want to know how bad this problem is, these two solutions that I'm going to show you that are used today, this is current standard of care. This isn't from something that we did in the 1980s or 1990s. This was presented, I'm not kidding, 10 days ago at the American Society of Plastic Surgery, their national conference that was held in New Orleans, as two up-and-coming procedures to prevent infection in women going through breast reconstruction. What are they?
One is you take a bunch of bone cement, and you make a big giant plate out of it. You mix antibiotic into it, and you make this, you form this big wafer or plate out of it, and you place that into the breast. You have this big giant piece of cement in the breast. It releases antibiotic slowly over time, and that prevents infection. You can see the reduction in post-operative infection rate from 13% in that trial down to 4.8%. It's a very significant reduction. You make the same cement, you put it in little beads, and you throw the beads in there. If you look at that, this was done now in salvage cases. These are cases where the likelihood of infection was much, much, much higher. Their post-operative infection rate dropped from 35%- 6.3%.
These were procedures that were developed, I'm not kidding, in the 1980s for bone infections. That is why it's cement. The idea of having your breast reconstructed with cement is a suboptimal outcome. I think we can all agree with that. It shows that the concept works, that if you deliver locally antibiotic into this field, it will prevent post-operative infection. By the way, this is exactly the same thing we saw with EluPro in the pacemaker space. It works really, really effectively. What we did was we just made a better delivery system. Instead of a real big heavy plate of cement, we made a nice conforming biological material that needs to be there anyway, because keep in mind, those biological matrices are used in every case, always, every time to hold the implant in place.
Instead of it having been an inert biologic, we added the powerful antibiotics, rifampin and minocycline, to just one side of them and have sustained release of those antibiotics for five weeks so that the woman has the implant put in, the biological mesh goes over that, and for five weeks, local antibiotic is delivered into that space, preventing the opportunity for infection. Why did we pick rifampin and minocycline? They're really, really good antibiotics for this indication. First of all, we're using two antibiotics that attack a bacterial growth and protein synthesis in sequence, which significantly reduces the likelihood of a bacteria developing resistance to them. It was one of the reasons that rifampin and minocycline make really good antibiotics for this. The other reason, though, is we know what bacteria, what organisms cause post-operative infection in women.
It's most likely to be Staph aureus, Staph epidermidis, Pseudomonas, Enterococcus, or E. coli. It's going to be largely from one of those five. All five of those are very, very susceptible to this combination of rifampin and minocycline. The other thing about rifampin and minocycline that's really good, it's known for a long time, is it protects against something called biofilm. Biofilm is really a big problem that sets up. It's when bacteria, they don't just grow, but they actually grow and they create their own sort of matrix that they live within. That matrix protects them from other antibiotic delivery. Rifampin and minocycline are really good at breaking up and preventing biofilm. In the concentrations that we use them, they're actually quite safe for the patient. That is our technology solution that we're bringing here. This is Elutia, by the way. It's a real company.
It's headquartered in Gaithersburg, Maryland, although four of us are lucky enough to be headquartered here in La Jolla, California, which does not suck at all. This is where our GMP manufacturing facility is. This is where our R&D headquarters are. This is where the team that actually is developing and making all of this come true. They go to work every single day. We've been at this for a while. We actually started in breast reconstruction, developing the breast reconstruction back in 2023. We've gotten pretty far down the road here. We've developed the matrix. We have the animal data for NXT41. We've actually held our pre-submission meeting with the FDA, which is something that you do right before you file with the FDA. What do we have coming up?
We'll actually be taking the matrix without the antibiotic through the FDA first, and then following that up with an approval of the matrix with the antibiotic. By the way, if you hear me use the term NXT41 or NXT41X, the 41 is referring to the matrix, and the X means like RX prescription, means it has drug associated with it. We will be taking the matrix through the FDA. We'll be filing that in the first half of 2026. We would expect the clearance in around the third quarter for the matrix alone, and then right after that, refiling for approval of the matrix with the antibiotic or NXT41X and expecting first half approval for the combination product. I'll finish up here, and I'll take any questions if you guys want after this. Why own Elutia now? Three reasons.
One is we have a technology platform that's effective that we know works. We know physicians will adopt. EluPro, our first product, is selling like gangbusters both in our hands and now with Boston Scientific. That's strategic value. Second, we've de-risked the regulatory pathway. We've already taken a matrix with the same antibiotics through the FDA combination 510K pathway, which is something we just did with EluPro. We're very familiar with it. We're now taking this same technology through there, but after a much bigger market and going after a much more significant unmet medical need. Lastly, we have the team and we have the capital to get there without Elutia. The Elutia team has been together. I've worked with our Chief Scientific Officer all the way going back to when we were at Osiris Therapeutics together for the last 21 years.
We know how to both get these products through the FDA and commercialize them. We don't need to bring in any money in order to accomplish that. I will thank you for listening to the presentation today. If there are any questions, I'd be happy to take a couple. Thank you guys very much.