Revenue run right now about $27 million and growing. Elu Pro is the product I'm going to spend most of the time talking about today. It's our brand new, just approved product going to full launch this January. It's a product designed to protect pacemakers that have been implanted in patients. We'll talk a lot about it. Right behind that is our SimpliDerm product. It's used in breast reconstruction. This is reconstruction following mastectomy. It also has a great trajectory. We've pioneered this concept of drug-eluting or antibiotic-eluting biologics and biologic envelopes. On June 17th, we were super fortunate to get the first ever approval of one from the FDA. That's EluPro. It's about a $600 million market that we're going into. We're very, very excited about going and capturing that market share.
So let's talk a little bit about the basics behind the company and why we believe in this concept of humanizing medicine. So it starts with something fairly simple. What happens when you get a splinter in your finger? Well, your body does some pretty typical things that happen. First starts this inflammatory phase. It gets all red and kind of hot. Your body's then defense system is going to try to do the best it can to wall it off and to expel it, literally eject it from your body. You've gotten a splinter before.
You probably know that comes next. If it can't get rid of it, just maybe because of the size or how deep it is, the next thing it's going to do is it's going to try to create a fibrotic capsule around it and try to keep it contained.
The problem there is fibrotic capsules inherently don't have a lot of blood vessels. They're what we call avascular tissue structures. And those avascular tissue structures, if there's not blood, then there's no way for your immune system to get there. There's no way for antibiotics to get there. And that sets up just a perfect breeding ground for infection. So inflammation, migration, fibrosis, and infection, very, very typical path that happens when you get a splinter. So why am I talking about splinters? Well, to your body, what's the difference between a pacemaker and a splinter? And the answer is not much. Because when you get a pacemaker implanted in your body, the same exact foreign body response starts to take place. There's an inflammatory response. There's this migration, erosion, fibrosis, and ultimately infection.
And so this was the concept that we said, you know what, we could actually probably do something about this. So I talk about this stuff in sort of cartoon pictures. But clinically, is it real? The answer is yeah. 5%-7% of pacemaker implantation procedures end up in a procedural failure. And almost none of those are related to the actual device failing. Pacemakers almost never fail. Instead, what happens is there's a failure in the compatibility between the device and the patient that it's intended to serve. And so here's an example of an acute inflammatory response in a patient who's had a pacemaker placed in. Migration, it looks like that pacemaker there, the X-ray, it looks like that pacemaker's sitting in the bladder.
It's not. It's just slid all the way down the chest wall. And it's pulling on those lead wires.
Now, if you think about what a pacemaker is designed to do, those wires go into the ventricle in your heart. When a pacemaker moves and it pulls on those wires, it dislodges it from that ventricle, and once it's dislodged from the ventricle, pacemaker's kind of useless, so that's migration. Erosion, we talk about this. Your body's natural instinct is to try to expel foreign bodies. That actually happens with pacemakers too. That is a significant problem. Fibrosis, that white fibrous capsule that can set up making changing out a pacemaker a real problem, and then lastly, infection, and infection sort of doesn't need much description behind it, so we looked at that and we said, you know we think we can fix that.
We think we can do something about that by combining biological materials with active pharmaceutical ingredients, so what does the biologic bring?
Let's start with this natural biological matrix. Well, three things are going on there. One is a biological material will downregulate the inflammatory response that a patient sees. So the patient might be wanting to build up an inflammatory response to the pacemaker, but the biological material will downregulate that inflammatory response. The biological material also serves a pretty good physical anchor. So it will literally hold it in place and prevent migration. And then the last thing is this biological material will prevent this fibrotic encapsulation that takes place. So that's why we start with that biological base. To that, we add a pharmaceutical payload. Now, in the case where we want to fight infection, we'll add different drugs. Rifampin and Minocycline are the two that we currently use right now.
We put those two things together and we create this drug-eluting biomatrix.
And the cool thing about a biological matrix is you put it in the body as a biological material. You come back six months later and it's gone, but in its place, the body has regenerated that envelope into its own natural, healthy, and most importantly, vascularized tissue. And then the addition of the drugs makes sure that you don't get an infection. So that's the base premise that we started with. And this is actually our first version of that product. So this is EluPro, antibiotic-eluting BioEnvelope. We went after clearance initially after the cardiac implantable electronic devices or pacemakers and internal defibrillators. And we were also actually quite fortunate to pick up approval for all kinds of neurostimulators.
So this is for things like sleep apnea, urinary incontinence, fecal incontinence, deep brain stimulation, and the like. So we just got approval about this.
Let me tell you a bunch of cool stuff about it. The first is the market dynamics that go on with this pacemaker space. There's about 600,000 pacemakers in the United States that are implanted each year. And again, we talked about that 5%-7% complication rate. Here's the thing. If you need a pacemaker, usually it's because you're in some form of heart block. That means the conduction of your heart isn't working the way it's supposed to work. And you need a pacemaker. That's not like an optional thing. You really need that pacemaker. A 5%-7% complication rate's actually a real significant problem. As far as this market goes, there's only four players in the United States that make a pacemaker. Four. This becomes important. Medtronic, Boston Scientific, Abbott, and Biotronik.
One of these companies actually acquired an antibiotic-eluting envelope called TYRX. That's Medtronic. So they acquired back in 2014. And this is a plastic polymer mesh. And it sort of gets implanted into the patient. And it dissolves. This sort of polymer, the plastic dissolves. And as it dissolves, it liberates antibiotic. And I got to tell you, they crushed it. They're the only one that has an antibiotic-eluting anything on the market for pacemakers. And they took this concept and they've now grown it into about a $300 million business, about $200 million of that in the U.S. alone. So they've gone out there and created a market. But it's the only one on the market. That would be a problem for us if Medtronic didn't own it. But Medtronic does own it.
That means 60% of the market out there for pacemakers. If one of those electrophysiologists wants to use an antibiotic-eluting envelope, they've got to go to their competitor, Medtronic, and get it. Boston, Abbott, or Biotronik don't have a complete solution to implant a pacemaker. Right now, only Medtronic does. That leaves 60% of the market open to our product. Not where we're not competing, but we're actually invited in as a partner into this procedure. Why do I say that? The one thing that Boston Scientific and Abbott can agree on is they don't want a Medtronic rep and a Medtronic product in their pacemaker procedure. That's not good business.
But little old Elutia, we don't make a pacemaker. We're kind of like Switzerland. Yeah, we need an antibiotic-eluting envelope. We'd love to have you guys come in on our procedure.
More importantly, keep Medtronic out of our procedure. It sets up very, very favorable market dynamics as we come in and get ready to launch this product. This isn't a me-too product. I want to be super clear about this. TYRX is a product that's Medtronic's product, which by all accounts is really crushing it. TYRX is a product that was developed in 2012. It is a good first-generation product, but it is old. It is synthetic. It doesn't do much other than just dissolve and liberate antibiotic. EluPro is the superior product coming into this $600 million market. We know that actually because of the market data that we've gone out and done.
So before we launched this product, before we got ready to launch this product, we went out and we did blinded market data where we were actually polling electrophysiologists that use TYRX. So they use the competitor product. And we showed them TYRX and we showed them what was coming in EluPro. We didn't tell them what it was. It was blinded. And we asked them, "So if this product were on the market, would you use this?" And 88% of the electrophysiologists said they would switch some or all of their business right away to EluPro once that product was on the market. So we feel really good about this.
Again, not just as the second entrant into a $600 million market, but actually as the superior entrant into a $600 million market. So that's what we're going to do. It is on, by the way.
So we got approval for this product in late June. We're actually not doing our official full-scale launch until January. But we got some electrophysiologists that just can't wait to get this going. And so we've done some selective cases. Now, this was the first one that was ever done. It was done by Dr. Ketan Koranne at East Carolina University and Medical School there. He's the chief of electrophysiology there. And he says, "You know, from an electrophysiologist perspective, EluPro offers a superior solution for both the procedure and the patient." That's really, really important. It's both better for the patient, for their outcomes. I don't think an infection, they don't have this thing move.
But it's also much easier for the physician to use than TYRX, than the existing product out there. It's a less invasive incision. So they literally are making a smaller incision, easier placement.
It gives them exactly what they want: antibiotics and a biologic solution instead of a polymer. We're super excited about the launch of this product. Our next step then is to get busy and to launch it. As I said, our full launch is starting in January. That doesn't mean we don't have a lot to do right now. We do. First things first, we need to make it. This product is now rolling off our manufacturing facilities. We have manufacturing facilities in Atlanta. They've been up for the last 10 years making our base products and doing a great job there. This is a fun switchover for them to start adding pharmaceutical agents to it. I didn't talk about this, but we have an existing product that's on the market in this space that didn't elute antibiotics.
And so that's the one we're obsoleting with EluPro. It's called CanGaroo. The good news there is we already have a commercial team. We're already in 400 hospitals across the country. And so right now, what we're busy doing is we're busy converting those 400 CanGaroo hospital systems into EluPro hospital systems. In order to do that, this is a really important part of this. We're in a pretty cool position launching a new product here because we're not demand-constrained and we're not supply-constrained. So at least initially, our revenue won't be governed by how many people want to use it. We have more people that want to use it than we can get it to them. The reason for that is the thing that's governing us is what's called the Value Analysis Committee in a hospital.
That is the committee that sits in every hospital in the country that says, "Before you can put your product on our formulary, you've got to go through this committee and you've got to show us that there's a good cost-benefit argument to be made here." Now, we have that cost-benefit argument. It's actually really clear. Medtronic actually did a really, really nice job showing how important it was to have local antibiotic delivery in these procedures. But we still have to get one by one all of those VAC submissions in and all of those VAC submissions approved. So as you're watching us launch and as you're watching us grow here, getting through value analysis committees is the thing that is the proxy or the leading metric for how we're going to do from a revenue standpoint.
We are really fortunate that we have a number of aggressive KOLs that love the company and have been with us for a long time that are aggressively pushing it through, but on average, this is something that usually takes about six months to do, so I want to sort of temper expectations on this, so from a timetable standpoint, we're currently in this soft launch period right now. We're initiating a clinical registry. That's just so we can follow the clinical aspects of our patients going forward, but what we're really doing is we're gearing up for full launch in the Q1 of 2025. We have our collateral and beautiful product packaging and the like, and most importantly, our reps are out there spending time getting the product approved through the different hospitals.
I should say from a commercial standpoint, we have 13 direct reps that have been in place for now quite a while across the country, and then we have augmented them with an additional 22 1099 reps that detail the product. So we actually have pretty nice coverage of the country, and then we supplement that with individual relationships with some of these pacemaker distributors like Abbott and Boston Scientific, where they are strongly motivated to have EluPro in their case so they can not have Medtronic's product going around their pacemaker, so that is EluPro. We are really, really excited about that. That is, like I said, going to launch in the Q1 of this year. Not to be outdone, we have SimpliDerm. This is our biologics product that's used in breast reconstruction surgery.
A lot of times, people don't understand how a biologic would be used in a breast reconstruction procedure. So let me sort of explain it with some pictures here. So first of all, when we talk about breast reconstruction, we're talking about the reconstruction process that happens after a woman goes through a mastectomy. So you're talking about somebody who's developed breast cancer and has needed to go in and have either a unilateral or a bilateral mastectomy. When that happens, there's a really significant amount of tissue that's removed. In fact, there's so much tissue removed that once you put the implant back inside, there isn't enough tissue to actually bring the edges of the chest wall down with the pectoralis muscle that goes over. You can see on the picture on the left.
And so where a biologic matrix is used, it's used to actually sort of serve as a sling in order to hold the implant in place. So this happens 151,000 times a year in the United States. It is an enormous market. So it's about a $1.6 billion addressable market. And it's one that we think can be made much, much better. So this is a market where right now, we're looking at, with this procedure, about 15%-22% of these procedures end in post-operative surgical infection.
So if you think about this, you're a woman, you're going through this, you've just given this horrible diagnosis of breast cancer, you have to go and have this procedure, you know you're going to be facing chemotherapy, and you go and have your mastectomy and you end up with a surgical site infection that requires everything to get put on hold until you get that resolved. So we think we can make this procedure a lot better by taking the same antibiotic delivery system that we've developed for EluPro and putting it into this biological matrix.
So right now, we start with our base product, SimpliDerm, which is, we like to say simply, a great product. It's a super flexible, sterile, hydrated biological material that the surgeon can just drop right in. We are a biologics company at base. That's sort of an important thing to understand.
Our lineage, where we come from, we really, really, really understand biologics. And we think our competitive advantage is to be able to take a biologic approach into a synthetic device world and then just totally kick their ass. And so that's what we're doing here. I only say that to show you here. We can engineer our biological materials, do all kinds of really cool things. In this picture, you don't have to be a pathologist to sort of get this. This shows the inflammatory response that our SimpliDerm product has compared to the market leader out there. It's a product called AlloDerm. And you can measure this both systemically through the blood TNF-alpha, which is a marker of systemic inflammation.
But you can also measure it histologically. So this brown staining that you see in these two different pictures, this is a marker of CD68.
It's actually a marker of invasive inflammation going in and it's when your body has actually a real problem with the foreign body that you see in front of it. So we're able to significantly downregulate this inflammation. Why is that important? Because wherever you see inflammation, you're ultimately going to see fibrosis and infection. And we don't like that in what we do. So we try to get that out of there. So this product, SimpliDerm, is again the first-generation product. It doesn't have the antibiotics yet. With that said, it's still growing pretty nicely. 34% growth rate. So this is at about a $13 million run rate right now, growing at 34%. We distribute this product two ways. One is we have our own proprietary distributor network.
We also have a non-exclusive partnership with a breast reconstruction company called Sientra, which was recently acquired by Tiger Aesthetics, and it's doing really well. I will read this list of cool things and stop here and take any questions with the few minutes we have. We're a fully integrated company. What I mean by that is we have our own manufacturing. We have our own R&D. We have our own sales and marketing infrastructure. We have a company with a $27 million run rate poised for really significant growth. We've already developed and gotten regulatory approval for the first drug-eluting biologics ever. We're super thrilled about that. That's EluPro. We're about to go into a market that we think we can take literally hundreds of millions of dollars of business over time.
Behind that, we have SimpliDerm, which is growing at a $14 million run rate, but growing really nicely. And we are in the process of adding our drug-eluting technology to that. And then from a financial standpoint, I didn't talk a lot about this because I'm not the CFO. But we've done a nice job too. And Matt Ferguson, our CFO, has done a nice job really shoring up the company. So as we were going through the approval process for this, we knew we were going to go into a time where we were going to be launching the product. And we didn't want any distractions from that. So we've recently done sort of a collection of offerings where we brought in another $28 million into the company. So we're also a really well-funded company right now. So super excited.
If anyone has any questions, I would be happy to answer them at this time.
Yeah. What's the tax rate on the Medtronic envelope? Are all the Medtronic space vendors using it? Is it portioned?
Yeah, it's a great question. So no. So Medtronic has about 200, they do about 200,000 procedures in the United States where they put an envelope on them, but only about 120,000 are on their pacemakers. 84,000 go on Boston Scientific and Abbott pacemakers. But because the Medtronic envelope doesn't really do anything other than elute antibiotics, the only procedures where they've been able to show a benefit to this product are changeouts, so not de novo placements of the pacemaker, but when you're changing the pacemaker out, and the reason for that, remember I mentioned something about fibrosis being avascular, and there's no vascular, so those changeouts are notoriously fibrotic.
They're at a higher risk of infection. So that's why they use the antibiotics. But our product would be able to be used in both.
The reimbursement codes for your product, are they the same?
Yeah. All under a global DRG, reimbursement for EluPro isn't a problem. From a hospital standpoint, it's a really good deal.
Okay. What is the amount?
The ASP is about $1,000 on the product. We are actually out of time. If you guys have any additional questions, we can think about that. Cool. I'll be happy to do it. Thank you all so much. Thank you.