Mills of Elutia. Randy, the stage is all yours.
Thank you, Anana. Thank you everyone for joining us today on this call and talking to you about my favorite, at least, industrial subject, which is Elutia. A little bit before we move on, a little bit of a forward-looking statement, as always, for the lawyers. Getting into the company and introducing Elutia at a higher level. So our mission as a company is humanizing medicine so that patients can thrive without compromise. So what does that mean? Well, for us, that means this concept of humanizing medicine means combining traditional pharmaceuticals, medicine, with biologics, and so we create drug-eluting biologic products, and we do that so patients can thrive without compromise. It always means...
It also means, I should say, humanizing, means we never forget that there's a human at the other end of everything that we do, and we don't view people as just patients, but we view them as mothers, fathers, brothers, sisters, and that's really, really important to us. We are a commercial-stage company, so we have a run rate of about $27 million in revenue based off of two of our proprietary product lines: EluPro, which is the one I'm going to spend the vast majority of the time talking about today, is our really exciting brand-new product, and SimpliDerm, which is a product that we have that's emerging right now in the breast reconstruction space. But as I said, really, the spotlight right now from an investment standpoint is really on EluPro.
EluPro is the first antibiotic-eluting bioenvelope ever. We received FDA clearance for it on June 17th of this year, and what we're doing with EluPro is we're going after this $600 million pacemaker and implantable defibrillator market, and we'll explain a little bit more what it has to do with that coming up. We are, as a company, a commercial-stage company, fully integrated with R&D, sales, marketing, manufacturing, distribution, poised to really take a big chunk out of this pacemaker and implantable defibrillator protection market. Let's get into it. This is a really important concept to understand at a high level about how we view what it is we do. Think about this: What happens when you get a splinter in your finger?
There's actually a very predictable series of things that take place. Your body will first have this sort of profound inflammatory response that goes on, right? And that's bringing all of the king's horses and all the king's men from your immune system to the point, so they can start working on this foreign invader. Second thing that happens, there's this migratory phase or migration phase. Your body's literally trying to expel this thing that shouldn't be in your body out of it. What it can't expel, it likes to wall off, and so there's this fibrotic phase. Unfortunately, that fibrotic tissue that sets up usually doesn't have a lot of vascularity to it, and so that leads into the fourth phase, which is very frequently an infection. So this is kind of what happens not just with a splinter, but any foreign body.
The question is this: To your body, what's the difference between a splinter and a pacemaker? Unfortunately, the answer is not much. Both of them will elicit this same type of foreign body response: inflammation, migration, fibrosis, and infection. That can lead to some pretty significant complications for this very much needed surgical procedure. I'm gonna focus my comments again today on pacemakers and internal defibrillators, 'cause we're really putting the spotlight on EluPro, but this is really a generalizable concept between any long-term implantable device. We have another product, as I mentioned, SimpliDerm, we use in breast reconstructions, but you see this phenomena with ports and pumps and anything really LVADs, anything that's gonna be in the body for a long period of time.
550,000 implantable defibrillators and pacemakers each year in the United States are implanted. What a lot of people don't know is 5%-7% of those will go on and develop one or more of these problems, this inflammation, migration, erosion, fibrosis, and infection. Here's the deal, 5%-7% of the time this is happening, it will lead to a failed procedure, and it has nothing to do with the pacemaker. It's not like the pacemaker's breaking. It's that interaction between the pacemaker and the patient that it was intended to serve. We looked at that, and we thought, "You know, that's actually unacceptable," because patients who get pacemakers need pacemakers.
But it's also something that we think we can address and stop and make a pretty big impact in healthcare. And so we started working on this concept of the drug-eluting biomatrix, and we did it to specifically address this series of problems that happens, not just one of them, but all of them. So the first thing we do is we start with a natural biologic matrix, and this biological material that we use, the purpose of using it is because it will actually down-regulate inflammation, it will prevent migration, so it'll literally prevent the device from moving, and it will prevent scar tissue from setting up. And those are three big things that happen and take place during this foreign body response.
But we don't leave it there. We add to it a pharmaceutical payload that we actually impregnate into the product. We combine those two things together, and that's what ultimately leads us to this drug-eluting bio matrix. So it's this natural biological material that down-regulates inflammation, prevents migration, prevents fibrosis from setting up, but it also has an extended release of antibiotics so that the patient is protected from getting an infection from this procedure.
The great thing about using a biologic is this: A great way to prevent a foreign body response is for there to not be a foreign body, and when you implant a biological material like the bio matrix that we use, it is remodeled and incorporated into the patient's own healthy tissue over time. So in not very long, you know, in a few months, this implant that we've put in there has now been completely remodeled into the patient's own healthy tissue. It's their tissue that's protecting them, and if it's their tissue, then they can't have a foreign body response to it. So introducing EluPro. This is. We're super proud of this. EluPro is the first antibiotic-eluting bioenvelope.
It received FDA clearance, as I said, in June, for both cardiac implantable electrical devices or pacemakers and defibrillators. We also received clearance, though, for all forms of neurostimulators. That's another about $8 billion market in the United States, the neurostimulator market. These are for things like urinary incontinence, pain, sleep apnea, and things like that. So this is EluPro. First thing I think to understand about with EluPro is to understand where it fits into this market and the market that we're going after because we developed a great product, but we also developed a great product in a really, really great market with really favorable market dynamics. And this is why I say that.
So 600,000 of these procedures a year, a complication rate of 5%-7%, in this pacemaker and CIED space. There's only four players in this pacemaker and CIED space in the United States. Medtronic's largest at 40%, then there's Boston Scientific and Abbott, and then lastly, Biotronik at 10%. So the whole space is divided up between these four. Medtronic several years back looked at this issue and saw an opportunity, and so they actually acquired a product called TYRX. They bought this back in 2014 for about $200 million, when there was really no device protection market to speak of at all.
TYRX is an interesting product because it is also an envelope for pacemakers, but it's a fully synthetic envelope. And what it does is, it basically dissolves within the patient, and as it dissolves, it elutes an antibiotic. It elutes actually two antibiotics, rifampin and minocycline. And that prevents the patient from developing an infection. And it's fairly simple technology, but they've done a phenomenal job with it, right? So they launched this product, I think, back in 2014 or 2015. And it generates somewhere between $250 million-$300 million a year for them in this space, and they're the only ones that have it. And so we looked at this, and we thought, "You know what?
It's a great idea, and it's a great first-generation product, but two things: One is, if you're Boston Scientific, Abbott, or Biotronik, that's 60% of the market that doesn't have access to an envelope, one. And two, we think we can make a much better envelope, and so that's what we set about doing with EluPro. And so now we have 60% of the market that's really just sort of pure white space for us. And it's even better than pure white space, because if you're Boston Scientific or you're Abbott, the one thing that those two companies can agree upon is neither one of them wants a Medtronic wrapper going on the outside of their pacemaker. And so that creates a very favorable dynamic for us. Elutia doesn't make a pacemaker, so come on into our procedure.
We'd much rather have your envelope around there. And so they haven't had access to an envelope, an antibiotic-eluting envelope, until now. And like I said, we didn't just make EluPro to introduce another antibiotic-eluting envelope. We made EluPro to introduce a better antibiotic-eluting envelope. And we're not alone there. So we actually went out, and we got 50 electrophysiologists together who were TYRX users, and we polled them, and we asked them, would they switch some or all of their business to EluPro, to a biologic envelope once we were able to get it to market? 88% of electrophysiologists polled said they would, in fact, switch some or all of their business.
That just goes to show you, we're not just putting a product into a market with a very favorable market dynamics. We're actually putting a better product into the market that electrophysiologists are really, really excited about. The next thing we need to do is, now that we've gotten it cleared, and we have really great market dynamics, we need to get it out there, and get on with launching the product. That's what we're doing right now. We are underway with the market launch of EluPro. We've started to manufacture the product, and the first units are rolling off the production line as we speak.
Because we had a base business here to start with, we actually are already active in about 400 hospital systems right now in the United States, and we continue to add more to those every day. The most important and the most critical aspect, we like to say the rate-limiting aspect to the adoption of EluPro, we believe, is actually at the VAC submission process or the Value Analysis Committee submission process. This is where hospitals need to review the product in order to put it on formulary so that the physicians can order it for their patients. So in order to do that, you need to submit these packages to the hospital systems so they can evaluate the costs and the benefits of the product.
So we have completed our VAC submission package, and those are now being submitted by each of the individual system's key opinion leaders in order to expedite that process. So that's underway. Not only are we submitted a whole lot of VAC systems, but we actually already now have approval at a lot of these VAC systems. We're really excited about the early traction we're getting there. So the timetable for this whole launch is we're looking at soft launch starting imminently in the second half of 2024 . We're initiating a registry. We're collecting real-world data on this.
The physicians that are using this product are really, really excited about it and the publications that will come out of that, and that's all in preparation for our full launch, which will start January 1st, 2025 . We also have all of our collateral and packaging made, so it's a really, really exciting time as we launch this product. So that's what I have for you today. We like to say we didn't develop EluPro to get to the finish line. We did it to get to the starting line of what we have. So we're a fully integrated company with a revenue run rate of about $27 million. We have a really great platform technology.
We've started this off with EluPro, but we actually see applications for this across a range of products, including breast reconstruction, which we're also very active in. Have FDA clearance in the $600 million market. Right behind EluPro, we have SimpliDerm, which already has a $14 million run rate and is growing really, really well. And then lastly, from an investment standpoint, we've actually also completed just recently a series of offerings. We have twenty-eight. That just brought in $28 million into the company. So we're a very well-capitalized company. We have the financial resources that we need in order to be able to get our plans done. So with that, I'll turn it back to you.
Thanks very much, Randy. Great talk.
Thank you.