Hi, good morning, everybody. Welcome to day two of Cantor's Global Healthcare Conference. I'm Kristen Kluska. Very happy to introduce a company that I cover, Humacyte. They have lots of exciting things going on. Presenting from the company will be Dr. Laura Niklason, the CEO. Thank you so much for being here.
Thank you, Kristen. It's great to be here. We always love coming to the Cantor conference. There's always a lot of great investor and analyst interactions. So, I'm going to be providing an update today on Humacyte and our platform technology, which creates, as the slide says, universally implantable regenerative human tissues. Humacyte's platform uses human cells and a proprietary bioreactor system to essentially use those cells to, and harness their power, to create new human tissues, in our manufacturing suite. The tissues that we grow are grown from a cell bank, but after we grow the tissue, and right now we're growing arteries, human arteries, the arteries are decellularized, and what's left behind then is really the human extracellular matrix that the cells made.
By doing that, we create an engineered human tissue that can be implanted into anyone without rejection. In fact, we've treated nearly 600 patients now over more than a decade, having a whole range of diseases, and we've never had an instance of immunologic rejection. Also importantly, because our vessels are non-cellular, but they're human tissue, after they're implanted, they repopulate with cells from the patient and essentially become a living artery over time. Humacyte's technology platform is really first in class. There's no other company on the planet that's doing this, and importantly, we've taken our technology up to a commercial scale. In fact, we transitioned to our commercial scale manufacturing facilities more than 3 years ago now, in June 2021.
So all of our ongoing clinical trials have been performed using product that we've made at our manufacturing scale, so we commercial scale, so we're already there. We're very near market launch. We submitted a BLA in December of last year, and we're awaiting a final decision from the FDA, but all of our indicators have been positive throughout the review. Importantly, we have some great interactions that really validate both our engineered vessels and also the technology platform, including a strong relationship with the Department of Defense, who's very interested in using our vessels to treat wounded warfighters, and also, for example, Fresenius Medical Care, which is the largest provider of dialysis services worldwide, so here's a very high-level view of how our technology works.
As I mentioned, we have a human cell bank that's proprietary, and when we launch a batch of tissues, we grow 200 arteries at a time, and the arteries are grown inside large bioreactor systems that we've developed that are housed inside of an incubator that's as big as a school bus. It's this incubator system that we've installed in our manufacturing suite, and these incubator systems are modular, so each incubator system, called a LUNA 200, can make about 1,000 engineered arteries per year, so anyway, when we start the process, we thaw a vial of cells, and we grow them, and we seed them onto scaffolds, polymer scaffolds, that are the size and the shape of the tissue that we want to grow.
The cells attach to the scaffold, and they're grown inside this bioreactor system, and over a period of two months, the cells proliferate, and they secrete extracellular matrix proteins like collagen, and while that's happening, the polymer scaffold dissolves. After two months, we have an engineered artery that is the size and the shape of that we dictated, but by the size and the shape of the scaffold, but there's really no scaffold left. In a final step, we wash the cells out of the tissue. Again, the final product is an engineered human artery that's acellular. It has a shelf life because it's non-living.
We can store it for a year and a half in the fridge, and we can make batches of vessels and then ship them to hospitals and clinics, where they can be sitting there and ready when a surgeon or a patient needs them. So as I've mentioned, we've implanted more than 600 patients, or nearly 600 patients, in a variety of disease states. Our lead clinical indication is in using our vessel to treat traumatic injuries. And in fact, we've collected data both in civilians and in military patients who've sustained severe arterial injuries that have been repaired and essentially cured with our engineered arteries. That's our lead indication. In addition, we've completed phase III studies using our engineered vessel as an arteriovenous graft in the arm for dialysis access.
This is for patients with kidney failure, and in fact, about six weeks ago, we had a readout of top-line results of a phase III trial that compared our vessel to the gold standard in dialysis access, and that was positive for superiority over the one-year timeframe. So we're very excited about that as a second indication. In addition, we've completed phase II trials in peripheral artery disease, and we're actively designing a phase III trial now in patients who are suffering from critical limb ischemia. And many analysts and our internal folks argue that actually the PAD market may be the largest of the three markets that we're targeting right now. But, you know, to step back more broadly, you know, our technology platform really is a platform.
So beyond these three clinical indications that we're studying right now, we also have preclinical work that we've published and that's actively ongoing, using smaller caliber vessels, versions of our vessels, in pediatric heart disease models, in coronary artery bypass, and we're also using our current size vessel as a cell delivery vehicle to deliver islets for patients with Type 1 diabetes, so we've got a lot on offer here. I think that we have many shots on goal as a company, and we have executed on and are approaching additional value inflection points, so I mentioned that the vessel repopulates with cells from the patient over time, and this is just an image of that.
So when our engineered vessel is implanted in the patient, again, there's no cells in it, but over time, after implantation, stem cells from the patient sort of crawl in, and they migrate in, and they take up residence inside the wall of the vessel and essentially turn it into a living artery over time. And you can see that in this image here. The red color, spindle-shaped cells, which make up most of the wall of our acellular tissue engineered vessel or the ATEV, which is what we call it. Those cells essentially populate the entire ATEV wall. This is a biopsy of a patient who had our vessel in his arm for nine months and was using it for dialysis access.
We got a small biopsy of the vessel at that time, and this is the amount of cellular repopulation. What the cellular repopulation does, we believe, is a couple of things. One is because the tissue becomes living over time, it becomes self. It's durable. In fact, we've had these vessels implanted in patients for dialysis and for peripheral artery disease going on 10 years, and we've seen no evidence of mechanical deterioration. So these vessels are very durable. But in addition, because they become living, we've also seen that they have a very low infection rate. Unlike plastic grafts that are made out of Dacron or Teflon, which, if they get seeded with bacteria, they can become infected, and that's almost impossible to clear. Our vessels have a very low infection rate.
So I'm gonna talk about our first indication in vascular trauma and, you know, I'm gonna start off right now and warn the audience there are some gory photos here. Just apologize if you've just eaten breakfast. But essentially, thank you for that. That's great. Anyway, but essentially, what we have is in traumatic injury, if you have patients who are presenting to the emergency room, say, at 2:00 A.M. in the morning with a car accident or a gunshot wound, typically, if the arteries are injured, blood flow is cut off, you know, distal to the injury, and typically, these wounds are contaminated.
So these patients will get worked up for a few hours and then will finally arrive in the operating room, and at that time, the vascular or the trauma surgeon has a couple options. He can spend another hour harvesting vein from some uninjured part of the body and then tying off all the branches and moving that vein over to fix the injury. The disadvantages there is that it further injures the patient, and it also takes time, and it extends the ischemia time that these patients are suffering. Secondly, if he feels he doesn't have time, he can reach up on the shelf and pull down a synthetic graft made out of Teflon, for example.
In most conditions, surgeons are really hesitant to put a plastic graft into a contaminated wound because the chances of it getting infected are really very high, so if the surgeon feels like option A and option B aren't really feasible, then he can cut off the limb, and that's the state of play, so we believe our engineered vessel or the ATEV really is uniquely qualified to improve the options for patients and surgeons in vascular trauma, and the reason is that it's kind of the best of both worlds. Our vessel is immediately available, you know, from the time the nurse takes it out of the refrigerator and opens up the packaging, and the surgeon cuts into the packaging to take the vessel out. It's about two minutes.
So these vessels are immediately available for patients who are suffering acute injuries. So that makes them sort of like plastic grafts, but the upside is that, our vessel is not plastic. It becomes living tissue, and so it has a low infection rate. And in fact, with some data that I'll show you, implantation of these vessels into contaminated wound beds has actually resulted in a very low infection rate. So it's kind of the best of both worlds for surgeons and for patients. So we have completed enrollment, and we actually read out top line last year, on a phase II/III trial. That was a single-arm trial. That was a civilian trial, looking at patients in the U.S. and in Israel who were suffering extremity traumatic injuries.
And this is again car accidents, gunshot wounds, industrial accidents, and this was all at Level I trauma centers in the U.S. and Israel. And the primary endpoints here were mostly at 30 days, looking at patency, which is: Is there blood flow going through the conduit? Has the limb been salvaged, and is the conduit infected? I do want to point out, though, that all of the patients in this trial are followed for 3 years or until they're lost to follow up... So again, these are some of the injuries that were treated in this trial. Again, different mechanisms of injury, gunshot wound, knee dislocation, et cetera. So these are the outcomes that compare the civilian data to an external benchmark, which is actually that of synthetic grafts.
Because it's, you know, if you're treating acute traumatic injury, where patients present to the emergency room, literally bleeding to death, randomization in that setting is essentially impossible, and the FDA acknowledged that. What they did was they allowed us. They agreed that we would look at the published literature in synthetic grafts and compare our outcomes to those published outcomes from the last 20 years. This is just a comparison of our civilian patients for that outcome. What I wanna also show you is an additional, very important data set for the Defense Department and for our company.
While this civilian trial was ongoing, war broke out in Ukraine, and a few months later, we began receiving requests from Ukrainian surgeons asking for access to the vessel in order to treat wounded warfighters. We worked with the FDA, we got permission to do this, and we sent our vessels to five frontline hospitals. These results have been presented at military medicine meetings, most recently just a few weeks ago. Essentially, we treated a total of nineteen patients, and when the FDA was informed about some of the outcomes, they actually asked us to go back to Ukraine and re-consent these patients and retrospectively collect data and include that as real-world evidence as part of our BLA file. We did that.
So we were able to collect data on 16 patients who had non-iatrogenic extremity vascular injuries, who were around to provide consent. The couple patients that we lost actually returned to the front lines and just were not consentable. But essentially, these were the outcomes from those patients, and as you can see, most of the patients that we treated in this setting suffered really horrific injuries, most of them blast and shrapnel injuries. You know, bullet wounds are not as common in modern warfare. Most of the wounds in modern warfare are actually much dirtier and much more difficult to treat. And in this case, our outcomes were outstanding. I also want to say that we were not able to go to Ukraine and train these surgeons.
In fact, we had to train them over Zoom in Ukrainian to teach them how to take the vessel out of the bag and sew it into the patient. So this is not a difficult product to use for surgeons, and the learning curve is very short. So when we combine the civilian experience and the military experience into a single cohort, which is actually what the FDA asked us to do, and then when we compare that to our benchmarks, we see that the results are really very impressive. So, we had significant improvement in patency at 30 days, in the rate of infection, which was vastly lower than for synthetics, and also, probably most importantly, in the rate of amputation.
What the literature tells us is if you have an arterial injury in the limb, and if you get a plastic graft to treat that, you have a one in four chance of losing the limb. If you got our vessel, you had a one in 20 chance of losing the limb. This is a huge efficacy benefit that helps patients and also helps surgeons. As I mentioned, we filed our BLA in December of last year. We've marched through the entire review process. The file was accepted in February. We've gone through all of our inspections, our manufacturing inspections and clinical inspections, and we've discussed and finalized post-approval requirements and also have had extensive discussions on the label.
Our initial PDUFA date was August tenth, and actually, CBER reached out to us the day before and said that they needed more time. This is a first-in-class product. We are regulated as a biologic by CBER, but the Center for Devices also consults on this product because it's a surgically implanted device-like thing, and so FDA has told us that they just need more time. We do not have a new PDUFA date, but we also have gotten no indications from them that they are asking specific questions or need more data or anything like that, so we are standing back and allowing the FDA to work through its process. We still have outstanding confidence that this is going to get approved.
We've gotten no signals to the contrary, and I believe this is just really a time thing for a fundamentally new technology that the FDA is still getting its arms around, so I'd like to touch a little bit on our clinical results in dialysis, which I think are also very exciting. Again, this is an engineered artery, which we've made in a size which is 6 mm in diameter and 40 cm in length, and some of our vascular surgeon colleagues say that this is one size fits most, and so this same diameter, the same configuration of engineered artery has been used in all three of our clinical indications.
So, end-stage kidney disease, which is a growing clinical problem, despite what you may be hearing about GLP-1 inhibitors, hypertension and diabetes and other diseases and obesity are still driving end-stage renal disease. If you have to go on dialysis and go to a dialysis clinic three times a week to get your blood cleaned, patients who undergo that need to have a conduit, typically in their arm, that connects an artery and a vein, that has a high blood flow rate going through it so that nurses can insert needles into that conduit, draw blood out, run it through the machine, and treat the patient.
So the standard of care for providing access is what's called a fistula, an AV fistula, which is where a surgeon goes into the arm and sews an artery and a vein directly together. When that operation works, that fistula, that conduit is very durable, and it really is, and has a low infection rate, and really is the standard of care. The problem, though, is that about 40% of the time, that operation fails. And again, vascular surgeon colleagues of mine say that there is nothing else we do in medicine where I go into the patient, and I say, "I'm doing this operation. It's the standard of care," but it's a coin flip as far as whether or not it's gonna work.
So the reason for that is that after the artery and the vein are sewn together, about 40% of the time, the vein doesn't dilate up over the subsequent months and become large enough so that nurses can insert needles into the vein, and the blood flow rate doesn't increase enough. So for those patients where the fistula operation is done, but it doesn't work, they're forced to rely on plastic catheters, which are in the neck, and which have high rates of infection, and sepsis, and hospitalization, or they can fall back to a plastic graft in the arm, which also has low durability and a high infection rate.
So again, we believe that the product profile for the ATEV really provides a huge value proposition in dialysis as well, and that's because, again, this is an off-the-shelf product that's already the right diameter. It's 6 mm in diameter, so after the surgeon sews it in, after it heals for a few weeks, it's usable for dialysis. There's no waiting for the vein to mature. But in addition, our prior studies have shown in multiple indications that this vessel, after it's implanted and is rapidly usable, also has a very low infection rate. So again, it kind of has the best of both worlds in the dialysis indication as well.
So what we recently read out a few weeks ago is a phase III trial that we call the V007 trial, which was a prospective, randomized, head-to-head study in U.S. centers in 240 patients, where we looked at randomizing patients to either fistula or our vessel, and in fact compared outcomes in terms of usability for dialysis and also patency or blood flow rate at 6 and 12 months. So here's the top line, which is a co-primary endpoint, and again looking at 6 months and 12 months, what we see overall is that the usability for dialysis by a very strict set of criteria was about 81% for our vessel and was only about 66% for fistula.
And again, the patency was also better at twelve months at 68% and 62%. So what this reflects really is, you know, when you see those low numbers on fistula, that's actually not surprising to clinicians. In fact, to get into this trial, you had to be a really good fistula candidate. So poor fistula candidates weren't even admitted in this trial. And we still won by a huge margin with a P value of 0.007. So we are doing. As we've messaged the market, we're doing subgroup analyses in this trial.
And what we're seeing, and what I think we'll be able to provide a webinar on in a month or two, is that some of the subgroups of patients that are known to have real problems with fistula maturation, like women, obese patients, diabetics, et cetera, that are known to have problems with their fistulas and are known to be very expensive to the healthcare system, these patients did particularly well. And we're very excited to share some of these data, because we really think it will support not just the clinical efficacy case, but frankly, the health economic case. Because for these high-risk groups in particular, if you can provide durable, usable access that doesn't get infected, it can really change healthcare costs and also morbidity for patients.
Going along with this, in order to bolster some of our health economic arguments, we've actually been working with Fresenius, who's our commercial partner in Europe, to really look at their data and understand what demographics of patients do have problems with their access and how much does that cost the system. And in fact, we're writing a paper on this now, but we did a webinar on this a couple of months ago, and what we showed is when we looked at tens of thousands of U.S. patients from the Fresenius database, that if you fell into an upper quintile of costs, which had a lot of women in it and a lot of obese and diabetic patients in it, for example, the upper quintile of patients was extraordinarily expensive for the system.
In fact, their estimates of cost just to maintain dialysis access was on the order of $90,000 per year or greater. So these are enormous costs that we believe in these high-risk patients we can mitigate for the system because we'll be able to provide a vessel that works, and it's durable, and it doesn't get infected. So in further support of this, we're actually doing a trial just in women in dialysis access. It's never been done before, where we're comparing head-to-head our vessel against fistula in women, all comers, diabetic, non-diabetic, obese, non-obese, et cetera, et cetera. And that trial is enrolling pretty briskly, and we're gonna be excited to share results on that in the future.
So I'm gonna skip over PAD because I'm conscious of the fact that we've only got a few more minutes. But I do wanna talk a little bit about path to market and commercialization. So again, in terms of commercial launch, Humacyte as a company has been gearing up for this, for actually a couple of years. We have in place a commercial team, that's comprised of marketing and some health economics, which, you know, we've been able to make very potent cases that the health economic argument in trauma, in particular, is actually a very easy one.
You know, if you cut amputations by a factor of five, the savings to the hospital and the savings to the insurers are enormous, to say nothing of the fact that patients would really rather not undergo an amputation. So making these health economic arguments has actually been fairly straightforward in our first indication. So that's all sort of in the bag. We've also laid out a commercial and a sales plan. Interestingly, trauma is an indication that we're launching ourselves in the U.S., and it's actually a doable lift for even a small company because there's only about 200 Level I trauma centers in the United States. And that can be reached with a sales force of about 18 reps.
Because we fully anticipated getting approval on August tenth, we've actually brought in half of our sales force. And they're training now, and they're in the process of understanding their primary commercial targets in their territories, and they're getting to know who's on the value analysis committees, et cetera, et cetera, et cetera. Even though the response from the FDA has been delayed a little bit, we're moving forward, and continuing to get our sales reps out there, train them up on the technology and the clinical results, and get them focusing on their targets so that when we do get approval, then they'll be able to take off, and that ramp will hopefully be even steeper.
But in addition, as far as other markets, we do have a collaboration in place with Fresenius, who has pledged to do the commercialization in Europe, actually for our first three indications, including trauma, dialysis access, and PAD. And we're working with them very closely, as I said, on health economics in the dialysis patient population, even in the U.S., but also talking with them about when we do move into Europe, those commercialization plans. So I think that. Again, what I'd like to say is that in terms of manufacturing readiness, I believe we're there. Again, as I mentioned, we do manufacturing ourselves. This is a complex process, and outsourcing it is something that's not really the most efficient approach for this technology, so we keep this in-house.
I like to say we're a vertically integrated biotechnology company, but essentially, currently in our facility, we have eight of these large manufacturing units installed and ready to go. Each unit can make about 1,000 vessels per year, which means that our current capacity is about 8,000 vessels per year. If we look at some analyst estimates of uptake and our own internal estimates, that capacity is certainly enough to carry us for the first couple of years of commercialization, and because we've got a lot of space in the building, we've actually got room to build out a total of 40 of these units, so the total capacity in this building is about 40,000 vessels per year. The next question we always get is anticipated price point.
We have not given definitive guidance about a price point for the vessel. However, some of our SEC filings have provided estimates in the $25,000 range, and what we've guided is a price point in the $25,000-$30,000 range for all customers, is probably where we're gonna land. So with that, I think I'll finish. But I guess I'll end here by saying that we've made a lot of progress the last year or two. We've hit a lot of milestones, and we've executed like we said we were gonna execute. So we are holding our breath. You know, the FDA is holding its breath a little bit, and you know, I think we'll get an answer from them soon. Could be a couple of weeks, could be a couple of months.
But again, we fully anticipate approval in this first indication. And with dialysis access, our second indication, we're moving forward. We're scheduling meetings with the FDA. We're doing the data analysis. We're presenting the detailed results. We're moving. So we're really looking forward to the end of this year and to next year for a lot of catalysts and value inflection points. So thank you very much.