Introduced to you today, Humacyte. Humacyte possesses a very innovative product, one of the most innovative products I've seen in a long time in the cardiovascular disease and damage space, called the ATEV, the acellular tissue vessel. With us today is Laura Niklason, CEO. Laura, please take it away and introduce us to the company.
Thank you, Vern, and really appreciate the opportunity to speak with you all today. And so I am going to be speaking about Humacyte. I'm the Founder and the CEO. With me also in the room today is Dale Sander, who's our Chief Financial Officer. Okay. Well, I'm pressing forward. There we go! Okay, so Humacyte's acellular tissue engineered vessel, or ATEV, as we're calling it now, is really a first-in-class advance in the regenerative medicine space. And we really like to call our engineered tissues essentially spare parts for people, because that's what they are. We are growing human tissues from scratch in our biomanufacturing facility, and these tissues can be stored on the shelf in hospitals for up to 18 months until they're needed by surgeons and patients.
Again, these are first-in-class tissues that can be implanted into any patient without being rejected, and indeed, we've treated nearly 600 patients with a range of diseases with our engineered arteries. Importantly, patients don't need to be immunosuppressed after they receive these engineered vessels. So in any event, Humacyte's platform has really been validated by a number of important partnerships. One is the fact that we are partnered with Fresenius Medical Care, which is the leader in outpatient dialysis services. We also have active partnerships with the U.S. Department of Defense, who's very interested in the use of our engineered blood vessels for treating wounded warfighters.
Importantly, Humacyte already has commercial-scale manufacturing in place and has had that system in place since 2021. We are in the final stages of FDA review of our BLA, or Biologics License Application, and we expect that review to be completed later this year. Here's an overview of our bioengineering process that we use to make engineered tissues, and really, this starts from a human cell bank. This is a cell bank that Humacyte has developed over more than a decade, and in fact, this cell bank now is sufficiently large that it can support our engineered tissue production for the next 30 or 40 years.
So it's important to know we don't have to take cells from the patient in order to make our tissues, and in fact, the cell bank that we have is large enough that we actually stopped isolating new tissues, new cells, several years ago. But regardless, we start with a cell bank, and then we take an individual vial of cells, and we thaw it, and we expand those cells, and then seed them onto scaffolds. And these scaffolds are biodegradable, and the size and the shape of the scaffold really dictates the size and the shape of the tissue that we ultimately grow. Each scaffold is contained inside an individual bioreactor bag, and it's inside that bag that the vessel grows over a period of two months.
After the growth period, we then fill the bag with solutions that wash the cells out of the tissue. What this means is that after a few days, we produce an engineered tissue that is non-cellular, which means that it's non-living and has a shelf life of a year and a half. But it also means that it does not induce immune rejection, as we've seen in the treatment of hundreds of patients over the last 10 years. The engineered vessel that we make is actually contained in a bioreactor, and believe it or not, we've got show and tell here, so I'm going to ask Dale to pass this around. But this will give you a sense of what the vessel looks like when it arrives in the surgical suite, for use by the surgeon.
The surgeon can cut into the bioreactor bag and remove the engineered artery, and this process takes just a minute or two, and then the surgeon can be sewing it into the patient. So, as I've mentioned, our engineered vessel has been used in hundreds of patients in a number of clinical indications. Our lead indication is illustrated by the use of the vessel in treating traumatic injury. This is an area where the U.S. Department of Defense has a tremendous amount of interest. And indeed, the U.S. Department of Defense has supported part of our pivotal trial, that's been the basis of our BLA filing to the FDA. But in addition, we've completed Phase III trials in dialysis access in patients with kidney failure, and we've completed phase II trials in patients with peripheral artery disease.
Because this is a platform and because we can grow tissues of different shapes and sizes, we also have an important pipeline. So we're able to grow tissues that are smaller, engineered arteries that are smaller, that we're currently testing in non-human primates for heart bypass. We're also using these vessels as delivery vehicles for cells, specifically islets, so that we can treat Type 1 diabetes. So this is just an example of how our engineered vessels behave once they're in the body. After implantation, these engineered arteries repopulate with cells from the patient and basically become living tissues over time. This makes this an important regenerative medicine therapy, that really has not ever existed, with any previous product candidate. So I'd like to talk about our first indication in traumatic injury repair.
So this is, again, a target for our first FDA approval, which we are expecting later this year. Essentially, when a patient presents to the emergency room, having suffered a serious injury, whether that's from a car accident or a gunshot wound or what have you, typically, that patient requires several hours of workup, and then by the time the patient finally gets to the operating room, it's been several hours, and in that case, the patient's arm or leg has been without blood flow for really quite some time. At that point, when the patient arrives in the operating room, there's really three options.
The surgeon can spend another hour and injure the patient further, and take vein out of the patient's leg, and then move it over and repair the injured artery. That's obviously not optimal because it takes additional time and increases the ischemia time for the patient and also further damages the patient. Alternatively, if the surgeon feels he doesn't have time, then he can pull a plastic graft down off the shelf and restore flow immediately. The problem there, though, is that if you put a plastic graft into a contaminated wound, the rate of infection is really quite high. So then, the third option is that the surgeon can amputate the limb, and really, that's the state of play right now in injury repair, both for civilians and for wounded warfighters.
We believe that the acellular tissue engineered vessel is really ideally suited for the treatment of traumatic injuries for two reasons. The first is, as I mentioned, it's immediately available. It's off the shelf. The surgeon doesn't have to spend an hour digging vein out of the patient in order to try to fix the problem, but also, importantly, after the vessel is implanted, it becomes repopulated with cells from the patient, and because of this biologic basis, it really, we have observed in multiple clinical trials that our vessel resists becoming infected, and as I'll show you with some of our clinical trial results in the area of trauma, our infection rate, even when these vessels are implanted into contaminated wounds, our infection rate is very low.
So we believe that this vessel has all the advantages of an off-the-shelf product, but also the advantages of a vein from the patient. So, after working with the FDA to design this trial, we conducted a single-arm trial looking at the efficacy and safety of our vessel in treating patients with traumatic injury at 20 centers in the U.S. and also in Israel. The endpoints in this trial are patency of the vessel at 30 days, but also limb salvage and the conduit infection rate, also at 30 days. That said, even though this is a short endpoint, we follow all of the patients for three years during this study.
Sorry for the gross photos, but this is just some of the injuries that we've treated during the course of this trial. Again, we've treated car accidents, gunshot wounds, industrial accidents. We've treated a patient who was crushed by a cow, a patient who was crushed by a crane. You know, some of these injuries are really pretty heinous and would be debilitating if the surgeon was not able to restore blood flow. So I'm going to include now some discussion of a humanitarian effort that we undertook in Ukraine.
So in addition to the civilian trial, which we enrolled for several years in the U.S. and Israel, over the last two years, we've been involved in a humanitarian effort in Ukraine that was really prompted by some surgeons requesting availability of our vessels to treat wounded warfighters in that conflict. For a one-year humanitarian period, between June of 2022 and June of 2023, we treated a total of 19 patients who had serious war wounds, many of them shrapnel wounds from IEDs and blast injuries. This is just one example of one patient who was badly injured by an IED blast injury. You might be able to see there's a CAT scan here, where this patient's thigh is just filled with shrapnel and metal and rock. So these injuries are really pretty horrific.
But despite the fact that these patients sustained terrible injuries, and despite the fact that we had to train these surgeons over Zoom, because we couldn't go to Ukraine and train the surgeons, they actually achieved outstanding outcomes in terms of patency at 94% and 100% limb salvage. So if we combine the US data and Israeli data in civilians with the wartime data in Ukraine, which is what the FDA asked us to do upon seeing sort of the totality of the data in our file, these are the combined outcomes.
So the patency rate for our vessel at 30 days was about 91.5%, whereas the benchmark, which was a literature review of how well synthetic grafts do in similar patients, the literature benchmark was only 79%. Our conduit infection rate was very low, less than 1%, which compared very well to the 8% for synthetic grafts. And most importantly, I think our amputation rate was very low. Despite some pretty heinous injuries, only 4.5% of our patients had amputation of the treated limb, whereas one in four patients, or 24% of patients treated with synthetic graft, went on to amputation. So, as I mentioned, we filed the BLA in December of last year.
The BLA was accepted by the FDA in February, and we marched through multiple steps of the BLA approval process. We, we've completed inspections and discussions of post-approval commitments, and we've begun discussing labeling. Our initial PDUFA date was August 10th. However, the FDA contacted us on the day before the PDUFA date and said that they needed a little bit more time to consider the file. This to us is not shocking, given the novelty of the product and our manufacturing process, and also given the large impacts that this has, not just for trauma care, but also for vascular surgery more broadly. So we do not have a new PDUFA date, but we are expecting to hear from the agency in coming weeks or coming months, regarding what we anticipate will be an approval decision.
So I'd like to talk about our second indication, where we've had really some excellent news more recently. And this is in using our vessel as an access point for hemodialysis patients. So for patients who have kidney failure and who are on hemodialysis, what they need is a conduit that connects an artery and a vein in their arm, so that blood can be taken from the patient three times a week and run through the dialysis machine to clean their blood. The standard of care in this space is what's called a fistula, which is a connection of an artery and a vein directly together. However, in many cases, fistulas fail, or fail to mature, particularly in certain subgroups, like women and obese patients and diabetic patients.
So we undertook a head-to-head trial, looking at the usability for hemodialysis of our engineered vessel, and also looking at patency of our engineered vessel over the first 12 months, as compared to fistulas. We believe that the value proposition for our vessel in hemodialysis patients is the fact that, unlike a fistula, which needs to mature, which means the vein needs to dilate up over time, in fact, our vessel does not need to mature. It, it starts off at the correct diameter, and it's immediately usable after implantation. So we undertook a phase III trial in the U.S., at more than 20 clinical sites, where we did a head-to-head comparison of our engineered vessel, the ATEV, against the standard of care, which is PDUFA date or AVF.
That trial completed enrollment in April of 2023, and we recently announced top-line results about six weeks ago. So this is a summary of our top line. This is a co-primary endpoint, where we looked at usability for dialysis at six months, combined with patency, or blood flow through the conduit at 12 months. And as you can see, this combined endpoint had a strongly positive p-value of point zero-zero seven, meaning that we hit our endpoint with a vengeance, and that we showed significant improvement in both usability for dialysis and patency over what is now the standard of care.
We also have built-in subgroup analyses that we've not yet shared with the market, but which but which are very encouraging, particularly for certain subgroups of fistula patients that are known to have a lot of trouble with fistula maturation, particularly women and obese patients. And we look forward to sharing some of the subgroup analysis with the market in several weeks at an upcoming key opinion leader webinar. So I'd like to, I'd like to go on to some of our commercialization plans, given the short time that we have left. But, but essentially, what I'd like to point out is that in addition to the completed phase III study looking at all patients, we also have a woman-only study in dialysis access, which is the first of its kind, where we've enrolled a substantial number of patients already.
Because we believe that women, who are nearly half of dialysis patients, are really underserved in terms of, in terms of access usability, and not only do they suffer higher complications, but they also drive enormous costs in the system, for some of these patients, more than $90,000 a year just to maintain their access, so I'm going to skip ahead to some of our commercialization plans, because I think it's important to share those, so as I mentioned, Humacyte is a platform. We have ongoing clinical trials in multiple large markets, and we also have preclinical work addressing clinical problems such as coronary artery disease and Type 1 diabetes, so we believe that the platform and the potential value for Humacyte is enormous going forward.
Importantly, as I've mentioned, we are ready, and we are poised for commercial launch once we have approval of our vessel in our first indication in trauma. We have a manufacturing facility, which is up and running, and which has been up and running at commercial scale since 2021. We also have strong strategic relationship with Fresenius Medical Care, and we anticipate that once we get our second approval in dialysis access, that the partnership with Fresenius, both in the U.S. and overseas, will really help to drive commercialization and market adoption. I'd just like to show a slide of our commercial manufacturing facilities.
As you can see here, these facilities are built out with state-of-the-art, but also proprietary equipment that allows us to produce the engineered vessels that you saw in batches of 200 at a time. This is a highly automated and already scaled process, and importantly, the amount of production capacity that we have in place right now is already sufficient to meet the first several years of commercial need. So we do not anticipate a huge spend for commercial launch. Again, because the trauma market, which will be our first indication, is a fairly narrow market, we don't anticipate a very large sales force, you know, fewer than 20 representatives, and again, our commercial scale manufacturing is already built out.
So, with that, you know, I see that I'm coming up on time, so I'd like to take any questions if folks are interested.
Could you speak a bit more about the manufacturing facility? What's it doing now? It sounds like it's burning money, unless you're able to subcontract out to do work for other people.
So the manufacturing facility is dedicated to our engineered vessels. We are currently running clinical trials, so we're producing product at a low rate, for purposes of supplying our clinical trials and also for purposes of ongoing, regulatory compliance. But again, it's not like the entire facility is built out. The engineering platform is modular, so we've built out only about 20% of the facility. The rest of the facility is shelled. It's ready for installation of additional, production lines as we ramp up, but right now, our capacity is at 8,000 vessels, which we believe is necessary to cover us for the first couple of years of launch. But the total capacity of the building is 40,000 vessels, so we're only 20% built out, so it's not like we're fully built out and sitting around idle.
The other question is, I'm sorry, I didn't hear you clearly. Is the vessel - Are the vessels, once produced, do they need to be refrigerated, or-
They are refrigerated, yes.
Thank you.
Great! I wanna thank everybody for attending the second day of the H.C. Wainwright Global Investment Conference. I wanna thank Laura for presenting us the story of Humacyte. We look forward to the approval of the ATEV later this year. Thanks, Laura.
Thanks.