Thank you everybody for coming. I'm really glad that we had a chance to walk through some of these things in person, and that you could hear some viewpoints from Dr. Curi. I'm gonna talk a little bit about our clinical trial results, which we actually announced at a virtual forum last week. In addition to that, Dr. Curi is gonna talk about a few cases that he's cared for with the HAV and the trauma trial. We're also very fortunate to have Devin and her mother here. Devin was a patient who was actually working on the docks in New Jersey. I don't wanna, I don't wanna spill too much of your story, but Dr. Curi treated her in this trial as well.
And if you'll notice, she's standing on some fabulous high heels. Okay? So I just wanna get that across right there. Okay.
Real quick, Laura, those online, if you could speak-
Yeah, just speak into the microphone.
Speak into the microphone. Yes.
We can hear.
Okay, can they hear better now? Are we hearing better now? Excellent. All right, I will do that. So here are Humacyte's standard disclaimers. These are the folks that are gonna speak to you today. The folks in the room, you've already basically met all of us. But for those online, I will be giving the presentation of the clinical trial outcomes, and then Dr. Curi is going to talk about some of his treatment experiences, and also we'll hear from Devin about her experience as a patient. So just to remind everyone in the room and online, the Humacyte's HAV or human acellular vessel is really a regenerative medicine product. It's grown from cells, and it's grown in such a way that after the tissue is formed in our manufacturing facility, we then wash those cells away.
The final tissue is actually proteins. It's collagen and other protein molecules that form a blood vessel that's mechanically very strong. I think everybody in the room can testify to that. And it's also very durable after it's implanted in the patient. But because it's human proteins, it's really viewed as the body treats it as its own tissue. It treats it as self, and in fact, cells from patients repopulate the vessel over time, so it becomes a living artery. So one of the, as Dr. Curi had discussed, one of the significant problems with traumatic injury is that patients who are injured in trauma do not have clean wounds. These are not sterile wounds that you might get in an operating room.
These are typically contaminated with bacteria and fungi, and that infection can be a real problem, in addition to the fact that the vascular injury means that blood flow to the limb is cut off. As Dr. Curi mentioned earlier, there's really three options for treating patients who have severe injuries, whether they're a civilian or military personnel. The first is to take vein from the patient, which takes time. The second is to take a plastic graft off the shelf, which is fast, but which has a lot of downsides, particularly infection and loss of function, loss of blood flow.
And/or lastly, if neither of those works, then right now, the remaining option is ligation and amputation, which is what obviously has been suffered by a huge number of soldiers in the recent Iraq and Afghanistan wars, and also is suffered by many patients in the US undergoing a civilian trauma. So the HAV, as we've seen, and as I mentioned earlier, becomes populated with cells from the patient over time. So after the HAV is implanted, it's initially non-living, but then cells from the patient migrate in and turn it into a living artery. It becomes the patient's own blood vessel over time. Because it becomes living, and because of the properties of how the HA...
The composition of the proteins in the HAV, what we've seen in clinical trials and in the laboratory is that bacteria don't really set up shop very well on the HAV. In fact, the patient's immune system is able to clear bacteria and prevent the HAV from getting infected, and we think that that's one of the hallmarks of some of our great outcomes that we've seen in trauma. So the indication statement that we're going after in our first filing for FDA approval, it sounds a little bit convoluted, but essentially what it says is that the HAV will be indicated for use in patients who have a traumatic injury, in whom vein is not suitable, and in whom the surgeon thinks that a plastic graft off the shelf is really not gonna be suitable either.
Since most traumatic injuries qualify as plastic graft, probably not preferred, what that means is that there's a significant number of patients who have vascular injury, who we think will fall under this indication once we get approval from the FDA. I will say that we've been studying the HAV in trauma since 2018, for about five years. We've amassed now between our this US trial and some of our humanitarian work in Ukraine, we've now treated over 90 patients with traumatic injury. And it's really that whole dataset that we're going to be submitting to the FDA later this year in order to get approval and so that the HAV can be on the shelf and treat, be used to treat anyone who needs it.
So essentially, as I mentioned, the V005 trial, which is the trial that we've just completed, that's the in trauma, which is the baseline of, or really the backbone of our filing with the FDA. We treated a total of 69 patients, and we treated patients with all sorts of injuries. We treated patients with motorcycle accidents, gunshot wounds, car accidents. We treated a patient in North Carolina who was crushed by a cow. We treated a lot of different types of injuries.
But because those injuries were so variable, the FDA asked us, they said, "We'd really like you to focus on a set of injuries that's a little bit more reproducible." So we said, "Okay, we're gonna focus for our data package for you, we're really gonna focus on injuries in the arms and legs, and a lot of the torso injuries we're gonna analyze in a separate group." So once we got to 50 patients with injuries in the arms and legs, that was really the trigger for us to be able to file for approval. So this is just some demographic data, which I'm actually not gonna focus on very much. But I will say that overall, the 69 patients in the trial were overall pretty young. The average age was sort of in the mid-30s.
Not surprising, because, you know, patients who are injured in car accidents and industrial accidents and with gunshot wounds are typically not older, although we did treat patients as old as 82 in this trial, or 81 years old, I'm sorry, and the youngest patient we treated was age 18. In addition, we had multiple different types of injuries, as I mentioned. Some were penetrating, which is where a knife or a gunshot or a metal fragment, you know, got injured the patient or sometimes there were crush injuries, like that situation where the cow crushed the farmer against the fence. He's doing very well, by the way. But the injury severity was pretty high.
There's a score that trauma surgeons use called the ISS or the Injury Severity Score, and it goes from 0 to 60. Typically, if the injury severity score is more than 16, that usually indicates serious or severe injuries. The average level of injury in this trial was around, the average injury score was around 21. These were not patients with little, tiny, you know, booboos. These are patients who had polytrauma, who were very sick. How did we do? Well, when we look at how well blood flow was performing in the HAV after 30 days after implant, what we saw is that roughly 90% of patients had good blood flow at the 30-day endpoint.
When we compare that to what's been published in the literature with synthetic grafts or plastic grafts that you can also pull off the shelf, that number came in at around 81%, which means that our, that our patency values were substantially better than those that have been reported for synthetic grafts. So that's already, in our view, that's already a win. You know, if you can pull an HAV off the shelf or you pull a synthetic graft off the shelf, if you pull the HAV off the shelf, the patient's about half as likely to lose, to lose their blood flow. So that's, that's, in my view, that's win number one. Win number two is at least as important and probably more important.
If we look at the rate of amputation in patients who have injuries in their limbs and were treated with plastic grafts off the shelf, what we see is that that amputation rate was about 20, 20, 21%, which means one in five patients who get an injury like this, who are treated with a plastic graft, will go on to amputation. In our study, with a lot of very sick patients, what we saw was slightly less than 10% of patients went on to amputation. Now, that's still a lot. I would like it to be zero. I would also like to point out that in some cases, like a crush injury, for example, sometimes the injury is so severe that even if you restore blood flow, as Dr. Curi said, the limb is still not salvageable.
What I can tell you is that for every single patient in our trial, if they had an amputation, it was in the setting of the HAV working, but the patient's limb was just too badly damaged. Infection, that's pretty important. Avoiding infection, being able to resist getting infected. If you're putting an HAV into a wound that has contamination, avoiding infection is important, and what we saw is that our infection rate, our infection rate was only 2% in the first month, and synthetic grafts were almost 10%. So there was a more than fourfold improvement in your risk of infection.
So overall, in my view, if you're a trauma victim and if the surgeon doesn't feel like he can get vein out of your leg, he doesn't have the time to do that, then if you had to pick between these two, in my view, you would probably want an HAV. So based on all of the foregoing and also based on some clinical trial data that we've gathered in Ukraine, which I'm gonna touch on in a minute, we are planning to file our Biologics License Application or BLA with the FDA later on this year. And then we hope that that will lead to evaluation and then approval sometime later in 2024. So we've mentioned Ukraine a couple times.
As many in the room may know, Ukrainian surgeons reached out to us in March of 2022, shortly after Russia invaded. They asked if they could get HAVs to restore blood flow in limbs of people who've been injured in the conflict. In the Ukraine war, there's a lot of gunshot wounds, but there's also a lot of explosive injuries, IED injuries, where there's shrapnel that essentially can fill up half a patient's body. Those injuries are complex, and they're dirty, and they create a lot of damage to a lot of different tissues. Humacyte worked actually with the FDA here in the U.S. and also with the Ukrainian government, and we got permission to ship vessels to 5 hospitals in Ukraine.
And we had a one-year period for this humanitarian effort, and during that time, we treated 19 patients. All of these patients were viewed by the surgeons as not having any vein. So I think a lot of these patients would have had to undergo amputation if they had not had the HAV. What I can tell you is that in the 19 patients we treated, we had 0 amputations and 100% limb salvage, and we had 0 infections. So, I was actually amazed at how well this how well we did here, especially considering that we had to train the Ukrainian surgeons over Zoom. We couldn't fly to Kyiv and train them. So with surgeons that were trained over Zoom and in a wartime setting with some really severe injuries, the HAV did very well.
So that tells me that this may be valuable not just for injured civilians, but also for injured warfighters, in the U.S. and elsewhere. I'm gonna skip this because that's a little bit more detail than we need. I would just ask, are there any questions in the audience, about what we've observed, in the clinical trial? And if not, I'll ask Dr. Curi to come up. No questions. Okay, Mike, you've got it.
Thanks, Laura. I'm basically here for show and tell. I think, we're gonna show a couple nasty pictures, and some really cool pictures of how the nastiness is addressed. So, this is a case of a patient who was in a motorcycle injury, and that's his leg. You can see the other knee down here to get an idea of where this is. And that patient, that was a really bad injury because there's so much devitalized tissue in this patient. And, he had no pulses in his foot, and so when we explored him, we found actually, a really beat-up, destroyed artery. And these two arrows are pointing to the ends of the artery here and here that we've transected. You kinda have to debride it to healthy, clean artery.
There's about 10 cm, I think that's a 10 cm mark, a gap there. You can see some of the vein back behind there that was also destroyed. That patient, reconstructing him with an HAV, worked really well. You know, the longer segments, you know, you can't bring them together. Now you know that this thing's a, you know, really badly injured limb with a lot of devitalized tissue, and with devitalized tissue, there's always a risk of infection. This bypass worked actually great for him. Here's a patient that actually had an industrial accident, and the distal thigh in the lower part of the left leg was crushed. You can see here on the right, this is the patient's right leg.
This is the artery that's got dye in it. That's why it's white, because it's got IV dye. And you can see the artery up at the top here, and then it's gone here, and you can see the amount of soft tissue injury. And you can see the size of the soft - this leg, how much bigger it is, and there's soft tissue injury all the way out here. This is all just really crushed muscle that ... On an axial cut, now we're looking where you basically are cutting like this and looking up the leg. You can see on the other side how clean these planes are here. That's the popliteal or distal superficial femoral artery right above the knee joint, and this is the kind of the end of the femur.
And you can see there's no artery where it's supposed to be there. Look at the size of this leg, how much damage, and this is air, pockets of air inside. The patient hasn't even been operated on, but there's a lot of air in there from that smash, and just it's kind of a, almost like an explosion that went on in there. And, this patient had an HAV reconstruction and, went on to do quite well but had a prolonged course because of the amount of soft tissue injury, all the muscle that was dead from the actual injury, not from the lack of blood flow. This is muscle in the thigh, not down in the lower leg. The lower leg all did great....
A month later, in a CAT scan, this, this area here is actually a fluid collection, and these are the vessels, the HAV and the femoral vein right next to it. And had that been a prosthetic graft, based on even just the appearance of this, we may have just gone in and taken it out, knowing that it's just not gonna do well. But this HAV never got infected, and this patient is gonna be talking to you a little bit later. Here's actually a... So these first two were considered blunt trauma. This is a case of a penetrating trauma. This is a high-velocity ballistic that transected the superficial femoral artery. So this is a CAT scan.
Dr. Curi ?
Yeah.
Can you dim the light of the CAT scan here?
Oh, sorry about that.
It's okay.
On the screen right, there's a CAT scan, and you can see the patient's right groin. That's the common femoral artery, and it's starting to bifurcate, and there's an artery that's about to come off and go backwards that way. In the left leg, that artery already came off, and that's the deep femoral artery. The superficial femoral artery is this little circle here, and you can see contrast coming out of the artery. This patient was actively bleeding in the CAT scanner. Brought up to the operating room and resected that part of the artery and reconstructed it with about a 4-centimeter piece of HAV. This patient is now three years out, doing fantastic, complaining about her back pain. Runs, you know, regularly.
She's actually super active and, you know, walks a mile when she comes and sees me. This is actually a case from about, you know, from 2018. This is a gentleman who was actually in a low-speed, blunt injury, actually on a skateboard, and fractured his femur so badly that the femur hit the artery. You can see on the screen right, this is the superficial femoral artery coming down, and there's a gap where there's no blood flow, and it's right next to, you know, an obvious fracture in the femur. You can see on the screen left, where there's a picture of the right leg with a superficial femoral artery there, and there's no superficial femoral artery where it should be on the patient's left leg.
This patient also had a, about a 4-centimeter interposition graft, and this is sewn in in an end-to-end fashion with the HAV. You can see that the HAV is, is a great match for that particular artery. The artery that runs from the groin, where the common femoral artery splits, and the common femoral artery in young or healthy adults, is usually at about a 7 or 8-millimeter vessel in diameter, and it splits into two arteries, the superficial femoral and the deep femoral artery. The superficial femoral goes from the groin down to the knee, and about the knee, we call it the popliteal artery. That entire length is typically right around 6 millimeters in most healthy adults.
So the 6-millimeter HAV actually winds up working really well, and that's the most common artery that is injured in traumatically injured lower extremities. And those are the 4 cases that I had for you. And we actually have one of my patients who has taken some of her time to come here. So I'm gonna let maybe Laura introduce her, and I'll just say that, you know, it, it's a, it's a super privilege of mine to be here in a, in a setting like this. I was talking to her and her mom earlier about how crazy, having met the two of them in the middle of the night in a trauma bay, and a couple of years later, we're here talking about this incredible technology that has helped me take care of her.
It's a pretty cool thing, and we're gonna be. We're gonna know each other for life because one of the things about vascular surgery that really attracted me to it and is kind of my favorite thing about being a vascular surgeon is, in vascular surgery, it's not like one and done. Your patients are yours for life because we have to follow these reconstructions forever, and so we get to know patients a long time. So it's a pleasure for me to introduce Devin Barnett. I guess, should I take some questions first, or?
You know, you can. You can take some questions, or, or you two can chat, or whatever. Are there any questions in the audience? No. Okay. Well, Devin, why don't you come up? And, I'm not gonna do a very good job of introducing you. I think. But, but I will say that, that Devin has been, has been incredibly gracious with her time and with her story. You know, some parts of her story have actually appeared on the Humacyte website, previously, and she's
... you know, she has just a remarkable story that she tells also with her mother. So her mother is a big piece of what happened on that fateful day when she got injured in New Jersey. And you may get asked, you may be put on the spot, too. We don't know. But anyway, I'm gonna shut up now, but I'll let Devin sort of tell her story to start off.
Hi, my name is Devin Barnett, and I was Dr. Curi's patient. I am a longshore worker over at Port Newark, and I was in an accident, a crush accident, between a gantry crane and a van. So, with that, brought me to Newark Hospital, where Dr. Curi basically operated and put the HAV vessel in my left leg in order to help improve my, I guess, my vascular blood flow. I really don't remember too much. I kinda was in and out of consciousness or screaming, and they, my mother and Dr. Curi made the decision to use the HAV vessel for my leg. My major thing that I do remember was screaming, "I don't... Save my leg.
I don't want it to get amputated." And then I kept saying: "I think I have compartment syndrome." I do remember those two things. Other than that, I'm not a doctor, at all, so I was just probably saying some stuff that I've heard before, probably from Grey's Anatomy. But, I'm thankful for the HAV vessel and the fact that I am here today, and I'm walking, and I can do basically anything and everything that I've ever was doing and that I want to do. I have other injuries that was not, that I didn't fully recover from, but that has nothing to do with the HAV vessel, so.
So... Is this on?
Yes.
So, Devin comes and sees me, regularly. As part of the trial, we do have, patients coming and see us, seeing us, a couple times a year. And typically, in vascular surgery, after a reconstruction, we see patients the first year, every three or four months, and then every six months, the second year, and then pretty much yearly thereafter, just to look at the vessel with an ultrasound. And this is not even part of the trial, but the trial was structured in a way that was pretty much similar to the, what we do in clinical practice. And whether it's a prosthetic graft or a, patient's own vein, we do look at it with time.
Because even in vein grafts, we've had patients 10, 15, 20 years out, develop aneurysms of the vein graft or, you know, complication of the vein graft. They get something called Iintimal hyperplasia , and we haven't seen that much of that kind of thing at all in the trauma patients that we've been treating. But Devin, you had more than one operation, is that correct?
Yes.
Do you remember how many?
I think it was seven. I think I had seven operations on my left leg, from plastics to orthopedics to vascular, infectious disease. I don't remember the other ones. But-
Yeah, that's the kind of injuries that typically, you know, we see when there's a vascular injury, because the vessels are pretty well protected in the body, and so for them to get hurt, there's usually associated significant soft tissue injury, especially in the blunt trauma patients like hers, where it's a crush injury. And so when the muscle... There's so much dead muscle, many of those surgeries were literally just going in and removing more muscle because dead muscle sits like a... It's kind of like a culture medium for bacteria. And in Devin, in particular, she had what we would expect, which is some infections in that tissue. And with a prosthetic conduit, you know, you really worry that when there's an infection, the conduit does not do well and with PTFE.
And, she's a testament of, you know, what this thing can do. So, we're really happy with how she's done.
Can you talk, Mike, about the decision that you made with Devin's mom and sort of that consent process and your decision-making at that time?
Sure. As part of a clinical trial where there's, you know, we need to consent somebody to participate in a trial, you know, that's the hard part. Consenting her for the surgery was, you know, is easy because, you know, that's what we do every day, and she knew she needed surgery. And just consenting somebody to participate in a trial and having them trust you that you're doing what is in your, in their loved one's best interest, is a challenge. In a, especially in a setting like this, where it's so, you know, there's so much time sensitivity.
And typically, what I would do is, you know, consent somebody, because before we get in there, we don't necessarily know that we're gonna use the HAV, and I consent them for the potential of using the HAV, and then when we're in the operating room, you know, we make that call, because if we could just bring the artery back together, much better, right? We don't have to reconstruct. That's, that's easy. But, if you have to reconstruct it and there's not a vein or there's a time situation... I think in Devin's, you did not wind up with fasciotomies, if I'm correct, right?...Yeah.
Her leg, she had done it.
Yeah.
I don't think so.
Yeah. Yeah, we did not have to open up her. Like, I think had we had to go chasing veins, she probably would have wound up with fasciotomies, where we would have had to open up both her legs all the way down to the ankles. She, a lot of times, that winds up with skin grafting to heal those wounds. 'Cause she was on the cusp of time, and by the time we got there, and I think you probably remember that conversation about the time issue. So it worked out really well.
I will say one thing, though. Me making a decision was hard but easy because I know my daughter as a person. Being athletic as she is, she from the age of 5 to 11, she was a competitive gymnast. Okay? I knew she could tolerate pain. Okay? When I saw her that night, I knew the pain was over the top. Talking to Dr. Curi was hard, but easy. He was very compassionate about, you know, what could happen. He gave me options, saying that we could go use the other leg for an artery, and my outlook on that was, I didn't want something to happen to the other leg if that didn't work. That's why I made the decision to say, "Go ahead, do it. I'd rather have one leg bad than two legs." You know?
He sound very confident in what he was doing, and I actually asked him, "What would you do? You know, you're the doctor. If that was your child, what would you do?" He said, "I would attempt to do, you know, you know, the one leg compared to the two." I do remember that, you know. My son was there, too, I must say. You know, me and him. I knew I was on time. I knew time was of the essence, you know, so it wasn't like we could have, "Oh, let's go have, like, a half an hour to talk about what..." It was very, very quick, you know? But like I said, a lot of my decision was based on I didn't want two legs, and if one had to be amputated, I didn't want it to be two legs amputated.
I very much look forward to the day that I don't have to convince patients to be in a clinical trial to use this. I know all of us in the vascular community look forward to that because, yeah, there's challenging conversations that we have every day, taking care of patients with these kinds of injuries. Adding on to that, you know, the participation in a trial, it's a very difficult conversation for, you know, family members who just-- and, and patients who, you know, this is their first experience ever having to deal with anything like this, and we deal with it every day.
Taking that out of the equation and just being able to talk to them about the risks and benefits of using, you know, a prosthetic like this versus a prosthetic like what's out there, and not having to make them feel like they're being, you know, enrolled into a trial would be pretty, uh, nice from, from my standpoint.
Hi, this is Kristen Kluska at Cantor. Devin, thank you so much for sharing your story for us, as well as your mother. You know, really brave to have gone through that, and I'm so glad that the outcome is positive for you. Was wondering if you could touch more about the, the healing process of this relative to some of the other options that are out there. Obviously, we touched on things like, infections and, and, you know, risk of amputation, but just from, like, a healing standpoint, especially because from a trial perspective, you're kind of in a unique position 'cause maybe there's perhaps a little bit more follow-up. Thank you.
So I would say that the healing that I've seen with this has been no different than using any prosthetic, you know, that we put in. And it obviously has the advantages compared to vein, of not having an additional incision to heal. So when we use a vein graft, you know, about three months ago, I just saw a 16-year-old boy who was back in the hospital for a third time because of the contralateral leg. He wasn't a candidate, obviously, being 16, for being in this trial. We harvested his vein from the other leg. Actually, the trauma surgeons had already made that incision and done that, and we came in and put the vein graft in for him, and he's done great on his leg that you know, that was reconstructed.
He's had three different admissions to the hospital for the vein harvest site, which is not kind of... It's not that common, but it's, you know, for a 16-year-old boy, it's kind of a pain. I will say that as Laura had mentioned, there has been a couple patients that have had an amputation despite having a graft that was intact and had normal blood flow running through it. We did get a chance to look at the vessel that has been in there for just under 30 days, and the patient wound up, just because of the mangled extremity, needed an amputation, not because of a perfusion deficit.
Seeing that vessel, where it was, on that one case where we had experience with that, it looked like it was healing as if it was the patient's own body. We didn't actually, you know, look at it under a microscope, but it was sent out, and I, I don't know at what point we start seeing the ingrowth of cells.
Yeah. All that data is gonna go to the FDA. We start seeing cells move in in the first week. Yeah. Happens pretty fast. Is trial conducted in Europe so as well, or only United States? So the trial was done just in U.S. sites. We actually attempted to expand into Poland. We've done a number of trials in Poland. But when we tried that expansion, that was just when COVID hit, and doing clinical trials was difficult in any case. So we have U.S. sites, about 20 sites in the U.S., and then the HAV's been implanted, actually in 2 sites in Israel and in 4 sites in Ukraine. Is it not working? It's not working.
Well, anyway, did you guys hear me?
Yes.
Yes. Okay. People in the room heard me. People online, I'm sorry, did not hear me. I'm sorry about that. It's all in the U.S. and Israel.
Currently, for the trial, one of the subsets you said is when synthetic graft is not indicated. One, how does that decision get made in the trial? Let's say that's how the label reads, the way the indication is, how is that decision made with regard to whether somebody's going to sign off on using HAV? I know that's perspective, but how would you imagine that decision would be made? Would that be in the surgeon's hand? Would there be a payer component that's got to do this on in real time?
So I will take a stab at that, and then I will ask Mike to comment. So in the trial, we didn't specify that the patient had to be not suitable for PTFE. It was just that the patient couldn't have vein available. It's my view, and I think this is probably correct, that if a surgeon had a very clean and simple wound that he thought would be fine for a synthetic, he probably didn't approach the patient about the trial. Any patient that got approached for the trial, it was because there was a patient who didn't have vein and who probably was not gonna do well with synthetic in the view of the surgeon. But, you know, whether or not to use the vessel in an, in an...
In any case, it is always going to be the purview of the surgeon in the operating room at the time. The decision about whether or not the vessel is available to the surgeon in the hospital is made by the hospital. That is going to be a really active part of our commercialization process, talking with individual hospitals and their value committees and pointing out that, particularly if the HAV gets used instead of synthetic grafts, you are going to see fewer amputations, you are going to see less infection, and you know what? That is going to save the hospital money. I actually believe that we will have very potent economic arguments, that for patients with severe injuries, the HAV will actually help the hospital in addition to helping the patient.
I think you hit that pretty, pretty well. You know, from a surgeon standpoint, you know, we have, you know, choices of conduit that we already make today, and I think it would just be another choice out there available to us. And I would say that in the traumatically injured limbs and the iatrogenic or injuries that we see, and then also in the replacement of vessels that need to get taken out for trauma or oncologic, like cancer operations. We always make that decision whether we're gonna use a piece of PTFE or Dacron, which are the two available synthetics, versus going and taking the patient's vein.
And, you know, we have results that we know how those all behave, and if this winds up showing that the results are somewhat better than those other two options, then it's gonna really become, come down to availability and, and, you know, if the hospital has it. As a surgeon, you're gonna use what's best.
Yes. I learned after working in the operating room for nearly 20 years, that you absolutely can't tell a surgeon when to operate or how to operate. That I've learned.
For good reason.
Any other questions?
Thank you. Maybe one for Dr. Curi here. Just curious to gauge interest in HAV among your surgeon colleagues. I mean, I'm sure there are folks who see cases like Devin's and are interested in using HAV for themselves. To what degree do you think there's interest in folks adopting this technology once it's approved?
I think it's very high. I just brought on a new surgeon who joined us from a very good institution, you know, in the top places in the country, and he is—one of the exciting things that, you know, he's really excited about is getting his hands on this. You know, when I told him what I was coming into the city for today, those were his words. He's like: "I can't wait to get to try that thing." I think the very small amount... I've actually been amazed how little this has been kind of put out in front of the vascular society so far. Every time that little bit comes out, there's a lot of excitement about it, and people are talking about it.
So I think the VEITHsymposium coming up in November, I think there's gonna be a lot of chatter, and a lot of people are gonna get excited about it. Nobody wants to put a piece of PTFE in any trauma patient ever, ever. It's just like, we all cringe at the thought of it. And, you know, even if when you do have just a straightforward little SFA injury, that it's... And it's a closed injury, we don't you know, it's not a gunshot wound, it's not an open injury, it's not all that dirty. Even in those patients, we don't typically put PTFE in.
Well, and, you know, tooting Humacyte's horn, you know, I mean, as Dr. Curi will tell you, there hasn't been a new conduit of importance in vascular surgery for 20 or 30 years. So there's been no innovation. So the PTFE grafts have been around since the 1970s, and vein has been around that long, too, and that's still what we're talking about. There are other biologic conduits, like cryopreserved vein, which tends to do poorly. There's pig vein, which tends to do poorly. There's cow artery, which kind of does okay, but it's... Boy, there hasn't been a lot of innovation, and so I feel like surgeons are hungry for something new that may be better for a lot of their patients.
And, you know, the thing that's kind of the most exciting about it is, what you see in the microscope, right? The fact that there are cells growing into this thing is, game changing. It's totally different than any other thing that we put into patients. Whether you use a vein that's a cryopreserved vein, or you use the cow artery that's called an Artegraft, it's nothing like... That doesn't happen.
Okay, any other questions? Well, I would like everybody to thank Devin and Dr. Curi for joining us. And taking their time and braving the traffic in Midtown with the UN. Those crazy people.
I get to see my brother after this.
Oh, you do?
Yeah.
Okay, okay. So is he at the UN?
No, he lives in the city.
Okay, okay, okay. Well, anyway, thank you very much, everybody, and we're gonna have treats, and... Are we having wine? I hope we're having. Oh, good! We're having wine and, and Q&A. So thank you very much.
Thank you.