Good afternoon. Hi, I'm BJ Scheessele, Chief Commercial Officer for Humacyte. Probably new to some of you, so actually I thought I'd do a quick introduction of myself. Roughly 30 years in the healthcare industry, biomedical engineer by training, and I've most of my career worked on building and leading successful sales and marketing teams, both domestically and then internationally.
Worked for Johnson & Johnson in the vascular space doing that, smaller companies like LifeCell in regenerative medicine, where I did compete against synthetics, poor-performing synthetics, similar to the situation here. This was obviously an opportunity to bring all that together, my vascular experience, regenerative medicine into one package. What I've been doing the last couple of years in anticipation of this launch, building sales and marketing, health economics, market access, a lot of which we'll have an opportunity to cover today. Definitely appreciate you joining.
We'll be a little bit in person and virtual given the weather and some of those challenges, but we were excited and wanted to make sure that we pulled this off today. What I'll first do is introduce Laura Niklason. She's going to be virtual dialing in here. She obviously is our founder and CEO. She'll have an opportunity to walk a little bit through company and technology for those that aren't as well-versed in it.
I'll have an opportunity to then give you an update of where we stand early with our commercial launch. We have two surgeon speakers, experienced with our product, to talk about their use of Symvess, where they use it today, where they think it can be taken into the future, and then an opportunity for Q&A on the back end. With that, I'll turn it over to Laura.
Thank you, BJ. Yes, I'm sorry I could not be there. Tried to get in last night, tried to get in this morning, but the weather in New York was just not cooperating. If we could just click ahead two slides. I'm not going to spend much time here because I think really the story is about our commercial launch and you want to hear from our surgeons. Just at a very high level for folks who are not familiar with the Humacyte story, Humacyte, I like to say, is in the business of making spare parts for people. We have developed proprietary technology that uses human cells to make functional human tissues at a commercial scale. We manufacture these tissues in such a way that when they're implanted into any patient, they won't be rejected.
Also, very importantly, after implantation, our engineered blood vessels repopulate with cells from the patient and they become a living artery over time. We believe that this repopulation confers durability and also a resistance to infection. You're going to hear about some of those characteristics from the clinical cases from our surgeons. Next slide.
At a very high level, Humacyte received our first FDA approval for using our engineered blood vessel , the ATEV, which is also called Symvess , trade name. We received this approval late in December of last year and we announced official commercial launch just last week. Humacyte as a whole is addressing large markets. We are not a biotech company that's looking at little tiny orphan markets with 40 patients. We are looking at large markets in traumatic injury, both civilian and military. We're looking at dialysis access.
We're looking at Peripheral Arterial Disease. We control manufacturing. We do our own commercial scale manufacturing in-house and we are located in North Carolina. We believe that mitigates a tremendous amount of execution risk. We have great partnerships with Fresenius Medical Care and with the Defense Department. Next slide. At a very high level, as I mentioned, we use human cells to make our tissues. We use human vascular cells that we expand in the laboratory and then we seed these cells onto a scaffold. It's a degradable polymer and the size and the shape of the scaffold dictates the size and the shape of the vessel that we grow. The vessels that we grow are 42 cm long and 6 mm in diameter.
After the cells attach to the scaffold, they grow for a period of two months, during which time they also secrete matrix proteins like collagen and the scaffold is also dissolving. In a final step, we take the engineered artery that we've grown over two months and we wash the cells out of it. The final product that gets delivered to the patient is an engineered human vascular tissue. It's mechanically very strong. It has a rupture strength over 3,000 mmHg , which is about 30 times your blood pressure. It's mechanically very strong because it's non-living. It has a shelf life. It can be stored for up to a year and a half in the refrigerator and it can be immediately available when surgeons and hospitals need it. Next slide.
For our approval in vascular trauma, we're currently approved for use in adults who require urgent revascularization to save a limb and in cases where autologous vein or vein harvesting from the patient is not feasible in the eyes of the surgeon. Next slide.
The current state of trauma care now, both in the civilian and the military settings, is that when a patient presents with a traumatic injury and several hours later is finally in the operating room getting a repair, the surgeon can either spend another hour harvesting vein from the patient and injuring him further, or the surgeon can take a plastic graft off the shelf, which may become infected, or he can amputate the limb. That's prior to the approval of Symvess . That was really the range of possibilities available to surgeons and patients. Next slide.
In our two single-arm trials that looked at both civilian populations in the U.S. and Israel and in a military population in Ukraine, what we showed is that compared to plastic grafts, which are the synthetic graft benchmark on the right in gray, what you can see is that the blood flow or patency levels of Symvess were substantially better than those reported for synthetic grafts. The infection rate was much lower, about one- ninth of the infection rate for synthetics. Probably most importantly, limb salvage was much better. The 24% limb amputation rate with synthetic grafts means that if you're a trauma patient and you were treated with a plastic graft, there's a one in four chance that you lose the limb. In our studies, that chance was reduced to one in 20.
We would argue that this is particularly important for patients, obviously, and surgeons, but also hospitals. These data were really the basis of the approval for Symvess in arterial trauma. Next slide. Interestingly, we also did a retrospective comparison. This was not a head-to-head study, but we did a retrospective comparison of how well outcomes like patency and limb salvage and infection are with our vessel, Symvess , as compared to vein. To do this, we looked at a historical database of trauma victims called the PROOVIT database. We propensity matched patients who were in the PROOVIT database two to one to patients that we had already treated with Symvess . As you can see from the numbers on this slide, our patency numbers for Symvess are a little bit lower than they are for vein.
If you look at infection rates and amputation and reinterventions, you know, treatments for complications, we actually compare pretty well. This is very encouraging data. We're hoping to publish these data soon. This really provides an answer to surgeons, you know, because once we show surgeons that our vessel performs better than synthetic, the next question that they ask is, how do you perform compared to vein? Again, this is not a head-to-head comparison, but at least gives us a ballpark estimate that actually we do fairly well. Next slide. Okay, I'm going to turn it over to BJ now because I think you've heard enough from me.
Thank you, Laura. On the commercial side, first I would start with how do we view the trauma market? I will take one step back that actually we had to build this database, build our market understanding. When you think of trauma, there is not just a lot of data there. There is not something that you can buy off the shelf. We work with Definitive Healthcare, a leader in claims database, to actually build this up.
I think this was important for us, one, to know the size of the market, but also that targeting has actually helped us to know then where exactly to send our sales reps, which hospitals, which surgeons perform the procedures. We look at it around a 26,000 applicable market for trauma vascular repair. That includes and really is focused on when you need an open surgical repair.
That does not include, for instance, where it is a more simple, let's say a patch or an endovascular type repair. We are obviously focused on the open surgical. Our label is also on extremities. This 26,000 does not include torso and other types of injuries. What it does also include is iatrogenic cases. I think these are highly underreported, underappreciated. This would be where a surgeon is cutting out a cancer and therefore needs to cut vessels and repair them. It also includes where there could be a hip replacement being done and a surrounding vessel is lacerated. You obviously, in that case, the surgeon is highly upset and having something readily available is important to them.
Specific to where we're looking to target in the market, we believe right now, and this is based off of that PROOVIT database, really definitive source of information that Laura had mentioned earlier, that it's about 74-75% of the time saphenous vein graft used and then synthetic and other type of products the remainder of the time. Our initial target with our indication is on the synthetic and other, but we believe over time label expansion, just general usage, that we believe that we could capture roughly around half of this particular market.
A good portion of the synthetic other, but then also within saphenous vein where saphenous vein is not available, but also where they might use saphenous vein, but it's been such a time delay from getting that patient in that really the risk of complication and amputation is significantly more, that something off the shelf would be more amenable. Where we stand in kind of, in essence, the pillars of building for commercial and commercial launch, you know, these four areas, we do believe, you know, a concentrated market, you know, back to that Definitive Healthcare database, understand exactly which hospitals, Level I trauma centers is the majority, but actually we've also learned that there's some Level II centers that have a lot of volume that we had underappreciated and making sure that that's within our targeting.
Vascular surgeons perform the majority of these cases, but selectively trauma surgeons who do have those vascular techniques are also important targets for us too. Our initial direct sales team is 10 sales reps. We would look to expand, you know, based on opportunity. They have a background in vascular and trauma, regenerative medicine. They all have a performance of success, all President's Club winners, which basically means award winners from their previous companies.
Complementary to our commercial activities, there's medical affairs, medical education. I'm absolutely a big believer. You'll speak and hear from two of our surgeons. Peer-to-peer discussions are very important, not only in terms of how best to use the product, but how to best position it for not only current usage, but future usage. Market access is, as it sounds, but also within that is our work with the DOD.
Now that we have approval, we've actually started to submit to the procurement and contracting vehicles such as ECAT and SAC as part of working through our process. We have begun that. You know, on the right-hand side, I kind of, you know, when I talk to, you know, my team and surgeons and others, kind of think of it as kind of the science, the clinical, and the health economic.
You need all three. Laura spoke to the science of how we make our product, the clinical data that she just showed with you, which is quite strong. I would also though say is that when we take our data out into the market, there really hasn't been any other studies done in trauma before. We stand apart actually having clinical data behind our product. Then there's the health economic side.
You know, can you show that you reduce costly complications like infections and amputations that more than offset, you know, the initial acquisition price of our product? To that point, I'm actually excited to share that actually just this morning, we actually had our budget impact model published. Journal of Medical Economics, peer-reviewed journal, validating the approach that we've taken here.
You know, important because it benchmarked off of our clinical studies, both the clinical data and health economic data that we collected in those studies showed, you know, that it more than offset the cost and use of our product, you know, versus synthetics, versus these other products that we call, but those would be cryo vein, so the cryopreserved vein product, and then the bovine carotid product. Again, amputations and infections, you know, the majority of those cost savings.
I would say also though, you know, we're very early in this launch, but you know, you could well imagine some of the early questions we've had have been around the price of our product. I'm also happy to say that when we have the opportunity to walk surgeons or an administrator or even a payer through our budget impact model, and it's a dynamic model, we can actually sit down with a hospital or a payer, put in their usage data, put in their complication data and the cost of complication and run that model. When we've had that opportunity, they have seen and been supportive of our price point given the clinical and health economic benefit that we can provide. I think also part of when you think of health economics and value is reimbursement.
We're working on and have applied for an NTAP New Technology Add-On Payment. This is with CMS for Medicare patients. You know, I'd also note that, you know, if you can get through CMS and with Medicare patients, Medicaid, Tricare with the government and private payers many times draft off of or leverage that work and will pay if you can, you know, get through CMS. We've, you know, well along our way, we've not only submitted, we've had a successful town hall. We're actually in pretty regular communication with CMS and have learned that things continue to stay on track. Not everyone can say that with every government agency right now. If things continue to go well, it would be August timeframe we would hear back on that it is approved and then it's an October implementation.
That goes with that what we've worked on previously is the ICD-10-PCS or procedure codes. That's how you track procedural usage, but that's important to have because that actually has to be in place and implemented for actually for that payment to take place, the NTAP once it's implemented. The last piece I'll mention on my side is just a quick update of where we stand. We've actually now, I guess our press release.
The ICD-10-PCS codes have to be in place. Where are they in terms of that timeline?
No, they're completed. They're actually, they're available to surgeons at this point. Yep. And they're only specific to us. They're actually unique to what we do. Others are actually unable to use them. So quick update, you know, with our press release, we were at 21, we're now to 26. VAC submissions, two have made it through and approved at this point.
You know, we're excited to say that that typical is a three- to six-month process. The ones are a mix of those that we've submitted to are, you know, large institutions, names that you know, some that were part of our clinical studies, some smaller institutions and larger institutions that we had no contact with before, but saw the value and said actually to submit. It's individual hospitals, but actually also hospitals that represent networks or collectives or IDNs and systems of hospitals.
If you're approved within one, it could actually be multiple hospitals. You know, the last thing I would mention here too is that yes, we were approved in December of last year, but it wasn't until just a little over a week ago that the FDA released and approved for sale of our commercial lot. We're now just, you know, just a little bit a week over. I think, you know, when we were doing some of our reconnaissance, there were plenty of hospitals that wanted to see that before, you know, finally pushing through. Now that we have that, and that's why we called it, you know, now the official commercial launch because we have all things ready and available to do so.
We're eminently, you know, first sale any day, you know, now at this point as we have all this laid in place and then that'll ultimately have us off and running. With that, actually to introduce our first surgeon speaker, Dr. Mike Curry, Associate Professor of Surgery, Chief of Division of Vascular Surgery, just across the Hudson here, Rutgers, New Jersey Medical School. I'll turn it over to him and hear about his personal experience. Probably has some of the most, if not the most experience with Symvess as part of our V005 trauma clinical study.
Thank you. Good afternoon. It's a pleasure to be here and talk about the product here that is, you know, truly something different, you know, for all of you who I'm imagining looking at companies that are putting out new technologies. This is a real big difference. This is not just a different stent. This is a whole different science. For what it means for us is pretty impactful. I am a vascular surgeon. I run the vascular surgery program at Rutgers, which is in Newark, New Jersey. We have one of the busiest trauma centers in the country with one of the highest penetrating injury rates in the country. What that means is that we have a lot of vascular injuries. Believe it or not, some of the cases that I'm going to show here are not penetrating.
This is actually a blunt injury where that's not considered penetrating injury. It wasn't a shot, a gunshot wound or a stab. It was actually a crush injury. And these crush injuries are really challenging. Somebody puts a hole in an artery, that's a pretty easy thing to fix because a bullet has gone through it or a, you know, knife has hit it, a laceration. These injuries where there's a lot of soft tissue injury, they're the ones that get very complex.
When you think about what's the ability to salvage a limb, there's something called the mangled extremity score. That's mostly for really high impact injuries with, you know, large ballistics or crush injuries. This first case is a leg that had a severe crush injury, as you can see, with a lot of devitalized tissue. There was an arterial injury.
You know, while the bones needed to be repaired, the soft tissue needed to be healed or replaced, the only way this patient was going to keep that leg was to replace or, you know, reconstruct the artery that was damaged. In this one, there was about a 10 cm gap after getting down to the artery and then taking away all the devitalized part of it. It left a decent size gap, not something we could bring the ends together, so we got to reconstruct it. You got to think about, well, am I going to go get some vein out of the other leg? You can't use the vein on the same leg because most of the time the vein is also damaged on this side.
You don't want to take the superficial vein, which is the alternative pathway for the blood to get out of the leg. If the deep veins are already injured, you don't want to take the saphenous vein from the same leg. The other leg, not really available to us or in many of these cases, you know, it's been close to that six-hour mark where the patient had a prolonged ischemia. The damage done to the tissue beyond what's actually injured from the ischemia, from the lack of blood flow, you know, there's a ticking clock. Typically we think somebody at the six-hour mark is at their limit of what they could tolerate.
As we get, you know, more complex injuries and the workup is longer or if there's prolonged extraction from the vehicles or whatever, we wind up bumping up against that time and going and spending 45 minutes to an hour getting vein out of the other leg makes it difficult, the additional issues of having to prep the other leg and making, you know, the actual operation work.
Plus you're, you know, creating wounds on the other leg. So this case, you know, we did an interposition graft with the Symvess from the popliteal artery, which is just at about the knee to the tibioperoneal trunk, which is below. It's a smaller vessel. And these reconstructions are more challenged for long-term patency than, you know, larger arteries. And this turned out really well. This patient was able to save the leg.
Prolonged time in the hospital after the repair, lots of other surgery for the bone, for the plastic surgeons to come in and try to cover things. The patient did really well. This is another crush injury where this patient was actually crushed between, it was actually at the Port of New Jersey, New York in Elizabeth, and a large crane crushed her up against a box car. You can see the amount of tissue damage here where there's, you know, all of this is all just basically, you know, affected. You can see all the clean plane lines. This is the artery on the other side. The artery here no longer has any blood flow in it. There is air. These black pockets are, you know, air, which means that that's a, you know, high risk of infection.
You can see the clean artery and vein on this side and not there on the other side. This patient required a significant amount of soft tissue reconstruction and debridement, taking out a lot of dead tissue. We were able to use the Symvess to reconstruct her artery. She was in the hospital for months. You can see here, this little pocket here is basically a pocket of pus and that's her graft right next to it.
This is what we're deathly afraid of as surgeons when we're putting in a piece of, you know, we call it plastic, but usually it's GORE-TEX or Dacron, which is polyester. If you have a piece of GORE-TEX in there, your heart drops when you see something like that and you know that it's not going to last. This is incredible how this patient has done amazingly well.
She's a couple of years out, like nothing's happened. This is the third case. This is a more straightforward gunshot wound to the upper thigh. You can see here, you know, that's the femoral head on the right side. On the left side, basically the proximal superficial femoral artery had a bullet go through it. The vein was also transected, required ligation. It's harder to repair and replace veins. They don't tolerate that well. Typically they get tied off. Using her vein on that side was not an option. She was beyond the six-hour mark. We spoke to her and she was okay enrolling in the trial. You can see the replacement vessel is actually this portion from here to here. It's about a 4 cm, 3.5 cm piece.
To make an incision on the other leg and go chase that vein on the other leg to do that is a whole different type of operation than being able to open up a package and, you know, use that at, you know, 2:00 A.M. She did really well. She was a couple of years out as well. This was actually, I believe this might have been the very first case in the United States.
This was a patient who had a pretty bad fracture of the bone. You can see it here. You would think that that was like a, you know, a high velocity car accident. It is actually a skateboarder. He had an open door swung open up from a car while he was on a skateboard. I do not know. He must have been going really fast.
Yeah, a skateboarding incident wound up being the first patient enrolled in the clinical trial for replacing an artery with a grown blood vessel. And this patient is now four years out, doing great. There's the interposition graft. You can see it. It looks like tissue. It's just a lot cleaner, obviously, looking than the other stuff. If that vessel had not been in a field where there was a tremendous amount of bleeding, that's what that vessel would look like. It's just that, you know, there's so much hematoma and bleeding in there and this artery actually has a bunch of blood in its wall. That's kind of like what a real artery looks like if you do in a clean dissection. It really works quite well.
It acts a lot like normal artery and a lot better than what we have from a standpoint of what's available from a prosthetic standpoint at this point. Yeah.
I said we'll have some time for a Q&A at the end. Dr. Siada, are you on? Excellent. Assistant Clinical Professor, University of California, San Francisco, will speak to not only his experience with Symvess , it was actually an expanded access case, so he'll walk you through that, but his hospital was actually also the first one to approve the VAC approval to bring Symvess into his institution.
All right. Can you hear and see me okay?
We can.
Okay, great. My name is Sammy Siada . I'm a vascular surgeon in Fresno, California. The hospital I work at is a Level I trauma center. It's the busiest trauma center in California by volume and the third busiest emergency department in the state. We see tons of trauma, but with that, we also see tons of Peripheral Artery Disease and a wide variety of vascular conditions. Next slide, please. This was an expanded access case. This is a patient of mine that I've been following for a few years. I had treated her right leg. She was kind of lost to me for a couple of years and she came back with a new blister on her left calf close to her ankle. She's diabetic. She has high blood pressure. She has known Peripheral Artery Disease.
Interestingly, somebody thought it was a good idea to do a saphenous vein ablation on her for varicose veins. Obviously, you can see this wound. It's pretty ugly. It was infected when I saw it. I put her on some antibiotics. One of the surest ways to assess limb perfusion is to obtain a blood pressure of the toe. The great toe is kind of what we use typically. She had no detectable blood pressure in her great toe, indicating pretty severe ischemia or lack of blood flow to her foot. Next slide, please. With that, I took her to the cath lab to do a diagnostic angiogram. This basically is, you know, shooting dye down the leg to obtain a roadmap of the blood flow. The images on the right hand are the left leg.
Obviously, the kind of the reference there is the right leg. Go ahead and click again, please. You can see here, first of all, there's a narrowing of the common femoral artery in the groin. Furthermore, you can see a little wisp of the superficial femoral artery, but that bracket indicates where the superficial femoral artery is normally supposed to be. Here, you can't see it light up whatsoever because it's completely occluded. The big branch going off to the right is the profunda femoris. That's the deep femoral artery. Click again, please. This is below the knee. You see the popliteal artery come back. If you could click one more time, the anterior tibial artery is the only blood vessel supplying her foot. That popliteal artery appears relatively healthy.
We need a solution to revascularize the patient in order to salvage her limb. Next slide, please. My decision-making in this case was, first, she does not have any saphenous vein for, you know, for a long segment occlusion that starts in her groin and goes all the way to her knee.
The best option usually is a bypass. If the patient has a good saphenous vein, that would have been a no-brainer solution. Unfortunately, she had both of her saphenous veins ablated. In this case, an endovascular treatment was not ideal, A, because of the length of the occlusion. It could have been attempted, but she also had that stenosis, the narrowing in her common femoral artery. That was prohibitively risky, in my opinion, especially since she had a large wound. I wanted something that would have pretty good patency.
I really felt that a bypass was the best option for her. Now, this wound was in a location that was close to where my incision would be for a bypass. I did not want to use PTFE or GORE-TEX or plastic because it is really close to this infected wound. Furthermore, the patency is not really that great with plastic anyway. Another alternative is cryopreserved saphenous vein, which is a cadaver vein. That is another alternative. The issue with that is the patency on cryopreserved conduits is abysmally low and they are not very durable. They have a tendency to fall apart. Those have kind of fallen by the wayside. Another alternative is Dacron or a woven graft. That is also not preferable in an area that has a high risk of infection.
Fortunately, I had some experience in the past with the ATEV when I was a fellow and a strong believer in the technology. It was nearing FDA approval, so I was able to team up with the Humacyte folks and my hospital and the FDA to obtain Emergency Use Authorization. Click the next slide, please. Basically, the strategy is to do a bypass, and that's basically rerouting the blood flow around the blockage. This is kind of a nice schematic showing you there. That's obviously a vein. We did not have vein, so I used the ATEV. Click again, please. Here you can see me, I sewed the artery to the common femoral artery. I opened the artery, I cleaned out that narrowed segment, and I sewed the graft onto the common femoral artery. Click one more time.
I had to sew two pieces of the ATEV for it to have an adequate length to reach the below-knee popliteal artery. Next slide, please. She did very well. She went home post-operative day two, which is pretty remarkable. Saphenous vein, even though it's a very durable conduit, is fairly morbid to take out. I mean, we'll still take it out if the patient has it, but it requires multiple incisions along the thigh. Usually, the patients end up staying in the hospital for at least three to five days. In this case, since the patient did not have a saphenous vein harvest, she had two small incisions, one in the groin, one below the knee. She was able to go home the second post-operative day. When she followed up in my office, initially, she had no detectable blood pressure in her toe.
Her great toe pressure was 130 mmHg , which is a remarkable improvement considering where she started. Her wound, you know, we watched her wound very closely and it healed within weeks. It's been about six months since her surgery. I follow her with ultrasound surveillance and her bypass is widely patent. She has no issues, no symptoms. On the right side, those are just some Doppler waveforms indicating kind of the blood flow at various areas in her foot. She had a really positive outcome. Next slide, please. With that experience, good result. I approached the hospital to get this approved, not just for trauma, but just that, you know, obviously, it's FDA indicated for trauma. We're going to get it on the shelf for vascular trauma, given that we're such a busy trauma center.
I think there's definitely an unmet need in the trauma population in patients who don't have saphenous vein or if they have multi-organ trauma. There's a lot of indications for that. I think long-term, there are far greater Peripheral Artery Disease patients than there are vascular trauma patients. We are in need of an alternative conduit besides autologous vein because very often autologous vein is not available. The alternative conduits that currently exist on the market are suboptimal, whether it's the cryopreserved allografts or the kind of the plastic, the GORE-TEX graft. Those tend to have a high infection rate relative to an autologous conduit, and their patency, importantly, is very poor. That was the rationale of the hospital that I gave the hospital. Luckily, I have a very good relationship with the Value Analysis Committee.
Their sole question was how often it's going to be used because of the cost. I mean, that's kind of the, at this point in time, that's kind of the limitation of its widespread use is the cost. And so what I told them is it would probably be used a few times a year, at least to start. It only comes in one size and one diameter and one length. Over time, as the technology evolves and more sizes and lengths come out, I can only see it being used even more as we have more data about patency comparing to autologous vein and comparing it to alternative conduits like plastic and cryopreserved. I think that the use of this conduit is only going to expand over time. With that, happy to take any questions or comments.
Be available. Obviously, Laura, Dr. Siada are online. While we just quickly set up, I thought I would, I can pass along and around. This is actually the Symvess , the ATEV. We grow them within these bioreactor bags . As Laura described, seed it with donated human aortic smooth muscle cells, feed it a media, grow it into a vascular structure and tubular structure , decellularize it so it is universally implantable. Dr. Curry, Dr. Siada would just take this off the shelf, cut it open. The white piece in the middle there is the vessel itself, and then be able to immediately implant it. It does not require washing off, does not require rehydration. What we talked about, time is such the essence, but, you know, again, just readily available off the shelf.
I'll pass it around and we can open it up for questions for the surgeons, for Laura, for Dale, our Chief Financial Officer and Corporate Development Officer, and myself, please.
Yeah, I'm just curious. You've had good results with the pictures you've shown us with the patients, and you said they all recovered. I'm just wondering, has it worked for everything that you've been involved in, or the patient was just too far gone in terms of the injury? I'm trying to get a percent of how this works.
That's a great question. In trauma, I spoke about the mangled extremity score a little earlier. You know, sometimes we push our boundaries in the effort to try to save a limb that may or may not really truly be salvageable. We had, at our institution, one case where the patient lost his limb. The actual bypass was still open.
You know, that's a failure of, you know, our therapy, not a failure of this graft. This is, you know, the patient's limb was just too mangled. I had one of these grafts that was used to save someone's limb. Unfortunately, he was a really challenged patient, wasn't taking any of his medications. He came back and the graft was actually thrombosed. This was about a year, year and a half after he was walking around with a great result.
He had some psychiatric issues and was not following up appropriately and came back and the graft had thrombosed. One of my partners actually, you know, did a standard therapy to open it back up. It opened up and the graft was doing great. Because he had had such a long time with, you know, no blood flow down to his leg, he lost his foot. At the time of the amputation, the bypass was still running wide open, which was very helpful because otherwise he would not have healed the amputation. That was not an issue from my perspective that was graft related. Those are the two that we have had issues with.
Go ahead.
If you don't mind, I'd like to ask a question.
Sure.
I found it fascinating that Dr. Siada talked about PAD. You know, I don't think the street, Wall Street, has really factored PAD in, at least not at these valuation levels. What's it going to take for us to see use in PAD prior to results of a clinical trial? Will we see vascular surgeons, you know, going in that direction now based on your experience?
When we have a tool available to us as surgeons, oftentimes they've been, whatever tool it may be, a stent, a graft, whatever it may be, has an FDA indication. I mean, you guys probably could do an analysis of lots of other devices that are out there of what their on-label indication use is versus the total use.
I just think about an aortic stent graft that, you know, was supposed to have a 2 cm neck to put that stent graft in there by FDA indications. That probably is maybe half of what aortic stent grafts are being used today. I mean, 50%, I would guess, 40-50% are being used outside of its FDA indications. Once this becomes available, just like Dr. Siada said, I mean, we do not have good options when the patient has, you know, no saphenous vein.
They're just really not any great options. That's a really standard case. None of us like to use the prosthetic grafts in those. We reach for these Cryopreserved Veins and they just don't work well.
Does this ultimately obsolete saphenous harvesting? I mean, it just seems like it should, right?
I'll let you answer then we'll have Dr. Siada jump in too. Go ahead.
Yeah. I think that remains to be seen. Okay. I think, I mean, for me, very data-driven, you know, there's got to be some data to show me that this is equivalent to make me not do the extra work to get the vein out for my patient. There are a lot of surgeons who are going to be like, "That's a lot easier operation.
I think they're about equivalent. Let's go." That is the reality of the world. I think that, and me as a researcher, I look forward to the opportunity of putting this graft up and kind of comparing it and seeing what happens. Even if it doesn't work as well as saphenous vein, if it's a lot better than the PTFE, which I'm pretty convinced it is, I think there's going to be a significant amount of use in PAD.
It's amazing how often we don't have saphenous vein. He mentioned something that's amazing that he said is that he couldn't believe that somebody had burned her vein or ablated it. That's one of these other technologies that I don't know if any of you have been involved in commercializing or putting out there, but that's a technology that is completely overused. There's a lot of money in that business of sclerosing veins. There's a lot of veins that don't need to be sclerosed. They wind up, there's a lot of patients that don't have vein because of it. It's just getting more and more.
Dr. Siada , please jump in.
Yeah, I agree with everything Dr. Curry said. Saphenous vein remains king right now. Until there is high-level data to demonstrate its equivalence or non-inferiority, that's when we're going to see wide use. That's an aspirational goal, but we don't even need for it to be that good for it to have a widespread use in the PAD population. There are tons of patients that don't have saphenous vein. Really the long-term question that I have is what is the patency and how does that compare? You know, the patency in the trauma population is pretty good, but trauma patients otherwise have healthy vessels. PAD patients have diseased vessels. When you do a bypass, there's several different bypasses you can do. You can do to the above knee, below the knee, tibial, to the foot.
We're going to need patency data on all those things. For example, a femoral to popliteal artery bypass above the knee has very good patency with plastic. It's not as good as vein, but it's pretty good. I agree in the sense that Humacyte, I think, or the ATEV is going to be, you know, I think it is better than PTFE. There are a lot of people who do a lot of PTFE bypasses. I think there's a role there. Ultimately, I think the majority of surgeons are guided by what they feel is the best thing for their patient. In the case that I presented, I felt like the ATEV was the best option given the entire circumstances. Do I have strong Level I data to prove it?
Not yet, but I felt in my heart of hearts that that was the best solution for the patient. That's why I fought for it hard and went through the whole FDA process to get it approved for the patient. I definitely think there is a role going forward. The technology is fascinating and very convincing. I think, and you know, most of my partners in my group of seven surgeons, I mean, we agree with it. I mean, we believe in the technology. Ultimately, how widespread its use is going to be is going to be dictated by long-term patency data.
You don't realize, but you're on a split screen right now, and I can see Laura right next to you. So I'd ask Laura, help me understand what's Humacyte doing to empower Dr. Siada so that we can see this kind of going mainstream.
I think Humacyte as a company, of course, you know, we have a huge belief in other market opportunities, including dialysis access, where we've put a ton of investment into phase three trials and where we think we're going to get our second indication. We haven't talked about dialysis access, but I think there are important groups of patients who will benefit enormously once we get approval there.
The same with PAD. You know, we've supported three phase two trials in PAD, all in patients who did not have vein, all in patients with critical limb ischemia or chronic rest pain . The limb salvage data from those trials is outstanding, including one that's recently been published sort of in process out of the Mayo Clinic. We strongly believe that there are a lot of patients who can be helped by this.
Obviously, Humacyte would never market to off-label indications. That's not what we would do. Certainly on my to-do list is once we do have approval, is to help support investigator-sponsored studies that want to look at some of these other, some of these other indications so that we can help build out the dataset in addition to working on our own phase three prospective study. I think having additional data from surgeons in the community actually using the vessel now that we are approved will be vital for expanding our knowledge on how many patients we can help.
I would just say one add-on to that is one of the other things when you're asking about is how do we, you know, how does it wind up getting used for these other things? I think once a surgeon touches it, it's one of these things that it's so different than anything else that we have. It feels so normal, so much like the human body. It's just one of those visceral responses. When I think about what is on our shelves in a trauma center, we'll use it a couple of times a year in a trauma. There's no doubt it will be used at least as many times for either what was already presented, that kind of bypass, or the patient who comes with an infected AV graft or an AV fistula.
You know, we've been involved in those AV access, you know, arterial venous access for dialysis patients. And we've seen it perform really well in those situations.
Hi, this is Kristen Kluska at Cantor. Thanks for hosting this. One question for the company and one question for our surgeon guests today. First, to the Humacyte team, it was nice to see that some of the centers that started the VAC process do not actually have any experience yet with the product. Can you talk about how they became aware, what drove their interest, especially right out of the gate with the approval and launch, and how you think their uptake could look versus the centers that already have some experience under their belts?
Yeah, I can take that one. I guess the next question will be for you guys. Yeah, I mean, you know, once we had approval back in December, we were able to go out and start to seed the market, speak to, you know, not only, you know, our label indication, the data that supported that, the health economic messaging behind it. It's also, frankly, just a really good sales force that has relationships, relationships in places and institutions that weren't part of our clinical study. I think it's, you know, it's connection, it's the hard work, it's the messaging, but also the relationships. It's interesting. I mean, I think some of them could be as, has as much, if not more volume than some of the places that you know.
I mean, that's kind of what's been interesting and exciting that as we dug into that Definitive Healthcare database and understand volume, there's some places Level II and others that do a lot of cases not a lot of people know about, but we've identified them and now are working to capture them. It's one of those that you kind of don't assume just because it's a big name or a small name, you know, volume can be deceiving. We've, you know, we're being very obviously data and analytical and fact-based and making sure that we go after the ones with the most volume. The second question was surgeons.
Yes, thanks for the two surgeons. Maybe can you speak about the comment about the VAC and the question regarding how often would you use it? Is there any chance these conversations could change should you find that you're using it more than you anticipated? Also, how might real-world evidence and experience help with conversations moving forward, especially if this product is used in other indications down the line? Thank you.
Sam, you already spoke about this, so yeah.
Luckily at my hospital, we had already trialed it. We had an Emergency Use Authorization. The hospital saw its utility immediately with a good patient outcome. Hospitals tend to want to be on the forefront of technology because they want to be able to market that, say, "Hey, we have the latest and the greatest." If you have buy-in from the surgeons, what follows from that is buy-in from the hospital. To convince the hospital that we should have it wasn't a very difficult conversation. The one limit is the cost. You know, the hospitals get a bundled payment per procedure. When you have a device that's pretty pricey and sometimes you're using two pieces, that can be an obstacle.
That being said, once the New Technology Add-On Payment comes through, I think that will make that conversation even easier with the hospital. As time goes on and technology matures, you know, costs and prices go down. I think the sky's the limit really long-term because there is a clear need, at least from a vascular surgeon's perspective, for an alternative conduit. I don't think it's going to be difficult to, you know, persuade surgeons that there is a role for this graft. Once you have that, I think the hospitals will follow suit.
Specific to your question about, will a hospital come back and say, "Limit its use because of its, you know, if you're using it more than what you say?" If on the VAC application, they ask you, "How many times are you going to use it a year?" and you say, "We'll use it 12 times a year."
And then, you know, in the first two months, it's already 10 times. Are they going to come back and tell us, "We can't use it?" I've never been in that situation in 20 years of practice. I've run a VAC both at my university hospital, which is a state-run, you know, hospital that takes care of a lot of underserved people. I also am on the leadership integration group for our health system. We have a private community hospital that is part of a 15-hospital system.
We're getting it, we're putting it through the VAC at that hospital. It's actually in Jersey City. Once it's approved there, it's approved in the system. Whether those other hospitals then stock it is up to whether the surgeons at those hospitals say, "We want to have this," but it's already approved for use. That usually comes to, in our system, you know, the leadership group, which is like the heads of vascular across the different hospitals, and it's usually made a decision whether or not it's allowed.
There you go.
Hi, thanks. Josh Jennings from TD Cowen. Just hoping to just follow up on the VAC approval process. It sounds like at the University of California, San Francisco, it was smooth sailing. Maybe you could just help us, not just for the decision to adopt or get the VAC committee through the adoption decision on Symvess , but also for other technologies.
I mean, what is held, what is at the top of the list of boxes to check? I mean, my understanding for Symvess and vascular trauma, you know, clinical data is there, cost-effectiveness is there, but maybe you can just help us think about why it was so smooth or just more details on why it was so smooth at University of California, San Francisco, and then maybe over in New Jersey, you know, what's the path forward there with the VAC approval process?
For the record, I'm not at UCSF Hospital. My hospital is called Community Regional Medical Center. It's affiliated with UCSF, but it's not a UCSF hospital. To answer your question, really there's a clinical need for it. I think that's number one. If there's a clinical need, you know, a quaternary level hospital is going to want to be able to provide that comprehensive care. If you can make that case to the VAC committee, they're usually, you know, that's why it was so smooth. I had a case example that didn't really cost, that didn't cost the hospital anything. They saw the clinical need. They tend to get excited about these new technologies that come out, especially when they see it, you know, benefiting somebody in the community. They can use that as a marketing tool.
I found that to be probably the main reason why it was very smooth. We had no obstacles. They asked me, "How many times are you going to use it a year?" I said, "Probably a handful to start." We will see. This is not something we are going to be using every single day, every single week. If that was the case, probably would have been a different conversation, at least until the New Technology Add-On Payment comes through.
I would say that there are two things that get priority in the VAC analysis. One is, are there substitutes available? In this case, there's really not, right? It's a different biology. It's a different technology. I think that that can be, that argument can be made. It's not just another stent graft to treat an, you know, we've got five different aortic stent grafts, right? Or 12 different balloons. We just need to add on a 13th balloon. This is unique. The uniqueness of the product. The other thing is that I think is helpful in VAC is, you know, when things are used in an emergency basis, it's a different concept of how you look at things compared to stuff that's elective.
Hospitals get nervous when they can't take care of a patient with an emergency condition that would otherwise be treatable. I think this is, you know, for trauma-related stuff, it's really rare that, you know, we've ever really said, "No trauma surgeons, you don't get this," unless it's just another thing that is like an add-on to, you know, multiple others.
Thank you for that. Just to follow up on your download about just the visceral reaction, maybe an aha moment for a vascular surgeon when you just first feel the ATEV in your hands, maybe for both surgeons, just maybe expand on that and just the handling. I know you demonstrated a case out west about where you had end-to-end or you anastomosed two ATEVs together for that bypass surgery. Maybe just talk about the handling and maybe build out more about why it's such a visceral aha moment for vascular surgeons when they first handle it.
When we take another graft out of a box, it's usually a relatively stiff material that doesn't feel like human tissue. And when you sew it, there's a compliance mismatch that is like it's just palpable. You can feel the difference. When you feel it, it feels, you know, like, you know, tissue rather than a, you know, you know, some foreign or mechanical piece. When the suture goes through it, it goes through it as if it's a healthy vessel. And that, you know, the way you pull the suture through, it feels normal.
Yeah, I agree. I think tissue handling works really nice. The challenge is the size mismatch if you're going distal to smaller arteries. I think technical success with the graft is going to be close to 100%. I think if you're selecting the right patient, handling it, and actually getting a technically sound bypass done, I don't think it's going to be any issue. It's very easy to handle, very easy to use. Over time, you know, hopefully we'll have longer grafts. You know, I anticipate that we're going to have a greater selection, and that's only going to make it easier down the road.
I think we're bumping up on time. Maybe last question. Go ahead.
Yeah, you actually kind of just touched on it, but I was curious outside of the clinical data aspect, what would be the driving factors that would increase your adoption? It sounds like it is going to be different sizes and whatnot, but if you guys could just speak on that a little bit more. Thank you.
Yeah, if it's available in different sizes and lengths, that's going to be helpful. Once you're below the knee, the vessels are smaller. Obviously in the belly, their vessels are bigger. There are places where, you know, you could expand its use by having different sizes. The length, sewing two together is a lot easier than going and getting vein out of somebody's arm, which is like the alternative, which isn't done a lot, but we still do it. If they don't have vein in their legs, we go chasing three different pieces. I mean, there are patients who have had all four veins in the arms kind of sewed together, wrote a paper back in around 2000 about using arm veins composite grafts. Yeah, so that'll be nice to be able to have various sizes.
They also think the ultimate kind of dictator of how widespread is going to be the long-term patency. If I never have to harvest the saphenous vein again, I would love that. Unfortunately, nothing rivals the saphenous vein. I am going to keep harvesting it as long as that's the best option. Ultimately, once we understand there's preliminary data coming out, once we see its comparison to saphenous vein and prosthetic graft over time, that's kind of going to dictate, you know, how, you know, let's say it's equal to saphenous vein, then why ever harvest the saphenous vein again if it's the same? I would much rather use a conduit that rivals that patency without having to fillet the whole patient's leg open and keep them in the hospital for an extra couple of days for pain control.
You know, that's obviously a lofty goal. That's not the only, I mean, you don't need to be, you don't need it to be that good for it to have widespread use. It's probably, I predict, is going to be better than GORE-TEX and plastic. That alone will expand its use to patients who don't have adequate saphenous vein, which is a large contingent of PAD patients.
In patients with saphenous vein, and you've got a three, and I'm sure Sam's going to, you know, back me up on this. If you've got a 3 cm or 5 cm defect in a femoral artery, if this is available, I'm not, it's just, it's unlikely I'm going to be going and chasing a vein at 2:00 A.M.
It's just, you know, because I know that that conduit is not a challenge. The only reason I don't use the prosthetic in those situations is because a bullet has gone through there and I worry about infection. You know, rather than getting the saphenous vein out of the other leg for those short pieces, it's still got to use a whole 40 cm piece, but I'm going to take that and cut my three-piece, 3 cm or 5 cm piece out and use it.
Great. I was going to say, Laura, any final words?
No, it's just, I, you know, I've spent so many years in the operating room with surgeons, and, but I, every time I listen to you guys, I learn more and more. Just really appreciate your time. Thanks so much.
Thank you guys for joining.