Good afternoon, and welcome to the Humacyte Data Call. At this time, all participants are in a listen-only mode. A question and answer session will follow today's formal presentation. If you would like to submit a question, you may do so at any time throughout today's webinar by using the Q&A function at the bottom of the webcast player. To our covering analysts in the room, please raise your hand to indicate that you would like to ask a question. At this time, I would now like to turn the call over to your host, Laura Niklason, Chief Executive Officer of Humacyte. Please go ahead, Laura.
Thank you, Sarah, and welcome everyone to our top-line results and KOL webinar call regarding our V005 trial of the HAV in vascular trauma. This is Humacyte's typical disclaimers regarding forward-looking statements. Just as a reminder to those on the call, Humacyte really leads the field of regenerative medicine in the bioengineering of tissues and organs. Our Human Acellular Vessel, or HAV, is available off the shelf and is universally implantable with no immunosuppression. In addition, we've observed that the HAV repopulates with cells from the patient over time after implantation, becoming a living tissue. We believe this is category-defining innovation that creates new tissues for patients with a variety of medical conditions.
If we look now at vascular trauma or vascular injuries in general, whether they're civilian or military-related, there are over 70,000 vascular injuries that occur in the United States every year. If we look at the available treatment options that are used, on a realistic basis, there are really three. One is harvesting vein from the patient, in order to revascularize, the injured limb. This typically requires time, up to an hour for vein harvesting, which can really delay the revascularization of the limb and can lead to further complications. Alternatively, off-the-shelf options are typically made of synthetics or plastic, like Teflon or Dacron, and while they're immediately available and speed revascularization, they're often fraught with other complications, such as infection and thrombosis.
If neither vein nor synthetic is suitable because of a patient who has a severely ischemic limb and that's also severely contaminated in the wound bed, then those patients might face ligation and amputation. The HAV, we believe, may be an outstanding method for treating patients with acute vascular trauma, and the reasons for this are several. One is that the HAV is immediately available. Surgeons can take it literally off the shelf, and it can be available within minutes after removal from the packaging. In addition, as we mentioned, the HAV repopulates with cells once implanted into the patient. We've observed that this results in microvascularization of the HAV and also an important resistance to infection that we've seen in multiple clinical scenarios and that you'll hear about later on in this presentation.
So between the immediate availability to provide revascularization and blood flow and the resistance to infection, the HAV may represent an outstanding alternative for patients with vascular injuries. Humacyte will use the V005 clinical trial as the basis for filing a Biologics Licensing Application, or BLA, with the FDA later this year. Our target indication statement reads that: The Human Acellular Vessel will be indicated for urgent arterial repair following extremity vascular trauma when synthetic graft is not indicated and when autologous vein is not feasible. The top-line results of this V005 trial will be reported today, but more full results and outcomes, including secondary and safety outcomes, will also be presented at the VEITH Symposium in New York in November of this year. So with this, I'd like to turn the podium over to Dr.
Parikh, who's our Chief Medical Officer, who will describe the V005 trial and the top-line results we've observed.
Thank you, Dr. Niklason. I'm Shamik Parikh, CMO at Humacyte, and I'll walk you through the top-line data for V005 study. V005 is our pivotal study in trauma. It is a single-arm, open-label trial. We recruited patients in more than 20 Level I trauma centers in U.S. and Israel, and it looks at vascular repair, but the focus for this indication is on arterial injury repair. Our primary endpoint is 30-day patency in patients with extremity injuries. We recruited 69 total patients in this study as of June 30, and that is our data cutoff for the BLA file. 51 of these patients had extremity injuries and will be the focus for the BLA filing. All our patients had no autologous vein for repair, as assessed by treating surgeons.
Hence, these patients would have received either a synthetic graft or ligation for their bleeding vessel or amputation if an HAV was not available. The patients with the extremity injuries were all assessed to be at a high risk of contamination or infection.... Because this is a single-arm study, we are comparing it with a historical benchmark that has been discussed with the agency. The benchmark is a systematic literature review of synthetic vascular trauma. The primary comparison will be a 30-day endpoint of patency. Our secondary comparisons are infection and amputation rates. Our success criteria when comparing to synthetic graft is that we should have comparable patency. Our infection rate would be comparable or lower than synthetic graft. Amputation rate would be comparable or lower than synthetic graft, and no unexpected safety signals. Let me start with the demographics for V005 study.
Here we present race, sex, and mean age of patients. In the first column, you will see extremity subset, which is 51 patients, and then the entire study, which comprises of 69 patients. So we had 43% male patients, 49% Black patients, 8% other. 75% of our patients were males. Mean age was 34 in the extremity subset and slightly higher in the overall V005 study. And the age range was from 18-72 in the extremity subset and went from 18-81 in the overall group. These demographics were comparable to the patient population that we found in the literature in our systematic literature review. This slide talks about injury type and location in V005 patients. Again, in the extremity subset, about 20% of injuries were in the upper extremity, 80% in the lower extremity.
Blunt injuries was 43% and penetrating injury, 57%. Our Injury Severity Score was 20.8, and an Injury Severity Score of greater than or equal to 16 indicates severe injuries. The overall patient population also was quite similar to extremity subset. The distribution of this blunt versus penetrating trauma, the severity of injuries, and even the location of limb injuries overall were comparable to the systematic literature review that we performed for synthetic grafts. I now present to you the primary endpoint of patency. Shown in the first column is the total, patients of 69 patients, in the middle column is the extremity patients, and the far right column is the synthetic graft meta-analysis estimates. So the 30-day patency, which is secondary patency, was 89.9% for the total group and 90.2% for the extremity subset.
This 90.2% will be compared to the synthetic graft point estimate of 81.1%. The primary patency in our study was 81.2% for overall group and 84.3% in the extremity subset. However, there was no clearly reportable primary patency in the synthetic graft literature, and hence it's not reported here. So our point estimate for HAV patency is higher than synthetic graft point estimate. The lower end of 95% confidence interval for HAV patency is consistent with the synthetic benchmark point estimate. We have successfully met the patency outcome for this study. Amputations.
Amputation rate in the total V005 patient population was 10.1%, and it was 9.8% in the extremity subset, which has been compared to the synthetic graft point estimate for 20.6% for amputations in synthetic grafts. Conversely, limb salvage rate is 90% in the total group and 90.2% in the extremity group, compared to 79.4% for the synthetic grafts. Again, based on the aforementioned criteria, we have successfully met the amputation rate endpoint, the point estimate being lower than that of synthetic grafts, and the 95% confidence interval at the top end being consistent with the point estimate for the synthetic graft. Infections. The conduit infection rate overall in the study was 2.9%.
We had one patient with HIV infection in the extremity subset for infection rate of 2%, and this is being compared to a synthetic graft infection rate of 8.9% in the literature. Again, this meets the aforementioned success criteria for infections in this study. The V005 study enrolled very sick patients with vascular injuries in both United States and Israel. Majority of our patients, 47 out of 51 extremity patients, came from U.S., four patients from Israel. Many injuries were contaminated and were typical for high risk of infection. All patients in V005 trial had no autologous vein available for vascular repair. The top-line results for V005 trial show that V005, that in this study, point estimate of patency for HAV was greater than for historical synthetics.
Our limb salvage point estimate with HAV was better than historical for synthetics, and our point estimate for HAV infection rate is lower than reported for synthetic grafts. There have been no unexpected safety signals in this sick and diverse trauma population. The V005 trial was successful, and it demonstrates the potential benefit of HAV.... In addition to V005 study, we also have Ukraine real-world experience for use of HAV in vascular repair. The significance of which would be clearer on the next slide, as this will be part of our BLA filing. We specifically supplied HAVs in Ukraine at the request of surgeons from Ukraine, who had likely heard about our vessel through the Polish surgeons, where we had conducted some of our earlier studies. In all, 19 patients were treated with an HAV in Ukraine. 17 of these have consented for data collection and study participation.
16 of these had extremity trauma repair. One patient required HAV for iatrogenic trauma repair. Our Ukraine humanitarian experience has been presented at the Military Health System Research Symposium meeting earlier in August 2023, and these are our findings for the 30-day data. The 30-day patency in Ukraine population is 94.1% overall, and 93.8%; there was one person in Ukraine who did not meet the patency endpoint. Amputation rate was 0. Limb salvage, conversely, was 100%. Conduit infection rate was 0%. On the right of the panel is one of the patients in Ukraine. In the top graphic, it shows the patient turned on one side, the lateral side of the left thigh, the result of a blast injury, and you can see the extent of the soft tissue trauma.
Over two-thirds of our patients in Ukraine had this mine blast type injuries. You can see in the CT scan the fragments, the shrapnel fragments in white, dispersed throughout the thigh area. Some of these shrapnel fragments had cut through the inguinal region and had damaged the femoral artery. This femoral artery was repaired with the HAV, as you can see in the middle panel. At day 113, this patient was able to walk with support once again. With this, I would like to turn it back to Dr. Niklason.
Thank you, Shamik. So our guidance from that we've received from the FDA regarding BLA filing is as follows: The basis for filing will be our V005 study, as we've mentioned. These data will be supplemented by the Ukrainian real-world experience, and the FDA has informed us that these two data packages will be sufficient for BLA submission. As Dr. Parikh mentioned, 17 of our 19 patients in Ukraine have consented to provide their data to the BLA as part of this filing. The BLA approval mechanism will be a traditional approval mechanism. In contrast to an accelerated approval mechanism, which typically requires a post-approval randomized controlled trial in order to confirm results, Humacyte will not be required to perform a post-approval randomized controlled study for this confirmation. We view this as a very positive development.
In addition, in May, the HAV for vascular trauma received the Regenerative Medicine Advanced Therapy designation. This will provide a basis we anticipate and hope for a priority review of our BLA application with the FDA. With this wrap-up, I'd like to now turn it over to Dr. Michael Curi. Dr. Curi is a surgeon at Rutgers University, and is a vascular surgeon and has treated a number of patients in the V005 study with severe vascular injuries.
Thank you, Laura. It's my pleasure to just present a couple cases that we experienced at the trauma center in Newark, New Jersey, where patients were enrolled in the V005 trial. This is a case of a patient who came in after a motorcycle accident with a severe injury to his left leg. The issue of extensive soft tissue damage was obvious, but when exploring the patient, it was noted that he had a large defect in his popliteal artery. And you can see with the two arrows pointing to the ends of the remaining artery, the intervening segment had to be resected due to its damage. And so now we were left with what to do about reconstructing this artery.
The patient had consented to being in the trial, and he underwent reconstruction with the HAV. And this picture shows approximately 10-centimeter interposition graft that worked great in this patient. The inflow artery was the popliteal artery just above the knee, and the outflow artery was the tibial-peroneal trunk. This is a relatively challenging reconstruction given the size of the smaller vessels in the calf muscle. The next case is a case of a blunt injury to the left thigh. This is a different patient. But again, this is now a CAT scan to give you an idea of what we look at when we're evaluating these patients.
On the left side of the screen, you can see the patient's right leg and the bright white linear, I guess, finding there is actually the femoral artery or superficial femoral artery just above the knee. On the left side, you do not see that artery on the left side was damaged. You can see the soft tissue defect in the skin and muscles and soft tissues with air in the wound suggesting significant soft tissue damage. Then this is just an axial view, again, showing on the screen left, the normal right leg with a popliteal or distal superficial femoral artery filling with contrast with this, which is that bright white dot just below the big bone, which is also white.
Then on the screen right is the damaged right, left leg, and you can see little black dots all throughout the tissue, which is air, which comes into the tissues when you have a bad crush injury such as this. Then this patient also was enrolled in the trial and had an HAV reconstruction. And about one month later, while the patient had a exceptional distal perfusion from the arterial reconstruction, she had significant soft tissue complications with infections. The arrow here is pointing to a pocket of fluid, which is the darker appearing kind of almost looks like a pond or a lake. And that dark fluid is pus that was drained. Immediately to the left of that, you can see two white circles.
Those are the femoral artery and the HAV, or the femoral vein and the HAV, right there immediately next to, you know, the soft tissue infections. A significant concern in these patients, and lots of vascular reconstructions fail due to this. In this patient, the infection was drained, and the patient continued to do well and is doing exceptionally well now. So these are just two typical cases of challenging vascular trauma and that are often associated with dramatic soft tissue injury and challenges in not just the vascular reconstruction, but getting that vascular reconstruction to last in these difficult patients.
That's very helpful. We also have a video from one patient. Well, actually, before we show the video, I'd like to ask Dr. Charles Fox, who's also a trauma surgeon practicing at Baltimore Shock Trauma at the University of Maryland. Dr. Fox is an ex-military surgeon and also has participated as an investigator in the V005 trial. We were hoping that Dr. Fox could provide a little bit of context as far as the utility of the HAV in civilian and also perhaps in military settings.
Thank you, Laura. Good morning, everyone. I'm calling you from the operating room, so my apologies for the background noise. Can everyone hear me?
We can.
Okay. Well, as Laura said, I've been a trauma surgeon for almost 20 years and deployed many times to the Middle East, where we were confronted with severe vascular injuries, with the inability to do the perfect reconstruction, because of a lack of saphenous vein and the infectivity of the contemporary prosthetic materials. And so I can't say enough about the process of developing a conduit that allows us to perform really good limb salvage operations. I was the principal investigator in Denver, where we used the Humacyte HAV, and I had really excellent results with it. Used it in torso, upper extremity, and lower extremity trauma numerous times. And, it's really important because time is so critical.
There just isn't always sufficient time to harvest the perfect conduit, and this is an off-the-shelf option for us, in mostly contaminated wounds that resist infection when we use this material. It's really quite magical. It's very easy to handle and sew, too, and it's off the shelf. I use a lot of bovine carotid in my current practice because it's approved for use, and it's similar to that material in that it's biological, and it's easy to handle, and it holds sutures very well. Because I'm in the operating room and I'm in the midst of doing an operation now, I'll just take any questions.
Dr. Fox, we're not seeing any questions come in from the analysts, so I think we're gonna let you go and take care of your patient, and we really appreciate you taking a few minutes with us. Thank you very much.
Okay, thank you. I wish I had more time to spend with you. Thank you all very much.
So, Sarah, I think we have a patient video that we can show, and then we can take general questions from the audience and from our analysts.
My name is Devin Asia Barnett. I'm 34 years old, so I'm a longshoreman with Port Newark. I was working at the port as a holdman, and when I noticed that the van was too close to the crane, I went to go see if the crane was going to clear the van, and it didn't. And by the time I turned around, the crane was crushing me into the van. So the extent of my injury was very severe. It was a crushing injury to my knee, and then it ripped through my hamstring and my femoral artery. Because my biggest thing was, can I keep my leg? And were you able to save my leg? I think that was the biggest concern of mine, so they wanted to address that.
To those doctors and scientists who are working in the technology field in order to create something like the HAV vessel, I'm extremely thankful and proud to be able to utilize your vessel.
I can truly say it's been a blessing for me to just have my daughter here with me, instead of actually the possibility of having her leg amputated. So I am thankful for the clinical study. I'm thankful that the HAV was available for my child.
Okay, thank you, everyone, and now this brings us to our Q&A session. So with that, as a quick reminder to the audience, if you're watching on the webcast, please submit your questions via the Q&A function, which lives below the webcast player. You can type your questions in there. And to our analysts, please raise your hand to indicate you'd like to join the queue. So we'll kick it off with the first question from Bruce Jackson at Benchmark. Please go ahead, Bruce.
Hi, thanks for taking my questions. I was curious to know about the, the data you said is going to be presented later on at the VEITH Symposium. Is that going to be a podium presentation?
Hi, Bruce. This is Laura Niklason. Yes, we're going to do a scheduled dinner presentation that will allow the participation of analysts and also a variety of key opinion leaders. We'll present the top-line data in much more detail, and also our safety events and our longer-term follow-up.
Okay, super. That's it for me. I'm going to hop back in queue.
Great. Thanks, Bruce. The next question comes from Ryan Zimmerman at BTIG. Go ahead, Ryan.
Hi, can you hear me okay?
We can.
Oh, wonderful. Okay. So first off, a very nice video. I thought it was nice to see this story. I guess a couple questions for me, just two. One, there were some slight differences between the Ukrainian data and the broader study population. I'm just wondering kind of what you attribute those differences to? And then I'll ask my second question up front as well, which is: What do you specifically attribute the higher secondary patency rates to with the HAV relative to synthetic grafts? Is there something structural that you'd kind of, you know, now looking back, can point to? Is there something, you know, just at a cellular level that you think is driving that secondary patency rate? Thanks for taking the question.
Yep, thank you. Thank you for the question. Your first question is about the results in Ukraine versus V005 study. So V005, in both cases, we did mandate that autologous vein was not available. Having said that, in V005 study, we did see a lot more complex and sicker patients. Relative to that, what we are seeing in Ukraine are patients otherwise in generally good health. They have severe blast injuries, but these are localized injuries to the extremities in most case, and the HAV did really well in them, and we didn't have. And achieved very good patency rate. So I think a lot is attributable to the good health, relatively good health of the Ukraine patients compared to the V005 study participants.
And with res-
Yeah.
Yeah.
Go ahead, Laura. Sorry.
No, that, that's all right. With respect to your second question, you know, that's a very good question. The HAV is a biological conduit. As we know, it's comprised of a lot of collagen and other matrix molecules. We also know from a lot of patient explants and publications that we've done, that the HAV stimulates essentially no foreign body response and very, very low inflammatory response. So it's our belief that the low inflammatory response and lack of foreign body response really contributes to the patency outcomes of the HAV. It's also possible that in contrast to material like Teflon, which is very hydrophobic and not very biologically friendly, it may be that proteins from the bloodstream passivate the surface of the HAV after implantation and relatively protect it against thrombosis.
So I think it's a combination of the surface characteristics and also the low inflammation and foreign body response that we see.
Yeah, I'll be looking forward to the full top line or the full results later this year, and congrats on the progress.
Thank you.
Thank you.
Laura, I might just add to that. The thought about the difference between this conduit and the synthetics. For the similar reasons why vein grafts have significantly better patency than the synthetics, this conduit feels much more like a vein graft. And you know, just the compliance mismatch between the vessel and the conduit, and how the vessel sits within the body, especially if it's crossing the knee. You know, these are issues that we've seen for a long time in the comparison between a vein graft and a prosthetic. Here, like I said, like Dr. Fox spoke about, it handles much more like an autogenous conduit.
Thanks for the addition. So the next question will come from Kristen Kluska at Cantor Fitzgerald. Kristen, you can go ahead.
Hi. Good morning, everybody, and let me also add my congratulations on these data. I was hoping you could talk more about specifically what you collected for the historical data and your confidence that the agency will support the comparability among the different extremity injuries present in your trial relative to some of these historical data.
Thank you, Kristen. Yes, the historical comparator dataset, I looked at the world's literature of using synthetic grafts to treat extremity vascular trauma, upper and lower extremity, over the last 20 years. We actually worked out the protocol for doing the meta-analysis with the agency before we performed it, and we've already submitted the results of the meta-analysis to the agency. So we have a high degree of confidence that the agency will accept this benchmark, given that it was developed in collaboration with folks at the FDA.
Okay, thank you. And then your, your turnaround for filing here is pretty rapid relative to what we're used to seeing in the biopharma space. So maybe can you touch here about things that you've already checked the boxes off of and prepared versus what's still needed over the next 3-4 months here?
Well, Kristen, as you may recall, our manufacturing system, called the Luna 200 system, which allows us to make HAVs at commercial scale, has already been in use. We've been using this system to produce vessels for our ongoing clinical trials since the middle of 2021. As part of transitioning to that commercial scale system, we did a very detailed filing to our IND with the FDA back in 2020, and they reviewed that filing and have given us a sign-off to use our current commercial system in our clinical studies. What this means is that a lot of the manufacturing documentation has actually already been submitted to the agency, and that's typically a huge part of a BLA filing for this type of product.
Between the 30-day endpoint, primary endpoint for our pivotal study, combined with the fact that we already have much of our manufacturing and all of our preclinical work on file, that really allows us to file the BLA more rapidly than other companies might be able to.
Thank you again. Appreciate it.
Thanks for the questions, Kristen. The next question-
Sure.
will come from Josh Jennings at Cowen.
Hi, good morning, and, congratulations on these positive results. I wanted to, just ask about the level of complexity in the patients that were enrolled in this study relative to the, meta-analysis control group, if that's the right, terminology. I mean, our suspicion is that just due to the, consent process, that the patients enrolled, those 51 extremity patients particularly, were at the highest level of complexity, and we may even see stronger results in the real-world experience, due to that dynamic, and maybe we saw some of that with the, Ukrainian, small Ukrainian, dataset. But just wanted to better understand, you know, that study group and, the complexity of that, patient population.
Well, we're going to speak more to the comparability of the patient populations at our presentation at the VEITH Symposium in November. But I will say that the systematic literature review population included both civilian injuries and also wartime injuries because, in fact, the patients that we've treated have been both civilian and wartime. I would say that on the wartime injury side, many of those injuries are very severe and comparable to the V005 population. Overall, from the Injury Severity Score standpoint and from the Mangled Extremity Severity Score standpoint, which is another metric that we look at, actually, the V005 population and the systematic literature review population were pretty similar.
But that said, if you're using a PTFE graft, a synthetic graft, in an injured patient, oftentimes that means that that patient has no vein, and oftentimes that, that implies really severe injuries. So I do think we believe, and the, and the agency will believe that these populations are comparable. And going further, though, we also anticipate that when the HAV is used in patients who have less catastrophic injuries, that, as you said, the outcomes may even be better.
Thanks, Laura. One follow-up just on, I guess, patient follow-up over the next, I guess, will we see six-month and twelve-month results? Is that important for the clinical committee? Clearly, you guys have hit the mark for FDA or BLA approval, it seems. But just in terms of adoption and utilization, how important are the six-month and twelve-month follow-up results? And how should we be thinking about those results rolling out? Thanks.
So we will report longer-term results, as we mentioned at the VEITH meeting and also in subsequent publications. Of course, longer-term perfusion is important for any trauma patient or any patient. As you may be aware, we've reported some long-term results with really excellent patency in our peripheral arterial disease patients, although this is not the trauma population. I would say that in terms of the decision of which conduit to use in the setting of acute injury, the caregivers are primarily interested in saving life and limb, and getting the patient out of the operating room as quickly as possible. Certainly long-term patency is a factor, but in the setting of trauma, it is not the primary factor. The primary factor is saving life and limb at the time of the acute crisis.
This is why the FDA has acknowledged that 30-day patency is actually a salient endpoint. It's a clinically meaningful endpoint in the trauma population. While we expect that our longer-term outcomes will be good based on what we've seen in the PAD literature, we also believe that in the trauma population, short-term endpoints matter a lot.
Yes, that's really helpful. Thanks, Laura, and congratulations again.
Thank you for the questions, Josh. I think we have one more analyst in the queue, so we'll hand it over to Suraj Kalia from Oppenheimer.
Hi, Laura. Can you hear me all right?
Yes, we can.
Perfect. Hey, congrats on the data. So, Laura, three questions. I'll ask them together. So first, in terms of the Ukrainian population, was this cohort prospectively defined in any way, and what was the adjudication process? That's question number one. Question number two would be... And maybe I misheard this. Please forgive me. The indication for HAV in trauma, did I hear you say it's not indicated, or patients not indicated for synthetic grafts? I'm sure I misheard that, but I just wanted to clarify. And the third question would be, this was secondary patency, right? Can you give us a relative framework of the ancillary interventions that were done for secondary patency? Thank you for taking my questions.
So, Suraj, I'm going to do my best to remember your questions. So in Ukraine, the population of patients that received the vessel was prospectively prescribed. In fact, when we sent vessels over to Ukraine, to those five frontline hospitals, in collaboration with the Ukrainian Ministry of Health, we pre-specified that patients who would receive the vessels would have injuries to arteries in the limbs, and also that these patients would have no existing saphenous vein or autologous vein to treat their injuries. So in that sense, the inclusion criteria, even though this was not a clinical trial per se, but the inclusion criteria for the humanitarian effort actually mirrored the inclusion criteria for the V005 trial. So for that reason, we believe that the patients and the types of injuries between the two studies are roughly comparable.
We had no formal adjudication of outcomes in this humanitarian effort. But once the FDA expressed an interest in seeing data from Ukraine, we reapproached surgeons who had implanted the HAV in Ukraine, and those surgeons reached out to patients who had already consented for the humanitarian effort. Those patients provided a second consent in order to collect their data so that we could provide it to the FDA. But again, because this was not truly a controlled trial, the outcomes of what was observed in Ukraine were not independently adjudicated. As far as the second question regarding the indication, I don't think you heard correctly. So, the HAV is indicated. Our proposed indication, we don't know what our final indication will be because we haven't had these discussions with the FDA.
But our target indication is patients in whom there is no autologous vein for repair, and in whom PTFE or synthetics would not be indicated, either in the view of the surgeon because the wound is too contaminated or at risk for infection or, you know, what have you. On your third question, which is what types of interventions were needed in order to restore patency in those small number of patients who clotted their vessels in the first 30 days? I'm glancing over at Dr. Parikh to confirm what I'm saying here, but the interventions, which we'll present more fully in November, were really standard vascular surgical interventions, either thrombectomies or angioplasty. There was nothing really extraordinary about the interventions to restore patency in this patient population.
Thank you.
Laura, that ends the Q&A session for the panelists, and if there are any questions within the chat that you would like to address, please go ahead. Otherwise, I'll turn it over to you for concluding remarks.
Yes, we do have a few questions in the chat that I think we, we should address. So the first question comes from a viewer and asks: Is there any application in surgery in the US after receiving the FDA's Regenerative Medicine Advanced Therapy designation? So unfortunately, simply receiving the RMAT designation does not, in and of itself, provide approval to use the product in a commercial setting. What it does provide is an acknowledgment by the agency that they view the product candidate, the HAV, as being novel and potentially very high impact for a set of patients who are currently have an unmet clinical need. The RMAT designation also allows us more frequent and closer communication with the FDA as we develop our BLA package.
So the advantages of the RMAT are really closer communication and also a potential for a more accelerated review once we submit the BLA filing. In the second question, it says, "Greetings from Kyiv, Ukraine. On the global scale of traumatic injuries of other localizations, including aortoiliac, popliteal tibial segments, what is the prospect for the creation of HAVs of other diameters?" Certainly, Humacyte's Luna 200 platform for producing HAVs is designed to be a platform, a flexible method for producing vessels in a range of sizes, both diameters and lengths. Indeed, Humacyte is already producing smaller caliber vessels that are 3.5 millimeters, and we're testing these vessels in animal models of heart bypass and also pediatric heart surgery.
But in addition, we've shown the feasibility already of growing larger diameter vessels up to a centimeter in diameter. So we anticipate that vessels that are produced by Humacyte's platform, in the long term, could address vascular injuries almost entirely throughout the body. A possible exception is treating aortic trauma, but everything outside the aorta, in the long term, may be fair game. The third question is: What's the percentage of vascular trauma patients who would be eligible for the HAV? In other words, synthetic graft not indicated and autologous vein not feasible. I'm actually gonna ask Dr. Curi to answer this question because he really has the best sense of how patients present in the emergency room.
Sorry, Laura, could you just repeat that question?
The question is, what percentage of vascular trauma patients would be eligible for the HAV?
So, all patients who require a reconstruction, I think would be really, potentially, you know, considered for using this. There's a subset of vascular injuries that can be repaired primarily, which means that we don't have to reconstruct the vessel. Either we can put a stitch in it, or we can mobilize the vessel and bring it together end to end. In those cases, obviously, no graft is used. But whenever we're using a graft, having something readily available, that works in a similar fashion to a harvesting of the patient's vein, I think all of those patients would be candidates for this, depending on, you know, future studies looking at, you know, the comparison of this, to vein in and of itself.
But right now, about 20% of vascular reconstructions in a traumatic situation, 25% don't have a saphenous vein available to them. And that's that comes from the military experience. And those are in healthy, young, you know, military population. When you think about this in the broader population, where older patients may be involved, I would think that that proportion may even be bigger because the saphenous vein may have been used for a coronary bypass, or they may have progression of venous disease that would make the saphenous vein not usable.
Thank you for that. The fourth question is: What is the specific process for the FDA to approve and formally license for commercial sale? So this is a multi-step process that begins with filing of the Biologics License Application, which we will do later this year. Following that, the BLA, the FDA will notify that they have accepted the file, which occurs a couple of months after the filing. Subsequent to that, there's an ongoing review process that's followed by an inspection, a pre-approval inspection of Humacyte's facilities. Following all those steps, there may be an advisory committee of external advisors that confer with the FDA regarding the product and the clinical data at hand. Following all those steps, the FDA issues approval.
The fifth question is, are we continuing to work in Ukraine, and at what scale? So we're continuing to follow our patients in Ukraine that we've implanted with the HAV. Per our agreement with the Ukrainian Ministry of Health, the humanitarian effort lasted for one year. And the Ministry of Health has not extended that. So we have completed our implantations, but we're continuing to follow these patients and work closely with the surgeons to make sure that we understand how these patients are doing. The next two questions have to do with CMS reimbursement and also with pricing. So I'm going to allow or ask Dale Sander, our Chief Financial Officer, to deal with these questions.
Yeah, thanks, Laura. We, the pricing itself will be set at the time of launch, dependent upon, you know, a variety of factors, including, the outcome from a budget impact model, which is currently under development. That, that's a model that will demonstrate to hospitals what the budget impact will be of using the HAV versus current standard of care. And certainly, we expect that with lower rates of amputation, lower rates of infection, and lower rates of other complications, that the savings and costs of treating the patient by avoidance of these complications and reducing time in the hospital will certainly offset, the cost of the HAV. In addition, from a... You know, keep in mind that typically, in the trauma setting, it's an inpatient surgical setting.
In general, the hospitals are generally reimbursed under a DRG or fixed-price reimbursement system. But we do believe that for both CMS and for private pay patients, that the HAV will qualify for an NTAP, or new technology add-on payment reimbursement, due to the novel nature and innovative nature of the product. That will also supplement or provide an additional reimbursement to the hospitals for use of the HAV.
The last question I'm seeing is: What about the process for approval for use in peripheral arterial disease, or PAD? I'm going to ask Dr. Shamik to field that question.
We have conducted two trials in Peripheral Arterial Disease, and we continue to work with the agency for ways forward in designing trials that would satisfy the regulatory criteria. So the clinical work for Peripheral Arterial Disease, as well as the regulatory planning, is actively ongoing, and we will keep you updated on the progress on PAD.
So Sarah, I think that's all of our questions. If we could just return to the last couple slides, I think we can wrap up. So I really appreciate people taking the time this morning to hear about our top-line results, and the question and answer has been very stimulating and helpful for us. So we appreciate that. But really, I just want to emphasize that Humacyte's HAV, the Human Acellular Vessel, and the tissues that we can make related to that, really represent a first-in-class technology and manufacturing platform. Because we can make tissues of different shapes and sizes with different mechanical properties, we believe that we will be able to address a huge range of markets, not just in vascular disease, but in other cardiovascular diseases and even ancillary diseases, such as type 1 diabetes.
We're very close to market launch. We're planning to file our BLA later this year in vascular trauma, and we expect to file subsequent BLA submissions in additional indications, including in hemodialysis access. In addition, our pathway for pursuing a approval in Europe is currently underway. As I mentioned earlier, we're currently using systems that allow us to perform commercial-scale manufacturing, and the total capacity in the building in which we now occupy will allow us to produce approximately $1 billion worth of product when we're fully built out. We're also well capitalized. We've been very fortunate to have sustained support from our private investors during the private phase of Humacyte's development and also from the public markets.
We've raised more than $700 million to date, and as you all know, we are currently listed on the Nasdaq under HUMA, H-U-M-A. So with that, I'd like to wrap up. I'd like to thank Sarah and the LifeSci team for hosting this webinar, and we look forward to continuing to communicate with our analysts and our investors as we go forward.