ATEVs for vascular repair and replacement. In December last year, FDA approved SYMVESS as a vascular conduit for treating extremity vascular trauma, and the product was launched in February of this year. The company is also evaluating SYMVESS in other diseases, such as peripheral artery disease, and also has a second product that is designed for use in CABG surgery. To learn about SYMVESS's commercial potential and the development strategy going forward, I welcome Laura to this fireside chat. Good day, Laura. Glad to see you.
Great to see you.
I appreciate you accepting our invitation to speak at this conference. To start us off, and for the benefit of the folks who may not be familiar with the name, could you please highlight what is an ATEV and why is it better than what vascular surgeons are currently using?
Right. Our engineered blood vessels, and indeed all the engineered tissues that we make, are made from human cells, and we make them at manufacturing commercial scale in our facility in North Carolina. The way we use human cells to grow human tissues is we can—we use a scaffold that dictates the size and the shape of the tissue that we grow. After we grow the tissue, which takes about eight weeks, we actually wash the cells out of the final tissue that we've grown. What gets implanted into the patient is an engineered human tissue. In our case, SYMVESS is 40cm long and six mm in diameter, so it's a large tissue. It contains no cells, which means that in the 12 years that we've studied it and more than 600 patients, we've never had a bout of rejection.
It's a human spare part, basically, that's available off the shelf. It has an 18-month shelf life and can be used whenever surgeons need it. The reason it's better than some other options is that the two other options that surgeons really have now are to take a vein out of the patient and use that to repair an artery, which means that you're damaging the patient in order to repair another injury. Alternatively, a surgeon can use a plastic graft made out of Teflon that's available off the shelf. Those grafts are really foreign bodies that are implanted into the patient, and they can also have a high rate of infection.
I completely agree. All right. I know that vascular trauma, which SYMVESS is approved for, is a very large indication in terms of both patients and healthcare spend. Could you help us discuss how big this market is and how do vascular surgeons manage these patients with vascular trauma?
Sure. Traumatic injury to the blood vessels is a limb and life-threatening condition. If you add up all of the cases in trauma centers around the nation, there are about 26,000 cases per year of vascular injury that require vascular surgery to repair the artery, either putting in a segment or a bypass or what have you. It is a reasonable size market. It is 26,000 cases. A lot of those cases are concentrated in about 200 level one trauma centers nationwide. What that means is that there is really a finite number of call points. For Humacyte, with our first commercial launch, having a finite number of call points means that we do not have to mobilize an enormous sales force in order to reach those centers.
Great to know. To go dig a little deeper then into this SYMVESS, the product recently got approval in December. What are some of the data highlights that led to this approval, and what's your commercial strategy for this launch?
The data in our BLA, because we're regulated as biologic, even though it sort of feels like we'd be a device, we're biologic. The data in our BLA really came from two single-arm studies. One was in civilians in the U.S. and in Israel, where we took care of patients with car accidents, gunshot wounds, industrial accidents, et cetera. A second single-arm experience was actually a wartime experience where, under a Humanitarian Program, Humacyte provided vessels to warfighters in Ukraine. We treated active duty military warfighters who sustained terrible IED injuries, and we also treated civilians. It was that combination of the single-arm trial in the U.S. and the real-world experience in wartime Ukraine that provided the data for the BLA.
The key findings in the BLA, which we submitted to the FDA and then which we published in JAMA Surgery in November of last year, what we found was that when we compared our outcomes to historical published outcomes with plastic grafts, we found that our patency was substantially better. In other words, the blood flow through the graft. We also found that the infection rate was much lower than with plastic grafts, about 1/9. Probably most importantly, the amputation rate for these patients was about 1/5 of the amputation rate that had been reported for plastic grafts. This is a conduit that's immediately available. You know, the surgeon can take it off the shelf and be sewing in about two minutes. It has all the convenience of an off-the-shelf piece of plastic. From our studies published in JAMA, it actually works a lot better.
Sounds great so far. I know that recently you guys reported first-quarter financial results. You showed $500,000 revenue from the first month or so of launch, which we felt was really encouraging considering it's a brand new product that's on the market. Could you please talk to us about whether this launch has met your expectations and what metrics are you tracking internally that ensure that SYMVESS will be successful on the market?
This is an interesting sale. We're tracking sales, obviously, but we're also tracking other sort of intermediary metrics because this is not a sale to physicians or individual practices. This is a sale to hospitals. Hospitals are reimbursed for the care of trauma patients on a DRG basis or fixed-price basis, which means depending on the size of the injury, there will be a DRG that applies to that patient. Because the hospital is sort of on a fixed budget, their strong motivation is to limit the total costs of care and particularly to limit expensive complications, which prolong hospitalization and drive up costs of care, which then they have to absorb. As part of working through and getting on the formulary in these hospitals, we have to work through the Value Analysis Committee or VAC process.
At our last quarterly update call, what we reported is that we now have active files that have been submitted with the VACs in over 40 trauma centers, which corresponds to nearly a 1/4 of the 200 level one trauma centers in the U.S. Our rate of uptake as far as engaging in the VAC process has been about two or three a week, and that's been pretty consistent ever since we launched. That's an encouraging metric to follow. The time required to work through the VAC process can be three or six months or even longer, depending on the hospital. Once we work through the process, then the hospital is able to order. In addition to following VAC submissions, we're also tracking, obviously, orders and consignments, et cetera, et cetera.
Great to know. This is, even though it's maybe a little slow to get started, but we can get the—once you can really get the ball rolling, we can start to see some great results.
Yes. We've really messaged the market that we anticipate the substantial bulk of our sales to be in the second half of the year, just because this VAC process, it just builds in a long lead time.
Great. To dig a bit into the reimbursement, I know that in your previous public comments, you mentioned that you expect to receive a reimbursement decision in August through the NTAP system. Could you help us explain what NTAP is and why you think this decision could benefit the adoption of SYMVESS?
Sure. So, you know, again, as I mentioned, in the trauma indication, the hospital purchases the product and then pays Humacyte directly. So, there's no explicit reimbursement that we have to obtain from insurers. But that said, you know, we've developed a budget impact model, which shows that because of the much lower rates of infections and amputations, if a hospital purchases a SYMVESS unit and uses that in trauma patients, that on average, the cost of caring for that patient that gets SYMVESS is actually lower than the average cost of caring for a patient that's treated with a synthetic graft. So, on a head-to-head comparison basis, we've published our budget impact model.
We just published that in March, which shows that, you know, for an individual patient, on average, if they get treated with SYMVESS, they will be less expensive for the hospital to care for than if the patient is treated with a plastic graft. All that said, we expect that adoption will be driven even faster if we do get the new technology add-on payment. What that is, is it's a process where once a year, companies can apply to Medicare. If you work through the approval process, and we applied last October, and as you mentioned, we're expecting to get a decision from them in August, if they provide the new technology add-on payment, then what that means is that for two or three years, up to about 65% of the list price of the product is actually reimbursed directly to the hospital.
That essentially cuts the cost to the hospital by two-thirds. We anticipate that if we get that reimbursement, that will really drive adoption and accelerate adoption. That said, you know, compared to plastic grafts, we believe the economic case stands on its own. Not only are the clinical outcomes better, but we believe that the cost to the hospital are better, even without the impact.
Okay. Great to know that there is potential upside then later this year. Moving on from the commercial launch onto your pipeline programs. I know that the company has been evaluating ATEVs for fistula repair in end-stage renal patients. Could you explain what this indication is in terms of vascular repair and what the clinical programs that Humacyte has been conducting so far?
Sure. End-stage kidney disease, where patients generally wind up on dialysis, is a growing problem due to age and obesity and diabetic status. There's roughly 500,000 people in the U.S. who are on hemodialysis right now. That number grows by a couple percent every year. In order to have hemodialysis, what you need is essentially a conduit or a blood vessel that connects an artery and a vein in your arm. Getting that conduit surgically implanted and getting it to work is actually very challenging for some patients. In fact, the failures of these conduits drive a tremendous amount of cost of care of dialysis patients. What we reported out last fall was a phase III study where we hit our top line, where we compared the usability of our vessel, which is the same vessel I was describing for trauma.
It's exactly the same product, but it's implanted into the arms of patients who need access for dialysis. We compared that to what is currently the gold standard, which is where a surgeon forms a fistula, which is where an artery and a vein are sewn directly together. What we found is that if we looked at usability over the first year, our vessel was significantly more usable during that first year than the gold standard, which was a great observation. Even more importantly, I think if you dig into the data, what you see is that the patients who have been historically have a very high unmet need in the dialysis population, which is women and men with risk factors like obesity and diabetes, those patients really don't mature their fistulas very well.
What we found was that the delta between our vessel, the ATEV, and the gold standard was actually quite large. Based partly on those observations, we've actually embarked on another phase III trial, which we've enrolled half of right now, called our VO12 trial, where we study this vessel compared to fistula in women. We are very excited about this program because I think, you know, there hasn't been a new conduit to really support hemodialysis in decades. This has been a really tough problem for patients and for nephrologists. We are really looking forward to, you know, hopefully applying for a second indication next year.
Great to hear. Especially with the phase III that met its co-pilot endpoints already, and you have another phase III ongoing. What exactly are the next steps in this program then, as well as the timelines? When can investors expect the next major clinical or regulatory milestones?
Sure. As far as the publication of results of the VO7 trial, which is the trial that read out last fall, that paper is under review right now. We'll see. I hope it comes out soon, but it's not for review. In addition, the VO12 trial, which is in women, we passed our pre-specified half enrollment halfway mark in April, where we enrolled 80 patients. We have a pre-specified interim analysis when those first 80 patients reach a year. We expect to read out our interim analysis shortly after April of 2026. If that's positive, then we would expect to file a supplemental BLA in the second half of 2026 in the dialysis indication.
A lot of things we can expect over the next 12 months or so.
Yes. Even in the trauma indication, I'd be remiss if I didn't say that we have long, even though we just published the top line results last fall, we have long-term military results that are going to publish in a few weeks. We're actually submitting long-term trauma clinical data for publication probably next week in the civilian space. There's going to be a lot of news flow.
Great to hear that. Beyond the hemodialysis, Humacyte also has two early-stage programs in peripheral arterial disease and CABG. Could you please provide an overview of these programs and what data expectations should investors have from these two?
In peripheral arterial disease, we've actually completed three phase II trials. One has been investigator-sponsored and two sponsored by the company. Some of those already have publications. In all of those patients, these are patients who have critical limb ischemia, which means they have constant pain or ulcers and necrosis, and they are at risk of amputation. All of these patients, in addition, had no vein of their own to revascularize their limbs. What we've shown in these three phase II trials is that our limb salvage is outstanding. In particular, the most recent physician-sponsored trial at the Mayo Clinic, about which there have been several publications, what those surgeons have shown is that in patients who have no vein and who are facing potential amputation, the amputation rate at a year is actually quite low.
These are patients who are so sick that the amputation rate could have been as high as 50%. In fact, it was low. It was below 20%. This corresponds to important clinical outcomes. This is limb salvage in patients who really had no options. We are in the process of designing a phase III program there. You know, again, I think, you know, cash is finite. We are going to modulate when we kick off that phase III program, depending on how our sales ramp goes.
Yeah. Makes sense, especially in this market.
Yes.
All right. For the last couple of minutes then, we have—so, what's the company's current cash position? What's your expected cash runway? And have you given any guidance regarding revenues or financial performance in the near to midterm?
We have not guided as to revenues for the first year. You know, again, I think the VAC process is long and it's a little bit cumbersome. We have been hesitant to give guidance. I do think that there's a consensus number out there of—I don't even know what it is now, but it's probably $7 million or $8 million for this year. That's probably not too far off, but we have not officially guided. You know, as far as cash on hand, we reported, I think it's either $113 million or $119 million as of March 31st.
We also reported at our last quarterly earnings call that we've taken a close look at some of our expenditures, and we've really honed down our cash burn rate to really enable us to focus on trauma, dialysis access, on the coronary artery disease program, which we're going to file an IND this year, and then supporting all of those functions. With our sort of more focused spend, we've managed to extend our cash runway by up to $50 million. With the cash on hand and the decreased burn rate, certainly we expect to get through the end of 2026. That's very exciting for us.
Yeah. That's great to hear the safety net, I guess, in these volatile times.
Yes.
Okay. If I haven't, thank you very much, Laura, for joining us and for this informative chat.
Could we ask any questions?
Do you have time for that?
Maybe not on the screen, but afterwards.