Humacyte at H.C. Wainwright Conference: Promising Developments in SimVess

On Tuesday, 20 May 2025, Humacyte Inc. (NASDAQ:HUMA) presented at the H.C. Wainwright 3rd Annual BioConnect Investor Conference 2025. The company highlighted the commercial potential of its engineered blood vessel, SimVess, amid ongoing regulatory and market challenges. While the initial launch has shown promise, Humacyte is navigating complex approval processes and financial considerations.

Key Takeaways

• Humacyte’s SimVess is approved for vascular trauma and is being evaluated for additional medical uses.
• The company reported $500,000 in revenue from the initial launch of SimVess.
• Humacyte is seeking a new technology add-on payment (NTAP) from Medicare, which could significantly boost adoption.
• As of March 31, Humacyte has between $113 million and $119 million in cash, with a reduced burn rate.
• Ongoing trials and regulatory filings are expected to expand SimVess’s market applications.

Financial Results

• First-quarter revenue reached $500,000 from SimVess’s initial launch.
• Analysts project annual revenue between $7 million and $8 million, though Humacyte has not provided specific guidance due to variable VAC process timelines.
• The company has decreased its cash burn rate, extending its financial runway through the end of 2026 with a focus on trauma, dialysis access, and coronary artery disease programs.

Operational Updates

• SimVess launched in February and is approved for vascular trauma.
• Humacyte is actively engaging with hospital value analysis committees (VACs) across over 40 trauma centers, nearly a quarter of the 200 level one trauma centers in the US.
• The VAC process, a critical step for hospital adoption, can take 3 to 6 months or longer.
• Humacyte has applied for NTAP from Medicare, with a decision expected in August. Approval could reimburse up to 65% of SimVess’s list price.

Future Outlook

• Humacyte is preparing to file a supplemental Biologics License Application (BLA) in the second half of 2026 for dialysis indication, pending positive trial results.
• The company is designing a phase three program for peripheral arterial disease and plans to file an Investigational New Drug (IND) application for coronary artery disease this year.
• Publications of trial results are forthcoming, including long-term military and civilian trauma data.

Conclusion

For further details on Humacyte’s strategic initiatives and financial performance, please refer to the full conference call transcript provided below.

Full transcript - H.C. Wainwright 3rd Annual BioConnect Investor Conference 2025:

Unidentified speaker: EVs for vascular repair and replacement. In December, FDA approved SIMVAS as a vascular conduit for treating extremity vascular trauma, and the product was launched in February of this year. The company is also evaluating SymVest 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 Symvest’s commercial potential and the development strategy going forward, I welcome Laura to this fireside chat. So, good day, Laura.

Glad to see you.

Laura, Humacyte: Great to see you.

Unidentified speaker: And I appreciate you accepting our invitation to speak at this conference. To so to start us off and, for the benefit of the folks who may not be familiar with the name, so could you please highlight what is an ATEV, and, why is

Laura, Humacyte: it better than what vascular surgeons are currently using? Right. So, so our engineered blood vessels and, indeed, all the engineered tissues that we make are made from human cells, and we make them at at at manufacturing commercial scale in our facility in North Carolina. But the way we use human cells to grow human tissues is we can we we use a scaffold that dictates the size and the shape of the tissue that we grow. And after we grow the tissue, which takes about eight weeks, we actually wash the cells out of the final tissue that we’ve grown.

So the what gets implanted into the patient is an engineered human tissue. In our case, SimVess is 40 centimeters long and six millimeters in diameter, so it’s a large tissue. And it, it contains no cells, which means that in the twelve years that we’ve studied it and more than 600 patients, we’ve never had a bout of rejection. So it’s a it’s a human spare part, basically, that’s available off the shelf. It has an eighteen month shelf life and can be used when whenever surgeons need it.

The reason it’s better than some other options is that, but the two other options that surgeons really have now is 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 a surgeon can use a plastic graft made out of Teflon that’s available off the shelf. But those grafts are really foreign bodies that that that are implanted into the patient, and they can also have a high rate of infection.

Unidentified speaker: I completely agree. So alright. So I know that vascular trauma, which CIVAS is approved for, is a very large indication in terms of both patients and health care spend. So could you help us discuss, how big is this market, and how do vascular surgeons manage these patients with vascular trauma?

Laura, Humacyte: Sure. So traumatic injury to the blood vessels is a limb and life threatening condition. If you add up all of the cases in in trauma centers around the nation, there’s about twenty six thousand 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. So so it’s it’s a reasonable It’s twenty six thousand cases.

But a lot of those cases are concentrated in about 200 level one trauma centers nationwide. And so what that means is that we there’s really a finite number of call points. And so for Humacyte, as it with our first commercial launch, having having a finite number of call points means that we don’t have to mobilize an enormous sales force in order to reach those centers.

Unidentified speaker: Great to know. To go dig a little deeper than the list invest. So the product recently got approval in December. So what are some of the, data highlights then that led to this approval, and what’s your commercial strategy for this launch? Mhmm.

Laura, Humacyte: Well, the the data in our BLA, because we’re regulated as a biologic, even though it sort of feels like we’d be a device, we’re a biologic. And the bay data in our BLA really came from two single arm studies. One was in civilians in The US and in Israel where we took care of patients with car accidents, gunshot wounds, industrial accidents, etcetera. A second single arm experience was actually a wartime experience where, under our humanitarian program, Humacyte provided vessels to warfighters in Ukraine. And so we treated active duty military warfighters who sustained terrible IED injuries, and we also treated civilians.

And it was that combination of the single arm trial in The US and the real world experience in wartime Ukraine that provided the data for the BLA. The the key findings in the BLA, which which we submitted to the FDA and then which we published in JAMA Surgery in November of last year, what we found was that that the when we compared our outcomes to historical published outcomes with plastic grafts, we found that our patency was substantially better. In other words, the the blood flow through through the graft. We also found that the infection rate was much lower than with plastic grafts, about one ninth. And probably most importantly, the amputation rate for these patients was about one fifth of the amputation rate that had been reported for plastic grafts.

So so this is this is a this is a conduit that’s immediately available. You know, if the surgeon can take it off the shelf and be sewing in about two minutes, so it has all the convenience of an off the shelf piece of plastic. But from our studies published in JAMA, it actually works a lot better.

Unidentified speaker: Sounds great so far. So, I know that you recently, you guys reported, first quarter financial results. You showed half a million of revenue from the first month or so of launch. So which we felt was really encouraging considering it’s a brand new product that’s on the market. Mhmm.

So could you please talk to us about whether this launch has met your expectations, and what metrics are you tracking internally that ensure that SymVest will be successful in the market?

Laura, Humacyte: Well, I this is this is an interesting sale. So we’re tracking 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. Mhmm. And 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, that there will be a DRG that applies to that patient.

So because the hospital is sort of on a fixed budget, their strong motivation is to is to limit the total cost of care and particularly to limit expensive complications, which prolong hospitalization and drive up cost of care, which then they have to absorb. So but as working 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. So 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 is corresponds to nearly a quarter of the of the 200 level one trauma centers in The US. So and we’re our our 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. Launched.

So so so that’s an encouraging metric to follow. The the time required to work through the VAC process can be three or six months or even longer depending on the hospital. And but once we work through the process, then the hospital is able to order. So in addition to to to following VAC, submissions, we’re also tracking, obviously, orders and consignments, etcetera, etcetera.

Unidentified speaker: Great to know. This is even though it’s maybe a little slow to get started, but we could get the once you can really get the ball rolling, we can start to see some great results.

Laura, Humacyte: Yes. And we’ve really we’ve really messaged the market that we anticipate the the substantial bulk of our sales to be in the second half of the year just because this fact process, it just it just builds in, you know, a long lead time.

Unidentified speaker: Great. And, but to dig a bit into, the reimbursement Mhmm. I know that in your previous public comments, you mentioned that you expect to receive a reimbursement decision August through the, NTAP system. Mhmm. So could you help us explain what NTAP is and why do you think that could benefit this decision could benefit their adoption unless?

Laura, Humacyte: Sure. So, you know, again, as I mentioned, in 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 SIMVEST unit and uses that in in trauma patients, that on average, the cost of caring for that patient that gets SIMVEST is actually lower than the average cost of caring for a patient that’s treated with a synthetic graft. So on a on a head to head comparison basis, we’ve published our budget impact model.

We just published that in in March, which shows that, you know, for an individual patient, on average, if they get treated with SIMVEST, they will be less expensive for the hospital to care for than if the patient is treated with 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. So what that is is it’s a process where once a year, companies can apply to Medicare. And, 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.

So 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. But that said, you know, compared to plastic grafts, we believe the economic case stands on its own. So not not only are the clinical outcomes better, but we believe that the that the cost to the hospital are better even without the end.

Unidentified speaker: Okay. Good to know that there is potential upside then Yep. Later this year. Okay. So moving on from the commercial launch onto the your pipeline programs.

Mhmm. So I know that the company has been evaluating, ATVs for fistula repair being, end stage renal patients. Mhmm. So could could you, explain what the this indication is in terms of, you know, vascular repair and, what the clinical programs that Humacyte has been conducting so far?

Laura, Humacyte: Sure. So, 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 a half a million people in The US who are on hemodialysis right now, and that number grows by a couple percent every year. In order to have hemodialysis, what you need is essentially a conduit or a or a blood vessel that connects an artery and a vein in your arm. And getting that conduit surgically implanted and getting it to work is actually very challenging for some patients.

And in fact, it the failures of these conduits drive a tremendous amount of cost of care of of dialysis patients. So what what we reported out last fall, was a phase three 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. And 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. And 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 than the gold standard, which was a great observation.

But even more importantly, I think, 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 those patients really don’t mature their fistulas very well. And what we found was that the delta between our vessel, us, the ATEF, and and the gold standard was actually quite large. Based partly on on those observations, we’ve actually embarked on another phase three trial, which we’ve enrolled half of right now called our v o twelve trial, where we study at this vessel compared to fistula in women. And so we’re very excited about this program because I think, you know, we there hasn’t been a new conduit to really support hemodialysis in decades. And this has been a a really tough problem for patients and for nephrologists, and, and we’re really looking forward to, you know, hopefully, applying for a second indication next year.

Unidentified speaker: Great to hear. And especially with the, phase three had met its co primary endpoints already, and you have another phase three ongoing. So what exactly are the next steps in this program then and and as well as the timelines and when can when can investors expect the, you know, next major clinical or regulatory milestones?

Laura, Humacyte: Sure. So, as far as the publication of results of the v o seven trial, which is the trial that read out, last fall, that paper is under review right now. So we’ll see. I I hope it comes out soon, but it but it’s not for review. In addition, the the, the v o 12 trial, which is in women, we passed our our prespecified half enrollment halfway mark, in April, where we enrolled 80 patients.

So we have a prespecified interim analysis when those first eighty patients reach a year. Mhmm. So we expect to read out, our interim analysis, shortly after April of twenty twenty six. If that’s positive, then we would expect to file a supplemental BLA in the second half of twenty twenty six in the dialysis indication.

Unidentified speaker: So a lot of things we can expect over the next twelve months or so.

Laura, Humacyte: Yes. Well and and even in the trauma indication, we also I’d be remiss if I didn’t say that we have long even though we just published the the top line results last fall, we have long term military results that are gonna publish in a few weeks, and we’re actually submitting long term trauma clinical data for publication probably next week in the civilian space. So there’s gonna be a lot of news flow.

Unidentified speaker: Great to hear that. Beyond the hemodialysis, you hemo Hemocyte also has, two early stage programs in, peripheral arterial disease and, CABG. Mhmm. So could you please provide an overview of these programs and what data expectations should investor have from these two?

Laura, Humacyte: Mhmm. Well, in peripheral arterial disease, we’ve actually completed three phase two trials. One has been investigator sponsored and two sponsored by the company, and some of those have have already have publications.

Unidentified speaker: Mhmm.

Laura, Humacyte: In all of those patients, these are patients who have critical limb ischemia, which means they they have constant pain or ulcers and and necrosis, and they are at risk of of amputation. All of these patients, in addition, had no vein of their own to revascularize their limbs. So what we’ve shown in these three phase two 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 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. Mhmm.

So these are patients who are so sick that the amputation rate could have been as high as fifty percent, and in fact, it was low. It was below twenty percent. So so this this corresponds to important clinical outcomes. This is limb salvage in patients who really had no options. So we are in the in the process of designing a phase three program there.

You know, again, I think, you know, cash is finite. And so we’re we’re going to modulate when we kick off that phase three program depending on how our sales ramp

Unidentified speaker: goes. Yeah. Makes sense, especially in this market. Yes. Alright.

So the last couple of minutes then Yep. 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? Right?

Laura, Humacyte: So we have not guided as to revenues for the first year. You know? Again, I think the VAT process is long, and it’s a little bit cumbersome. And so we’ve been hesitant to give guidance. I do think that there’s a consensus number out there of I I don’t even know what it is now, but it’s probably 7 or 8,000,000 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 a hundred and 13 or a hundred and 19,000,000 as of March 31. We also reported at our last quarterly earnings call that we’ve we’ve taken a close look at some of our expenditures, and we’ve really honed down our our cash burn rate to really enable us to focus on trauma, dialysis access on the coronary artery disease program, which we’re gonna file an IND this year, and then supporting all of those functions. And so with with our with our sort of more focused, spend, we’ve managed to extend our cash runway by up to 50,000,000. So so with with the cash on hand and the decreased burn rate, certainly, we expect to get through the end of twenty twenty six.

And so that’s that’s very exciting for us.

Unidentified speaker: Yeah. That’s, great to hear you have the safety net, I guess. Yes. Yes. Volatile times.

Laura, Humacyte: Yes.

Unidentified speaker: So I haven’t thank you very much, Laura, for joining us and for this informative chat.

Laura, Humacyte: Could we ask any question?

Unidentified speaker: Have time for that? Maybe I’ll just wait afterwards, please.

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