Humacyte at TD Cowen Conference: Launches SimVest with Growth Potential

On Tuesday, 04 March 2025, Humacyte (NASDAQ: HUMA) presented at the TD Cowen 45th Annual Healthcare Conference, unveiling its strategic direction following the FDA approval and commercial launch of SimVest, an engineered vessel for vascular trauma treatment. While the company is optimistic about its market potential, challenges such as slow initial sales ramp-up due to Value Analysis Committee (VAC) processes were acknowledged.

Key Takeaways

• Humacyte’s SimVest received FDA approval and launched commercially, targeting vascular trauma.
• The company is pursuing NTAP reimbursement from CMS to enhance hospital adoption.
• Manufacturing capabilities are established in North Carolina, with strategic partnerships in place.
• A supplemental BLA filing is planned for 2026, pending positive trial results in women.
• Sales are expected to increase in the second half of the year due to VAC processes.

Financial Results

• Average Selling Price: SimVest is priced at $29,500.
• Reimbursement: Hospitals operate under fixed-price models; NTAP from CMS could provide up to 65% reimbursement.
• Cost Comparisons: SimVest may offer cost savings by reducing amputation and infection rates compared to synthetic grafts, with costs comparable to vein grafts for long ischemia times.

Operational Updates

• Commercial Launch: SimVest was launched the week before the conference.
• Manufacturing: Facilities in North Carolina are fully operational.
• VAC Engagement: Over 21 VACs engaged, with two approvals secured; processes take 3-6 months.
• Partnerships: Collaborations with Fresenius Medical Care and the Department of Defense.
• Clinical Trials: Ongoing trials, including a focus on women, show promising results.

Future Outlook

• Supplemental BLA Filing: Planned for late 2026, contingent on trial outcomes.
• Market Expansion: Aims to capture significant shares in vascular trauma and dialysis markets, focusing on underserved subgroups.
• Challenges: Initial sales may be slow due to VAC processes; NTAP approval is crucial.
• Opportunities: Dialysis access market presents growth potential, particularly for patients with fistula maturation issues.

Q&A Highlights

• Dialysis Access Market: Approximately 150,000 surgical procedures annually; Humacyte targets women and obese diabetic men.
• Fresenius Partnership: Positive discussions on improving dialysis access and reducing catheter use.
• CMS Reimbursement: Incentives for minimizing catheter exposure align with Humacyte’s goals.
• Veith Meeting: Generated excitement for SimVest, highlighting its innovative approach.

The full transcript of the conference call is available for readers seeking more detailed insights.

Full transcript - TD Cowen 45th Annual Healthcare Conference:

Josh Jennings, Medical Devices Team, TD Cowan: Hey. Good afternoon.

I’m Josh Jennings from the TD Cowan medical devices team. We are excited to have, Humacyte executives participating in the forty fifth annual TD Cowan Healthcare Conference up here in Boston. And I’m gonna hand it over to to Laurel Nicholson from, the founder and CEO of of Humacyte to to take us through some slides, and then we’ll open it up for some q and a, at the end. Laura, thanks so much for participating in the our conference this year, and it’s great to see you.

Laurel Nicholson, Founder and CEO, Humacyte: Thank you, Josh. It’s always great to be at the Cowen conference. I’m excited because this is the first talk I’ve been able to give at a conference where we not only have FDA approval, but we’ve also announced commercial launch. And so it’s a very exciting time for our company. So for those who don’t know about the technology, Humacyte is really a world leader in creating what I’d like to say are spare parts for patients.

We have a unique and proprietary platform technology that allows us to use human cells to make, universally implantable human tissues. In our case, our first several products are our blood vessels. These blood vessels are available off the shelf. Importantly, they don’t require any immunosuppression. In fact, we’ve treated more than 600 patients with our blood vessels over more than a decade, and we’ve never had a bout of rejection.

In addition, after implantation, our initially acellular tissues repopulate with cells from the patient over time, making them a living tissue. So as I just mentioned, we we just announced commercial launch last week. The FDA approved our engineered vessel, which which is trade name SimVest, in late December of last year. We have very large addressable markets that we’re looking at for this vessel. The first market that we’ve gained approval in is in treating traumatic injury, but we have a series of other markets that we think we can address, and I’ll talk about some of that today.

Importantly, we have commercial scale manufacturing in place. And in fact, our commercial scale manufacturing has been up and running for several years, and we’re located in The US in North Carolina. And we also have multiple important partnerships, including with Fresenius Medical Care, who’s very interested in what I think will be our second indication in dialysis access, as well as the defense department who’s very interested in our first indication in trauma. So at a very high level, this is how the platform works. We start off with a a bank of human cells that we have cryopreserved that are proprietary and that we’ve developed.

We we expand those cells in the in the laboratory, and then we seed them onto degradable scaffolds that are the side degradable scaffolds that are the size and the shape of the tissue that we want to grow. In this case, our engineered vessels are 42 centimeters long and six millimeters in diameter. In fact, I think Dale Sander, our CFO, has an example of one of our vessels. And if you like, he can pass it around so you could see it, like active show and tell. Anyway, so after the cells are seeded onto the scaffold, the the the bioreactor bag that you’re that Dale’s passing around now is filled with culture medium and the cells grow for about two months.

During that time, the cells secrete extracellular matrix and the polymer underneath the cells is dissolving. So after two months, we have an engineered human tissue that we’ve grown from scratch, and it contains just cells and matrix proteins. And then in a final step, we wash the cells out of the tissue, and that’s what makes it non immunogenic, and that’s what gives it a shelf life. It can sit in the refrigerator for up to eighteen months and be at the hospital in the OR right there when the surgeon needs it. This is just an example of what I mentioned earlier, which is how our engineered blood vessel repopulates with cells over time.

I won’t spend a lot of time on this slide, but I will say that this is a tissue section taken from a patient who was on hemodialysis using our vessel as a dialysis access, and we obtained a small biopsy of the vessel at around month nine. As you can see from the cross section image here, the the wall of the vessel is which we call ATAV, which is the generic name for our vessel. The wall of the vessel is filled with spindle shaped red colored cells, which are actually vascular smooth muscle cells, which came from the patient and and migrated into the tissue over time, turning it into a living artery. So as I mentioned, we are FDA approved, for SimBES in the indication of extremity vascular trauma. Our, our indication statement reads that SimVest is an acellular tissue engineered vessel.

That’s where we get ATAV from that’s indicated for use in adults as a vascular conduit for extremity arterial injury when urgent revascularization is needed and when autologous vein graft, in other words, vein from the own patient’s leg, is not feasible. So what is the value proposition that that Symvest brings to the vascular trauma market, both civilian and military? Well, the reality is that prior to the availability of Symvest, when a patient presented to the emergency room with some horrific injury, that that destroyed a blood vessel in in an extremity, the the surgeon, once the patient gets to the OR, really has three options. He can spend an extra hour harvesting vein from the patient and further injuring the patient and then moving that vein over to fix the artery. If he thinks he doesn’t have time for that or if the patient’s too injured to do that, then he can take a plastic graft off the shelf and use that graft to repair the injured blood vessel.

But as you might imagine, if you put a plastic graft to an into a contaminated wound, the frequency of infection is pretty high. So failing those two options, if the surgeon thinks that neither of those will work, then then he’ll take the limb. And the problem there is that there’s really no conduit that’s immediately available that doesn’t require injuring the patient and that can also have a low infection rate. And I would say there was no product available until the approval of Simvest just a few weeks ago. So here’s the data that formed the basis of our BLA approval, by the FDA.

So I’d like to point you to, let’s see if this this cursor work. No. It doesn’t work. And so if I can point you to the left hand to to the right hand column, in blue, which you can see is the is the patency outcomes and the infection rate and the, amputation outcomes for patients, both civilian and military, who were treated with SimVest with Humacytes vessel. And then compared on the right hand side in in the in the gray column to our external comparator group, which was the outcomes of patients who are treated similar patients, but who are treated with synthetic graphs.

And what you can see is that our patency values are substantially above those that are reported for synthetic graphs. Our infection rate is about one ninth of what was reported for synthetic grafts. And probably most importantly, our amputation rate is much lower. So at a with synthetic grafts, if if you got treated with a plastic graft after a vascular extremity injury, the literature would say that you have a one in four chance of losing the limb. In our studies, we we saw only a one in twenty chance of losing the limb.

So that’s a five times reduction in your likelihood of going on to amputation, which is obviously important for hospitals and patients and surgeons. When when I talk to surgeons about this, they often ask, well, you do better than synthetic grafts. That’s great. But how do you do in comparison to to autologous vein? In other words, the vein that’s harvested from the patient.

Well, we haven’t done a head to head study on that, but we have done a retrospective comparison where we’ve gone to a large, trauma vascular trauma database called the Pruvit database. And we did some propensity score matching where we looked at our patients who were treated with SimVest, and then we found two matching patients who were very similar in the trauma database, in the Pruvit database, who had been treated with vein. And when we look at their outcomes in terms of patency, the vein patency is actually a little bit better than it is for SimVest. But if you look at the amputation rate, our amputation rate in our studies was seven and a half percent, and the amputation rate with vein was eight was eight point two percent. The infection rate for both SymVES and for vein in these patients was very low, and the mortality, was identical.

So as you can see, even in patients where vein is not feasible, what our retrospective post hoc study shows is that if a surgeon uses Symvest, you know, he can feel confident that the that the outcomes may not be that different from those that that might have been, occurring if he had been able to use Vein. So if we talk about the commercial launch of the product, which we’re very excited about, when we talk about the total addressable market in in vascular trauma, we like to say that there’s probably from from looking at hospital databases and and discharge, databases, there’s probably about twenty six thousand cases per year in The US where there’s a significant vascular traumatic injury that requires a surgical repair. Now this is a mixture of injuries that occur in the community, like car accidents and gunshot wounds, but it’s also iatrogenic injuries. These are injuries that are caused by surgeons in the hospital, sometimes on purpose, like when they’re taking a a tumor out, and sometimes not on purpose, like when the orthopedic surgeon is operating on your knee and accidentally lacerates your artery. So so if you add up all of these cases, it’s about twenty six thousand.

If you look generally at how they’re treated, this is again from the Pruvit database, what you can see is that about a quarter of these in the orange part of the of the pie chart there are treated with either synthetic graphs or what we call other graphs, meaning cryopreserved vein, bovine grafts, others other sorts of things. Whereas about three quarters of these types of injuries are treated with vein. So vein is considered the gold standard here. But it’s also important to note that that for patients who are treated with vein, some of these patients are treated in the setting of having a very short ischemia time. In other words, there’s a short time from that time of their injury to the time of their repair, like an hour or two.

But some of these patients who were treated with vein are actually treated in the setting of a long ischemia time. Patients who have a car accident and take a while to get to the hospital, sometimes it’s four or five hours before the surgeon can be in the Operating Room Repairing Their Limb. And in that case, in those patients who who do use vein and where the surgeon spends an extra hour, that can actually increase the risk of amputation and necrosis and gangrene and other other types of stuff. So we actually believe in terms of the market that we will ultimately capture over several years of commercialization and trauma, we believe that we will capture, the vast majority of that twenty six percent, that one quarter of patients who are treated with synthetics. We also believe that we’ll we’ll capture a fraction of the vein market, particularly patients where it’s been a long time since, since their injury and surgeons need to move quickly and have a conduit that’s immediately available.

If we think about if we think about reimbursement and how how the vessel is paid for in the setting of trauma, all all of those hospitalizations operate under a DRG, diagnostic related groups or or a a fixed price basis. And what this means is that the hospital purchases our product and there’s no separate reimbursement. So really, in order to in order to work with hospitals and to work through the value analysis committee, it’s necessary for us to show not only improved clinical outcomes, which I believe our data show, but also a compelling budget impact model, which talks about the total cost to the hospital that they incur every time they take care of these patients. And, this budget impact model is actually gonna be published, in the next week or two. The the publication is imminent.

But at at a price point of $29,500 what we’re able to show is that if if SymVES is used as compared to the the twenty six percent of patients who are currently treated with synthetics or bovine grafts or cryovane, actually, the hospital probably saves money, primarily because of the reduced rate of amputations and the reduced rate of infections that will occur in patients who are treated with Symvest as opposed to these other graphs. In addition, the the total cost of treating the patient as compared to the cost of using vein for a patient who’s had a long ischemia time, it’s actually not that different. And and that if you’re almost on par in terms of costs, then other factors, begin to weigh in such as surgeon preference, time pressure, desire to get out of the Operating Room in in a with a badly injured patient. We’re also very excited to be working on a new technology add on payment of reimbursement or NTAP from CMS. Even before we got approval, we submitted, an application for for an NTAP, to CMS last fall, and we had our town hall meeting in December.

We’ve gone back and forth with them and answered some questions. And, and we believe we have a strong case for getting an NTAP payment because there’s really two important criteria for getting an NTAP. One is that, that the technology is new and we clearly qualify. And two, that the that the technology, provides an important clinical benefit above and beyond what’s currently available. So I believe that we we, check both those boxes and that we have a strong case for getting NTAP reimbursement.

We should hear that decision in August. And if we do get that reimbursement, it would begin to kick in in October of this year, and it would provide up to 65% of a reimbursement to the hospitals when they use our vessel in the treatment of trauma. So going beyond the trauma indication, I’d like to talk about other indications that we’re excited about in the pipeline for, SimVES or Atev, as the generic name. So in dialysis access, which is which is a chronic and very challenging medical problem, we believe that there are aspects of the Atev that really make it ideally suited to treat patients who are who need access for hemodialysis. One is that, the diameter of our vessel is actually ideally suited.

It’s six millimeters in diameter, and so it doesn’t have to mature or dilate or grow after implantation. In fact, after implantation, after about four weeks of healing, the vessel is usually, usable for dialysis. In addition, we’ve done several clinical trials which have shown a very low infection rate for our vessel despite the fact that it gets punctured with needles three times a week for dialysis access. And thirdly, we’ve seen that it’s that it’s durable. And, because of this and because of our our connection with Fresenius Medical Care, we’ve been very interested in understanding how well our vessel performs relative to what is currently the gold standard now in dialysis access, which is the autogenous fistula.

And so we recently reported about six months ago the top line results on a prospect of randomized head to head phase three trial comparing our vessel, the ATAV, to the gold standard, which is autogenous fistula. This was a US based trial within about two forty two patients, where we looked at patency and usability for dialysis during the first year. So just very briefly, these are the top line results on that trial where, as you can see, the the functional patency at month six and the secondary patency at month twelve for our vessel, the Atev, were both greater than than those, observed for AVF, which is autogenous fistula. The p value there was point o o seven, so it was a very convincing result. In addition, the number of months that the vessel was usable for dialysis across all patients, was better for ATAV than for AVF.

So we were very encouraged by these results, but we also wanted to understand at a more fundamental level, you know, in the whole dialysis community, what are the patients who really struggle with arteriovenous access and who are the patients who could benefit most from our vessel? Because, again, at a $29,000 price point, we believe that we’re gonna have to show enormous clinical value as well as potentially savings to the system in order to get broad market adoption. So this is a Kaplan Meier curve of the functionality of of our vessel, the ATAV, in red and then compared to autogenous fistula in blue. And what this what this Kilometers curve is showing is is the results for two subgroups. One is women, all women, and the other is men with diabetes and obesity.

If you add those two subgroups together, it’s actually more than half the market, so it’s not a teeny tiny subgroup. But as you can see, the separation in these Kaplan Meier curves is enormous, and it extends out to two years. What’s also sort of sobering about this curve is the fact that you can see that in in women and in men with diabetes and obesity, the the success rate of fish of the fish oil operation is only about fifty percent because that Kilometers that blue Kilometers curve sits right around the 50% line, which means it’s like flipping a coin. Every time you do a every time you do a fistula operation in these patients, chances are one and two one and two times it’s gonna fail. And when it fails, what happens is the patient winds up staying on a catheter and and having to survive repeated infections, sometimes sepsis, sometimes hospitalization.

This causes a lot of morbidity for the patient, and it’s also expensive to the system. So we believe that the ATAV in in the dialysis population really has the potential to get patients who really struggle with fistula maturation to get those patients a reliable surgical access and get them off catheter and keep them out of the hospital. Importantly, if we look at the safety results for for patients overall, but but I would say even more importantly for this subgroup of women and, and men who who have diabetes and obesity, what we can see is that if we look at the at the number of complications or the number of interventions that are required to keep the vessel working, if we look at it in terms of events per patient year, we can see that actually the event rate for for the ATAV is very similar for the intervention and event rate for fistula. The number of interventions that are required to keep the access going is pretty similar. Importantly, though, if we look at important safety events like rupture, in fact, there were there were several there were two ruptures reported with fistulas, and there were none reported with our vessel.

So we believe that the efficacy results, which are very strong in this subgroup, combined with really encouraging safety results, means that this is a good population for us to go after in this very important market. After discussions with the with the FDA about a supplemental BLA filing, we’ve we’ve decided to include to to go after this general subgroup, but but before we file supplemental BLA, which we’re hoping to do in later in 2026, our plan is to complete an, currently ongoing phase three trial, which we’re doing just in women, which compares our vessel, the ATAV, to women who are receiving a fistula for hemodialysis. This is a small trial that the total enrollment is only about a 50 patients, and we’re doing an interim analysis at 80 patients. We expect to hit this interim enrollment number in the next couple months and expect to get interim data in the middle of next year. If those data are positive, then our plan would be to file a supplemental BLA in this in this target, subgroup because we believe we’ll show both outstanding function and outstanding efficacy compared to the gold standard and also outstanding safety.

So more to come, but, you know, I think that while the trauma market is very exciting and for for Humacyte, I believe that the second follow on market for the same vessel in dialysis access could be even more exciting. So so the ASP that we’ve announced is 29,500. The cost of harvesting a vein, you don’t have to buy a vein. There there is the cost of operating room time, and it can cost up to it can take up to an hour to harvest and prepare a vein. There’s also costs associated with wound infections at the vein harvest site.

But we believe more importantly, in trauma, the the the cost of using vein in a patient who’s had a long ischemia time can be greater than just the OR time. Because if you add that extra hour to somebody who’s had an ischemic limb for four hours and then you make it five hours, the chances that that patient goes on to amputation, which is very expensive, get higher and higher. So we believe that the total cost of care that that that gets factored into the into the cost of the hospital bears in the DRG, you have to think about not just the acquisition cost of the vessel, but also all of the complications that I believe we avoid. That make sense? Yeah.

Well well, thanks for that. So as far as the TAM and the AV access market, you know, when we’ve talked about, you know, the addressable market for for dialysis, we we’ve always thought that we would aim for about 20 or 25% of the market. And that that’s what we’ve that’s how we’ve guided, analysts for a long time. I actually think we may be able to aim for a bigger chunk of the market. But but in answer to your question, the total number of dialysis patients in The US right now on hemodialysis is a little under five hundred thousand.

If you look at the total number of surgical access procedures that that are done every year to maintain access, it’s about a hundred and fifty thousand or so. If you assume that half of those are in our target population, which is women and obese diabetic men, then let’s say that’s seventy five thousand, cases per year. That’s a lot of cases.

Josh Jennings, Medical Devices Team, TD Cowan: Okay.

Laurel Nicholson, Founder and CEO, Humacyte: I think that is the right way to think about it. In fact, we had some leadership from Fresenius visiting, visiting Humacyte just last week to talk about some of these clinical results because, you know, we think they’re exciting and Fresenius obviously thinks they’re exciting too because Fresenius wants their patients to do better and wants to get them off catheter. And what’s important from the standpoint of Fresenius’ mind view, in addition, obviously, they want their patients to do better and have better surgical access. But from a reimbursement standpoint, up until about a year ago, CMS used to reimburse, dialysis clinics based on how many fistulas they had because they were trying to push as many patients getting fistulas possible. About a year ago, that reimbursement paradigm changed.

And now the thinking is get patients off catheter because because it’s abundantly clear that catheters are bad for the system and bad for patients. And so now CMS has changed the reimbursement so that the more catheters a center has, the more of a ding they take on their reimbursement. So we believe that the incentives are gonna be aligned because we believe we can improve dialysis access in these target populations, while also helping Fresenius meet its goals of minimizing catheter exposure.

Josh Jennings, Medical Devices Team, TD Cowan: One Okay.

Laurel Nicholson, Founder and CEO, Humacyte: Sure. Yeah. So, the Veith meeting was very exciting. We had actually expected to have already been approved by the time of the Veith meeting, which was in November of last year. As it turns out, the FDA dragged their feet a little bit, and we got approval after the Veith.

But even preapproval, there was a tremendous amount of buzz. You know, we gave several presentations, and there was a lot of traffic at our booth. And I think that’s really because if you look in in vascular surgery writ large, there hasn’t been a new conduit that conducts blood introduced for the last thirty or forty years. All of the innovation in vascular surgery has been stents and syringes and catheters and this and that and and, not not not to diminish catheters and stents, but but there’s been no fundamental new conduit to enter this space in decades. And and we’ve been presenting at the podium for for years, and and there’s a fair bit of surgeon awareness about this.

And now that we have approval, there is a lot of excitement, and there’s a lot of, there’s a lot of sort of, boostering from from local surgeons at a lot of these trauma centers. So even though we just announced a commercial launch launch last week, what I can tell you is that we’re already through, more than 21 VACs, which means that we’re, you know, there’s only 200 level one trauma centers in The US. So we’re already we’ve already we’ve already introduced our, our materials into into more than 20 of them. And we also already have have two VAC approvals, which in my mind is sort of the land speed record. But I I would say, Josh, you know, to your question, you know, as far as guiding the market on on on what type of sales we expect during this year, you know, the reality is that most VAC processes requires three to six months.

And so since we got our approval only a few weeks ago and we just had our commercial launch last week, you know, we really expect that for the first one or two quarters, sales are gonna be pretty low. We’re not gonna have a lot of sales. We really think the sales will be back ended in the second half of the year, but we will continue to inform the market about our our progress with VACs, our our track record with how many approve it and how many how many don’t approve it, etcetera, etcetera. So we think there are lots of surrogate markers where we’re gonna show progress in our commercialization effort, but we do think that sales are gonna be, loaded in the back half of the year. Yeah.

Well, I think having it having it in the peer reviewed literature will be helpful. Although I will say, you know, our our our commercial team has these vac packs, right, which is all of our clinical data and also our entire budget impact model. And they even have sort of an interactive version of the budget impact model where where these centers can input their own complication rates and their own numbers of patients treated per year and can directly calculate the impact of Symvest on their bottom line. So so we’ve actually had pretty good traction with, with the VACs, although you’re right. I mean, a peer reviewed publication would would give us even more momentum.

I think it might even help more, frankly, with surgeons because surgeons are so you know, it’s not just the hospital administrators. Surgeons are also conditioned to think about cost.

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