All right. Well, we are a couple minutes into our time here, so we're gonna have to talk fast, Laura.
Okay.
Very pleased to have with us here at our conference Humacyte, Laura Niklason, Dr. Laura Niklason, founder, president, chief executive officer, and Dale Sander, CFO. Thank you for coming. You know, just a quick snippet of history. I told you before, I think we met a long time ago at the very early stages, and I was fascinated by the technology and a lot of things happened from that meeting to, like, launching in the last year or two. I feel like I've missed the hard part and showed up for the good part, or the fun part maybe. But it's been fun to see this develop over the years. With that sort of prelude, the launch last year into vascular trauma and the cadence being vascular trauma, dialysis, and CABG, I guess
Mm-hmm.
In round, you know, figures. There was some, you know, excitement out of that. Success, obviously clinical success of the product, but also some learnings and some course corrections during the year. Maybe just
Mm-hmm.
Catch us up to, you know, what you've learned, what you've changed, and how you're entering 2026.
Thank you, Matt, for the opportunity to do this. 2025 was, you know, the first year you launch a first-in-class product into the market. You know, there's always a lot of learnings. What I would say we learned is that the process, especially going through the VAC committees, the value analysis committees, takes a little bit more time than we had initially envisioned. That's a learning. I think that's a post-COVID thing where hospitals and hospital systems are just a little bit more spend conscious than they were previously. I would say that we've also learned that our clinical and our health economic arguments, you know, they carry the day. We have greater, I think, than a 70% VAC approval rating.
More than 70% of the time they say yes, it just takes time. That's one learning that we had. Another learning is that we did have to adjust the price. Our current ASP depending on the hospital and the specific indication, but it's around $17,000-$20,000. Being under that $20,000 price point, we found has really helped with getting through the administrative processes in the hospitals and hospital systems. That's the second learning. I would say the third learning is that we've really increased our focus on education, both of surgeons and of hospitals. Because you know, this is a first-in-class product, and there hasn't been a new vascular conduit introduced into the market in 30 or 40 years.
That means every single surgeon we talk to has never used a new conduit ever during his career. There's training and just sort of teaching and intellectual understanding. We've been growing our medical science liaison team, and we're looking at bringing on some senior surgical talent as well, which we're very excited about. I would say that lastly, what we have seen in terms of when the product is used is that it's used in patients who are very sick and who don't have a lot of options or who have no options. Surgeons by and large are having a good experience. Surgeons who use it, use it again. I am quite sure that we are saving life and limb. I am quite sure.
That's excellent. Just on the economics part, on the pricing, you know, the returns are clear. You know, the sort of cost of adverse events and reoperations and those costs are clear. I would say you're, you know, you're not the first company that's with the resources you should have, you know, experts in bioengineered tissue implants, but maybe not fully, you know, staffed in the department of what are the health economics and what will CMS and hospitals exactly be willing to pay. Especially not having another commercial product in the market, you know, with which you can, as a conduit for interacting with hospitals or any experience. You know, yes, it was an adjustment, but, you know, no, it was not that surprising.
Yeah.
There had to be something.
Yeah. No, no, there's gotta be something and I think we've weathered that, and I think the team has come out, if anything, smarter and stronger, both our sales team and our medical education folks. And, and, you know, we can feel the momentum. The salespeople can feel the momentum. We're talking to GPOs now.
Great.
It's exciting.
To support that, you have a pretty strong set of cadence of clinical evidence. Maybe talk a little bit about, you know, what came through last year that you found was significant and that clinicians are responding to, and maybe VAC committees are, you know, what's on deck for this year.
You know, as far as publications in 2025 that support sort of the trauma indication and the data there, we had multiple publications come out. The first was a budget impact model that came out about a year ago in the Journal of Medical Economics, which showed that even at our higher price point, we still saved money for the trauma center by avoiding amputations and infections. We have some other papers, some data, retrospective comparison papers that came out. We had a paper that came out that said, in the trauma indication, in vascular injury, our outcomes with our vessel in patients who don't have vein available for patient survival, amputation, infection, what have you, our outcomes are actually pretty comparable to vein. They're not significantly different from similar patients who were treated with vein.
To be the fallback option for situations who don't have vein and to have outcomes that are similar to vein, that's a great story to be able to tell surgeons. You know, I would say in terms of data upcoming, you know, as you mentioned, and as I'm sure you know, we have a phase III trial that read out in dialysis access comparing our vessel to the gold standard, which is fistula. That trial read out one and two year data were positive, and we're actually in the process of publishing that now. But we have a second trial in women looking again at our vessel compared to fistula and dialysis access. We're gonna get an interim read on that trial in just a couple of months. If that's positive, then we expect to file a supplemental BLA later this year in dialysis.
Okay. That will be, I guess, maybe the major catalyst for driving your commercial efforts in renal dialysis. Maybe talk a little bit about why the cohort of women, not that women aren't always important, but why is this particularly important for adoption and driving, you know, driving interest?
Well, you know, as I mentioned, fundamentally, there hasn't been a new conduit introduced to vascular surgery or trauma surgery or dialysis in 30 to 40 years. It's been known for decades that while the gold standard in dialysis access is fistula, if you're a man like Dale here with fairly large veins or you, that option works pretty well. It's been known for decades that for women, it works poorly, and it fails almost half the time. The reason nobody has addressed this is because there hasn't been another conduit option to solve the problem. We think that's an important clinical message, and it's an important value message, because again, our value proposition is providing dialysis access for patients who have a hard time with fistula maturation.
By doing so, we also get the catheter out of the patient, and that saves dollars, it saves hospitalizations, it saves morbidity and mortality.
Okay. Right. Maybe drawing an analogy to, like, medical devices have a history of starting in difficult to treat patients. These might be the difficult to treat anatomies of.
Mm-hmm
of fistula. Maybe also talk a little bit about the difference in the commercial efforts in sort of vascular trauma, you know, and the going hospital to hospital and network to network and working through the committees to what we should expect to be the process for hemodialysis centers in the U.S.
Dale, you want to take that?
Yeah, absolutely. There's a lot of synergy and parallels. The vascular surgeons that we target in our trauma commercial launch are in many cases the same vascular surgeons that will be implanting, either performing a fistula procedure or as an alternative, implanting our product, Symvess, as an alternative to provide access in dialysis. We are already educating the same population in many ways that we'll be targeting in dialysis. Differences with dialysis, it's an outpatient market, so for most patients, it won't be the DRG reimbursement methodology that we see in trauma. It'll be CMS reimbursed. We've started those discussions with CMS already.
The value proposition in terms of getting patients, particularly in these key subgroups like women, off of catheters early, which is critical to reducing cost, we believe we'll be able to make a very strong argument that use of our product in these important subgroups will actually save the payer money in the sense of CMS.
Got it. In the timeline for CMS, what does that look like ahead of commercialization?
As Dale said, we're actively engaging CMS right now. You know, there's some discussions with them about the data that we have in hand and the health economic arguments that we have in hand now. Those discussions are gonna continue through this year for sure. You know, we're actually approaching CMS at exactly the right time, in that, we have data coming very soon, and we already have an approved indication. They have sort of intellectual platform from which to, like, view the product and then understand its potential impact. So again, if we file the supplemental BLA late in 2026, best case, we get approval mid-2027.
We are anticipating that our engagement with CMS right now really helps the reimbursement, which we're aiming for a pass-through reimbursement at ASP plus six. That's the goal. We're hoping that reimbursement matches up with the approval date.
Okay. All right. The relationship or investment and relationship with Fresenius also kind of plays a role. Maybe describe, I guess, the largest owner of or one of the largest-
Yeah. We greatly appreciate our relationship with Fresenius. Fresenius is the largest provider of renal care services in the world, and so we're certainly proud to have them as our number one shareholder. You know, they've been certainly supportive of the activities we've undertaken. You know, I think they, like us, believe that innovation in patient care and dialysis is critical.
Yes.
We can provide that for important subgroups with our product, Symvess.
Okay. Any, you know, sometimes these investments are arm's length. Sometimes they have, you know, a strategic or go-to-market element. You know, what would you describe this one?
Yeah. Fresenius is more than a shareholder. It's also a collaborator of ours. Within the United States, we have retained the rights to distribute Symvess. Outside the United States, particularly in Europe, Fresenius holds the right to distribute our vascular product, Symvess, in the first three indications, which are trauma, dialysis, and PAD.
Okay. Within the US, you know, I guess it. When you're discussing, like, uptake and contract negotiation with these centers, Fresenius own centers, essentially you're discussing them with Fresenius or is it gonna be like a sort of called a hunting license sometimes to go? Like, you have freedom to roam in our centers, but it's up to them to work out how they're gonna use your product. Well, I think we're gonna have to work out the details on that. I mean, obviously Fresenius, like us, will wanna understand the outcomes, the clinical outcomes in this second study. We're also working alongside them and with them to really nail down what the cost savings, you know, the total cost of care savings might be in these patient populations.
My guess is that the strength of those two arguments might dictate, you know, how, you know, whether it's just a hunting license or whether it's a mandate or somewhere in the middle. We'll just have to see. Certainly, as Dale said, we appreciate Fresenius's input and collaboration. You know, frankly, the data that they have at their fingertips in terms of clinical outcomes and cost of care is unrivaled anywhere in the world. That really helps us formulate our arguments for the market and for CMS, et cetera.
Okay. That brings us to CABG, you know, coronary artery, smaller, conduit. Sort of slightly different dimensional design, but same technology.
Mm-hmm.
That I have to say, when we first met and wherever that was, 10 years ago, it felt like, boy, that's. As a medical device analyst, we know about CABG, right? We know about coronary indications and operations, so that sounds.
Right.
Exciting, but it's really just kind of getting started. Maybe talk about the timeline for that.
Right. We've developed because, again, Humacyte's platform is a platform. We can make tissues in different shapes and sizes, and we don't have to redo all of our production machines to do that. We have to change the size and the shape of the plastic bags we work with, but it's a pretty easy lift. Yes, we've tested a smaller caliber version of our vessel in large animals for a number of years for heart bypass, and we've published some of that data. We filed an IND late last year, and we're still trading data back and forth with the FDA.
We anticipate that when we've sent them, you know, all the data that they're looking for, that we'll be able to start a phase I/II trial in patients for heart bypass probably in the Q3 of this year. You know, one of my favorite phrases on this is, you know, as in vascular surgery, where there hasn't been a new conduit in 30 to 40 years. I believe it's true, Matt, and maybe you can correct me, but I believe it's true that there hasn't. Since coronary artery bypass started in the 1960s, there hasn't been a prospective trial in heart bypass with a conduit ever.
Yeah. I think that's right.
Not in the U.S. This work has always been done overseas because the data package was never strong enough to make it in the U.S. I'm very proud of that. I mean, that really speaks to the quality of Humacyte's data and our platform and, you know, the regulatory oversight. Yeah. This is very exciting.
Yep. No, I think so too. I would, you know, in the time that we have here, the short time in this session, there's no way I could do justice to sort of the platform that you've put together. It is kind of impressive, the way it works and as much as I understand it, not being, you know, a tissue scientist. Maybe talk a little bit about this is a little bigger picture, but I think it's exciting. As you mentioned, you can make lots of shapes and sizes. You know, we're still gonna get through vascular trauma. We're on the verge of dialysis and then coronary bypass. What applications that you see for this tissue engineering platform?
Well, you know, as Dale mentioned and as you may recall, we've done several phase II trials in peripheral artery disease. We've treated probably more than 100 patients. Typically, we're treating patients who don't have vein of their own for revascularization and who have severe ischemia. You know, they're facing potential limb loss. Our rate of limb retention is pretty high. Again, not quite as good as vein, but pretty close, which is really saying something for patients who don't have vein. So we've been in the process of trying to design a phase III study, partnering with the FDA on those discussions. That continues to be sort of an active mental exercise that we're doing. Right now, in terms of our resources, we're focused on trauma, commercial execution, we're focused on dialysis.
We're focused on coronary. In terms of monetary capital resources, we're not deploying a lot on PAD right now, but that's clearly the next place we go.
Okay. Then maybe, in the time that we have left here, just the models. Maybe talk a little bit about how, you know, we sort of see a lot of small medical device companies which oftentimes are, you know, a better new version of an existing competitive product. You know, there's a fair amount of investment, say in the middle of the P&L to execute on that opportunity, which can take a long time to turn a corner. What's the shape of Humacyte over the next few years?
As the top line starts to grow, you know, how much in that, in sort of SG&A training, field resources, or does this become accounts are opened, accounts understand the value, they order and stock the product, and they use the product, and there may be a little bit more leverage? I'm leading you with the question, but maybe describe the shape of the P&L.
I think each of the markets is a little different, but, you know, R&D costs have been winding down because we've, you know. A year and a half ago, we had three phase III trials underway, and now we have one that, we believe, is about to wind down when we have the interim analysis.
Mm-hmm
In the Q2 in dialysis. Certainly clinical trial costs are coming down. We expect sales to continue to ramp in trauma. Now, trauma's not the largest of the markets we're targeting, but it's still a meaningful market and one where there's a high unmet need, and it's also an attractive market for the first launch because it's so concentrated. There's only about 200 Level I Trauma Centers in the United States, and so we've been able to reach it with a sales force of about 12 field reps currently to we believe get adequate coverage of the market. Beyond that, we think dialysis will be certainly very additive to revenues. It's a market that even by targeting meaningful subsets is probably at least three times the size of the trauma market. We think that will be very additive to revenue.
There'll be somewhat of an expansion of the commercial team to bring on dialysis, but as I mentioned, in many instances, we're targeting the same surgeons that we're currently targeting in trauma. We also believe that the relationship with Fresenius will help with them being our largest customer. That will help when we launch in dialysis, at least for that segment of the market. Although we'll clearly be marketing to the entire dialysis market within the United States. You know, we expect R&D costs to continue to ramp down for some period of time, sales to increase, SG&A to increase somewhat as we bring on dialysis in the second half of 2027.
Okay. Well with that, we're at time, so we should probably call it. Thanks so much for joining us.
Thank you.