Laura Niklason: Yes, Kristen, this is Laura Niklason. Thank you for that question. So yes, certainly, after the BLA file was accepted and we got our PDUFA date in August, the FDA moved rapidly to begin scheduling interim meetings and also our inspection, which is upcoming in the near future. As far as what we’ve been doing to prepare for this, we’ve actually run two mock inspections, one last summer and one just last month in February, where we brought consultants in to Humacyte who were all ex-FDA inspectors. And they really did a deep dive on two separate occasions, really helping us be as prepared as possible for this upcoming inspection. I would say that since we began preparing for this last summer, we’ve really been able to execute on all of the remediations that were picked out, certainly from 2023.
And we’re feeling very confident about how this inspection is going to go. We believe that the facility is in great shape. Our manufacturing processes are well characterized and well understood. Obviously, with the Center for Biologics, you’re right, a big focus is always on manufacturing and the facility and the robustness of the process. But we believe we’re in good shape.
Kristen Kluska: Great. And then the preclinical study that you talked about in the juvenile animal model, it seems to highlight the different applications of the HAV platform. So how are you thinking about the flexibility for your current platform as it relates to different vessels and how you might go about implementing this on pilot or larger-scale program?
Laura Niklason: So the – one of the beauties of the platform, and this was designed with intention is that our LUNA manufacturing machines each of which right now can make up to about 1,000 40-centimeter HAVs per year. Those were designed specifically so as to be modular and flexible. So using the same machine, we can grow tissues of different diameters and different lengths without changing the machinery itself. It really only involves changing some of the plastic bag sizes and some of the tubing. So as we mentioned in the call, we’ve been making 3.5 millimeter vessels that are suitable for heart bypass and pediatric heart surgery we’ve been making those in our current system for the last couple of years, and we’ve been testing them in animals.
It’s also, for us, we believe, a short hop to modify our system and make 6-millimeter vessels, but – that are shorter or longer, shorter vessels may have added utility in the trauma indication in the future because many traumatic injuries don’t require 40 centimeters of conduit. They can utilize a shorter vessel. Conversely, in peripheral arterial disease, where we’re also working pretty actively with our Phase II programs, it may be that in the future, some patients would benefit from a longer vessel, which can extend from the growing down to below the knee and we believe that we can also make longer vessels, again, using the same equipment. So we were very intentional when we designed the platform so that we could pivot and make vessels of different shapes and sizes.
And I would say we’re already doing that. And that will be after approval, going forward, follow-on product candidates will be manufactured in our same system just using slight modifications of the tubing.
Kristen Kluska: Great. Thanks for taking the question.
Operator: Thank you. Our next question is from the line of Josh Jennings with TD Cowen. Please proceed with your questions.
Joshua Jennings: Hi, good morning. Laura and Dale thanks for taking the questions. I wanted to just follow up on Ryan’s question on health economics data, thanks for the download there. But just wanted to better understand any – if there’s any color on preliminary discussions with payers and just how you expect Medicare and private payer reimbursement for HAV and the vascular trauma indication to evolve the DRGs is in place. And just any color as you think about launch time and then how reimbursement and payment can evolve from there?
Dale Sander: Yes. Yes, certainly. So in parallel to date, we’ve had discussions with hospital administrators, interactions with CMS and also interactions with private payers. And those discussions will – are intensifying with the data in hand. And as we start rolling out our budget impact model. The budget impact model itself, which really supports the value proposition of HAV and the implications of using the HAV and the extent to which you can save the cost of other complications. It is essentially – will essentially be presented and then published through the course of the year, presumably in advance of launch. Beyond that, though, specific – your specific questions around reimbursement, how the HAV is reimbursed is going to be dependent upon the indication and also where the patient is being served.
So specifically with regards to trauma, that’s an inpatient surgical setting. And so the hospitals are generally going to be reimbursed on a DRG or a fixed price basis as you implied. And so the HAV would be an acquisition cost by the hospital, which is not separately reimbursed at its core, which is why the health economic implications of HAV, the ability to save the cost of these complications is so important. But keep in mind that as a new technology and also as a biologic HAV, we believe, will qualify for an NTAP or new technology add-on payment reimbursement, which will give the hospitals an additional reimbursement that they would not get under the normal DRGs. And clearly, the HAV qualifies for an NTAP reimbursement because it’s innovative and because it provides a meaningful patient benefit.
