Ramakanth Swayampakula : Very good. And then I’m assuming from what you just said, the 76 patient study that is being conducted up in Ireland, that also kind of plugs into what you’re just talking about the study that’s going on in the U.S. Is that how we should think about it? And the other question is at a later point, once you get through the burn indication in the U.S., can you take some of this data and use it for U.S.? Or do you need to kind of do separate studies?
Peter Carlson: We can use the data from the U.K. for activities in the U.S. associated with reimbursement and procurement. So with payers and with buyers, the FDA does look for us to have U.S. data. And again, we think we or have a robust set of the training data. We have more work to do on the validation side to meet what we think is the threshold here in the U.S. with U.S. specific data. The way to think about that work in the U.K. is it’s a subset of the overall study but it does give us a concentrated group on which to think about, assess and maybe potentially do some publications.
Ramakanth Swayampakula : Okay. Now that you have Jeremiah on board, so I’m sure he is kind of tasked with kind of watching the deployment in the U.K. And as you stated, U.K. is kind of weird in terms of reimbursement because we only have one entity to work with. But what sort of learnings would Jeremiah be looking from that experience because once we come back to this side of the pond, things are quite different, both in terms of commercialization and also in terms of reimbursement?
Peter Carlson: Yes. So there are several aspects of it, a couple of which were in my prepared remarks. It’s how clinicians and facilities are using the device. It’s capturing the real-world data. It also is a start to commercial transactions. And so understanding the ebb and flow or puts and takes of entering into commercial transactions with facilities and caregivers. And that certainly is a good help for us. Anytime you can begin commercial, get through terms and conditions, get financial terms in place. All of those are very helpful input into our strategy here in the U.S. And we do look to leverage the continuing real-world data we receive in the U.K. for payers and for facilities as we have those conversations. We think that will be very useful, while also leveraging the trial here in the U.S. for the FDA discussions.
Ramakanth Swayampakula : Okay. One last question from me. BARDA is a huge force behind you — behind the company, which is excellent. So I’m trying to understand where all BARDA can actually help you? Or is it part of the plan in terms of how much they can help you in terms of not only regulatory process, but also in the commercial process, certainly in the regulatory process, are they in any way involved in trying to make sure that you run your studies in such a way that you can get the product approved. Of course, for BARDA, they don’t care about the approval, they can still take the product as long as they’re comfortable with the data and the utility of the product. But I’m just trying to understand what sort of help are you getting in terms of the regulatory process in the U.S.
Peter Carlson: BARDA is a great partner. We very much enjoy working with them. We think our interaction with them has created a good discipline inside our company for interacting with a federal agency. So we think we’re well prepared for interactions with the FDA. BARDA certainly is holding us to standards that they think are appropriate for the clinical trials. And I do believe that’s informed by their experience with other companies working with the FDA. They do have a working relationship. I think it’s formalized somewhat in a document between the 2 groups. But — so we like the advice we receive from BARDA relative to the clinical trial work. They’ve been informative on, for instance, wanting the specific participation of the pediatrics.
They’re focused on having the device in both the burn centers and the emergency departments. And those things — we think those are to not only support BARDA’s mission but are good for approval by the FDA. And then as far as deployment, we think of BARDA as a bit of a distribution channel in that they are funding but also supporting and encouraging users, facilities to take the device on. So there will be some number of facilities covered within this next round or option of the Project BioShield contract and then we’ll work together with BARDA on further penetration across emergency departments in the U.S.
Operator: And the next question will be from John Vandermosten from Zacks.
John Vandermosten: Great. Thank you and hello, good afternoon, Pete and Vince. I’ve been going down the rabbit hole of how providers are diagnosing DFU and burn and triaging and things like that. And are we aware of how — the factors that the AI systems consider when making a diagnosis and how that relates to — and how that relates to how the system and the provider would do that. Any correlation there between those two that you’ve been able to tease out?
Peter Carlson: I don’t know that I’d say there’s been a correlation we’ve been able to tease out as we’re still in our early days of working with the or the payers here in the U.S. Obviously, the care setting matters, just even the difference between a burn center and an emergency department is going to be important on reimbursement. Those are 2 different reimbursement schemes, if you will, or approaches. What we believe this tool device does is better informs existing diagnoses. So the process is still going to be the same, I think, for once you get into the caregiving, what we’re doing, what this device will do is allow practitioners to be better informed in a couple of ways, just a more consistent, we think, and certainly, as you get away from experts into the emergency departments a better informed assessment of viability of the skin as well as some pretty specific measurements of where the viability, nonviability edge is.
So how much of a burn, for instance, needs to be addressed through skin grafts or something else. And what’s important there is the more precise you can be there the less impact you have to the patient, generally, these skin grafts are autologous, so the less impact you have to the patient somewhere else in their body of what is already a traumatic time.
John Vandermosten: Okay. And it’s been my sense, AI, we’re still in kind of the early days of approval for AI ML type products. In my sense has been those regulatory authorities and payer, they kind of want to know how it works and what it’s looking at. I mean, do you have that same sense as well? Or are they just looking for kind of the end result looking at those high percentage of accurate assessment?
