But I think both CMS and then private payers who can provide the equivalent of an NTAP reimbursement will be motivated to do so because not only are the savings associated with the HAV present during the time the patients in the hospital. But once the patient leaves the hospital, the reduction in amputations and other complications, we’ll save the payers a substantial amount of money in terms of ongoing rehabilitation and prosthetics and other costs like that. So we believe that within the existing DRGs the use of HAV will be very favorable because of the production and complications, but that we will also get NTAP in the equivalent from private pay due to the innovative nature of the product and the savings that it provides once the patient leaves the hospital.
Joshua Jennings: Excellent.
Laura Niklason: Dale. And the only thing I would add there, and that this is also in the public domain, but as part of applying for the NTAP, it’s necessary to obtain an ICD-10 code from CMS. And we had a recent meeting with CMS that was in the public domain on the ICD-10 coding and CMS has recommended that the HAV be given a unique code. And so that’s an important step. It’s an important precursor to filing for the NTAP application later this year. So I just wanted to say that from a CMS standpoint, in terms of coding and reimbursement we’re definitely on track. And I also want to reiterate Dale’s points, which I think are very important for CMS and for all private payers and Medicaid also is that the initial hospital costs for severe traumatic injury, the initial hospital costs are only part of the equation.
Readmissions and complications due to the amputation and infection and sepsis are huge cost drivers and the insurers are going to understand this. And the case for providing add-on payments to support HAV adoption in trauma, I think, is going to be very strong.
Joshua Jennings: Excellent. Thanks for that. And just a follow-up on the AV access indication. And you’ve done work with Fresenius taking through their large data set on patients that could benefit most from HAV as well as health economics, I’m not sure if there’s any details you can share from that or timing of when more intel could come from that collaboration? And then just also remind us how you can leverage the vascular trauma indication in the filing for the AV access indication as we move down the year here? Thanks.
Laura Niklason: Well, as we’ve said on several calls, we’re looking forward to sharing that information I think we have – so I can say that we’re going to do a KOL event actually next week, where we’re going to present a lot of the Frenova data that we’ve gathered with our partner, Fresenius for more than a year, that really paints a very clear picture of how costly some of the most costly patients are and who those patients are. So we’re really looking forward to that, and that will be next week. As far as how the trauma data will be leveraged for a potential follow-on BLA supplement in dialysis access. As you know, the agency tends to look at safety and efficacy data within indication, that will be their primary focus. Although, of course, the long-term safety updates that we’re going to be providing as part of our drug safety update report and also just trauma follow-on, I’m sure we’ll be part of that file.
But just realistically, I think that particularly from an efficacy standpoint, since dialysis really is a different indication from trauma. I think the efficacy focus will be on the dialysis data, but I would anticipate that safety information from all indications, but especially from trauma would factor into the FDA’s thinking.
Joshua Jennings: Excellent. And also I you can, I was my assumption is you can leverage the modules on manufacturing and preclinical [indiscernible].
Laura Niklason: Oh yes, of course. Absolutely. Yes. Thank you for that. Yes. No, the – since the product is identical, all of the preclinical and all of the shelf life and manufacturing data are identical. Yes, that would all be leveraged. So that will be very helpful. And efficiency generating.
Joshua Jennings: Excellent. Okay. Thanks so much.
Operator: Our next question is from the line of Suraj Kalia with Oppenheimer. Please proceed with your questions.
Unidentified Analyst: Hi, Laura and Dale. This is Seamus on for Suraj. Just to start, I know the HAV for dialysis access has been almost a year fully enrolled. I guess, at this point, when could we expect some topline results filing? Any updates you can give us on that? Thank you.
Laura Niklason: Sure. So our enrollment completed actually in late April last year. So technically, we’ll hit the 12-month point next month. This is a large trial that went on for a while. It started pre-COVID at many centers. So it’s going to take us several months to pull this data together. So what we’ve guided the market is that we would expect topline results on the V007 trial in dialysis sometime in the third quarter of this year.
Unidentified Analyst: Got it. Thank you. And then just thinking through the initial sales force for trauma. I know you’ve said somewhere around 20 individuals. How should we think about kind of the ramp for hiring as you do what you’ll have roughly around the PDUFA date? Any updates you can give us there where you would be and I guess, percentage-wise of those 20 people?
Laura Niklason: Yes. Go ahead, Dale.
Dale Sander: Go ahead.
Laura Niklason: No, you go ahead.
