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| That means we're entering the year with about $144 million in cash, which leaves us very well positioned |
| And we're feeling very confident about how this inspection is going to go |
| And the case for providing add-on payments to support HAV adoption in trauma, I think, is going to be very strong |
| We've previously reported excellent long-term six-month results in coronary artery bypass in large animals |
| And clearly, the HAV qualifies for an NTAP reimbursement because it's innovative and because it provides a meaningful patient benefit |
| So suggesting we're very well positioned with the cash that we have on hand right now |
| So we believe we'll be able to ramp production, tracking demand, we'll be able to ramp production and add more LUNA capacity and meet that as it grows |
| This is a very exciting time for Humacyte and all of our stakeholders |
| 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 |
| But we believe we're in good shape |
| In this case, the hospitals that the overall cost of treating a patient with HAV will be very favorable |
| 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 |
| Avoidance of these costly complications will, we believe, help to drive market uptake of this revolutionary product candidate in the care of traumatically injured patients |
| We believe that the facility is in great shape |
| This was supported by a robust data package that included positive results from our V005 Phase II/III clinical trial |
| And we believe that the Frenova data in combination with additional data that we're going to get on our clinical trials will really help make the health economic case around the HAV in female patients who have very high complication rates |
| But obviously, the HAV is the biologic, which has produced clinical results which are far superior to the comparable standard of care today, particularly synthetic grafts, it's going to be priced at higher acquisition costs than the current standard of care |
| The BLA acceptance brings us another step closer to our goal of providing an innovative regenerative medicine product for patients who are suffering traumatic vascular injury |
| Clearly, the health economic benefits that are going to be demonstrated due to this reduction of complications is going to be meaningful and certainly will support the pricing of the product |
| In presentations at the VEITH Symposium and at the Midwestern Vascular Conference, researchers observed that in the clinical study, the HAV was a safe, resilient and effective conduit for arterial bypass and limb salvage in patients who did not have vein to provide a conduit to restore blood flow |
| The entire team has worked incredibly hard to reach this point, and we are approaching what could be a transformational time not only for the company, but for patients suffering from a variety of vascular diseases and complications |
| Based upon historical results for synthetic graft outcomes, it's clear that the HAV can provide important health benefits as well as important economic benefits for the healthcare system |
| And efficiency generating |
| Obviously, our goal and our hope is that across the board, we will have superiority across the whole trial and for all patient groups |
| Our manufacturing processes are well characterized and well understood |
| Based on the strength of the data package, from our V005 trial in vascular trauma, combined with data from the humanitarian experience in Ukraine, we look forward to the PDUFA date with confidence |
| The infection resistance maybe due to the HAVs native-like tissue structure that supports superior compatibility with the body zone immune cells |
| And we are continuing to study the HAV in our earlier programs in order to maximize the full potential of our technology platform and its value |
| Our fourth quarter and the start of 2024 have been highly productive for Humacyte |
| We believe this also reflects their recognition that many patients with severe injuries are underserved by the current standards of care |
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| The net loss was $110.8 million for the year ended December 31, 2023 compared to $12 million for the year ended December 31, 2022 |
| Net loss was $25.1 million for the fourth quarter of 2023 compared to $3.7 million for the fourth quarter of 2022 |
| But again, based on our health economic data and looking at the complications that are suffered by dialysis patients, it's become clear from our work with Frenova that women in general, and there are certain subsets of women that have extraordinarily high complication rates and are extraordinarily expensive system |
| In other words, patients treated with the HAV were only 40% is likely to lose blood flow through their conduit after one month, which is a key period for recovery after traumatic injury |
| There are two main sources of decreasing COGS over time |
| So certainly, trauma care, there is some variability |
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