To Compare the Efficacy and Safety of the HAV With AVF in Female Patients With End-Stage Renal Disease Requiring Hemodialysis (HUMAXX)

1. Female patients with ESRD, currently receiving hemodialysis via dialysis catheter andwho are candidates for the creation of an AVF (see Inclusion Criterion #4 below) orHAV for HD access.
2. Patients who plan to undergo HD at a dialysis unit of a participating dialysisvider for at least 12 months after SA creation.
3. Patients aged ≥ 18 years at Screening.
4. Suitable anatomy for creation of a forearm or upper arm AVF and for implantation ofght, curved, or looped HAV in either the forearm or upper arm.
   NOTE: Suitable anatomy will be determined by both physical examination and ultrasoundging or vessel imaging modality in addition to consideration of all vascular sitesvailable, prior access failure, future access sites and possibilities to preserveuture alternate accesses. Vessel mapping is the preferred method to assesshe vascular anatomy, and will evaluate the following attributes during Screening:
   • Vein diameter
   • Arterial diameter
   • Presence of arterial calcification
   • Depth of the intended fistula conduit from the surface of the skin
   • Central vein patency
   • Previous vascular access location The ultimate decision of anatomic suitabilitybelongs to the surgeon and/or the investigator.
5. Hemoglobin ≥ 7 g/dL and platelet count ≥ 100,000 /mm3
6. Patients must either:
   1. Be of non-childbearing potential, which is defined as post-menopausal (at least 1year without menses prior to Screening) or documented surgically sterile (i.e.,hysterectomy or tubal ligation, or complete bilateral oophorectomy) at1 month prior to Screening.
   2. Or, if of childbearing potential:

             Must agree to use at least one form of the following birth control methods for theduration of the study:. Established use of oral, injectable or implanted hormonal methods of contraception.. Placement of an intrauterine device or intrauterine system at least 5 days priorg.. Barrier methods of contraception: condom or occlusive cap (diaphragm orvical/vault caps) with spermicidal foam/ gel/ film/ cream/ suppository.7. Patient or their legal representative can communicate effectively with investigatived willing to give written informed consent, and able to complywith entire study procedures including all scheduled follow-up visits.8. Life expectancy of at least 1 year confirmed by Charlson Comorbidity Index ≤ 8.usion Criteria:1. Male sex at birth.2. Planned AVF creation by means other than suture or vascular anastomotic clips (e.g.,dovascular surgery or other anastomotic creation devices). Venous outflow from studybe located more distally than the venous outflow of any previous failedhat extremity.3. Known serious allergy or intolerance to aspirin and alternative antiplatelet therapy.. Pregnancy, or women intending to become pregnant during the course of the trial.5. Treatment with any investigational drug or device within 60 days or 5 half-lives afterking the last dose (whichever is longer) prior to study entry (Day 1) or ongoingvestigational product.6. Documented hyper-coagulable state, as defined as either:1. Documented hyper-coagulable state, as defined as either: A biochemical diagnosis(e.g., Factor V Leiden, Protein C deficiency, etc.) - OR -2. A clinical history of thrombophilia as diagnosed by 2 or more spontaneousvascular thrombotic events (e.g., deep vein thrombosis (DVT), pulmonarybolism (PE), etc.) within the previous 5 years.7. Spontaneous or unexplained bleeding diathesis clinically documented within the last 5years or a biochemical diagnosis (e.g., von Willebrand's disease, etc.).8. Cancer actively being treated with a cytotoxic agent.9. Planned or anticipated renal transplant within 6 months after randomization.10. Any other condition that in the judgment of the investigator would preclude adequatevaluation of the safety and efficacy of the SA.11. Previous exposure to HAV.12. Any of the following within 8 weeks prior to screening: acute coronary syndrome,ke or congestive heart failure NYHA Stage IV13. Employees of Humacyte and employees or relatives of an investigator.