To Compare the Efficacy and Safety of the ATEV With AVF in Female Patients With End-Stage Renal Disease Requiring Hemodialysis

Inclusion Criteria:

1. Female patients with ESRD, currently receiving hemodialysis via dialysis catheterand who are candidates for the creation of an AVF (see Inclusion Criterion #4 below)or implantation of an ATEV for HD access.

2. Patients who plan to undergo HD at a dialysis unit of a participating dialysisprovider 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 ofstraight, curved, or looped ATEV in either the forearm or upper arm. NOTE: Suitable anatomy will be determined by both physical examination andultrasound imaging or vessel imaging modality in addition to consideration of allvascular sites available, prior access failure, future access sites andpossibilities to preserve patients' future alternate accesses. Vessel mapping is thepreferred method to assess the vascular anatomy, and will evaluate the followingattributes 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:

7. Be of non-childbearing potential, which is defined as post-menopausal (at least 1 year without menses prior to Screening) or documented surgically sterile (i.e., total hysterectomy or tubal ligation, or complete bilateraloophorectomy) at least 1 month prior to Screening.

8. Or, if of childbearing potential: Must have a negative serum pregnancy test at Screening, and Must agree to use at least one form of the following birth control methods for theduration of the study: i. Established use of oral, injectable or implanted hormonal methods ofcontraception. ii. Placement of an intrauterine device or intrauterine system at least 5 days priorto Screening. iii. Barrier methods of contraception: condom or occlusive cap (diaphragm orcervical/vault caps) with spermicidal foam/ gel/ film/ cream/ suppository.

9. Patient or their legal representative can communicate effectively with investigativestaff, is competent and willing to give written informed consent, and able to complywith entire study procedures including all scheduled follow-up visits.

10. Life expectancy of at least 1 year confirmed by Charlson Comorbidity Index ≤ 9.

Exclusion Criteria:

1. Male sex at birth.

2. Planned AVF creation by means other than suture or vascular anastomotic clips (e.g.,endovascular surgery or other anastomotic creation devices). Venous outflow fromstudy access cannot be located more distally than the venous outflow of any previousfailed access in that extremity.

3. Known serious allergy or intolerance to aspirin and alternative antiplatelettherapy.

4. 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-livesafter taking the last dose (whichever is longer) prior to study entry (Day 1) orongoing participation in a clinical trial of an investigational product.

6. Documented hyper-coagulable state, as defined as either:

7. Documented hyper-coagulable state, as defined as either: A biochemicaldiagnosis (e.g., Factor V Leiden, Protein C deficiency, etc.) - OR -

8. A clinical history of thrombophilia as diagnosed by 2 or more spontaneousintravascular thrombotic events (e.g., deep vein thrombosis (DVT), pulmonaryembolism (PE), etc.) within the previous 5 years.

9. Spontaneous or unexplained bleeding diathesis clinically documented within the last 5 years or a biochemical diagnosis (e.g., von Willebrand's disease, etc.).

10. Cancer actively being treated with a cytotoxic agent.

11. Planned or anticipated renal transplant within 6 months after randomization.

12. Any other condition that in the judgment of the investigator would preclude adequateevaluation of the safety and efficacy of the SA.

13. Previous exposure to ATEV.

14. Any of the following within 8 weeks prior to screening: acute coronary syndrome,stroke or congestive heart failure NYHA Stage IV

15. Employees of Humacyte and employees or relatives of an investigator.