An Efficacy and Safety Study of SRM003 in the Treatment of Subjects Undergoing Creation of an Arteriovenous Fistula to Facilitate Hemodialysis Access

Inclusion Criteria:

1. Subject must be 18 years of age or older at the time of signing and dating informed
consent (no upper age limit), can be male or female.

2. Subject who is of child bearing potential must agree to use adequate contraception
for 6 months after randomization.

3. Subject must be currently undergoing hemodialysis or anticipating the start of
hemodialysis and must require a new permanent, suitable access for the AVF creation
in the upper extremity.

4. Subject must have a life expectancy of at least 26 weeks after randomization.

5. Subject must be able to understand and be willing to complete all study requirements.

Exclusion Criteria:

1. Subject is currently on an active organ transplant list from a deceased donor or is
undergoing assessment and expects to be placed on the active organ or bone marrow
transplant list within the next 26 weeks from surgery, or expects to receive a living
donor organ or bone marrow within the next 26 weeks and is unwilling to change
transplant list status to "hold" for 3 months after randomization.

2. Subject has had more than 1 access placement surgery (defined as a new access, not a
revision) in the target limb.

3. Subject has medical conditions and diseases that may cause non-compliance with the
protocol

4. Subject has a known allergy to bovine/porcine products or collagen/gelatin products.

5. Subject has a history of intravenous drug use within 6 months prior to screening

6. Subject is morbidly obese, defined as having a body mass index >40.

7. Pregnant or nursing woman, or plans to become pregnant during the study.