# Vertically Integrated Approach to Design a Biologically and Mechanically Optimized Vascular Conduit for Dialysis Vascular Access

> **NIH NIH U01** · UNIV OF NORTH CAROLINA CHAPEL HILL · 2024 · $568,269

## Abstract

ABSTRACT
Dialysis vascular access (arteriovenous fistulae [AVF] and arteriovenous grafts [AVG]) is the Lifeline
for the 500,000+ patients on hemodialysis in the United States (3million+ worldwide). Unfortunately,
both AVFs and AVGs have high failure rates due to an aggressive venous segment stenosis which
results in multiple interventional procedures, hospitalizations, and increased catheter (CVC) use. This
results in vascular access also being the Achilles Heel of hemodialysis and an important unmet clinical
need which results in a very significant morbidity, mortality, and economic cost (over 5B USD per
annum).
In this proposal we will combine expertise and experience from both industry and academia to create
an innovative vascular conduit (the Functional INtegrated Electrospun [FINE] device) that comprises
an inner Cu-PAS core surrounded by an outer P4HB sheath that will have (a) a precisely controlled
microstructure to promote host cell integration (b) anti-bacterial and immunomodulatory properties (c)
vein-artery-matched geometry to minimize upstream injury pathways and (d) an intrinsic self-sealing
ability that allows for early cannulation.
At an operational level we plan to (a) selectively design, refine and prototype FINE devices (b)
document the safety and efficacy of selected FINE devices in a pig arteriovenous access stenosis
model and (c) develop clinical scale production capabilities for the FINE device.
In summary, this proposal brings together a trio of unlikely partners (industry x 1 and academia x 2)
that between them have the science, the infrastructure, the experience, and the people to bring
disruptive change to dialysis vascular access. While none of us on our own could have done what is
described in this proposal, we would also venture to say that the sum of the individual parts will in this
case be exponentially larger than the whole.

## Key facts

- **NIH application ID:** 10936374
- **Project number:** 1U01EB035996-01
- **Recipient organization:** UNIV OF NORTH CAROLINA CHAPEL HILL
- **Principal Investigator:** Peter M Crapo
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $568,269
- **Award type:** 1
- **Project period:** 2024-09-01 → 2028-05-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10936374

## Citation

> US National Institutes of Health, RePORTER application 10936374, Vertically Integrated Approach to Design a Biologically and Mechanically Optimized Vascular Conduit for Dialysis Vascular Access (1U01EB035996-01). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10936374. Licensed CC0.

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