# Slippery Omniphobic Coating for Hemodialysis Catheter to Resist Fibrin Sheathing and Infection and Improve Patient Outcomes

> **NIH NIH R44** · CERULEAN SCIENTIFIC INC. · 2024 · $751,776

## Abstract

PROJECT SUMMARY
Approximately 80% of patients beginning hemodialysis (HD) in the United States use a catheter at treatment
initiation, and 18.6% of all HD patients were using a catheter in 2017. However, the HD catheters (HDC) used
for longer-term dialysis in patients have a high complication rate because of infections and dysfunction, with a
catheter dysfunction rate of 0.5–3.42 episodes/1000 catheter-days. The most common catheter-related
problems are infections (catheter-related bloodstream infections; CRBSI) and thrombosis. Fibrin sheath
formation has a close relationship with pathogen colonization and biofilm formation on the catheter surface.
The entry of pathogens into the bloodstream through the catheter-extraluminal and intraluminal routes and the
seeding of pathogens that develop biofilm on the catheter surface cause CRBSI. In the US, annual HD
treatment costs ~$89,000 per patient, with total costs of $42 billion. In 2016, 80% of patients used a catheter at
initiation of HD and 18.6% of all HD patients in the US were using a catheter in 2017. However, no available
solutions to prevent catheter dysfunction can successfully prevent both thrombosis and infection.
FFMD is aiming to optimize and commercialize tethered liquid perfluorocarbon (TLP) coatings on medical
devices. Our TLP coating stops the adhesion of all biological components (bacteria, fungi, blood components)
to the surface of medical devices by immobilizing a thin layer of highly inert and biocompatible perfluorinated
liquid. In preliminary work, we optimized our TLP coating technology for HDC by incorporating a thin
fluoropolymer layer on the catheter surface. We also demonstrated that the optimized coating could reduce
colonization by CRBSI pathogens by >85% vs. uncoated polyurethane catheter while also effectively reducing
fibrinogen adhesion and thrombosis on the catheter surface.
The objective of this Direct to Phase II SBIR application is to complete our path toward marketability with our
TLP-modified HDC (TLP HDC). Using a previously established domestic sheep model, we will test the central
hypothesis that TLP HDC will out-perform standard HDC by decreasing fibrin sheath formation, which has a
close relationship with both catheter dysfunction and biofilm formation. This will be achieved using three aims.
Aim 1: Compare the in vivo effectiveness of TLP HDC and standard HDC (Palindrome®) at reducing fibrin
sheath formation and catheter tip occlusion. Aim 2: Obtain GMP-manufactured TLP HDC. Aim 3: Initiate the
510(k) application process to obtain FDA premarketing approval and perform a biocompatibility study. These
advances will allow FFMD to maximize the effectiveness of the TLP coating and dramatically improve HD
patient care by reducing catheter dysfunction and the CRBSI rate in clinical settings.

## Key facts

- **NIH application ID:** 10894142
- **Project number:** 5R44DK135256-02
- **Recipient organization:** CERULEAN SCIENTIFIC INC.
- **Principal Investigator:** Todd McFarland
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $751,776
- **Award type:** 5
- **Project period:** 2023-08-01 → 2026-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10894142

## Citation

> US National Institutes of Health, RePORTER application 10894142, Slippery Omniphobic Coating for Hemodialysis Catheter to Resist Fibrin Sheathing and Infection and Improve Patient Outcomes (5R44DK135256-02). Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/grant/nih/10894142. Licensed CC0.

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