# Slippery, Omniphobic Coating to Prevent Thrombosis and Biofilm Formation on Peripheral Vascular Grafts

> **NIH NIH R44** · CERULEAN SCIENTIFIC INC. · 2024 · $297,732

## Abstract

PROJECT SUMMARY
Critical limb ischemia (CLI) affects 2 million Americans with peripheral artery disease (PAD) each year and is a
frequent cause of persistent ulcers and wounds, amputations, hospitalizations with frequent re-admissions, and
death due to reduced blood flow to the affected limb. Untreated, CLI patients survive under 2 years. The main
treatment for CLI is to increase blood flow to improve limb perfusion using extremity artery bypass. When the
patient’s own vein is insufficient peripheral vascular grafts (PVG), frequently made from expanded
polytetrafluoroethylene (ePTFE), are used as a synthetic graft is used for both segments. Unfortunately, PVG
have failure rates ranging from 20% to 50% within the first year of surgery, which increases to >60% after 5
years. The primary reasons for PVG failure are neointimal hyperplasia, occlusion via thrombosis, and infection.
No current or in-development technology successfully addresses these challenges.
FreeFlow Medical Devices (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. Our preliminary data demonstrate that our TLP coating effectively resists
occlusion and pathogen colonization on vascular devices under physiological flow conditions.
In this Fast Track proposal, we will investigate the ability of TLP PVG to resist occlusion, thrombus formation,
and biofilm formation, which all contribute to graft dysfunction We will also finalize the TLP additive packaging
for GMP manufacturing in Phase II. This will be achieved using six Aims. Phase 1 Aim 1. Perform a 90-day in
vitro TLP PVG characterization to understand the durability and characteristics of the coating after 90 days.
Phase 1 Aim 2. Perform a 60-day protein biofouling study to test the ability of TLP surfaces to resist protein
adsorption since biofilm development, thrombus progression, and neointimal hyperplasia all begin with protein
adsorption. Phase 1 Aim 3. Perform 30-day in vitro thrombogenicity testing. Phase 2 Aim 4. Obtain GMP-
manufactured TLP PVG. Phase 2 Aim 5. Perform an efficacy study to compare the in vivo effectiveness of TLP
PVG with standard PVG (BD Impra®) at reducing thrombin formation, neointimal hypoplasia, and stenosis.
Phase 2 Aim 6. 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 PVG patient care by reducing graft failure dure to neointimal hyperplasia, infection, and
thrombosis.

## Key facts

- **NIH application ID:** 10822370
- **Project number:** 1R44HL172473-01
- **Recipient organization:** CERULEAN SCIENTIFIC INC.
- **Principal Investigator:** Todd McFarland
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $297,732
- **Award type:** 1
- **Project period:** 2024-09-25 → 2025-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10822370

## Citation

> US National Institutes of Health, RePORTER application 10822370, Slippery, Omniphobic Coating to Prevent Thrombosis and Biofilm Formation on Peripheral Vascular Grafts (1R44HL172473-01). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10822370. Licensed CC0.

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