# Omniphobic Coating of Extracorporeal Life Support Systems for Improved Thromboresistance

> **NIH NIH R43** · CERULEAN SCIENTIFIC INC. · 2021 · $223,937

## Abstract

PROJECT SUMMARY
Extracorporeal membrane oxygenation (ECMO) is commonly used in the critical care unit for gas exchange in
the event of severe respiratory and cardiac failure. Such circuits consist of one or more vascular access
cannulae, a blood pump, and an oxygenator composed of a bundle of microporous hollow fiber membranes
(HFM). Blood flow is drawn from the circulatory system via a pump and directed through the HFM bundle for
oxygenation and CO2 removal prior to being returned to the patient. However, ECMO has high incidence of
thrombosis and device failure, which are associated with activation of the coagulation cascade primarily due to
the non-biological blood-contacting surface of the extracorporeal circuit. Such thrombosis manifests clinically
as deep vein thrombosis, pulmonary embolism, oxygenator thrombosis, and small vessel thrombosis. Hence,
systemic anticoagulants are necessary, which leads to hemorrhage and associated complications. The ECMO-
associated venous thrombosis rate is as high as 85% and oxygenator thrombosis rate is 10–16% depending
on patient age and oxygenator design. ECMO has high severe hemorrhage rate of 40%, of which 16–21% is
intracranial hemorrhage. Despite the development of advanced biomaterials, ECMO use continues to be
hampered by bleeding and thrombosis complications.
FreeFlow Medical Devices (FFMD) is optimizing and commercializing tethered liquid perfluorocarbon (TLP)
coatings on medical devices. The goal of this SBIR project is to validate the hypothesis that our TLP-coated
ECMO membranes will reduce thrombosis. Our long-term goal is to improve outcomes for patients requiring
ECMO by reducing the rate of complications caused by thrombosis and bleeding. Our omniphobic coating
stops the adhesion of all biological components (bacteria, fungi, blood components) to the surface of medical
devices through the immobilization of a thin layer of highly inert and biocompatible perfluorinated liquid. Our
optimized coating technology incorporates a thin fluoropolymer layer on various surfaces with the help of
chemical vapor deposition technique.
The objective of this phase I proposal is to obtain the proof of concept that our TLP-oxygenation membrane will
reduce thrombogenicity under clinically relevant conditions. Once proof of concept has been obtained, we will
progress to Phase II for cGMP manufacturing of TLP-oxygenator and proceed with FDA-recommended
biocompatibility testing to make this ready for premarket approval. The goals of this phase I application will be
achieved by investigating the following Specific Aims. Aim 1: Optimize TP coating on PMP membrane to
maintain its original microporosity and gas exchange capacity. Aim 2: Optimize the LP coating to achieve the
highest thrombogenicity. Aim 3: Determine thromboresistance of the optimized TLP-coated oxygenation
membrane under ECMO-relevant flow-induced shear stress for the period of average use duration. Once proof
of concept has been obtained, we will prog...

## Key facts

- **NIH application ID:** 10253612
- **Project number:** 1R43HL156321-01A1
- **Recipient organization:** CERULEAN SCIENTIFIC INC.
- **Principal Investigator:** Saibal Bandyopadhyay
- **Activity code:** R43 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $223,937
- **Award type:** 1
- **Project period:** 2021-03-19 → 2022-09-18

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10253612

## Citation

> US National Institutes of Health, RePORTER application 10253612, Omniphobic Coating of Extracorporeal Life Support Systems for Improved Thromboresistance (1R43HL156321-01A1). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10253612. Licensed CC0.

---

*[NIH grants dataset](/datasets/nih-grants) · CC0 1.0*