# Ceragenin-based antimicrobial coating to tackle hemodialysis catheter-related infections.

> **NIH NIH R43** · N8 MEDICAL, INC. · 2022 · $299,155

## Abstract

PROJECT SUMMARY
The constantly increasing number of hemodialysis patients (2% increase every year in the United States) leads
to the subsequent increasing burden of catheter-related infections, with direct and indirect hospitalization costs
ranging between $17,000-$32,000 per episode and a mortality rate at 30 days of 18%. Current antimicrobial
strategies based on topical ointments lead to the selection of resistant bacterial strains, while lock solutions carry
the risk of thrombolytic and cardiac complications. Antibiotic (minocycline + rifampin)-coated catheters are able
to reduce the proliferation of Gram-positive bacteria (Staphylococcus aureus and Staphylococcus epidermidis)
but lack antimicrobial activity against Gram-negative (Pseudomonas aeruginosa) and fungal (Candida spp.)
strains, while metal-based coatings (silver and its combination with other metals) have shown inconsistent
bactericidal efficacy and the induction of adverse effects (e.g., pulmonary embolism). There is an urgent need
for an effective way to prevent and treat catheter-related infections. N8 Medical proposes an innovative coating
for these catheters based on the use of ceragenins (CSAs), designed to mimic naturally occurring antimicrobial
peptides and their bactericidal capabilities. Moreover, CSAs permeabilize the membranes of bacterial cells and
sensitize them to hydrophobic antibiotics. The coating will be designed to exert an anti-infective activity with the
incorporation of CSAs, investigated in preliminary studies demonstrating its effectiveness against Gram-positive
(methicillin-resistant S. epidermidis and S. aureus) and Gram-negative (P. aeruginosa) bacteria and fungal
infections (C. albicans), and to prevent the formation of biofilms. The antimicrobial activity of CSAs will promote
the complete eradication of bacterial populations (including resistant strains) responsible for catheter infections,
reducing hospitalization costs and mortality rates. In this SBIR Phase I project, N8 Medical will develop a CSA-
loaded, polyurethane-based hydrogel applicable to hemodialysis catheters and investigate its antimicrobial
efficacy and CSA release profile in the context of direct contact with blood shear forces (Aim 1). The validated
coated catheter will be tested in an animal model to assess its efficacy and safety (Aim 2). The success of this
project will de-risk Phase II activities where the company will focus on preclinical, IDE-enabling safety,
biocompatibility and efficacy studies against multiple challenge pathogens (Staphylococci, P. aeruginosa, C.
albicans).

## Key facts

- **NIH application ID:** 10602612
- **Project number:** 1R43DK133005-01A1
- **Recipient organization:** N8 MEDICAL, INC.
- **Principal Investigator:** Glenn Brunner
- **Activity code:** R43 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $299,155
- **Award type:** 1
- **Project period:** 2022-09-12 → 2025-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10602612

## Citation

> US National Institutes of Health, RePORTER application 10602612, Ceragenin-based antimicrobial coating to tackle hemodialysis catheter-related infections. (1R43DK133005-01A1). Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/grant/nih/10602612. Licensed CC0.

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