# Resorbable Antimicrobial Envelope to Prevent Infection of Implanted Cardiac Devices

> **NIH NIH R44** · N8 MEDICAL, INC. · 2022 · $1,002,182

## Abstract

PROJECT SUMMARY
Infections related to the implantation of cardiovascular implantable electronic devices (CIEDs) occur in 20% of
the interventions and are associated with a 2-fold increase in mortality rate. While pre-operative antibiotic
prophylaxis is currently used in clinical practice, targeting the infectious agents locally is recommended to reduce
the risk of antibiotic resistance. The use of an antibacterial envelope (TYRX, Medtronic), made of a polymer
mesh coated with two antibacterial agents (minocycline and rifampin), has been shown to reduce by 40% major
CIED infections. Despite these positive results, the product has several drawbacks. The envelope has variable
effectiveness against coagulase-negative Staphylococci and lacks effectiveness against fungi or biofilms.
Moreover, several methicillin-resistant Staphylococcus aureus (MRSA) strains have developed resistance
against it. Therefore, an antibacterial and antimycotic resorbable envelope that fully eradicates CIED-related
infections remains an unmet clinical need. N8 Medical is developing a new bioresorbable polymeric CIED
envelope that incorporates a proprietary ceragenin, a novel class of anti-infective agents that do not engender
resistance. The new compound is a synthetic non-peptide compound that mimics the activity of the body’s
endogenous antimicrobial peptides (AMPs) and it confers efficacy against difficult to eradicate strains, such as
MRSA and fungi. N8 Medical’s CIED Envelope is the first surgical envelope to prevent fungal colonization of
cardiac devices while providing superior inhibition of bacterial growth. Upon implantation of the CIED within the
N8 Medical device, the envelope physically secures and stabilizes the implanted pacemaker and releases the
ceragenin to eliminate infection-causing pathogens during the period before being fully resorbed by the body
within 8-12 weeks. This SBIR Phase II project builds on the results of a Phase I project that provided preliminary
validation of the efficacy of the envelope in vitro and in vivo and confirmed its potential broader spectrum of
activity compared to TYRX. The goal of this Phase II project is to perform pivotal preclinical studies required to
obtain an IDE and FDA device approval through a De Novo application. The project is articulated in three aims
over 2 years. First, industrial product development will improve the fabrication method to assure the commercial
viability of the envelope (Aim 1). The final design will then be validated in GLP pivotal safety (Aim 2) and efficacy
(Aim 3) studies. Comprehensive biocompatibility tests (including cytotoxicity, sensitization, pyrogenicity, and
genotoxicity assays), and in vivo acute and sub-chronic and chronic systemic toxicity will be assessed. The high
efficacy of N8 Medical’s CIED Envelope in eradicating resistant bacterial strains, fungi, and biofilms, will lead to
better patient outcomes in terms of morbidity and mortality, reduced infection-related complications, a...

## Key facts

- **NIH application ID:** 10483836
- **Project number:** 2R44HL137519-02A1
- **Recipient organization:** N8 MEDICAL, INC.
- **Principal Investigator:** Glenn Brunner
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $1,002,182
- **Award type:** 2
- **Project period:** 2018-09-01 → 2024-06-14

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10483836

## Citation

> US National Institutes of Health, RePORTER application 10483836, Resorbable Antimicrobial Envelope to Prevent Infection of Implanted Cardiac Devices (2R44HL137519-02A1). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10483836. Licensed CC0.

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