# Durable Zwitterionic Coatings: Dramatic Reduction of Implant-Induced Inflammation and Fibrosis

> **NIH NIH R43** · ZWICOAT MATERIALS INNOVATIONS, LLC · 2024 · $306,864

## Abstract

Project Summary/Abstract: Polydimethylsiloxane (PDMS), also known as silastic, is commonly used for
medical implants. Despite advantages over earlier elastomers and plastics, PDMS surfaces elicit a significant
foreign body response (FBR). This response, triggered by adhesion of non-specific proteins, leads to a thick
fibrotic capsule post-implantation, impacting the functionality, safety, and longevity of various medical devices.
For neurostimulators such as cochlear implants (CIs), this fibrotic tissue increases the impedance of the nerve -
tissue interface and has other deleterious effects, e.g., reduced hearing quality in the case of CIs. Similarly, in
stents, catheters, and tubes, the FBR can permanently damage tissue, narrow passageways, and restrict flow
rates. A notable example is endotracheal (ET) tubes, which commonly induce subglottic stenosis in long-term
intubated patients, leading to life-long complications. Moreover, PDMS-based implanted biomaterials are prone
to bacterial biofilm formation, presenting a significant risk for infections. Hospital-acquired infections associated
with implanted devices incur ~30 billion dollars annually in healthcare costs in the U.S. alone. To address these
challenges, surface modifications to enhance the biocompatibility of PDMS have been a significant focus of
research. While impressive antifouling properties have been realized in a variety of coatings—and particularly
those based on zwitterionic polymers—these coatings have yet to be incorporated in commercial biomedical
devices due to weak grafting to the PDMS surface, inadequate mechanical durability, and complex processing
steps that aren’t easily transferable to existing manufacturing processes. Our company, ZwiCoat Materials
Innovations (ZCMI), has developed the first ever ultra-low-fouling thin film coating that forms a permanent,
covalent bond with PDMS surfaces in a simple one-step process. This patented technology combines several
properties crucial for commercial viability: strong covalent bonding to PDMS, high lubricity, mechanical durability,
and exceptional antifouling capabilities—all achieved through a straightforward, single-step photoinitiated
reaction that can be integrated with existing manufacturing protocols. This SBIR project aims to establish the
technical merit and feasibility of applying our innovative coating to two existing medical implants, CI electrode
arrays and ET tubes—both of which would benefit from greatly reduced fibrosis and are representative of large
classes of biomedical devices. The project aims to develop efficient coating technologies, validate coating
durability, while confirming their robust antifouling properties on these devices. Phase I success is expected to
enable industry partnerships and pave the way for regulatory approval. Concurrently, targeted interviews with
hospitals, physicians, patients, and industry leaders will be conducted to inform and refine subsequent Phase II
work as well as our comm...

## Key facts

- **NIH application ID:** 11008220
- **Project number:** 1R43DC022208-01
- **Recipient organization:** ZWICOAT MATERIALS INNOVATIONS, LLC
- **Principal Investigator:** Kameron Rex Hansen
- **Activity code:** R43 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $306,864
- **Award type:** 1
- **Project period:** 2024-08-01 → 2025-12-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/11008220

## Citation

> US National Institutes of Health, RePORTER application 11008220, Durable Zwitterionic Coatings: Dramatic Reduction of Implant-Induced Inflammation and Fibrosis (1R43DC022208-01). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/11008220. Licensed CC0.

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