# Toward urinary catheterization with long-term resistance to bacterial colonization

> **NIH NIH R44** · WYNNVISION, LLC · 2024 · $540,238

## Abstract

PD/PI Kennard Brunson
Project Summary
Toward urinary catheterization with long-term resistance to bacterial colonization
Problem: Catheter Associated Urinary Tract Infections (CAUTI) are one of the most common
infections in hospitals and health care facilities. A study of urinary catheterisation involving over 9
million hospitalized patients found 12.9% were catheterised overall, but 72.9% were catheterized
in critical care. A long list of those who are susceptible to CAUTIs include those who are disabled
and the elderly and infirm with longer catheter indwelling times. Because of anatomy, women are
more susceptible to CAUTIs (~75%) compared to men (~25%). Increased antibiotic resistance,
and the increased prevalence of multidrug-resistant Gram-negative bacteria are serious threats in
view of the decreased pipeline of antibiotics. Solution: To fight CAUTIs, WynnVision LLC is
developing a new approach by introducing a robust surface component for silicone Foley
catheters that reduces bacterial colonization and biofilm formation. With discovery of “WynnGard-
1” silicone in 2010, WynnVision redirected research activities during Phase II. Patented
WynnGard-1 technology is novel compared to prior technologies that leach heavy metals or
antimicrobials. With no depletion of a leached agent, WynnGard-1 has the potential for long term
antimicrobial effectiveness. Challenge: A response from FDA to a WynnVision Pre-Request For
Designation in December 2021 posed questions that require experimental studies concerning
safety and efficacy. This Phase IIB proposal addresses FDA concerns that are embodied in
Specific Aims. Aim 1. Demonstrate negligible or undetectable leaching from WynnGard-1 silicone
with in vitro studies exceeding the maximum timeframe of patient use; Aim 2. Demonstrate
reduction of bacterial colonization in media comparable to human urine; Aim 3. Animal studies to
evaluate antimicrobial efficacy and biocompatibility; Aim 4. Establish a pathway to partnership for
licensing and manufacturing. WynnVision is confident in providing information to FDA that will
merit the designation “device” for WynnGard-1 silicone by FDA Office of Combination Products
and requirements for approval of a 510(k) application to the Center for Devices and Radiological
Health (CDRH). The proposed Phase IIB research and FDA actions will de-risk the technology
and make WynnGard-1 silicone attractive for commercialization. Impact: Low cost WynnGard-1
silicone will make this CAUTI-fighting technology widely available for all.

## Key facts

- **NIH application ID:** 10829346
- **Project number:** 5R44DK103398-06
- **Recipient organization:** WYNNVISION, LLC
- **Principal Investigator:** Olga Zolotarskaya
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $540,238
- **Award type:** 5
- **Project period:** 2015-07-08 → 2025-10-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10829346

## Citation

> US National Institutes of Health, RePORTER application 10829346, Toward urinary catheterization with long-term resistance to bacterial colonization (5R44DK103398-06). Retrieved via AI Analytics 2026-05-28 from https://api.ai-analytics.org/grant/nih/10829346. Licensed CC0.

---

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