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.