Abstract: Catheter-associated urinary tract infection (CAUTI) is the most common type of healthcare-associated infection, however currently there is no effective technology to address the problem. Antimicrobial (anti-biofilm) functionality on the catheter surface is an important field that has gained a lot of attention; however, commercial applications are limited due to a lack of infection control outcomes (silver-hydrogel coating) or irritation/discomfort (nitrofural) in clinical trials. Recent research has now shown that biofilm formation is caused by protein deposition which will also cause inflammation and immunoreaction. Therefore, the next generation technology needs both antimicrobial functionalities along with anti-immunoreaction capabilities to produce a compound effect for infection control. Our company invented a new category of polymer additive product (HaloAddTM) that can be cost-effectively blended into existing silicon rubber resins to produce silicone urinary catheters that can provide multiple functions such as antimicrobial, anti-protein adhesion and anti-inflammation. This phase I effort is geared towards answering some basic feasibility, efficacy, and safety questions about this approach using both in vitro and in vivo testing methods. We propose three specific aims: 1) optimize polymer synthesis and blending parameters to develop HaloAdd-blended silicone rubber formulas with maximum antimicrobial and anti-fouling efficacy; 2) determine uropathogen attachment prevention, biocompatibility, and stability of HaloAdd-blended silicone tubes; 3) demonstrate in vivo that HaloAdd catheter provides measurable anti-inflammation and anti-biofilm outcomes in a mouse infection model. Success with this phase I effort will lay the groundwork for FDA clearance for human trials.

Narrative Development of a new class of antimicrobial and anti-inflammation urinary catheters that can cost-effectively mitigate catheter-associated urinary tract infections. To prove the concept, we will optimize polymer synthesis and blending parameters to develop HaloAdd-blended silicone rubber formulas with maximum antimicrobial and anti-fouling efficacy , determine uropathogen attachment prevention, biocompatibility, and stability of HaloAdd-blended silicone tubes, and demonstrate in vivo that HaloAdd catheter provides measurable anti-inflammation and anti- biofilm outcomes in a mouse infection model.