In the U.S. alone, nearly two million patients acquire a nosocomial infection in the hospital each year, and approximately 100,000 of them die. Nosocomial infections are a leading cause of death in the U.S., and they result in major increases in hospital stays, human suffering, and healthcare costs. Nearly half of these infections are associated with the use of a medical device, and catheter-associated urinary tract infection (UTI) is the most common type of nosocomial infection, accounting for over 40% of infections in hospitals and nursing homes. Some 95% of UTIs are associated with urinary catheters, and these catheter-associated UTIs account for an estimated annual hospital cost of more than $400 million. The current paradigm for preventing bacterial UTIs has been to introduce antimicrobial agents to reduce the concentrations of bacteria associated with biofilm formation. However, use of antimicrobial agents leads to resistance patterns that make indwelling catheter infections more difficult to treat. By coating the catheter, the risk of infection is reduced;however, this strategy at best only delays the infection onset. Despite advances in prophylactic strategies, there are currently no definitive methods to prevent catheter-associated UTI. Sharklet Technologies therefore proposes development of a novel catheter design capable of sustained inhibition of bacterial biofilm formation that does not rely on traditional antimicrobial coatings or treatments. Preliminary studies have shown that micro-patterns on polymer surfaces can be designed to inhibit bacterial biofilm growth-with the Sharklet" micro-pattern being the most effective. Therefore, the overall goal of this project is to develop, validate, and commercialize the use of the Sharklet microscopic pattern (based on the unique antifouling characteristics of shark skin) to inhibit bacterial biofilm formation on urinary catheters without the use of antimicrobial agents. The Specific Aims for proposes development of a novel catheter design capable of sustained inhibition of bacterial biofilm formation that does not rely on traditional antimicrobial coatings or treatments. proposes development of a novel catheter design capable of sustained inhibition of bacterial biofilm formation that does not rely on traditional antimicrobial coatings or treatments. proposes development of a novel catheter design capable of sustained inhibition of bacterial biofilm formation that does not rely on traditional antimicrobial coatings or treatments. Phase I are 1) to validate the effectiveness of the Sharklet micro-patterned polymer surface for inhibiting biofilm formation with uropathogenic E. coli in growth media and artificial urine over the course of 14 days, and 2) to prove the feasibility of fabricating catheter-like prototypes that exhibit Sharklet-patterned extraluminal and intraluminal surfaces. Phase I success will validate the use of micro- patterned surfaces to prevent biofilm growth of a uropathogen and will demonstrate the feasibility of constructing a catheter-like prototype exhibiting the pattern. A follow-on Phase II project will be designed to develop manufacturing methods for the tube prototypes and to demonstrate efficacy with an in vivo pig model. The Phase I and Phase II SBIR data will be essential in attracting the types of "Phase III" private-sector investors and/or strategic partners with whom we are already discussing this technology. Phase III commercialization efforts will therefore be focused on establishing partnerships with medical device partners and distributors-particularly those in the urinary catheter markets. PUBLIC HEALTH RELEVANCE: Some 30 million urinary catheters are inserted into 5 million patients in the U.S. each year, and each one of those patients is at risk for acquiring a urinary tract infection due to the bacterial biofilms that form on the catheter surface. Current strategies for inhibiting biofilm formation on the catheter surfaces are expensive, ineffective, and give rise to serious complications such as toxic side-effects and multi-drug resistance. The overall goal of this project is to develop, validate, and commercialize the use of the Sharklet microscopic pattern (based on the unique antifouling characteristics of shark skin) to inhibit bacterial biofilm formation on urinary catheters without the use of antimicrobial agents.