Advanced Nitric Oxide Release Bactericidal Urinary Catheters

DESCRIPTION (provided by applicant): We propose a novel and competitive urinary tract silicone Foley catheter made from a proprietary polymeric formulation to effectively reduce catheter-associated urinary tract infections (CAUTI) via nitric oxide (NO) release. Preliminary studies show that the device will be able to: (1) continuously deliver NO at rates enough to maintain bactericidal properties for gt2 weeks at 37 C, (2) deliver controlled increased NO levels with enhanced bactericidal properties using light if needed, and (3) allow to be dry-stored for more than 2 months of shelf life even at 37 C. CAUTIs contribute to 0.5-0.7 million nosocomial hospital infections annually with a cumulative incidence of 3-6% per day of catheterization (50% at 10 days, gt90% at 28 days, 100% long term) leading to complications such as cystitis, pyelonephritis, gram-negative bacteremia, prostatitis, epididymitis, urosepsis, septicemia, orchitis, endocarditis, vertebral osteomyelitis, septic arthritis, endophthalmitis, and meningitis n all patients. The proposed device can be processed and assembled in the US at almost half the cost of current silver coated Foley catheters', and could potentially prevent ten thousand deaths per year due to CAUTIs. In terms of reimbursement, hospitals will see average care reduction costs of 700 per case by eliminating infection, and insurance companies will see significant decrease in length of hospital stay savings as CAUTI rates are reduced. To continue research and development of our product, we propose: (1) to study the NO release from the walls of the catheters containing our proprietary formulation to understand thresholds for effective biofilm prevention (Proteus mirabilis, Enterococcus faecalis, and Staphylococcus epidermidis); (2) tounderstand the light emission requirements at 590nm to photochemically prevent biofilm formation; and (3) to perform shelf-life, and sterilization studies to understand product reliabiliy and performance after 6 months of storage. Sterilization studies have been chosen over biocompatibility studies (to be done in Phase II) since the proprietary main NO donor molecule, once decomposed, is an approved drug. This proprietary technology has been optioned by Biocrede Inc. (Ann Arbor, MI) through the Offices of Tech Transfer at the University of Michigan (Ann Arbor, MI). BWTEK (Newark, DE) with offices in Japan, Germany, and China and a strong global sales team and vast experience with medical devices and laser startups, will acquire/incubate Biocrede for accelerated translation Phase II studies after positive Phase I feasibility results. PUBLIC HEALTH RELEVANCE PUBLIC HEALTH RELEVANCE: Catheter-associated urinary tract infections (CAUTI) contribute to 0.5-0.7 million nosocomial hospital infections witha cumulative incidence of 3-6% per day of catheterization (50% at 10 days, gt90% at 28 days, 100% long term) leading to complications and approximately ten thousand reported deaths annually. Current CAUTI prevention techniques such as the use of routine irrigation of the bladder with antimicrobials and silver coated Foley catheters have no significant preventative effects as stated by the Healthcare Infection Control Practices Advisory Committee. We propose a novel and price competitive urinary tract silicone Foley catheter made from a proprietary polymeric formulation to effectively reduce CAUTIs by allowing gt20 days of bactericidal effectiveness via Nitric Oxide release, and allow dry-storing for at least 2 months even at 37 C.