Catheter Associated Urinary Tract Infections, CAUTIs, comprising >40% of all institutionally acquired infections is a huge and silent reservoir of multi drug resistant organisms, delay patient recovery, and increase healthcare costs. (800-3000/episode). Over 80-100 million Foley catheters are used world wide per year. About 2/3rds of the microorganisms causing CAUTI gain access to the bladder extraluminally (via the external surface of the catheter), and about 1/3rd of the infections occur intraluminally from the collection bag.Under a phase II, we developed and conducted a pilot clinical trial on an antiseptic device (Foley GuardTM) that was placed between the bag and a commercial antimicrobial silver hydrogel infection control Foley catheter to study its effect on intraluminal infections. The results showed about a 50% reduction of the intraluminal infection, however the overall CAUTI was not significantly reduced due to the extraluminal route provided by the commercial catheter. Recognizing this need, we have developed our own coated Foley catheter based on our patented formulations, that is very superior the current commercial antimicrobial Foley catheters in the market today. The highly enhanced in vitro performance is related to the unique silver chemistry and its sustained delivery in biological fluids which is lacking in the current commercial coatings; safe lubricants, biofilm disruptors and antifungals in our formulation provide additional defenses. The prototypes have passed the basic biocompatibility tests. The coatings contain the same antimicrobial components as the extruded Foley Guard device. We present a plan for the continued development of a combined product (TIC :Total Infection Control - coated Foley catheter connected to the bag accessory developed in Phase II). An optimistic projection is made based on the favorable meta analysis for silver based products and our comparative data. The phase II continuation project will pilot manufacture the TIC system with well qualified OEM medical device manufacturing partners, collect data for FDA submission such as elution profiles, biofilm resistance and biocompatibility according to FDA guidance document, conduct clinical trials, demonstrate the clinical efficacy and aggressively commercialize this product using a business model that will bring this product quickly to the market.

Agency
National Institute of Health (NIH)
Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type
Small Business Innovation Research Grants (SBIR) - Phase II (R44)
Project #
5R44DK055891-06
Application #
7494115
Study Section
Special Emphasis Panel (ZRG1-RUS-D (12))
Program Officer
Mullins, Christopher V
Project Start
1999-05-01
Project End
2013-02-28
Budget Start
2008-09-01
Budget End
2013-02-28
Support Year
6
Fiscal Year
2008
Total Cost
$662,097
Indirect Cost
Name
Innovative Chemical/Environmental Tech
Department
Type
DUNS #
781335112
City
Norwood
State
MA
Country
United States
Zip Code
02062