Brighton Development — Department of Health and Human Services SBIR Phase II: 400

Description

The goal of this Phase II effort is bring to market a unique antimicrobial catheter to reduce the instances of the most prevalent healthcare associated infection Catheter Associated Urinary Tract Infection CAUTI This research and development effort will be to develop a urinary catheter with inherent long lasting antiseptic properties to protect the patient and prevent infection We have begun the discussions with the FDA and have a clear path of the requirements to complete the regulatory approval process The proposed device is a new approach to antimicrobial catheters It will use common Foley catheter designs and materials with the addition of an additive to the elastomer to render the catheter antimicrobial The additive replaces the silica reinforcing filler in the elastomer and is designed to give a long lasting time release of antibacterial agent to the catheter surface The catheter can be manufactured inexpensively with standard medical tubing manufacturing processes and materials but will have the value added property of antimicrobial activity A durable and effective antimicrobial catheter that can prevent or reduce CAUTI will save millions of dollars in healthcare cost and thousands of lives annually A top priority of the Health and Human Services and the National Institutes of Health is the elimination of Healthcare Associated Infections HAI Catheter associated urinary tract infection CAUTI the most prevalent HAI is the source of over of all HAI s There are approximately cases of CAUTI resulting an estimated deaths annually in the US The resulting increased hospital stay and increased antibiotic use results in an annual cost of over billion dollars to US healthcare