Therapeutic UV Disinfection System to Prevent Catheter Related Bloodstream Infections (CRBSIs) in Patients with Peripherally Inserted Central Catheters (PICCs)

Abstract
PuraCath’s goal with the Phase II SBIR is to develop an FDA-approved therapeutic system for disinfection of a
needleless connector (NC) for Peripherally Inserted Central Catheters (PICC) that reduces the risk of intraluminal
colonization as a source of catheter-related blood stream infections (CRBSI). More specifically, it utilizes Ultraviolet
(UV) light to eliminate microbes and biofilm (derived from fungi and bacteria) by 99.99% (4 log reduction) to prevent
Catheter Line Associated Bloodstream Infections (CLABSI). In Phase II of this SBIR project, we propose to complete
design and development, and verification and validation for the FireflyTM Therapeutic UV NC Disinfection System. This
system consists of a neutral, positive, or negative displacement, straight valve, UV-transmissive, NC; and a handheld
device with UV LEDs and sensor technology. This therapeutic development testing will be required and used for the
FDA 510(k) submission process and pre-clinical 99.99 percent biofilm reduction data for a 7 day NC use, and
publications in conjunction will help support sales, adoption and distribution of this therapeutic system
in hospitals nationwide. In Phase I, PuraCath Medical performed a series of bench-top tests on prototypes that have
demonstrated proof-of-concept of the Therapeutic UV Disinfection System (FireflyTM) for 4 log (99.99%) disinfection
versus controls with adequate sample sizes of NCs. Here, we complete steps needed for commercialization with three
aims: 1) Design, 2) Development and 3) System integration.
Completion of this project allows for the completion of the majority of the verification and validation of the
Therapeutic Firefly System necessary for ISO13485 and FDA 510(k) Class II submission.