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

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 2R44AI134553-02A1
Agency Tracking Number: R44AI134553
Amount: $3,000,000.00
Phase: Phase II
Program: SBIR
Solicitation Topic Code: NIAID
Solicitation Number: PA18-574
Solicitation Year: 2018
Award Year: 2020
Award Start Date (Proposal Award Date): 2020-02-01
Award End Date (Contract End Date): 2023-01-31
Small Business Information
Mountain View, CA 94040-1252
United States
DUNS: 963236661
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (650) 559-0388
Business Contact
Phone: (415) 305-4134
Research Institution

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.

* Information listed above is at the time of submission. *

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