Clinical Trial of the FAST Real-Time GFR System

DESCRIPTION (provided by applicant): PharmacoPhotonics (DBA FAST, Inc.) proposes Fast-Track research to determine GFR in its first human Pilot study. The long-term goal of this SBIR project is to test FAST's minimally invasive catheter based fluorescent device in humans and commercialize this device for rapid detection and quantification of glomerular filtration rate (GFR) in patients with acute kidney injury (AKI) and/or chronic kidney disease (CKD). AKI remains a vexing clinical problem resulting in unacceptably high patient mortality, development of CKD and enhanced progression to end stage renal disease. FAST has developed the FAST GFR SystemTM, a minimally invasive technique for direct measurement of GFR. In CKD patients, the estimated GFR (eGFR) methodfor determining baseline GFR and following disease progression and response to therapy has proved to be a disappointment. Having a rapid point of care ability to measure GFR (mGFR) would greatly improve patient stratification, management and evaluation