FAST BioMedical Invested 2011
FAST BioMedical’s patented clinical stage technology provides accurate and sensitive measurement of true kidney function and plasma volume for use in hospitals, intensive care units, organ transplant units, and clinical trials.
The FAST GFR system™ enables healthcare providers with a sensitive tool to move from delayed estimates of Glomerular Filtration Rate (eGFR) to measured GFR and plasma volume in real-time (mGFR). This will significantly aid clinicians in improving outcomes for millions of patients with acute kidney failure and chronic kidney disease, as well as guide drug and volume therapies for ICU, sepsis and post cardiac surgery patients.
The FDA has determined FAST BioMedical meets the requirements for a rare Expedited Review due to its assessment that this is a potential breakthrough technology addressing a significant unmet clinical need, with the potential for a clinically meaningful advantage over existing technology. This tool is revolutionary in the early detection and treatment of Acute Kidney Injury (AKI), the titration of AKI therapies, as well as the dosing of nephrotoxic drugs. This tool can also enable better stratification and monitoring of clinical trial patients, as well as improve outcomes in kidney transplantation. FAST BioMedical has completed their first in-human trial, and received FDA clearance to initiate a 2nd trial in 2013.
FAST BioMedical’s technology has the potential to satisfy an unmet $1.5 billion need in the initial European and U.S. intensive care market alone.
Investigational product not approved for human use.