Indianapolis, Indiana –
FAST BioMedical, a developer of medical testing technologies, announced today that the Food and Drug Administration has granted the company an expedited review of its technology for the rapid assessment of kidney function.
The company, which is a 2008 recipient of a $2 million grant from the state’s 21st Century Research and Technology Fund, is currently using the state funding and additional funding from the National Institutes of Health to prepare its early detection technology for further FDA review.
“Today’s announcement is another step forward for an Indiana company that is developing potentially life-saving technology,” said Mitch Roob, Secretary of Commerce and chief executive officer of the Indiana Economic Development Corporation. “The notice of an expedited review shows that the FDA has confidence in FAST’s technology and that this company is right in line with the mission of the 21st Century Fund.”
FAST BioMedical’s technology measures the body’s kidney function, known as glomerular filtration rate, or GFR, by monitoring inert markers that have been injected into a patient’s bloodstream. A fiber optic device inserted into a vein through a catheter tracks the markers, measuring how effectively the body filters waste giving an accurate filtration rate reading in only 40 minutes. There is currently not available any way to accurately and quickly measure GFR. Current estimates, which are not useful in Acute Kidney Injury, have accuracy limitations, and can take up to 24 hours for a reading.
FDA requirements for medical devices seeking an expedited review require that devices must treat or diagnose a life threatening or debilitating disease; and address an unmet medical need. The expedited status will allow FAST BioMedical’s documents and study results to receive priority during the approval process.
“Our team is thrilled with the Expedited Review status granted by the FDA”. Said Joe Muldoon, CEO of FAST. “It was especially gratifying that the FDA determined we had demonstrated that this is “Breakthrough Technology” that may provide a clinically meaningful advantage. This will help accelerate our pursuit of human trial data, and eventual market launch.”
Originally developed by researchers at the Indiana University School of Medicine, FAST BioMedical is partnering with Purdue University to assist in pre-clinical trials, and the Rose Hulman Institute of Technology for continued development of the device. A pilot human trial of the technology could begin as early as 2010, with full commercialization anticipated by 2012.
"Expedited marketing applications are placed at the beginning of FDA's review queue, and may receive additional FDA review resources" said Suzanne O'Shea, former FDA Officer and current Counsel in Baker & Daniels' FDA practice group. "Expedited applications have shorter review time goals."
FAST BioMedical is one of 71 businesses awarded a 21st Century Fund grant since January 2006. During that time, the fund has invested more than $100 million in high-tech Indiana entrepreneurial companies that collectively have the potential to create thousands of new jobs.
FAST BioMedical’s patent-pending device and in vivo methodology provide rapid and accurate measurement of true kidney function for use in hospitals, intensive care units, cardiac catheterization labs, and physician offices. This technology enables healthcare providers to improve outcomes for 3.5 million patients with acute kidney injury annually and the 20 million Americans suffering from chronic kidney disease.
Created by Governor Mitch Daniels in 2005 to replace the former Department of Commerce, the Indiana Economic Development Corporation is governed by a 12-member board chaired by Governor Daniels. Indiana Secretary of Commerce Mitch Roob serves as the chief executive officer of the IEDC. For more information about IEDC, visit www.iedc.in.gov.
Joe Muldoon (FAST BioMedical) email@example.com
Blair West (IEDC) – 317.232.8873 or BWest@iedc.in.gov
Related Topics: Acute Kidney Injury (AKI), Acute Renal Failure (ARF), Fluid Management, Kidney Disease (CKD), Kidney Function, Kidney Function Tests, FAST BioMedical Press Release, Food and Drug Administration (FDA), Indiana Economic Development Corporation (IEDC)