FAST BioMedical’s Phase 2 Clinical Trial Results Published in the Prestigious Journal of the American Society of Nephrology
Carmel, IN — May 18, 2018 — FAST BioMedical announced today the recent publication of their Phase 2 clinical trial data on kidney function measurement in the Journal of the American Society of Nephrology. The results were presented in an article entitled “A Novel Method for Rapid Bedside Measurement of GFR”.
The Phase 2 clinical trial assessed the safety and performance of the FAST technology. Performance was determined by comparing the FAST technology’s kidney function measurement (Measured Glomerular Filtration Rate or mGFR) to an iohexol clearance measurement methodology in patients with varying degrees of kidney function. Iohexol is a research methodology for accurate kidney function measurement. Iohexol is not FDA approved and is considered too cumbersome, with results too delayed, to be commercially viable.
The FAST technology demonstrated impressive accuracy via a high correlation to iohexol clearance. The per patient linear correlation to iohexol was greater than 99%. The FAST technology also demonstrated a strong safety profile and excellent repeatability.
“The results in this publication demonstrate that an accurate, safe, and clinically meaningful kidney function measurement is a major step closer to the patient.” said Dr. Bruce Molitoris, FAST BioMedical Medical Director and Co-Founder. “This technology has the potential to move us past the current poor estimations, to a clinically actionable answer for the individual patient.”
“The FAST technology was easy to use and can be comfortably translated to routine hospital protocols. It was well tolerated, and there were no serious adverse events,” said Dr. Dana Rizk, a nephrologist at University of Alabama at Birmingham Hospital, and one of the lead investigators for the trial. “This new technology has the potential to allow physicians to detect early kidney function loss and renal reserve, thus enabling earlier therapeutic interventions. In short, it opens the door to exciting new endeavors in the world of Nephrology.
About FAST BioMedical
FAST BioMedical is a privately held, clinical-stage medical technology company in Carmel, Indiana. The company’s globally-patented, first-in-class technology directly measures blood volume and kidney function in a clinically actionable way. This has the potential for profound impact on care of heart failure, cardio-renal, major surgery, sepsis, critical care, and kidney disease patients. The company has been financially supported by the NIH, Elevate Ventures, the Indiana 21st Century Fund, Rose-Hulman Ventures, BioCrossroads, Indiana University Medical Group, The Purdue Foundry Fund, Ellipsis Ventures, VisionTech Partners, and private single family office investors. The FDA has determined the company’s technology met the requirements for an Expedited Review. These products are investigational and not yet approved for human use.
For more information, please visit www.FASTBioMedical.com