Publication profiles results from the Estimating versus Measuring Plasma Volume and Kidney Function in Acute Decompensated Congestive Heart Failure (EMPAKT CHF) clinical study.
INDIANAPOLIS (April 28, 2021) — FAST BioMedical (FAST), a privately held late clinical-stage medical technology company, today announces the publication of results from a recent heart failure study demonstrating the utility of its technology in the European Society of Cardiology (ESC) Heart Failure Journal. The published data suggests that current standards of care are inadequate for assessing both kidney function and changes in kidney function in hospitalized patients with acute decompensated heart failure.
The Estimating versus Measuring Plasma Volume and Kidney Function in Acute Decompensated Congestive Heart Failure (EMPAKT CHF) clinical trial was a 50-patient observational study conducted in Germany at Charité Universitätsmedizin Berlin and Kerckhoff Klinik in Bad Nauheim. During the course of the study, FAST BioMedical’s technology was applied to measure patients’ Plasma Volume and kidney function based on glomerular filtration rate (GFR) at two points during the course of hospitalization for decompensated heart failure. The treating physicians were not given these measurements during the course of care. The objective for the study was to evaluate how measured Plasma Volume and GFR compared with current clinical standards in the evaluation of volume status and kidney function. The ESC Heart Failure publication reports that estimates of GFR using current standards of care are imprecise when compared to measured GFR.
“Knowing about kidney function and its changes over time is critical for clinical decision making in patients with acute heart failure,” said Principal Investigator and report author Prof. Kai Schmidt-Ott of the Department of Nephrology and Medical Intensive Care at Charité Universitätsmedizin, Berlin. “Currently, the serum markers creatinine and cystatin C are the only clinically used tools to estimate changes of GFR in heart failure patients. Our study showed that these standard diagnostics provided only rough estimates of GFR and frequently missed true worsening of GFR. FAST BioMedical’s technology offers the unique ability to directly measure GFR. In certain clinical situations, including heart failure, this may be a very useful option to rapidly and accurately assess kidney function and its changes.”
FAST BioMedical has conducted five human clinical studies including 157 patients in Europe and the United States. All studies have achieved their primary end-points which were targeted at the safety and performance of the FAST Technology across a variety of function levels and disease states. The trials have generated data demonstrating a favorable safety profile, as well as the ability to determine volume status and kidney function in the populations studied.
FAST‘s first-in-class technology aims to revolutionize treatment for heart failure patients by providing rapid, accurate, quantitative and simultaneous measurements of intravascular volume and measured glomerular filtration rate in clinically meaningful timeframes.
# # #
About FAST BioMedical
FAST BioMedical is a privately held company based in Indianapolis developing late clinical-stage medical technologies. The company’s globally patented technology is designed to be the first to directly measure volume status and kidney function in a clinically actionable way. This technology has the potential for significant impact on the treatment of patients with heart failure, cardio-renal syndrome, major surgery, sepsis, and acute kidney injury. These products are investigational and not yet approved for human use. Learn more at www.FASTBioMedical.com.