FAST BioMedical (FBM) has conducted 4 human clinical studies including 147 patients in Europe and the United States. All studies met their primary end-points which were targeted at the safety and performance of the FBM Technology across a variety of patients, 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. The trials included healthy volunteers and patients with Heart Failure and Chronic Kidney Disease.
The 2019 Estimating versus Measuring Plasma Volume and Kidney Function in Acute Decompensated Congestive Heart Failure (EMAPKT CHF) clinical study 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, patients had their blood volume and measured GFR determined by FAST BioMedical’s technology 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 clinical study met its primary and secondary end-points. The FBM Technology was shown to be safe and have good performance.
Upon the conclusion of the study, a Data Adjudication Committee (DAC) comprised of Peter McCullough, M.D., Maria Rosa Costanzo, M.D., and Michael Haase, M.D., reviewed each patient’s record and the course of treatment chosen by the treating physician. The DAC then considered whether the measurements of plasma volume, blood volume and measured GFR all determined using FAST BioMedical’s technology would have caused them to change the patient’s course of treatment had this information been available during routine care.
The Data Adjudication Committee determined that FAST BioMedical’s measurements would have changed their approach to diuretic therapy in a vast majority (80%) of patients.
In this video, DAC Chair Peter McCullough speaks to how FAST BioMedical’s measurements of vascular volume and GFR factored into the decisions made by the committee.
The 2017 Phase 2B Study was conducted at the University of Alabama Birmingham and ICON with 32 subjects including healthy volunteers and those with Chronic Kidney Disease (CKD). The study included multiple doses of the FBM markers and a volume challenge which was followed using the FBM Technology. The clinical study met its primary and secondary end-points. The FBM Technology was shown to be safe and have good performance.
Read more about the results of the study below:
FBM’s Phase 2A Study was conducted at the University of Alabama Birmingham in 2015 with 33 healthy volunteers and patients with CKD. This study met its primary and secondary endpoints, and the technology was shown to be safe and perform well.
The pilot study of FBM’s technology took place in Germany in 2012 with 32 healthy subjects. This study met its primary and secondary endpoints, and the technology was shown to be well-tolerated and effective.