FAST BioMedical, a privately held, late-clinical-stage medical technology company, today announces the completion of an open-label study using its technology in chronic dialysis patients.
The goal of the study was to use FAST BioMedical’s technology to determine total volume removal before and after dialysis treatment by measuring both plasma volume and interstitial volume.
Conducted at the Richard L. Roudebush VA Medical Center in Indianapolis, the study evaluated the safety, tolerability and performance of the FAST Technology in chronic dialysis patients with extremely reduced or no kidney function. Based on how FAST BioMedical’s technology works, this was the best initial patient population to establish clinical Proof-of-Concept.
Despite challenges due to the pandemic, the enrollment was successfully completed on time and all study endpoints were met. Specifically, the study demonstrated the company’s second-generation fluorescence instrument works well, clinical Proof-of-Concept in interstitial volume measurement, and the successful implementation of FAST BioMedical’s technology in the clinical workflow for dialysis patients and dialysis units.
“Objectively measuring volume and changes in volume is a critically important unmet need in clinical medicine,” said Arjun D. Sinha, MD, who served as the primary investigator in this study. “FAST BioMedical’s technology performed well in this study, and we look forward to reporting the results in the coming months.”
The clinical samples collected during this study were analyzed at the Indiana Biosciences Research Institute building in the 16 Tech Innovation District. FAST BioMedical has wet lab space in 16 Tech and was able to analyze the collected samples using their second-generation fluorescence instrument in a qualified lab environment.
“Over the course of 2020 and early 2021, the 16 Tech space has allowed us to concentrate on the further refinement of our instruments by providing a proper laboratory environment to validate and test our devices,” said Dan Meier, VP of product development at FAST BioMedical. “The facility itself has given us access to appropriate FDA-compliant resources in one efficient location.”
Although this was a preliminary Proof-of-Concept study for measuring interstitial volume in dialysis patients, the potential impact of measuring interstitial volume in all patients where volume is being managed is profound. Many clinicians believe measurement of interstitial volume is one of the key critical parameters in these patients.