Technology

Timely, Precise and Convenient

FAST BioMedical (FBM) is developing first-in-class technology that has the potential to revolutionize treatment of heart failure patients.

FBM’s technology is the first of its kind with the potential to enable titration of decongestion therapy for heart failure patients by direct and repeated measurement of volume status. Currently, there is no clinically viable way to directly and repeatedly monitor volume status quickly and easily. Additionally, there is no current technology that simultaneously measures PV and GFR which enables a physician to monitor both volume status and kidney function. FBM’s Technology is designed to be timely, easy, fit into a standard physician’s workflow and work with patients that have dynamically changing PV. The FBM Technology does not use radioactive markers, is not overly cumbersome or expensive, and allows for quick repeat PV measurements.

Because FBM’s Technology allows for repeat PV measurements it has the potential to aid in diuretic therapy titration while also protecting against renal dysfunction by simultaneously measuring renal function.

Treating decompensated heart failure patients is very challenging, and current standards of care often do not provide accurate or timely information to clinicians regarding a patient’s volume status or changes in renal function. Having access to a technology that would allow accurate measurement of both blood volume and GFR in heart failure patients could be a tremendous step forward for patient assessment and determining the correct approach to applying therapies.

Professor Stefan Anker, Head of Field “Tissue Homeostasis and Cachexia,” Charité University, Berlin, Germany

How It Works

FAST BioMedical’s Technology measures the concentration of 2 proprietary fluorescent markers over time. A small (3 mL) bolus IV injection of the markers is given to the patient. One of the markers is retained in the vascular space and is used to determine volume status. One of the markers is freely filtered by the glomerulus and is used to determine renal clearance.

This single dose of markers can produce as many plasma volume measurements as needed within a 6-hour time frame, including an initial plasma volume in approximately 30-45 minutes after the injection. The concentration of the markers is determined in each blood sample and proprietary algorithms are used to calculate PV and mGFR.

Highlights:

Timely

  • Volume status can be determined in approximately 30-45 minutes
  • mGFR can be determined in approximately 195-210 minutes
  • Allows for immediate clinical action

Precise

  • Coefficient of variation (R-squared) of >0.99 when FBM’s GFR was compared to iohexol GFR in a human clinical study

Convenient

  • Simple routine blood draws for analysis
  • No need for urine samples
  • No radioactive material

Lab results

INVESTIGATIONAL PRODUCT NOT APPROVED FOR HUMAN USE