CardioSafe 3D™ is a novel biological assay system that uses mature human heart cells derived from hPSCs to screen for heart toxicity in connection with our drug rescue activities. We believe CardioSafe 3D™ is stable, reproducible and capable of generating data to allow more accurate in vitro prediction of the in vivo cardiac effects, both toxic and nontoxic, of promising new drug candidates long before they are tested in humans.
Our internal validation studies included FDA-approved drugs and an experimental research compound widely accepted for studying cardiac electrophysiological effects. The studies were designed to test the ability of CardioSafe 3D™ to generate data to allow our scientists to predict the in vivo cardiac effects, toxic and non-toxic, of new drug candidates.
We believe the results of our internal validation studies indicate that CardioSafe 3D™ may be effective at identifying safer drug rescue variants with reduced heart safety concerns, which can be missed in animal models or in vitro cell culture testing currently used by biotechnology and pharmaceutical companies.