Clinical Trials in a Dish- hiPSC Cardiomyocyte HTS Electrophysiology System for Detecting Drug Induced Fatal Cardiac Arrhythmias

Abstract The goal of this project is to commercialize a novel high throughput cardiotoxicity screening assay based on using human cardiomyocytes. Human cardiomyocytes are obtained from commercial sources of stem cell derived cardiomyocytes, so called hiPSC-CMs. The commercial products to be released by the end of this phase IIb proposal include 1. proprietary extracellular matrix coated cell culture plates (already commercially available - marketed as CELLvo™ Matrix Plus), 2. Cardiotoxicity screening instrument (CARTOX), 3. Optical electrophysiology analysis software to enable HTS data analysis, and 4. Chamber-specific stem cell-derived cardiomyocytes. The FDA and other stakeholders in drug discovery and safety screening are adopting the use of hiPSC-CMs for pre- clinical testing and even for development of clinical trial in a dish approaches. Widespread adoption has been hampered because of limitations surrounding the maturation state of stem cell derived heart muscle and lack of HTS systems for measuring cardiac action potentials. The CARTOX instrumentation and StemBioSys proprietary Matrix Plus products solve these problems and provide further evidence for the adoption of human cell based cardiac assays to replace some animal focused safety screening approaches. The proposed work addresses a large unmet need, both scientifically and commercially.