VistaGen's stem cell technology platform is based on proprietary and licensed technologies for controlling the differentiation of human pluripotent stem cells (hPSCs) and producing the multiple types of mature, non-transformed, functional, adult human cells that we use, or plan to use, to reproduce complex human biology and disease and assess, in-vitro, the potential therapeutic benefits and safety risks of new chemical entities (NCEs).
We use our hPSC-derived cardiomyocytes (human heart cells) in CardioSafe 3D™, our novel, customized in-vitro bioassay system for predicting potential cardiotoxicity of drug rescue NCEs. We believe CardioSafe 3D is more comprehensive and clinically predictive than the hERG assay, currently the only in-vitro cardiac safety assay required by FDA guidelines, and that CardioSafe 3D offers a new paradigm for evaluating and predicting potential heart toxicity of drug rescue NCEs early in development, long before costly, high-risk human clinical trials.
Stem cell technology-based regenerative medicine (RM) has the potential to transform healthcare worldwide over the next decade by providing new approaches for treating fundamental mechanisms of disease. We are leveraging our stem cell technology platform and customized human cell assays to discover and rescue small molecule drugs with regenerative and therapeutic potential for CNS and other diseases. In addition, we are focused on collaborating with others to develop and commercialize potential regenerative medicine and cell therapy applications of our stem cell technology involving blood, bone, cartilage, heart and liver cells. In December 2016, we entered into an exclusive sublicense agreement with BlueRock Therapeutics L.P, a next generation regenerative medicine company established by Bayer AG and Versant Ventures, for our rights to proprietary technologies relating to the production of cardiac stem cells for the treatment of heart disease. We received an upfront payment of $1.25 million, with potential additional milestone payments and royalties in the future.