CardioCreate, Inc. is a late-stage preclinical company developing an autologus genetically-enhanced adult cardiac stem cell therapy that will be the first single-dose cure for heart failure. Unlike other attempts at cell therapy for heart failure, our product engraphs, commits and divides asymetrically to produce functional cardiac tissue that remains in the heart producing a sustained 2-fold increase in cardiac function (ejection fraction). Our autologus cell therapy business model is comparable to the successful single-dose CAR-T cell therapy cure for certain cancers. We plan to complete IND-enabling studies and file an IND in 2018. We plan to conduct the first-in-man clinical trail (Phase IIA in patients) using funds from the Series A round currently underway. We anticipate breakthrough therapy designation from the FDA based on the anticipated positive results from this study. A planned Series B round will fund a subsequent registration trial, BLA filing and approval in the mid-2020s.
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