Abstract

3D-Bioprinted Human Liver Tissue For Chronic Liver Failure and Inborn Errors of Metabolism

Keith Murphy, CEO, Organovo

Organovo has announced 3d bioprinted human liver tissue as the first transplantable tissue in its pipeline.  For patients in need of a liver transplant, no robust alternatives exist today.   Approximately 17,000 patients are on the U.S. liver transplant waiting list this year.  In addition, acute-on-chronic liver failure (“ACLF”), a recognized and distinct disease entity encompassing an acute deterioration of liver function in patients with liver disease, affects 150,000 patients annually in the United States.  Pediatric metabolic liver diseases represent another disease indication where a bioprinted liver tissue patch may show therapeutic benefits.  The combined total addressable market opportunity for treating these patients exceeds $3B. Organovo has performed preclinical studies in animal models showing engraftment, vascularization and sustained functionality of its bioprinted liver tissue, including stable detection of liver-specific proteins and metabolic enzymes.  With strong preclinical data in hand, Organovo is pursuing this compelling opportunity with a formal preclinical development program. Assuming development progresses according to its current expectations, Organovo intends to submit an Investigational New Drug (“IND”) application to the U.S. Food and Drug Administration (“FDA”) for its therapeutic liver tissue in three to five years.  As appropriate, Organovo will pursue breakthrough therapy designation, clinical development outside the United States, and other opportunities to accelerate time to market.