Biotech firm to develop 3D bioprinted liver tissue for direct transplantation to patients

Organovo is announcing its program to develop 3D bioprinted human liver tissue based on the achievement of strong results in preclinical studies that used animal models. These demonstrated engraftment, vascularisation and sustained functionality of bioprinted liver tissue, including stable detection of liver-specific proteins and metabolic enzymes. The company expects to pursue this opportunity with a formal preclinical development program.
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, but only 6,000 liver transplants are performed each year.
Organovo plans to develop clinical solutions in two initial areas. First, acute-on-chronic liver failure (ACLF) is a recognised and distinct orphan disease entity encompassing an acute deterioration of liver function in patients with liver disease, which affects 150,000 patients annually in the United States. Second, paediatric metabolic liver diseases are another orphan disease indication where a bioprinted liver tissue patch may show therapeutic benefits.
The total addressable market opportunity for these initial indication areas exceeds $3 billion. Assuming development progresses according to its plan, Organovo intends to submit an Investigational New Drug application to the U.S. Food and Drug Administration (FDA) for its therapeutic liver tissue in three to five years. Organovo will seek breakthrough therapy designation, clinical development outside the United States, and other opportunities to help accelerate time to market. The company will also present more detailed preclinical results at upcoming scientific conferences.