San Diego-based Organovo has unveiled plans to develop human liver tissue for transplants in patients with liver diseases, using its 3D printing technology.
The development of the therapeutic tissue program has been announced after its preclinical studies in animal models showed strong results.
The studies were conducted for engraftment, vascularization and sustained functionality of its bioprinted liver tissue, including stable detection of liver-specific proteins and metabolic enzymes.
Initially, Organovo plans to develop clinical solutions for two areas – acute-on-chronic liver failure (ACLF) and pediatric metabolic liver diseases.
The company said that the total addressable market opportunity for the two areas is over $3bn.
It plans to submit an Investigational New Drug (IND) application to the US Food and Drug Administration (FDA) for its therapeutic liver tissue in three to five years, if the program proceeds as per the schedule.
Organovo CEO Keith Murphy will be present bioprinted human liver as the company’s first therapeutic tissue to be advanced in its portfolio at the 2016 Cell & Gene Meeting on the Mesa in La Jolla, California.
Murphy said: “The scientific and commercial progress we have already made with ExViveTM Human Liver Tissue in drug toxicity testing has given us a firm foundation upon which to build a larger tissue for transplant.
“Advancing our first therapeutic tissue into preclinical development is an important milestone for Organovo, and it speaks to the power of our technology platform in addressing multiple applications, including preclinical safety, disease modeling and tissue replacement products for surgical implantation.
“We believe that 3D bioprinted tissues have an opportunity to provide options for patients who suffer from liver disorders.”
Besides, it expects to provide more detailed preclinical results at upcoming scientific conferences.
Image: View of the various organs and blood-vessels in proximity with liver. Photo courtesy of Dr. Johannes Sobotta/Wikipedia.