Organovo (PINK:ONVO) today announced it is developing 3D bioprinted human liver tissue designed for direct transplantation to patients.
The move to human development comes based on “strong results” from preclinical animal model studies, the San Diego, Calif.-based company said. The company expects to pursue a formal preclinical development program.
“We’re excited to introduce an implantable bioprinted liver tissue as the first preclinical candidate in our therapeutic tissue portfolio, and see the early results as extremely promising. The scientific and commercial progress we have already made with ExVive 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,” CEO Keith Murphy said in a press release.
Organovo said it plans to submit an investigational new drug application to the FDA within 3 to 5 years for the new tissue, as well as pursuing a breakthrough therapy designation to accelerate time to market.