SAN DIEGO , Jan. 29, 2014 /PRNewswire/ -- Organovo Holdings, Inc. (NYSE MKT: ONVO) ("Organovo"), a three-dimensional biology company focused on delivering breakthrough 3D bioprinting technology, today announced that it has performed its first 3D Liver tissue delivery.
The achievement marks the delivery of Organovo's 3D Liver tissue to a laboratory outside of the company to a key opinion leader (KOL) for experimentation, and marks the achievement of a milestone along the pathway to commercial launch of its 3D liver tissue product. Organovo achieved the milestone ahead of its April 2014 target date. Key opinion leaders are generally experts, in this case top research scientists, in a particular field whose opinions and publications will influence practice. Organovo expects KOLs to make recommendations on improvements to the tissue before launch and to influence peers through their reporting of their research results at conferences and through peer reviewed publications.
"This is an important milestone for Organovo R&D," said Organovo Chief Technology Officer and Executive Vice President of Research and Development Dr. Sharon Presnell. "In developing these tissues, we have gone through a careful set of research studies involving many individual tissues, and greatly increased our ability to produce them. By the end of January, we expect to have bioprinted nearly four hundred 3D Liver tissues during the month."
Organovo also introduced updated guidance on the timing of its product launch. Organovo had planned to launch its 3D Liver tissue product by the end of December 2014. It now expects to commence the commercial launch and start generating revenue through a services model prior to December 2014. "As pharmaceutical and biotechnology companies move to continue to outsource their R&D efforts," explained Keith Murphy, Organovo's chief executive officer, "our ability to deliver a service offering in addition to products will be critical to meet their needs and to enter the $7B preclinical research services market." The company anticipates that preclinical toxicology testing services can command prices in the high tens of thousands of dollars per compound for standard screening for liver alone.Organovo's 3D Liver tissues exhibit several key features that remain stable over time:
- Tissue-like cellular density;
- Multi-layered architecture with multiple cell types positioned relative to one another, reaching up to 500 microns thickness, with tissues comprised of up to 20 cell layers;
- Albumin production 5-9 times greater than matched 2D controls, suggesting superior functionality;
- Stable albumin production for over 40 days, fibrinogen and transferrin production, and inducible cytochrome P450 enzymatic activities, including CYP 1A2 and CYP 3A4;
- Cholesterol biosynthesis, which has been demonstrated for the first time in a multi-cellular 3D human liver system in vitro;
- Evidence of the formation of tight junctions in the liver tissues, demonstrated by cadherin and claudin staining by day 3 of tissue formation; and
- Demonstration of appropriate response to hepatotoxic insults from acetaminophen, acetaminophen in combination with ethanol, and diclofenac.
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