Organovo

Organovo (2)

Organovo is presenting the first data showing survival and sustained functionality of its 3D bioprinted human liver tissue when implanted into animal models. This data is being presented at the TERMIS-Americas Meeting in San Diego.

“With a critical shortage of donor organs and few alternatives to transplantation, Organovo is using its 3D bioprinting technology to develop novel therapeutic tissues for direct surgical implantation,” said Eric Michael David, M.D., J.D., chief strategy officer and executive vice president of preclinical development, Organovo.  “Our preclinical data show rapid vascularization and tissue engraftment, and evidence of function and durability of our 3D bioprinted human liver tissue over several weeks.  Most importantly, we see evidence of stable production of key human liver proteins in the animal bloodstream, and tissue staining for key human metabolic enzymes.  The presence of these enzymes provides an important first step in demonstrating the capability of this tissue to treat inborn errors of metabolism, a key indication we are targeting.”

Organovo implanted its 3D bioprinted human liver tissue patches onto the livers of NOD/SCID mice. The tissue was composed of human hepatocytes and select non-parenchymal cells. Function of the 3D bioprinted human liver tissue patches was seen via detection of human albumin, alpha-1-anti-trypsin and fibrinogen in the circulating blood of the mice as early as seven days and for at least 28 days post-implantation. Histopathologic evaluation of the implanted therapeutic tissue revealed retention of the bioprinted cellular organization through 28 days post-implantation, with robust staining for key human metabolic enzymes associated with inborn errors of metabolism, such as Fumarylacetoacetate Hydrolase (FAH) deficiency and Ornithine Transcarbamylase (OTC) deficiency. The tissues remained intact on the animal liver and were well tolerated by the animals. Taken together, these data support further preclinical development of Organovo’s 3D bioprinted liver tissue for therapeutic use.

Focusing first on acute-on-chronic liver failure and pediatric inborn errors of metabolism, both indications where a bioprinted liver patch may show therapeutic benefits, 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 help accelerate time to market.

Organovo Holdings, Inc. (OTCQX: ONVO) ("Organovo"), a creator and manufacturer of functional, three-dimensional human tissues for medical research and therapeutic applications, is working together with researchers at Autodesk, Inc., the leader in cloud-based design and engineering software, to create the first 3D design software for bioprinting.

The software, which will be used to control Organovo's NovoGen MMX bioprinter, will represent a major step forward in usability and functionality for designing three-dimensional human tissues, and has the potential to open up bioprinting to a broader group of users.

"Autodesk is an excellent partner for Organovo in developing new software for 3D bioprinters," said Keith Murphy, Chairman and Chief Executive Officer at Organovo. "This relationship will lead to advances in bioprinting, including both greater flexibility and throughput internally, and the potential long-term ability for customers to design their own 3D tissues for production by Organovo."

"Bioprinting has the potential to change the world," said Jeff Kowalski, Senior Vice President and Chief Technology Officer at Autodesk. "It's a blend of engineering, biology and 3D printing, which makes it a natural for Autodesk. I think working with Organovo to explore and evolve this emerging field will yield some fascinating and radical advances in medical research."

Organovo's 3D bioprinting technology is used to create living human tissues that are three-dimensional, architecturally correct, and made entirely of living human cells. The resulting structures can function like native human tissues, and represent an opportunity for advancement in medical research, drug discovery and development, and in the future, surgical therapies and transplantation.

The Autodesk Research group is dedicated to innovation and discovery ranging from methods to help users learn powerful digital prototyping tools to visualization and simulation techniques that enable designers to achieve new levels of performance. Advancing the state of the art in human-computer interaction, computer graphics and digital design technology, Autodesk Research collaborates openly with researchers at leading universities around the world. The bio/nano/programmable matter group within Autodesk Research is extending this expertise by developing software for the design and simulation of molecular systems and living systems.

Organovo designs and creates functional, three-dimensional human tissues for medical research and therapeutic applications. The company is working in collaboration with pharmaceutical and academic partners to develop human biological disease models in three dimensions that enable therapeutic drug discovery and development. Organovo's technology can also be applied to create surgical tissues for direct therapy. Their three-dimensional bioprinting technology was selected as one of the "Best Inventions of 2010" by TIME Magazine. Organovo leads the way in solving complex medical research problems and building the future of medicine.

For more information, visit: www.organovo.com/products/novogen-mmx-bioprinter

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