Organovo Holdings, Inc., (NASDAQ: ONVO) is a biotech platform company that has developed a leadership position with its revolutionary ability to 3D bioprint tissues with human functionality. The Company is pursuing multiple IND-track programs to develop its NovoTissues® to address a number of serious unmet medical needs in adult and pediatric populations, initially focusing on liver disease. Organovo’s first IND-track program for Alpha-1-antitrypsin deficiency recently received orphan drug designation from the FDA, and the Company expects to file its first IND in 2020. In order to help fund its plan to initiate multiple IND-track programs, the Company is providing access to its ExVive™ in vitro tissue disease modeling platform to facilitate high value drug discovery and development collaborations. Organovo’s wholly-owned subsidiary, Samsara Sciences, provides the Company and its clients with high quality human liver and kidney cells for research applications. Organovo is changing the shape of life science research and transforming medical care.

Organovo has been a pioneer in the development of 3-D bioprinted tissues comprised of human cells. After Organovo concluded that it had not generated decisive scientific data supporting the prolonged functionality and therapeutic benefit of its lead therapeutic liver tissue candidate, Organovo implemented a restructuring plan to significantly reduce expenses in order to focus on evaluating strategic alternatives, while retaining certain key management, IP, licenses, collaborations, and proprietary equipment.

 

Technology Platform:

 

3D Bioprinted Human Tissue

3D bioprinting is the automated fabrication of multicellular tissue via spatially defined deposition of

cells. The ability to spatially control deposition in the x, y and z axes allows for creation of tissue-specific patterns or compartments, with in vivo-like architecture that mimics key aspects of native biology. 3D bioprinted tissues exhibit a microenvironment more suited to in vivo-like cellular function in comparison to traditional 2D monoculture (or monolayer co-cultures), as well as maintenance of a more defined architecture than is observed in self-aggregated co-culture models. 3D bioprinted tissues exhibit tissue-like density with highly organized cellular features, such as intercellular tight junctions and microvascular networks. The ability to create architectural compartments, with different cell types placed in discrete locations relative to each other, results in a microenvironment with cell-cell interactions similar to that of native tissues. This in turn results in proper expression and localization of key cellular functions – such as key metabolic enzymes and key transporters – over several weeks in culture. The responses of 3D bioprinted tissues to acute or chronic exposure of drugs and known toxins resemble what is observed in vivo and in the clinic.

 

Bioprinting Process 

Our bioprinting process starts with the identification of key architectural and compositional elements of a target tissue, and the creation of a design that can be utilized by a bioprinter to generate that tissue in the laboratory environment. The next step is to develop the bioprocess protocols required to generate the multi-cellular building blocks – also called bio-ink – from the cells that will be used to build the target tissue. While the bioprinting process is cell-agnostic, most of our bioprinted tissues utilize primary human cells in order to produce the in vivo-like physiology most relevant for drug testing and therapeutic applications. We source many of our input cells through our subsidiary, Samsara Sciences.

The bio-ink building blocks are then dispensed from a bioprinter, using a layer-by-layer approach that is scaled for the target output. Proprietary biogels may be incorporated for temporary support or as filler to create channels or void spaces within tissues to mimic features of native tissue. The bioprinting process can be tailored to produce tissues in a variety of formats, including micro-scale tissues contained in standard multi-well tissue culture plates.

Our bioprinter technology has been used to create a spectrum of tissues: liver, kidney, intestine, skin, vascular, bone, skeletal muscle, eye, breast and pancreatic tumor.

Meet the dynamic CEO, Taylor J. Crouch

Mr. Crouch has been our CEO and President since 2017 and has over 25 years of experience building and leading technology, expertise and product-based companies in the life sciences and biotech industries. Prior to Organovo, he managed and served as an operational investor in a group of leading clinical research site companies. Specifically, Mr. Crouch served as Chief Executive Officer at eStudySite, a position he held from January 2009 to June 2016; as Executive Chairman of Meridien Research from December 2013 to September 2016; and as a Director of the National Research Institute from September 2011 through July 2016. He was instrumental in building these three sister companies, and helping them to achieve significant and profitable growth and to become recognized leaders in their respective fields of infectious disease, CNS disorders and metabolic disease. Prior to this, Mr. Crouch served as Senior Vice President of Operations/President International at Ligand Pharmaceuticals (NASDAQ: LGND) from 2005 to 2007, with responsibilities for new business development, technical operations, international sales and clinical research. Prior to Ligand, he was President and Chief Operating Officer of Discovery Partners International (NASDAQ: formerly DPII – a large drug discovery services and technology provider). Earlier in his career, he was Chief Executive Officer of Variagenics (NASDAQ: formerly VGNX – a leading pharmacogenomics company), Senior Vice President of Marketing and Sales at Parexel (NASDAQ: formerly PRXL) – a global CRO, and he also held international management positions in new product development and commercialization at Pfizer and Schering Plough. Mr. Crouch serves on the Board of Directors of BIOCOM, an organization comprising 1,100 life sciences companies throughout California. Mr. Crouch holds a BSE in chemical engineering, cum laude, from Princeton University and an MBA in international marketing and finance from the University of Chicago.