Changing the Shape of Medical Research and Practice: Organovo

Organovo designs and creates functional, three-dimensional human tissues for use in medical research and therapeutic applications. The Company develops 3D human tissue models through internal development and in collaboration with pharmaceutical, academic, and other partners. Organovo's 3D human tissues have the potential to accelerate the drug discovery process, enabling treatments to be developed faster and at a lower cost. The Company’s ExVive Human Liver and Kidney Tissues are used in toxicology and another preclinical drug testing. The Company also actively conducts early research on specific tissues for therapeutic use in direct surgical applications.

Words from the Chief:

“We’re changing the shape of life science research and transforming medical care. Our goal is to address the gaps that exist in pharmaceutical discovery and significantly impact the cost, predictability, and speed of drug development. We provide superior predictive solutions that recreate 3D native tissue architecture, which allows our customers to de-risk their drug discovery programs by enabling decisions points further upstream. We also have the potential to revolutionize therapeutic applications by creating tissue replacement products for surgical implantation, addressing the dramatic supply issues that are a constant challenge in transplant medicine.”

The Science & Technology at Organovo

Significant science and discovery are required to develop a tissue therapy, ensure safety and efficacy through controlled clinical trials, and gain regulatory clearance as a medical device. Supplemental tissue therapies that could come in forms of tubes, patches, or organoids are a developmental possibility today.

Organovo’s proprietary bioprinting platform captures the unique synergistic potential of engineering and biology to enable the reproducible, automated creation of living human tissues that mimic the form and function of native tissues in the body. Genomics and proteomics have revolutionized research through the creation of highly reproducible tools for studying the genome and proteome.

Organovo’s ExVive™ 3D Bioprinted Human Tissues are developed for use in Organomics™, the study of living organs in vitro. Organovo’s 3D bioprinted human tissues are constructed with precision from tiny building blocks made of living human cells, using a process that translates tissue-specific geometries and cellular components utilizing the NovoGen Bioprinter^® Platform. These bioprinted tissues share many key features with native tissue, including tissue-like cellular density, the presence of multiple cell types, and the development of key architectural and functional features associated with the target native tissue.

Organovo Tissues and Services

ExVive 3D Bioprinted Human Tissue Models

Organovo’s Bioprinted Human Tissue Models are multi-cellular, dynamic, and functional 3D human tissue models for preclinical testing and drug discovery research. Created using proprietary 3D bioprinting process, the tissues remain viable and dynamic for an extended time in vitro and exhibit key architectural and functional features that mimic key aspects of the natural 3D tissue environment. Biochemical, genomic, proteomic and unique histologic endpoints can be assessed over time.

ExVive™ 3D Bioprinted Human Tissues enable the capture of human tissue-specific data to support better predictive outcomes, de-risking total development time and resources.

• Functional, 3D human tissues for preclinical testing and drug discovery research.
• Complex, multi-cellular 3D human tissues that mimic native tissue biology.
• Obtain human tissue data to support better predictive outcomes.
• Assess biochemical, genomic, proteomic, and unique histologic endpoints.
• De-risk total development costs by capturing failures earlier.

ExVive 3D Bioprinted Human Tissue Models fill several unmet needs across the drug discovery and development spectrum, enabling a more efficient evaluation of drug compounds compared to traditional in vitro and in vivo animal studies.

Worthwhile Partnerships

Organovo works with industry partners to create tissues for both in vitro and therapeutic uses. The need for in vitro tissues stems from the need for more predictive preclinical models, as evidenced by the increasing rate of late-stage clinical trial failures for both toxicity and efficacy (ten high-profile late-stage failures in 2012 alone). The company work together with its partners to understand their needs and develop custom tissues for drug discovery, preclinical disease modeling, and ADME-Tox. These tissues can be supplied in multi-well plates or other formats, allowing researchers access to fully human, architecturally correct, functional 3D tissues—a revolutionary opportunity to test drugs on functional human tissues before entering clinical trials.

Scaffold-Free and Architecturally Correct

The company’s 3D tissue models are constructed of nothing but human cells and the extracellular matrix those cells secrete. Its thick tissues are densely cellular, with a micro-architecture that closely resembles in vivo tissues.

Biologically Relevant

The 3D tissues look and feels like living human tissue, and they can be used to elicit a response that’s representative of in vivo biology in an in vitro environment. They can be handled like real tissues—for example, researchers can perform serial biopsies on the same tissue, allowing them to measure how the tissue changes over time.

Any Tissue Type. Any Disease

Organovo can construct 3D tissue models using nearly any tissue type, for nearly any disease. I can start with a wide variety of cellular inputs, including patient samples, which is critical for rare disease modeling and genetic diseases. Tissue can be delivered in a variety of different formats, such as multiwell plates or larger blocks or slices of tissue, depending on need.

Howdy Chief!

Taylor J. Crouch, Chief Executive Officer, and President: Mr. Crouch has over 25 years of experience building and leading technology, expertise and product-based companies in the life sciences and biotech industries.For more than seven years, he has 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.Prior to this, Mr. Crouch served as Senior Vice President of Operations/President International at Ligand Pharmaceuticals from 2005 to 2007. Prior to Ligand, he was President and Chief Operating Officer of Discovery Partners International.Earlier in his career, he was Chief Executive Officer of Variagenics, Senior Vice President of Marketing and Sales at Parexel and he also held international management positions in new product development and commercialization at Pfizer and Schering Plough.

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.