Organovo Achieves Key Development Milestones for Its Liver Disease and Intestinal Tissue Models
SAN DIEGO, April 16, 2018 (GLOBE NEWSWIRE) -- Organovo Holdings, Inc. (NASDAQ:ONVO) (“Organovo”) today announced that along with its collaborators, it has achieved several breakthrough capabilities for its 3D bioprinted tissues. At last week’s International Liver CongressTM, two posters were presented illustrating the Company’s ability to create functional human liver tissue, produce a spectrum of NASH disease conditions, and then treat that disease successfully with a client’s development stage non-alcoholic steatohepatitis (“NASH”) drug. These posters highlighted the performance of Organovo’s human liver model in the generation of a robust non-alcoholic fatty liver disease (“NAFLD”) and NASH phenotype, including the presence of ‘gold standard’ histopathologic features.
“No other in vitro modeling system allows drug researchers to explore the evolution of NASH and related treatment strategies using histology, the only accepted measurement for efficacy, based on visual confirmation of the cellular disease process under a microscope,” said Taylor J. Crouch, CEO, Organovo. “Industry leaders at the International Liver CongressTM spotlighted the need for measurable ways to explore the efficacy of the approximately 250 NASH drug programs in relevant, translatable human systems. Organovo’s ExVive® tissue modeling capabilities represent a major advancement for drug development. We are particularly excited that we can work with clients to explore their clinical stage drug candidates, allowing them to address the patient specific needs of their drugs.”
Organovo continues to map out a range of relevant conditions for creating NASH, including all components of the disease (fat accumulation, inflammation and fibrosis). In addition to assessing donor-specific susceptibility to NAFLD/NASH conditions, the Company is also systematically testing major reference classes of compounds targeting NASH to inform treatment strategies. Ultimately, Organovo’s “patient-on-a-plate” platform allows researchers to conduct a broad range of high-value profiling studies in a more relevant, rapid and cost-effective manner than traditional cell culture and animal models before committing significant resources to human clinical trials.
Organovo and Merck & Co. (“Merck”) also jointly published a peer-reviewed study describing the Company’s bioprinted human intestinal model, which exhibits compelling architecture, barrier and metabolic functions, while also being able to model key aspects of toxicity and inflammation.
“The gut model is an exciting addition to our portfolio of high-value drug modeling platforms,” said Dr. Sharon Presnell, chief scientific officer, Organovo. “Its performance and features outshine current in vitro systems, and also has the potential to facilitate systems biology approaches for the study of diseases such as NAFLD and NASH, where disease initiation and progression involve significant interplay between the intestine and liver.”
About Organovo Holdings, Inc.
Organovo is developing and commercializing a platform technology to produce and study living tissues that emulate key aspects of human biology and disease for use in drug discovery, clinical development, and therapeutic applications. The Company develops tissue systems through internal research programs and in collaboration with pharmaceutical, academic and other partners. Organovo's living tissues have the potential to transform the drug discovery process, enabling treatments to be developed more effectively and with greater relevance to performance in human trials and commercialization. The Company’s ExViveTM Liver and Kidney Tissues are used in disease modeling for NASH and fibrosis, high-value drug profiling, target and marker discovery/validation, and other drug testing. The Company is also advancing a preclinical program to develop its NovoTissues® liver therapeutic tissues for critical unmet medical needs, including certain life-threatening pediatric diseases. The Company has received orphan designation for its potential treatment of alpha-1-antityrpsin deficiency, its lead indication within the category of inborn errors of metabolism. Organovo is changing the shape of life science research and transforming medical care. Learn more at www.organovo.com.
Any statements contained in this press release that do not describe historical facts constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. Any forward-looking statements contained herein are based on current expectations, but are subject to a number of risks and uncertainties. Forward-looking statements include, but are not limited to, statements regarding the potential for one or more customer’s electing to move toward framework agreements involving annual budgets, revenue commitments, and/or dedicated research plans, the expected costs, timing and operational benefits of the Company’s restructuring plan, the financial impact of the Company’s restructuring plan on its future operating costs and financial results, and statements regarding the potential benefits and therapeutic uses of the Company’s therapeutic liver tissue. The factors that could cause the Company's actual future results to differ materially from current expectations include, but are not limited to, risks and uncertainties relating to the Company's ability to develop, market and sell products and services based on its technology; the expected benefits and efficacy of the Company's products, services and technology; the Company’s ability to successfully complete studies and provide the technical information required to support market acceptance of its products, services and technology, on a timely basis or at all; the Company's business, research, product development, regulatory approval, marketing and distribution plans and strategies, including its use of third party distributors; the Company’s ability to recognize deferred revenue; the final results of the Company's preclinical studies may be different from the Company's studies or interim preclinical data results and may not support further clinical development of its therapeutic tissues; the Company may not successfully complete the required preclinical and clinical trials required to obtain regulatory approval for its therapeutic tissues on a timely basis or at all; and the Company’s ability to meet its fiscal year 2018 outlook. These and other factors are identified and described in more detail in the Company's filings with the SEC, including its Annual Report on Form 10-K filed with the SEC on June 7, 2017. You should not place undue reliance on these forward-looking statements, which speak only as of the date that they were made. These cautionary statements should be considered with any written or oral forward-looking statements that the Company may issue in the future. Except as required by applicable law, including the securities laws of the United States, the Company does not intend to update any of the forward-looking statements to conform these statements to reflect actual results, later events or circumstances or to reflect the occurrence of unanticipated events.
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