Organovo and Samsara Sciences Partner with New Manufacturing USA Institute
The Advanced Regenerative Manufacturing Institute (ARMI) will receive nearly $300 million in public-private investment from leading manufacturers, universities, nonprofit organizations and the federal government to develop scalable manufacturing processes for engineered tissues and organs
SAN DIEGO, May 03, 2018 (GLOBE NEWSWIRE) — Organovo Holdings, Inc. (NASDAQ:ONVO) (“Organovo”) today announced it has joined a new public-private Manufacturing USA initiative, the Advanced Regenerative Manufacturing Institute (“ARMI”). Headquartered in Manchester, New Hampshire, ARMI is the 12th Manufacturing USA Institute. ARMI brings together a consortium of nearly 100 partner organizations from industry, government, academia and the non-profit sector to develop next-generation manufacturing processes and technologies for cells, tissues and organs.
Approximately $80 million from the federal government will be combined with more than $200 million in cost share to support the development of tissue and organ manufacturing capabilities. As part of continuing efforts to help revitalize American manufacturing and incentivize companies to invest in new technology development in the United States, ARMI will lead BiofabUSA on behalf of the Department of Defense.
Under the umbrella of Manufacturing USA, a public-private network that invests in the development of world-leading manufacturing technologies, ARMI will work to integrate and organize the fragmented collection of industry practices and domestic capabilities in tissue Biofabrication technology to better position the US relative to global competition. ARMI will also focus on accelerating regenerative tissue research and creating state-of-the-art manufacturing innovations in biomaterial and cell processing for critical Department of Defense and civilian needs.
“We need to develop 21st century tools for engineered tissue manufacturing that will allow these innovations to be widely available,” said inventor Dean Kamen, ARMI’s chairman.
“By joining ARMI|BiofabUSA, we connect with a valuable network of resources focused on the development of standards and robust production methods that are critical to the long-term success of creating cell-based products,” said Dr. Sharon Presnell, president, Samsara Sciences and chief scientific officer, Organovo. “Samsara is a leading provider of highly specialized human liver cells, and we are committed to the development of industry-wide standards based on a clear understanding of customer requirements across a spectrum of applications. The ARMI|BiofabUSA network provides deep expertise to accelerate this mission and improve the consistency and performance of cell-based products.”
Presnell continued, “Organovo’s mission to deliver game-changing regenerative medicine products and in vitro liver models depends not only on a supply of well-qualified cellular raw materials, but also on our ability to further streamline and automate tissue production processes such as bioprinting and post-fabrication conditioning. By joining the ARMI|BiofabUSA group, we have the opportunity to learn from other innovators, to share what we have learned, and develop partnerships that bring ground-breaking products to the market.”
ARMI’s efforts are supported by forty-seven industrial partners, twenty-six academic and academically affiliated partners, and fourteen government and nonprofit partners. The ARMI partnership continues to grow.
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 ExVive™ 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-antitrypsin 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.
About Samsara Sciences, Inc.
Samsara Sciences, Inc. is a wholly-owned subsidiary of Organovo Holdings, Inc. and is a provider of primary human liver cells for use in research and development. Samsara has a worldwide customer base through its direct sales and distribution relationships, and is a major supplier of the human liver and kidney cells used by Organovo in the production of its bioprinted tissues (ExVive™ and NovoTissues™).
The Advanced Regenerative Manufacturing Institute (ARMI), headquartered in Manchester, NH, is the 12th Manufacturing USA Institute. It brings together a consortium of nearly 100 partners from across industry, government, academia and the non-profit sector to develop next-generation manufacturing processes and technologies for cells, tissues and organs. ARMI will work to organize the current fragmented domestic capabilities in tissue Biofabrication technology to better position the U.S. relative to global competition. For more information on ARMI, please visit www.ARMIUSA.org.
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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