Organovo and Samsara Sciences Partner with New Manufacturing USA Institute
May 03 2018 - 8:05AM
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 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-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™).
About ARMIThe 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.
Forward-Looking Statements 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.
Investor & Press Contact:
Steve Kunszabo
Organovo Holdings, Inc.
+1 (858) 224-1092
skunszabo@organovo.com
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