Organovo Presents First Preclinical Data on 3D Bioprinted Human Liver Tissues at TERMIS-Americas Meeting
December 13 2016 - 8:05AM
Organovo Holdings, Inc. (NASDAQ:ONVO) (“Organovo”), a
three-dimensional biology company focused on delivering scientific
and medical breakthroughs using its 3D bioprinting technology, is
presenting the first data showing survival and sustained
functionality of its 3D bioprinted human liver tissue when
implanted into animal models. This data is being presented at
the TERMIS-Americas Meeting in San Diego.
“With a critical shortage of donor organs and few alternatives
to transplantation, Organovo is using its 3D bioprinting technology
to develop novel therapeutic tissues for direct surgical
implantation,” said Eric Michael David, M.D., J.D., chief strategy
officer and executive vice president of preclinical development,
Organovo. “Our preclinical data show rapid vascularization
and tissue engraftment, and evidence of function and durability of
our 3D bioprinted human liver tissue over several weeks. Most
importantly, we see evidence of stable production of key human
liver proteins in the animal bloodstream, and tissue staining for
key human metabolic enzymes. The presence of these enzymes
provides an important first step in demonstrating the capability of
this tissue to treat inborn errors of metabolism, a key indication
we are targeting.”
Organovo implanted its 3D bioprinted human liver tissue patches
onto the livers of NOD/SCID mice. The tissue was composed of
human hepatocytes and select non-parenchymal cells. Function
of the 3D bioprinted human liver tissue patches was seen via
detection of human albumin, alpha-1-anti-trypsin and fibrinogen in
the circulating blood of the mice as early as seven days and for at
least 28 days post-implantation. Histopathologic evaluation
of the implanted therapeutic tissue revealed retention of the
bioprinted cellular organization through 28 days post-implantation,
with robust staining for key human metabolic enzymes associated
with inborn errors of metabolism, such as Fumarylacetoacetate
Hydrolase (FAH) deficiency and Ornithine Transcarbamylase (OTC)
deficiency. The tissues remained intact on the animal liver
and were well tolerated by the animals. Taken together, these
data support further preclinical development of Organovo’s 3D
bioprinted liver tissue for therapeutic use.
Focusing first on acute-on-chronic liver failure and pediatric
inborn errors of metabolism, both indications where a bioprinted
liver patch may show therapeutic benefits, Organovo intends to
submit an Investigational New Drug (“IND”) application to the U.S.
Food and Drug Administration (“FDA”) for its therapeutic liver
tissue in three to five years. The total addressable market
opportunity for these initial indication areas exceeds $3 billion
in the U.S. As appropriate, Organovo will pursue breakthrough
therapy designation, clinical development outside the United
States, and other opportunities to help accelerate time to
market.
About Organovo Holdings, Inc.
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 lower cost. The Company’s ExVive Human Liver
and Kidney Tissues are used in toxicology and other preclinical
drug testing. The Company also actively conducts early
research on specific tissues for therapeutic use in direct surgical
applications. In addition to numerous scientific
publications, the Company's technology has been featured
in The Wall Street Journal, Time Magazine, The Economist,
Forbes, and numerous other media outlets. Organovo is
changing the shape of life science research and transforming
medical care. Learn more
at www.organovo.com.
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. 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 market acceptance of the Company's products and
services; the Company's business, research, product development,
regulatory approval, marketing and distribution plans and
strategies; the Company's ability to successfully complete the
contracts and recognize the revenue represented by the contracts
included in its previously reported total contract bookings and
secure additional contracted collaborative relationships; 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 2017 outlook
and/or its long-range 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 9, 2016 and its Quarterly
Report on Form 10-Q filed with the SEC on November 3, 2016.
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 Contact:
Steve Kunszabo
Organovo Holdings, Inc.
+1 (858) 224-1092
skunszabo@organovo.com
Press Contact:
Jessica Yingling
Little Dog Communications
+1 (858) 344-8091
jessica@litldog.com
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