Organovo Receives Strong Customer Response for ExVive Human Kidney Tissue Launch
November 01 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,
today announced that it has received a strong customer response for
its second tissue service, the ExViveTM Human Kidney Tissue.
This kidney proximal tubule model was launched in September, and is
a natural expansion of the Company’s preclinical product and
service portfolio. Customers use Organovo’s 3D bioprinted
kidney tissue to study the effects of drug exposure through
toxicology panels and transporter studies. The Company
already has multiple commercial orders from several customers,
including with two, global, top 25 pharmaceutical companies.
“Nephrotoxicity is a key concern in drug
development and the proximal tubule is the primary site of renal
toxicity,” said Dr. Caroline Lee, senior director, Ardea
Biosciences, Inc. “Specifically, transporters in the proximal
tubule play a crucial role in the distribution and accumulation of
drugs in the kidney. The ExVive Human Kidney Tissue provides
an ideal means to study the impact of renal transporters on the
disposition of drugs because it closely resembles native human
kidney proximal tubule, with its polarized renal epithelial cells
and tubulointerstitial interface and in particular its native
expression level of transporters enabling formation of the
transport network.” Ardea Biosciences, Inc. is a wholly-owned
subsidiary of AstraZeneca PLC.
"At La Jolla Pharmaceutical Company, we
incorporate in vitro models to assess nephrotoxicity in
the preclinical stage of drug development,” said Dr. Andrew Seacat,
director, preclinical development, La Jolla Pharmaceutical
Company. “Early safety prediction of compounds is challenging
and many drugs fail in the clinic because of renal toxicity.
Organovo has developed an in vitro human kidney tissue
model that allows for study of renal toxicity,
biomarker expression, and overall cellular and tissue health
following compound exposure. La
Jolla currently utilizes the ExVive Human
Kidney Tissue model to assess the renal impact of our
compounds during development.”
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; the risk of further
adjustments to the Company’s select preliminary financial results
for the second quarter of fiscal 2016; 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, its Quarterly Report on Form 10-Q filed with the SEC on
August 4, 2016 and other filings with the SEC. 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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