Organovo Announces Initiation of Commercial Contracting for ExVive Human Kidney Tissue
September 07 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 begun commercial contracting for its
second tissue service, the ExViveTM Human Kidney. This kidney
proximal tubule model is a natural expansion of the Company’s
preclinical product and service portfolio, allowing customers to
study the effects of drug exposure on a key portion of the human
kidney relevant to drug discovery and development. Organovo
has already signed multiple commercial orders and is collaborating
on toxicology panels and transporter studies, including with two
global, top 25 pharmaceutical companies, as part of an early access
program.
The ExVive Human Kidney has demonstrated important functional
aspects that offer significant value in preclinical testing,
including:
- Demonstrated proximal tubule function for more than four weeks,
as measured by gamma-glutamyl transferase (GGT) production;
- Tissue-like complexity that supports the detection of injury,
compensation, and recovery
- Physiological expression of key transporters as measured by
gene and protein expression, which allows for the assessment of
kidney toxicity and drug:drug interactions by modeling normal
tissue function;
- Modulatable activity of key renal transporters P-gp, SGLT2, and
OCT2, demonstrating a high correlation to difficult to replicate
human biology;
- Demonstrated toxicity of model kidney toxicant cisplatin, and
inhibition of toxicity when blocking OCT2 function, demonstrating
specific inhibition of cisplatin transport through a known
transporter; and
- Barrier function (permeability) comparable to in-vivo values,
as measured by trans-epithelial electrical resistance (TEER).
“The powerful data Organovo is releasing on the ExVive Kidney
Tissue demonstrates significant potential value for our
pharmaceutical customers,” said Keith Murphy, chairman and CEO of
Organovo. “The compelling symphony of transporter function
and the demonstration of a response to a known toxicant boost our
excitement as we bring to market an advanced way to investigate
preclinical kidney toxicity of new drug candidates.”
The Company and its customers released several posters and
presentations during the scientific conferences at EUROTOX 2016 in
Seville, Spain this week, and expects to continue to release
information at the 12th Annual Applied Pharmaceutical Analysis
Meeting during the week of September 12, 2016.
The Company believes that, as it penetrates the toxicology
market, the ExVive Human Kidney tissue service has the potential to
grow into the tens of millions in annual revenue and has $100M+
revenue potential in the future as it pursues diligent sales and
marketing efforts (inside of a total addressable market of over
$2B). This kidney revenue opportunity is expected to be
accretive to previous market projections for liver tissue, which
are of similar magnitude. The ExVive Human Kidney and Liver
products are unique in the industry in the ability to replicate
complex cell-cell interactions and key elements of native tissue
architecture to enable the detection of multiple
clinically-relevant modes of tissue injury and to provide the
unique resolving power of a controlled human tissue
microenvironment to investigate mechanism and develop
solutions.
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.
Forward-looking statements include, but are not limited to,
statements about the potential benefits and functional use of the
ExVive Human Kidney tissue and the potential customer demand and
market opportunities for the ExVive Human Kidney and Liver tissues.
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, including the ExVive Human Kidney and Liver
tissues; the market acceptance and potential market opportunities
of the Company's products and services, including the ExVive Human
Kidney and Liver tissues; 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. 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 for the fiscal year ended March 31, 2016 and filed with
the SEC on June 9, 2016 and its Quarterly Report on
Form 10-Q for the period ended June 30, 2016 and filed with the SEC
on August 4, 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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