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 its plan to develop 3D bioprinted human liver
tissue for direct transplantation to patients. The Company is
announcing its program to develop this therapeutic tissue based on
the achievement of strong results in preclinical studies in animal
models showing engraftment, vascularization and sustained
functionality of its bioprinted liver tissue, including stable
detection of liver-specific proteins and metabolic enzymes.
Organovo expects to pursue this opportunity with a formal
preclinical development program.
For patients in need of a liver transplant, no
robust alternatives exist today. Approximately 17,000
patients are on the U.S. liver transplant waiting list, and only
6,000 liver transplants are performed each year. Organovo
plans to develop clinical solutions in two initial areas.
First, acute-on-chronic liver failure (“ACLF”) is a recognized and
distinct orphan disease entity encompassing an acute deterioration
of liver function in patients with liver disease, which affects
150,000 patients annually in the United States. Second,
pediatric metabolic liver diseases represent another orphan disease
indication where a bioprinted liver tissue patch may show
therapeutic benefits. The total addressable market
opportunity for these initial indication areas exceeds $3
billion. Assuming development progresses according to its
current plan, 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. As appropriate, Organovo will pursue breakthrough
therapy designation, clinical development outside the United
States, and other opportunities to help accelerate time to
market.
Keith Murphy, Organovo’s CEO, will be presenting
bioprinted human liver as the first therapeutic tissue being
advanced in the Company’s portfolio at the 2016 Cell & Gene
Meeting on the Mesa in La Jolla, Ca. Mr. Murphy will speak
today at 5 p.m. PT, and the presentation will be both webcast live
and available for replay at
http://www.meetingonthemesa.com/webcast/. The Company also
expects to present more detailed preclinical results at upcoming
scientific conferences.
“We’re excited to introduce an implantable
bioprinted liver tissue as the first preclinical candidate in our
therapeutic tissue portfolio, and see the early results as
extremely promising,” said Keith Murphy, CEO, Organovo. “The
scientific and commercial progress we have already made with
ExViveTM Human Liver Tissue in drug toxicity testing has given us a
firm foundation upon which to build a larger tissue for transplant.
Advancing our first therapeutic tissue into preclinical
development is an important milestone for Organovo, and it speaks
to the power of our technology platform in addressing multiple
applications, including preclinical safety, disease modeling and
tissue replacement products for surgical implantation. We
believe that 3D bioprinted tissues have an opportunity to provide
options for patients who suffer from liver disorders.”
“Organovo’s approach is designed to overcome many
of the challenges that cell therapies and conventional tissue
engineering have struggled to address, including limited
engraftment and significant migration of cells away from the
liver,” said Eric Michael David, M.D., J.D., chief strategy officer
and executive vice president of preclinical development,
Organovo. “In our preclinical studies, we deliver a patch of
functional tissue directly to the liver, which integrates well,
remains on the liver and maintains functionality. We believe
our tissues have the potential to extend the lives of patients on
liver transplant lists, or those who do not qualify for transplants
due to other factors.”
“Supply issues are a constant and growing challenge
in transplant medicine and liver has the second highest transplant
need among all organs,” said David A. Gerber, M.D., FACS, Professor
of Surgery and Chief of Transplant Surgery, UNC School of Medicine.
“New solutions in development, such as 3D bioprinted human tissues,
have the potential to create tissues that could augment and extend
organ function to give more time to those patients on transplant
waiting lists. Moreover, we are continuing to push the
boundaries and understand how to scale 3D bioprinting and tissue
engineering to develop larger tissues.” Dr. Gerber serves as
an advisor to Organovo on its liver therapeutic tissue preclinical
development program.
Dr. John Geibel, Vice Chairman of Surgery, Director
of Surgical Research, and Professor of Surgery and Cellular and
Molecular Physiology at Yale University, added, “There are many
conditions in areas such as liver, kidney, gastrointestinal,
vascular, and lung disease where supplying a tissue patch may be
curative, or bridge a patient a few more years before they need a
transplant. The promise of 3D bioprinting human tissues to
address these unmet needs is significant.” Organovo and the
Methuselah Foundation support Organovo’s bioprinter for therapeutic
research at Yale’s Department of Surgery.
The Company continues to conduct early research on
other tissues for therapeutic use in direct surgical
applications. Liver tissue, having ranked highly in an
initial strategic assessment performed by Organovo considering
technical feasibility, commercial opportunity, clinical,
regulatory, and reimbursement factors, has moved forward most
quickly as the Company’s first program for preclinical
development. Preclinical ‘proof-of-concept’ is currently
being pursued in additional areas, building on the breadth of
Organovo’s leading bioprinting expertise.
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. These forward-looking statements include,
but are not limited to, statements regarding the Company's
development plans and timeline for its human liver tissue,
potential therapeutic uses for its human liver tissue, and the
ability of the Company to complete the additional preclinical
studies required to submit an IND for its human liver tissue,
including having the necessary resources and achieving the required
results. 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 secure additional financing to support its long-term
development plans. 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 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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