BARDA Increases Contract Option with Cytori to Advance Countermeasure Clinical Trial
September 19 2016 - 7:00AM
Business Wire
Increased Option Value to $16.6 Million
for Burn Wound Treatment
Cytori Therapeutics (NASDAQ: CYTX) (the “Company”) today
announced that the Company and Biomedical Advanced
Research and Development Authority (BARDA), a division of
the U.S. Department of Health and Human Services, increased
the contract option originally signed in August 2014 to
fund continued investigation and development of Cytori Cell
Therapy™ for use in thermal burn injuries.
The amended option is valued at $16.6 million, an increase
of approximately $2.5 million from its previous value
of $14.1 million. Upon Investigational Device Exemption (IDE)
approval by the FDA, if received, Cytori will request that
BARDA provide additional funding to cover costs associated with the
completion of a pilot clinical trial. This trial will employ IV
administration of Cytori Cell Therapy.
The supplemental funds from this amended contract will be used
to support the remaining activities necessary to seek approval of
the IDE and support clinical readiness. The original contract
includes additional options, exercisable at BARDA’s discretion,
valued at up to $68 million to fund both pilot and pivotal clinical
trials and additional work in thermal burn complicated by radiation
exposure.
“BARDA and Cytori continue to work closely to develop this
technology in the interests of the nation,” said Dr. Marc
Hedrick, President and Chief Executive Officer of Cytori.
“Additional funding allows Cytori to complete activities necessary
for conduct of a pilot trial with the objective of getting Cytori
Cell Therapy into the clinic for thermal burn in 2017.”
The current healthcare system is ill-prepared for large numbers
of patients requiring simultaneous treatment for thermal burns
associated with radiation exposure. Current standard of care
consists of dressings, skin grafts and skin substitutes. Despite
these treatments, patients with severe burns commonly suffer from
prolonged pain, aggressive scarring, skin contracture and reduced
range of motion. Cellular therapeutics such as those offered by
Cytori may have the potential to improve the quality and rate of
wound healing and reduce scarring and also can be deployed in a
cost effective manner, even in mass casualty situations.
According to the American Burn Association, there were
approximately 450,000 burn injuries in 2013 that required medical
treatment in the United States, with approximately 40,000
requiring hospitalization. In a mass casualty event,
the Government Accountability Office estimates that as
many as 10,000 patients could require thermal burn care. The
limited number of specialist surgeons and burn centers in the U.S.
creates a public health need for a burn wound therapy that can be
quickly and broadly applied by non-specialist medical personnel
following such an event.
About Cytori Therapeutics, Inc.
Cytori Therapeutics is a late stage cell therapy company
developing autologous cell therapies from adipose tissue to treat a
variety of medical conditions. Data from preclinical studies and
clinical trials suggest that Cytori Cell Therapy™ acts principally
by improving blood flow, modulating the immune system, and
facilitating wound repair. As a result, Cytori Cell Therapy™ may
provide benefits across multiple disease states and can be made
available to the physician and patient at the point-of-care through
Cytori’s proprietary technologies and products. For more
information, visit www.cytori.com.
Cautionary Statement Regarding
Forward-Looking Statements
This communication includes forward-looking statements regarding
events, trends and business prospects, which may affect our future
operating results and financial position. Such statements,
including, but not limited to, statements regarding potential IDE
approval, Cytori’s use of the proceeds of BARDA’s $2.5 million
option exercise, anticipated future BARDA funding, and clinical
efficacy and cost-effectiveness of Cytori Cell Therapy, are subject
to risks and uncertainties that could cause our actual results and
financial position to differ materially. Some of these risks and
uncertainties include, a possible adverse FDA decision regarding
our IDE submission, changes in government funding and procurement
priorities that may adversely affect our thermal burn injury
program, the government’s sole discretion in determining funding
timing and amounts, the government’s ability to reduce, modify or
terminate the contract if it determines it is in the government’s
best interests to do so, the risk that Cyrori is unable to complete
development work necessary receive FDA IDE approval and/or future
BARDA funding, the quality of data supporting IDE approval and
execution of BARDA contract options, risks in the collection and
results of clinical data, final clinical outcomes, regulatory
uncertainties, dependence on third party performance, and other
risks and uncertainties described under the "Risk Factors" section
in Cytori's Securities and Exchange Commission Filings on Form 10-K
and Form 10-Q. Cytori assumes no responsibility to update or revise
any forward-looking statements contained in this press release to
reflect events, trends or circumstances after the date of this
communication.
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version on businesswire.com: http://www.businesswire.com/news/home/20160919005313/en/
CYTORI THERAPEUTICSTiago Girao,
+1.858.458.0900ir@cytori.com
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