Cytori Granted FDA Orphan Drug Designation for ECCS-50 in Scleroderma
November 14 2016 - 12:09PM
Business Wire
Cytori Therapeutics, Inc. (NASDAQ: CYTX) announced today that
the US FDA Office of Orphan Products Development (OOPD) has granted
Cytori an orphan drug designation for cryopreserved or centrally
processed ECCS-50 for scleroderma.
“This orphan drug designation is part of our long-term strategy
to facilitate the autologous retreatment of patients with
scleroderma, if it is needed,” said Dr. Marc Hedrick, President and
CEO of Cytori Therapeutics. “Our development plan for cryopreserved
ECCS-50 will be described in greater detail over the next few
quarters.”
Orphan drug designation is granted by the FDA to drugs and
biologics which are defined as those intended for the safe and
effective treatment, diagnosis or prevention of rare
diseases/disorders that affect fewer than 200,000 people in the
U.S. Orphan drug designation provides certain incentives which may
include tax credits towards the cost of clinical trials and waivers
from FDA user fees. If a product that has orphan drug designation
subsequently receives the first FDA approval for the
disease for which it has such designation, the product is entitled
to orphan product exclusivity for seven years.
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 the role of
Cytori’s U.S. orphan drug designation as part of Cytori’s strategy
to facilitate the autologous retreatment of patients with
scleroderma (if needed), and communication of Cytori’s development
plan for cryopreserved ECCS-50 over the next few quarters are
forward looking statements that are subject to risks and
uncertainties that could cause our actual results and financial
position to differ materially. Some of these risks include:
clinical and regulatory uncertainties, such as failure to generate
data supporting safety or efficacy of cryopreserved ECCS-50, and
risks that regulation of cell therapies may impose significant
hurdles and/or competitive challenges for our ECCS-50 product
(including any development plans for cryopreserved ECCS-50); risks
that a competitor may first obtain market exclusivity covering hand
impairment resulting from systemic sclerosis or that we do not
receive FDA approval of a cryopreserved ECCS-50 product and are
therefore unable to avail ourselves of the commercial benefits of
orphan drug designation; the challenges inherent in convincing
physicians and patients to adopt Cytori’s technology; dependence on
third party performance, including physicians conducting
investigator-initiated trials and studies using our Celution
platform; performance and acceptance of our ECCS-50 and other
products; and other risks and uncertainties described under the
“Risk Factors” in Cytori's Securities and Exchange
Commission Filings, including in its most recent annual and
quarterly reports. 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/20161114006194/en/
Cytori Therapeutics, Inc.Tiago Girao,
1.858.458.0900ir@cytori.com
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