Cytori Granted FDA Orphan Drug Designation for ECCS-50 in Scleroderma

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.