Cytori
Therapeutics, Inc. (NASDAQ:CYTX) will present data from two
preclinical studies describing safety and efficacy of ADRCs for
treatment of thermal burn injuries at the Annual
Meeting of the American Burn Association (ABA) in Chicago on April
21-24, 2015. This research, funded by the contract with the
Biomedical Advanced Research and Development Authority (BARDA) of the
Department of Health and Human Services, was part of the package of data
submitted to the US Government as part of the In-Process Review meeting
that led to the execution of the current contract option valued at $14.1
million, and part of Cytori’s $106 million BARDA contract framework.
The first presentation will describe the use of Cytori Cell Therapy in
combination with a widely used skin substitute in a full thickness burn
injury model. Data to be presented show increased wound vascularity and
maturation in wounds treated with Cytori Cell Therapy. The second
presentation will describe a novel model of full thickness thermal burn
injury with concomitant radiation exposure. Data to be presented
demonstrate that delivery of Cytori Cell Therapy accelerates wound
re-epithelialization in this context. These data will form the basis of
an Investigational Device Exemption (IDE) package to be submitted to FDA
for a proposed clinical trial using Cytori Cell Therapy in thermal burn
injury.
“These are encouraging data that support the advancement of Cytori
Cell Therapy to accelerate wound healing in severe burn patients,”
said Dr. Tenenhaus, a plastic surgeon from UCSD Burn Center who
specializes in reconstructive surgery for burns and other traumatic
injuries. Dr. Marc Hedrick, President and CEO of Cytori commented: “We
remain focused on continuing execution of key deliverables under our
BARDA contract and believe that, when coupled with ongoing research and
development activities, the data to be presented at ABA will support an
FDA IDE approval and unlocking of the next BARDA milestone, which
includes $8.3 million in clinical trial funding. We look forward to
their full publication in the scientific literature in the near future.”
The treatment of thermal burns remains a critical underserved medical
need. Despite standard of care primarily consisting of dressings, skin
grafts and skin substitutes, patients frequently suffer from pain,
scarring, skin contracture and reduced range of motion. Autologous cell
therapies such as those offered by Cytori have the potential to improve
the quality and rate of wound healing and reduce scarring.
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 reports 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
laboratory equipment and 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, please visit www.cytori.com.
Cautionary Statement Regarding Forward-Looking
Statements
This press release includes forward-looking statements that involve
known and unknown risks and uncertainties. All statements, other than
historical facts, including statements regarding our expectation that
the research and development activities, and the data to be presented at
ABA will lead to FDA IDE approval and unlocking of the next BARDA
contract milestone are forward looking statements. Such statements are
subject to risks and uncertainties that could cause our actual results
and financial position to differ materially. Some of these risks include
clinical, pre-clinical and regulatory uncertainties, risks in the
collection and results of data, uncertainty associated with any future
approvals by the FDA, dependence on third party performance, the right
of the Federal Government to cut or terminate further support of the
thermal burn injury program in its sole discretion, and other risks and
uncertainties described under the "Risk Factors" in Cytori's Securities
and Exchange Commission Filings, included in our annual and quarterly
reports.
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