Cytori`s Celution 700 System to be Regulated as a Medical Device by U.S. FDA

SAN DIEGO--(Business Wire)--
Cytori Therapeutics (NASDAQ:CYTX) was informed by the U.S. Food and Drug
Administration (FDA) that the Celution 700 System will be regulated as a medical
device under the Federal Food, Drug, and Cosmetic Act. This determination, in
response to Cytori`s Request for Designation, clears the way for Cytori to
compile and submit a marketing application to the FDA for the Celution 700
System for use as a medical device in aesthetic body contouring and/or filling
of soft tissue voids.

"This important decision provides greater clarity of our regulatory path in the
U.S. and is consistent with our interpretation of current device regulations,"
said Christopher J. Calhoun, chief executive officer for Cytori. "We are
preparing for the next steps in the process of working with the FDA to determine
the specific device marketing application to submit, including whether clinical
evaluations will be necessary."

Based on the jurisdictional determination from the FDA, marketing applications
for the Celution 700 device will be reviewed by the FDA`s Center for Biologics
Evaluation and Research under the law applicable to medical devices. Clinical
investigations, if required, would be conducted in accordance with the
Investigational Device Exemption (IDE) regulations, not the Investigational New
Drug regulations applicable to drugs and biologics.

About Cytori

Cytori develops and globally commercializes regenerative medicine technologies,
which provide real-time, point-of-care access to clinical grade regenerative
cells. Our technology is incorporated into two product families. The
Celution-related products are sold throughout Europe and Asia primarily into the
cosmetic and reconstructive surgery market and are under evaluation by the U.S.
FDA. Our StemSource products are sold globally for cell banking and research
applications. We are also developing additional clinical uses of our technology
for the treatment of multiple medical conditions, including cardiovascular
disease, urinary tract disorders, and wound related conditions. To commercialize
our technology, Cytori has partnered with global and regional leaders in
healthcare such as Olympus Corporation, GE Healthcare, and Green Hospital
Supply. www.cytoritx.com

Cautionary Statement Regarding Forward-Looking Statements

This press release includes forward-looking statements regarding events, trends
and business prospects, which may affect our future operating results and
financial position. These statements include the clarity in our regulatory path
moving forward, our intention to compile and submit marketing applications to
the FDA and whether any clinical evaluations or investigation will be required
in connection with those applications. Such forward-looking statements 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 our history of operating losses, the need for further financing,
regulatory uncertainties regarding the collection and results of clinical data,
dependence on third party performance, and other risks and uncertainties
described under the "Risk Factors" in Cytori's Securities and Exchange
Commission Filings. We assume no responsibility to update or revise any
forward-looking statements to reflect events, trends or circumstances after the
date they are made.

Investor Contact:
Cytori Therapeutics
Tom Baker, 858-875-5258
tbaker@cytoritx.com

Copyright Business Wire 2009