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
