Cytori
Therapeutics (NASDAQ: CYTX) today announced that the United States
Court of Appeals for the District of Columbia Circuit has ruled on the
Company’s conjoined appeals (case no. 11-1268).
The court upheld the FDA’s (Food and Drug Administration) previous
determination that Cytori’s cell processing devices were not
substantially equivalent to the cited predicate devices. Cytori will
continue to pursue its intended pathway to regulatory approval via the
PMA (Premarket Approval) route, such as the active ATHENA clinical trial
for refractory heart failure. Cytori received IDE (Investigational
Device Exemption) in January 2012 required to initiate the ATHENA
clinical trial.
“This decision reaffirms our primary regulatory pathway in the U.S.,”
said Christopher J. Calhoun, Chief Executive Officer of Cytori. “Our
priority remains unchanged, which is completion of clinical development
of our Celution® System in refractory heart failure under the FDA’s PMA
clinical trial-based pathway for class 3 medical devices. Such a pathway
provides the necessary data for approval, adoption, and reimbursement
and will raise an additional barrier-to-entry for potential competitors
who would be required to pursue the same PMA pathway. As a result, this
decision further clarifies the standard-of-evidence required for the
field.”
Cytori has been pursuing parallel pathways to market. One pathway has
been to obtain therapeutic indications, such as those being pursued in
our cardiac development. The other pathway has been to obtain clearance
for laboratory equipment that would provide technology access to
researchers, for which Cytori has achieved approval in Europe and Japan.
Cytori appealed the decision based on a series of prior 510(k)
clearances and a 2009 determination by the FDA, through a formal request
for designation by the office of FDA’s combination products, that
Cytori’s cell processing technology would be regulated as a medical
device and not a biologic. The appeal was related to the subsequent 2011
decision by the FDA to deny the 510(k) clearance for laboratory versions
of our cell processing technology.
Regulatory Overview
The FDA regulates medical devices as class 1, 2, or 3. Typically, class
2 devices require a demonstration of substantial equivalence to a
pre-existing device with limited or no clinical data. Class 3 devices
are considered novel and more complex, thus require clinical data and/or
clinical testing under the PMA pathway.
Cytori and the FDA agree that marketing approval for the Company’s
Celution® System for use in cardiovascular disease and other therapeutic
indications requires a PMA. The appeals rulings announced today relate
to the Company’s separate actions to seek approval for tissue processing
systems for use in banking and research as class 2 medical devices.
About Cytori Therapeutics
Cytori Therapeutics, Inc. is developing cell therapies based on
autologous adipose-derived regenerative cells (ADRCs) to treat
cardiovascular disease and repair soft tissue defects. Our scientific
data suggest ADRCs improve blood flow, moderate the inflammatory
response and keep tissue at risk of dying alive. As a result, we believe
these cells can be applied across multiple “ischemic” conditions. These
therapies are made available to the physician and patient at the
point-of-care by Cytori’s proprietary technologies and products,
including the Celution® system product family. 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 those
regarding our expected enrollment completion date of our Athena trial,
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, risks in the collection
and results of clinical data, clinical outcomes, 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.
The Celution® System is available in the United States for
investigational use only.
