Cytori Receives U.S. Small Business Designation - Substantially Reduces 2017 FDA Filing Fees
February 06 2017 - 9:00AM
Cytori Therapeutics, Inc. (NASDAQ:CYTX) announced today that the US
Food and Drug Administration (FDA) Division of Industry and
Consumer Education (DICE) has granted Small Business status to
Cytori Therapeutics for Fiscal Year 2017. The newly granted Small
Business status allows Cytori to receive significant financial
incentives, fee reductions, and fee waivers for selective FDA
medical device regulatory filings. Such designation makes the
company eligible for a substantial reduction in many medical device
user fees and a one-time waiver of the user fee for its first
premarket approval (PMA) application potentially occurring later in
2017.
“Cytori Cell Therapy benefits from being regulated as a device
through the PMA process. The small business designation will
substantially reduce filing fees in 2017 for our planned PMA
application for HABEOTM Cell Therapy, our lead development
candidate currently under investigation for use in scleroderma,
should our STAR Phase III data support filing of this application,”
stated Tiago Girao, VP of Finance and CFO of Cytori
Therapeutics.
The STAR trial is a Phase 3, US-based, multi-center (19 sites),
randomized, controlled trial of HABEO in 88 patients with hand
dysfunction and Raynaud’s phenomenon associated with scleroderma.
Enrollment was completed in mid-2016. Data unblinding
and analysis will commence once the last enrolled subject has
completed their 48-week follow-up visit, anticipated to be in
mid-2017.
In the United States, the scleroderma affected population
appears to be approximately 184 per million, which would account
for a market size of 45,000 scleroderma patients.1 Additionally, in
Europe, scleroderma is estimated to have a prevalence between 31
per million and 277 per million which equates to approximately
17,000 to 149,000 scleroderma affected people in the Europe.2
About Cytori
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: timeframes
for, and conditions under which, Cytori would submit a PMA
application for Habeo; projected savings to Cytori as a result of
obtaining SME status; and other potential benefits to Cytori of
small business status in the U.S. and Europe. 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 STAR clinical trial results (including
the risk that STAR data are deemed insufficient to support a PMA
application) and other clinical uncertainties; regulatory
uncertainties and other uncertainties that could cause us to lose
SME status in the U.S. or in Europe; unexpected costs and expenses
related to PMA approval unrelated to SME status; unforeseen delays
or hurdles in our anticipated Habeo PMA application process; the
challenges inherent in convincing physicians and patients to adopt
the new technology, dependence on third party performance,
performance and acceptance of our 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.
1. Furst, Daniel et al. “Epidemiology of systemic sclerosis in a
large US managed care population.” J Rheum 2012; 38:784-6.
2. Varga, John et al. “Scleroderma: From Pathogenesis to
Comprehensive Management.” 2012
Cytori Therapeutics, Inc.
Tiago Girao, 1-858-458-0900
ir@cytori.com
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