01.11.2007 12:00:00
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Cytori Receives European Approval for 2nd Generation Celution(TM) Stem & Regenerative Cell Processing System
Cytori Therapeutics, Inc. (NASDAQ:CYTX) received European approval - CE
Mark - for the second generation Celution™
stem and regenerative cell processing system. The Celution™
System is the only device approved in Europe to extract and concentrate
a patient’s own stem and regenerative cells
from within fat tissue in order to be delivered back to the same patient
in the same procedure. Fat tissue, known medically as adipose, is a
rich, accessible, and non-embryonic source of stem and regenerative
cells.
"With this approval, Cytori can begin
targeted commercial introduction of the Celution™
System next year to select reconstructive surgeons in Europe,”
said Christopher J. Calhoun, chief executive officer, Cytori
Therapeutics. "In parallel, we will conduct
our planned post-market studies of the Celution™
System for use in breast cancer reconstruction in order to drive market
adoption and reimbursement.”
The Celution™ System was evaluated in an
11-patient investigator-initiated safety and feasibility study,
designated as RESTORE I, conducted in Japan. This study investigated
adipose-derived stem and regenerative cells extracted and processed with
the Celution™ System to treat the
complications of surgery and radiation damage following partial
mastectomy for the treatment of breast cancer. Study results will be
presented at the San Antonio Breast Cancer Symposium on December 15,
2007.
Based on preliminary results, Cytori is planning two clinical studies,
designated as the RESTORE II and VENUS studies, which will further
evaluate the use of adipose-derived stem and regenerative cells in
breast reconstruction following partial mastectomy for the purpose of
offering optimal reimbursement in Europe. RESTORE II will evaluate up to
70 patients at multiple European trial sites. VENUS will be a 20 patient
single center study, adjunct to RESTORE II, in patients with more severe
radiation damage and contour defects resulting from a partial mastectomy.
Adipose-derived stem and regenerative cells extracted with the Celution™
System are currently being investigated in Europe for the treatment of
heart disease. A 36 patient clinical trial in chronic ischemia patients
is underway and a 48 patient clinical trial in heart attack patients is
planned to begin shortly.
Cytori Therapeutics
Cytori Therapeutics is a global leader in the development of
regenerative medicine products. The company is developing therapeutic
applications for its Celution™ System to
enable real-time regenerative cell therapy in conjunction with breast
reconstruction surgery, cardiovascular disease, and other large unmet
medical needs. The Company's StemSource™ Cell
Bank, which is based on Cytori's innovative Celution™
System, will be commercialized in Japan starting in 2008 to hospitals
and clinics to enable regenerative cell banking. www.cytoritx.com.
Cautionary Statement Regarding Forward-Looking Statements
This press release includes forward-looking statements regarding events,
trends and prospects of our business, which may affect our future
operating results and financial position. Such 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, dependence on performance
of third parties, and other risks and uncertainties described (under the
heading "Risk Factors") in Cytori Therapeutics' Form 10-K annual report
for the year ended December 31, 2006. We assume no responsibility to
update or revise any forward-looking statements to reflect events,
trends or circumstances after the date they are made.
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