Cytori Therapeutics (CYTX) was informed that positive longer-term
follow-up data were presented today from an independent,
investigator-sponsored breast reconstruction study in Japan. As part of
the study, adipose tissue-derived stem and regenerative cells, processed
with Cytori’s Celution™
600 System, were used to reconstruct breast tissue following partial
mastectomy. New data from the study showed:
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Patient satisfaction remained at 79 percent, with a mean follow-up of
12-months
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The procedure remains safe and well tolerated
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There was no significant loss of breast tissue thickness from one
month to a mean follow up of 12-months
The procedure reconstructed partial mastectomy defects in 21 women with
no metastases or recurrence at least one year after tumor resection. A
statistically significant improvement in average breast tissue thickness
at one month following treatment was reported in December at the San
Antonio Breast Cancer Symposium.
The results were presented at the 9th
Japan-Korea Congress of Plastic and Reconstructive Surgery by Kaoru
Kitamura, M.D., Ph.D., Department of Breast Surgery, Kyushu Central
Hospital, Fukuoka, Japan. Dr. Kitamura is a co-investigator of the study
with Dr. Keizo Sugimachi, M.D., Ph.D. of Kyushu Central Hospital and
Masaki Mori, M.D., Ph.D., of Kyushu University.
“The investigational procedure offers hope to
partial-mastectomy patients who have limited options,”
said Dr. Kitamura. “Unfortunately the concept
of ‘breast conserving therapy’
can often times be misleading, as even minimally invasive resections can
result in defects that leave patients dissatisfied with the cosmetic
outcome.”
In the study, tissue loss resulting from partial mastectomy was
reconstructed with each patient's own liposuctioned fat, which was
combined and enhanced with her own adipose-derived stem and regenerative
cells. These cells were made available at the time of surgery using
Cytori's device, the Celution™ 600 System.
Two clinical studies will be initiated this year in Europe by Cytori to
further evaluate adipose-derived stem and regenerative cells, processed
with the Celution™ 800 System, in breast
reconstruction following partial mastectomy. One study, RESTORE II, will
evaluate up to 70 patients at multiple trial sites. A second study,
VENUS, will be a 20-patient single center study in patients with more
severe radiation damage and contour defects.
Cytori Therapeutics
Cytori Therapeutics’ (NASDAQ:CYTX)
goal is to be the global leader in regenerative medicine. The company is
dedicated to providing patients with new options for reconstructive
surgery, developing treatments for cardiovascular disease, and banking
patients’ adult stem and regenerative cells.
The Celution™ 800 System is being introduced
in Europe into the reconstructive surgery market while the Celution™
900 System will be launched in Japan for cryopreserving a patient’s
own stem and regenerative cells. Clinical trials are ongoing in
cardiovascular disease and planned for spinal disc degeneration,
gastrointestinal disorders, and other unmet medical needs. (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.
