Cell-Enhanced Breast Reconstruction Study Shows Sustained Improvement
at 12-Months
Feb. 22, 2008
SAN DIEGO--(BUSINESS WIRE)--Cytori Therapeutics (NASDAQ:CYTX) was
informed that positive longer-term follow-up data were presented
today from an independent, investigator-
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:
Patient satisfaction remained at 79 percent, with a mean follow-up of
12-months
The procedure remains safe and well tolerated
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.
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.
Contacts
Cytori Therapeutics
Tom Baker, 858-875-5258
tbaker@cytoritx.
http://www.business
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StemCells subscribers may also be interested in these sites:
Children's Neurobiological Solutions
http://www.CNSfoundation.org/
Cord Blood Registry
http://www.CordBlood.com/at.cgi?a=150123
The CNS Healing Group
http://groups.yahoo.com/group/CNS_Healing
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