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Three Month Results Reported from Stem & Regenerative Cell Breast Augmentation Study
"Volume retention and softness of tissue at three-months is extremely encouraging compared to typical outcomes in non-cell-enhanced fat transfers," said Dr. Kamakura. "If volume retention holds at nine-months, the augmentations can be expected to be permanent. Such results offer women a revolutionary new cosmetic surgery option for smaller volume augmentations, where a more natural look and feel is desired."
At three months, breast circumference in the first three patients remained stable at an average increase of 4 centimeters, which is equivalent to a 1.6 cup size increase. An average net volume of 160mL (less saline) of cell enhanced fat tissue was transplanted into each breast of each patient. The procedure to date has been found safe with no report of any adverse events. Patient follow-up is ongoing in this 20 patient investigator-initiated study. Nine-month results will be reported in early 2009, shortly after the last patient follow-up.
The study is using a procedure whereby a woman's fat tissue is enriched with her own adipose derived stem and regenerative cells to create a natural filler. This technique is referred to as cell-enhanced augmentation. The cells in the study were made available at the time of surgery using the Celution(R) 800 System from Cytori Therapeutics (NASDAQ: CYTX). Further results from the study will be available following a nine month assessment of the primary endpoints of cosmetic improvement and volume retention.
Fat, known medically as adipose tissue, is the body's richest known source of regenerative cells. Adipose-derived regenerative cells include adult stem cells in addition to other important cell types that have been shown pre-clinically to improve tissue retention compared to non- 'cell enhanced' tissue transfers. For this reason, these cells potentially may improve and simplify traditionally complex fat transfer procedures as well as enable more predictable outcomes and graft retention when applied to cosmetic and reconstructive surgery.
Cautionary Statement Regarding Forward-Looking Statements
This press release includes forward-looking statements regarding events, trends and business prospects, 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 regarding the collection and results of, clinical data, dependence on third party performance, and other risks and uncertainties described under the "Risk Factors" in Cytori Therapeutics' 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.
SOURCE: Cytori Therapeutics
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