Enrollment Completed For Investigator-Initiated Stem & Regenerative Cell Breast Augmentation Study In Japan

Main Category: Stem Cell Research
Article Date: 07 Apr 2008 - 4:00 PDT

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Enrollment was completed in a 20 patient investigator-initiated study in Japan using adipose-derived stem and regenerative cells in breast augmentation procedures. The study, which began November 2007, is evaluating 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 reconstruction.'

The stem and regenerative cells in the study were made available at the time of surgery using the Celution® 800 System, an investigational device from Cytori Therapeutics (NASDAQ: CYTX). This independent, investigator-initiated study is being sponsored by Tatsuro Kamakura, M.D., Chief Medical Officer of Cosmetic Surgery Seishin in Japan. Results of the study will be available following a nine month assessment of the primary endpoints of cosmetic improvement and volume retention.

"Our clinic's goal for this study was to learn if cell-enhanced reconstruction is feasible for bilateral cosmetic breast augmentation as an alternative to implants," said Dr. Kamakura. "We look forward to assessing the procedure's effect on volume retention following the nine-month follow-up period as we believe that cell-enhanced reconstruction could overcome the challenges often associated with conventional, non-cell-enhanced fat grafting. We plan to continue offering cell-enhanced reconstruction to our patients in Tokyo and expand it to patients in our Osaka clinic as well."

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.

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. http://www.cytoritx.com

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.

Cytori Therapeutics

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