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Seven Investigator-Initiated Clinical Studies Announced

^{Published on 2008-11-19 05:19:38 - Market Wire}
 

SAN DIEGO--([ BUSINESS WIRE ])--Cytori (NASDAQ:CYTX) announced today it has been informed that seven new investigator-initiated clinical studies in Japan using adipose-derived regenerative cells have been approved by local ethical committees. The approvals are at leading academic university hospitals and include a diverse group of therapeutic applications.

All seven studies are investigator-initiated and to be performed under local and country guidelines. Cytori, who will not sponsor these studies, will continue work with country authorities, such as the Ministry of Health and Labor in Japan, to obtain specific regulatory approvals for its products. Data from these investigator-initiated studies may benefit Cytori in the future by establishing and broadening the utility for Cytori's Celution^® System platform currently sold in more than 30 countries around the world.

"There is a real groundswell of interest within the medical community to explore the full potential of adipose-derived regenerative cells," said Marc H. Hedrick, M.D., President of Cytori Therapeutics. "In countries where we have regulatory approval today, there may be an emerging market for the sale of Celution® Systems for cell processing and for translational research similar to the work being performed in Japan."

Investigator-initiated studies are sponsored entirely by each hospital, which independently oversees data monitoring and reporting. The breadth of applications being investigated reflects the broad potential for adipose-derived regenerative cells. The indications being investigated in the seven new studies are as follows:

• Restoration and reconstruction of facial wasting induced by HIV therapy
• Restoration of speech from vocal cord paralysis
• Breast reconstruction after cancer treatment without radiation therapy
• Healing of chronic wounds
• Chronic liver insufficiency and cirrhosis
• Urinary incontinence in female patients
• Peripheral vascular disease

About Cytori

Cytori's (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 is being commercialized globally 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 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's 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.