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Cytori Receives U.S. 510(K) Regulatory Clearance for Its Adipose Tissue Processing System With Related Celase(TM) Reagent

Posted on: Thursday, 25 January 2007, 09:01 CST

Cytori Therapeutics (NASDAQ:CYTX)(FWB:XMPA) received U.S. 510(K) regulatory clearance from the Food and Drug Administration's Center for Devices and Radiological Health (CDRH) for its adipose (fat) tissue processing system with related Celase™ tissue processing reagent. This system with the Celase™ reagent is intended for use in plastic and reconstructive, thoracic, gastrointestinal, urological orthopedic, and other surgeries when processing fat or soft tissue is desired.

"This is a critical addition to Cytori's compilation of U.S. regulatory clearances toward a fully automated adipose tissue processing system," said Christopher J. Calhoun, Chief Executive Officer for Cytori. "Cytori will submit additional regulatory filings this year to enable U.S. introduction of the optimal commercial system."

The specific claims for the adipose processing system, Cytori's Lipoplasty System with Celase™ Reagent, are as follows: The Cytori adipose processing system is indicated for use when the fragmentation, emulsification, and aspiration of subcutaneous fatty tissue is required and intended for use within Cytori's adipose tissue processing system.

About Cytori Therapeutics

Cytori Therapeutics (www.cytoritx.com)is developing and seeks to commercialize stem and regenerative cell therapies for cardiovascular disease, reconstructive surgery, and many other serious chronic and life-threatening conditions. To provide these therapies, physicians remove a small amount of a patient's fat, also known as adipose tissue, and run it through Cytori's Celution™ System. This System quickly separates and concentrates stem and regenerative cells from adipose tissue so they may be quickly administered back to the patient about an hour later. This system will dramatically improve the way in which personalized cell-based therapies can be delivered to patients.

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 and expected continuing losses; the need for further financing; our ability to develop and commercialize regenerative cell-based therapies; our dependence on third parties; our ability to obtain, defend, and enforce our intellectual property; 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, 2005, and subsequent SEC 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: Business Wire

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