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Cytori Therapeutics Achieves 510(K) Clearance for the Celution(TM) System

Posted on: Monday, 2 October 2006, 09:01 CDT

Cytori Therapeutics, Inc., (NASDAQ:CYTX) (Frankfurt:XMPA) was awarded 510(k) clearance from the U.S. Food and Drug Administration's Center for Devices and Radiological Health (CDRH) for the Celution™ Cell Concentration System as a cell saver device. The system is cleared for the collection, concentration, washing and re-infusion of a patient's own cells for applications that may include, but are not limited to, cardiovascular, plastic and reconstructive, orthopedic, vascular, and urological surgeries and procedures.

"This is our first U.S. clearance of a fully automated cell processing device with per-patient consumables, and demonstrates continued execution of our global regulatory and development strategy," stated Christopher J. Calhoun, Chief Executive Officer for Cytori. "While we do not intend to immediately commercialize this device, we view the clearance as a critical milestone in our development of related cell processing systems."

In January 2006, Cytori received European regulatory clearance (CE Mark) on a similar next generation system that processes cells from a patient's own adipose tissue in about an hour. This system will be used in the Company's European cardiovascular trials and is currently in use in an investigator-initiated clinical study in Japan to evaluate stem and regenerative cells for reconstructive surgery following a partial mastectomy.

About Cytori Therapeutics

Cytori Therapeutics, Inc., (NASDAQ:CYTX) (Frankfurt:XMPA) is discovering and developing proprietary cell-based therapeutics utilizing adult stem and regenerative cells derived from adipose tissue, also known as fat. The Company's investigational therapies target cardiovascular disease, spine and orthopedic conditions, gastrointestinal disorders and new approaches for aesthetic and reconstructive surgery.

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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