SOURCE: Cytori Therapeutics, Inc.

Cytori Therapeutics, Inc.

March 16, 2012 08:00 ET

FDA Grants Cytori 510(k) Clearance for Puregraft® 850

SAN DIEGO, CA--(Marketwire - Mar 16, 2012) - Cytori (NASDAQ: CYTX) has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the Puregraft® 850 System for body contouring using a patient's own fat. The Puregraft® 850 product line extension provides optimized and sterile processing of up to 850 mL of tissue, a significantly larger volume than the Puregraft® 250, which received a 510(k) in January 2010. Larger tissue volumes expand the range of soft tissue procedures for which the product line may be used.

The Puregraft® products are best-in-class innovative products which standardize the preparation of fat grafts. Puregraft® technology has been rapidly adopted since the original launch in 2010. Fat grafting is an important trend in reconstructive and aesthetic surgery, with broad applications in soft tissue procedures. The Puregraft® 850 System has also received European approval and will soon be launched in both the EU and US.

According to the American Society of Plastic Surgeons' most recent report, more than 57,000 fat grafting procedures were performed in the United States in 2010, a 14% increase over the previous year.

About Puregraft®

The Puregraft® technology is the standard for fat graft processing with its membrane-based tissue filtration combined with speed, simplicity, safety and precision. The Puregraft® technology takes approximately 15 minutes to purify a fat graft ranging from 50 to 850 mL, removing excess and unwanted fluid, lipid, blood cells and debris in a controllable manner. The single use system, used within the sterile field, purifies fat tissue without centrifugation or other methods. The ease of use and simplicity of this innovative system sets it apart from other traditional fat grafting methods.

About Cytori

Cytori Therapeutics is developing cell therapies based on autologous adipose-derived regenerative cells (ADRCs) to treat cardiovascular disease and repair soft tissue defects. Our scientific data suggest ADRCs improve blood flow, moderate the immune response and keep tissue at risk of dying alive. As a result, we believe these cells can be applied across multiple "ischemic" conditions. These therapies are made available to the physician and patient at the point-of-care by Cytori's proprietary technologies and products, including the Celution® System product family. www.cytori.com

Cautionary Statement Regarding Forward-Looking Statements

This communication 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, regulatory uncertainties, dependence on third party performance, and other risks and uncertainties described under the "Risk Factors" in Cytori's Securities and Exchange Filings, including its annual report on Form 10-K for the year ended December 31, 2011. Cytori assumes no responsibility to update or revise any forward-looking statements contained in this press release to reflect events, trends or circumstances after the date of this press release.

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