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Cytori Therapeutics, Inc. (CYTX) Receives 510(k) Clearance from the FDA on Puregraft 850

Cytori Therapeutics is developing cell therapies based on autologous adipose-derived regenerative cells (ADRCs) to treat cardiovascular disease and repair soft tissue defects. The company believes ADRCs improve blood flow, moderate the immune response, and keep at-risk tissues from dying.

The company announced today that it has received 510 (k) clearance from the U.S. Food and Drug Administration for the Puregraft 850 system for body contouring using a patient’s own fat. It had already received European clearance. This product line extension from Cytori provides optimized and sterile processing in only 15 minutes of up to 850 milliliters of tissue. Cytori’s best-in-class Puregraft products standardize the preparation of fat grafts. Fat grafting is an important trend in reconstructive and aesthetic surgery.

The increased amount of tissue processed is a significant step from Cytori’s previous Puregraft 250 system which processed up to 250 milliliters. The larger tissue volumes processed expands the range of soft tissue procedures for which Cytori’s product line may be used. This is important in a growing market. According to the American Society of Plastic Surgeons’ most recent report, more than 57,000 fat grafting procedures were performed in the U.S. in 2010, a 14% increase over the prior year.

For additional information about Cytori Therapeutics and its Puregraft line of products, please visit the company’s website at www.cytori.com