Cytori Therapeutics Receives FDA Clearance on Device for Saving and Reinfusing Cells

Cytori Therapeutics Inc., which develops therapies that use adult stem cells, said Monday the Food and Drug Administration approved its Celution Cell Concentration System for use as a cell saver device.

The system is cleared for the collection, concentration, washing and reinfusion of a patient's own cells. Applications for the process include cardiovascular, reconstructive, vascular, and orthopedic surgeries and procedures.

The company said the FDA decision marks the first U.S. clearance of a fully automated cell processing device.

"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," said Chief Executive Christopher J. Calhoun in a statement.

In January, Cytori received European regulatory clearance on a similar system that processes cells from a patient's own adipose tissue in about an hour.

Shares of Cytori rose 5 cents to $4.90 on the Nasdaq in morning trading.