Laboratory systems  

Cytori Therapeutics achieves US clearance for cell concentration system

5 Oct 2006

San Diego, USA. 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, orthopaedic, 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. The company says that this system will be used in its 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.

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