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