Cytomedix has submitted a 510(k) application to the US Food and Drug Administration (FDA) for use of the Angel Whole Blood Separation System to process a bone marrow aspirate.
The blood processing device is used to separate whole blood into red cells, platelet poor plasma (PPP) and platelet rich plasma (PRP) from blood and bone marrow in surgical settings.
Cytomedix said, in addition to spinal fusion procedures, the stem cell enriched concentrates produced by the Angel System offer clinical opportunities currently being evaluated to treat critical limb ischemia and cardiac ischemia.
The company claims clinical investigation is underway in numerous studies in both therapeutic conditions involving various aspects of autologous stem cells.
Cytomedix CEO Martin Rosendale said they continue to explore a variety of indications where the Angel System can provide added therapeutic benefit and expect its clinical results and ease-of-use will help drive sales in these expanded market indications.
The company develops, sells and licenses regenerative biological therapies primarily for wound care, inflammation and angiogenesis.