09.20.11
Cytomedix Inc, a developer of biologically active regenerative therapies for wound care, inflammation and angiogenesis, has submitted a 510(k) to the U.S. Food and Drug Administration (FDA) for use of the Angel Whole Blood Separation System for processing a bone marrow aspirate. The expanded indication includes processing a mixture of blood and bone marrow, a rich source of stem cells.
In vitro performance testing supporting the 510(k) compared Cytomedix's Angel System to the predicate device for preparing platelet rich plasma (PRP) from blood and bone marrow. According to the company, the test results yielded statistically significant data showing the Angel System: increased the concentrations of hematopoietic progenitor/stem cells; reduced the presence of pro-inflammatory cells that can be detrimental for treating certain medical indications; and provided better separation of PRP and red blood cells compared with the predicate device.
Expanded use of the Angel System for the production of PRP containing stem cells increases Cytomedix's ability to support and advance markets within personalized regenerative medicine. In the U.S., approximately 300,000 spinal fusion procedures are performed each year and the application of bone marrow or bone marrow concentrates has been the historical gold standard to support effective fusion.
The biologics market associated with spinal fusion procedures is approximately $800
million annually, the company estimates. While the Angel System currently is being used at a limited number of clinical sites for this purpose, FDA clearance for this expanded indication will allow Cytomedix to market the Angel System for this sector.
In addition to spinal fusion procedures, the stem cell enriched concentrates produced by the Angel System offer clinical opportunities currently being evaluated for the treatment of critical limb ischemia and cardiac ischemia. Clinical investigation is underway in numerous studies in both therapeutic conditions involving various aspects of autologous stem cells.
Cytomedix is located in Gaithersburg, Md.
In vitro performance testing supporting the 510(k) compared Cytomedix's Angel System to the predicate device for preparing platelet rich plasma (PRP) from blood and bone marrow. According to the company, the test results yielded statistically significant data showing the Angel System: increased the concentrations of hematopoietic progenitor/stem cells; reduced the presence of pro-inflammatory cells that can be detrimental for treating certain medical indications; and provided better separation of PRP and red blood cells compared with the predicate device.
Expanded use of the Angel System for the production of PRP containing stem cells increases Cytomedix's ability to support and advance markets within personalized regenerative medicine. In the U.S., approximately 300,000 spinal fusion procedures are performed each year and the application of bone marrow or bone marrow concentrates has been the historical gold standard to support effective fusion.
The biologics market associated with spinal fusion procedures is approximately $800
million annually, the company estimates. While the Angel System currently is being used at a limited number of clinical sites for this purpose, FDA clearance for this expanded indication will allow Cytomedix to market the Angel System for this sector.
In addition to spinal fusion procedures, the stem cell enriched concentrates produced by the Angel System offer clinical opportunities currently being evaluated for the treatment of critical limb ischemia and cardiac ischemia. Clinical investigation is underway in numerous studies in both therapeutic conditions involving various aspects of autologous stem cells.
Cytomedix is located in Gaithersburg, Md.