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Cytomedix (CMXI) Seeks to Extend Market Reach through 510(k) Submission to FDA

Cytomedix Inc., a leading developer of biologically active regenerative therapies for wound care, inflammation and angiogenesis, announced it recently submitted a 510(k) to the U.S. Food and Drug Administration (FDA) for extended use of the company’s Angel® Whole Blood Separation System to process a bone marrow aspirate. Angel is a blood processing device and disposable products currently used to separate whole blood into red cells, platelet poor plasma (NYSE:PPP) and platelet rich plasma (PRP).

By expanding the use of the Angel System to the production of PRP, Cytomedix gains ground to advance into markets within personalized regenerative medicine.

Citing market specifics, the company noted that in the U.S., approximately 300,000 spinal fusion procedures are performed each year; the biologics market for spinal fusion procedures is approximately $800 million annually. While the Angel System is currently used at limited clinical sites for spinal fusion procedures, obtaining FDA clearance to expand application of the system will subsequently expand Cytomedix’s market reach.

The company highlighted an in vitro performance test, supporting the 510(k), comparing Angel System to a “predicate” device for preparing PRP from blood and barrow. The results demonstrated statistically significant data, showing Angel System capable of several key factors:

• 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.

“We are pleased to have filed this 510(k) for a bone marrow concentrate indication as it expands the versatility and competitive positioning of the Angel System for both new and existing customers. Importantly, this indication serves a number of large markets that we believe the Angel System is well-poised to penetrate,” Martin P. Rosendale, CEO of Cytomedix stated in the press release. “We 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.”

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. Significant clinical investigation is underway in numerous studies in both therapeutic conditions involving various aspects of autologous stem cells. The Angel System is well positioned as a best-in-class device to participate in this evolving therapeutic arena.

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