Cytomedix Inc. (OTCBB: CMXI) shares jumped 8.6% to 38 cents Thursday, on exciting news surrounding its Angel® Whole Blood Separation System. Volume for the stock approached its full-day average of around 65,900 shares by noon ET.
The company, located in Gaithersburg, Md., issued a news release Thursday, in which it announced today the recent submission of 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.
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.
The release quoted Cytomedix CEO Martin Rosendale as saying, “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.”
Cytomedix develops, sells and licenses regenerative biological therapies primarily for wound care, inflammation and angiogenesis.