Cytomedix lands CE Mark approval in the European Union for its Angel concentrated platelet rich plasma system, which received FDA clearance last month.
The Angel cPRP system, which is designed to produce consistently high platelet yields for potential use in bone repair and regeneration in spinal, periodontal and joint revision surgery, received FDA clearance in November.
The company said the system features adjustable settings to "customize plasma formulations and prepare plasma from whole blood samples either at the patient's point-of-care or in a clinical setting."
"The CE Mark for the Angel cPRP System for use with bone marrow aspirate represents an important milestone for our overseas business," CEO Martin Rosendale said in prepared remarks. "We see this new indication having a noticeable impact on our promotional efforts and becoming a major driver of growth in various international markets. On the strength of this approval, we believe that international Angel revenues have the potential to double in 2013."
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