Cytomedix (OTC:CMXI) received the CE Mark approval in the European Union for its Angel concentrated platelet rich plasma system.
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."
International sales of the device have tripled over the past year, particularly in Europe and the Middle East where sales are expected to grew over $1 million for 2012, according to the press release.