Cytomedix, a healthcare products manufacturer based in Gaithersburg, Maryland, received CE Mark approval from the European Union for its Angel plasma system. The Angel concentrated platelet rich plasma system is designed for use in bone regeneration and repair during periodontal, joint revision and spinal surgery. The device received clearance from the United States FDA in November of this year.
According to a press release by the company, the Angel cPRP system gives healthcare providers the ability to create customized plasma formulations. In addition, the Angel cPRP system can be used to prepare plasma in clinical settings from whole blood samples.
Martin Rosendale is CEO of Cytomedix. In prepared remarks, he said, "The CE Mark for the Angel cPRP System for use with bone marrow aspirate represents an important milestone for our overseas business.” He continued, "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."
According to the press release, international sales of the Angel cPRP system have increased 300 percent over the last 12 months. Sales of the device have been brisk in both European and Middle Eastern markets.