Cytomedix, Inc. (OTCQX: CMXI), a regenerative therapies company commercializing and developing innovative platelet and adult stem cell technologies, announced today it has received CE Mark approval for the Angel Concentrated Platelet Rich Plasma (cPRP) System for processing blood and bone marrow aspirate. Cytomedix is now free to market and distribute the Angel cPRP system with this new indication throughout the European Economic Area and in other countries where the CE Mark is recognized. The new indication creates potential for use in bone repair and regeneration procedures that includes spinal, periodontal and joint revision surgery.
Cytomedix has established a broad network of experienced distributors to promote and sell the Angel cPRP system in international markets. International Angel sales have tripled over the past year with rapid expansion in Europe and the Middle East fueling growth to over $1 million expected for full year 2012. Angel is well represented in key European markets such as United Kingdom, Netherlands, Italy, and Poland with plans to expand the European base in 2013. Sales growth in the Middle East will be driven by entry into new countries such as Kuwait, Saudi Arabia and Bahrain with the expanded indications.
"The CE Mark for the Angel cPRP System for use with bone marrow aspirate represents an important milestone for our overseas business," said Martin Rosendale, Chief Executive of Cytomedix. "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."
The Angel cPRP System is intended to be used in the clinic or intraoperatively at the point-of-care for the safe and rapid preparation of platelet rich plasma (PRP) from a small sample of whole blood or a small mixture of blood and bone marrow. The system is designed to produce consistently high platelet yields using a fully automated process and represents a significant engineering advance in autologous whole blood and bone marrow separation. Angel's advantages compared with other commercially available systems include: 1) high platelet yields, 2) significant reduction in pro-inflammatory cells, 3) rapid processing time, 4) adjustable hematocrit from 0%-25%, and 5) flexible final cPRP volumes. Proprietary software automatically adjusts the separation parameters to deliver a consistent, high quality product.
CE is a mandatory European marking for certain product groups to indicate conformity with the essential health and safety requirements set out in European Directives.
About Cytomedix, Inc.
Cytomedix, Inc. is an autologous regenerative therapies company commercializing innovative platelet technologies for orthopedics and wound care with a pipeline of adult stem cell therapies for tissue repair. The Company markets the AutoloGel System, a device for the production of autologous platelet rich plasma ("PRP") gel for use on a variety of exuding wounds and the Angel Concentrated Platelet Rich Plasma System, a blood processing device and disposable products used for the separation of whole blood into red cells, platelet poor plasma ("PPP") and PRP in surgical settings. On February 8, 2012 Cytomedix closed the acquisition of Aldagen, a biopharmaceutical company developing regenerative cell therapies based on its proprietary ALDH bright cell technology, currently in a Phase 2 trial for the treatment of ischemic stroke. For additional information please visit cytomedix.com.