Regenerative therapies company Cytomedix has received clearance from the Therapeutic Goods Administration (TGA) to commercialize its Angel cPRP system in Australia.
The approval allows the company to use the system in the clinic or intraoperatively at the point-of care for the preparation of platelet rich plasma (PRP) using a sample of whole blood.
The company said the proprietary software embedded in the system automatically adjusts the separation parameters to deliver a consistent, high quality product.
The Angel system also offers other benefits including high platelet yields, significant reduction in pro-inflammatory cells, rapid processing time, adjustable hematocrit from 0%-25%, and flexible final cPRP volumes.
Cytomedix chief executive officer Martin Rosendale said, "Sales in international markets are a meaningful contributor to overall Angel revenues, and are growing at an encouraging rate."
Cytomedix said it has appointed Australian-based medical equipment and devices supplier Medtel for distributing and marketing Angel cPRP system in Australia.
Medtel regenerative medicine sports, orthopedic and tissue regeneration business development manager Jeannie Devereaux said TGA inclusion provides the company with an opportunity to develop the PRP market in aesthetics and sports medicine.
"We view the Angel cPRP System as the gold standard in platelet rich plasma preparation and expect a positive response to our Angel launch activities," Devereaux added.
The Angel system is also available in various countries throughout Europe and the Middle East.