The Australian Therapeutic Goods Administration (TGA) has approved Cytomedix's Angel cPRP system for the preparation of platelet rich plasma (PRP) from a sample of whole blood.
Using a fully automated process, the system produces consistently high platelet yields for use in the clinic or intraoperatively at the point-of-care.
The Angel system also offers other benefits including significant reduction in pro-inflammatory cells, rapid processing time, adjustable hematocrit from 0%-25% and flexible final cPRP volumes.
The proprietary software embedded in the system automatically adjusts the separation parameters to deliver a consistent, high-quality product, claims the company.
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."
The company said it has partnered with Australian-based medical equipment and devices supplier Medtel to expand the availability of 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 said.
The Angel system is also available in various countries throughout Europe and the Middle East.