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Cytomedix plasma preparation device gets TGA nod

12 February 2013 | Regulatory | By BioSpectrum Bureau

Cytomedix platelet rich plasma preparation device Angel cPRP System gets nod from Therapeutic Goods Administration in Australia

Cytomedix platelet rich plasma preparation device Angel cPRP System gets nod from Therapeutic Goods Administration in Australia

Singapore: Cytomedix's Angel cPRP System has been listed by the TGA (Therapeutic Goods Administration) in Australia. Following this, Angel will be marketed and distributed by Medtel, a leading supplier of medical equipment and devices, in Australia.

Australia is the latest international territory where the Angel System is now included and available for sale. The Angel is also on the market in various countries throughout Europe and the Middle East. Cytomedix has established a broad network of experienced distributors to promote and sell the product in international markets. Further territory launches are expected in 2013.

"We are pleased to launch Angel in Australia where there is significant growth potential for PRP" said Mr Martin Rosendale, chief executive officer of Cytomedix. "Sales in international markets are a meaningful contributor to overall Angel revenues, and are growing at an encouraging rate. We are fortunate to be working with Medtel as they have an excellent track record in launching and promoting innovative healthcare technology products."

Ms Jeannie Devereaux, business development manager, Regenerative Medicine Sports, Orthopedic and Tissue Regeneration, at Medtel added, "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. TGA inclusion provides us with a great opportunity to develop the PRP market in aesthetics and sports medicine."

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). The initial approved indication in Australia is for the preparation of PRP from a sample of whole blood. The system is designed to produce consistently high platelet yields using a fully automated process.

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