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Bone graft substitute receives FDA 510(k) clearance

Pioneer Surgical Technology : 04 September, 2008  (New Product)
Pioneer Surgical Technology has received 510(k) clearance from the US FDA to market FortrOss, a novel bone graft substitute that uses nanotechnology for orthopaedic applications.
The FortrOss bone void filler is a scaffold for the in-growth of new bone and other connective tissues, when superior bone regeneration is required.

Pioneer's president and chief executive officer Matthew Songer said, 'There has been an incredible effort to bring this next generation bone Graft substitute to the market. In a little more than a year since the 2007 acquisitions of Encelle, Inc. and Angstrom Medica, the three teams have combined the nanotechnology of the nanOss material with the osteopromotive scaffold technology of the E-Matrix to create the most advanced bone void filler on the market.'

The osteoconductive matrix in FortrOss utilises Pioneer's nanOss technology and is designed to mimic the nanostructures inherent in boney tissue. Dr Edward Ahn, vice president of biomaterials at Pioneer stated, 'Because the nanOss hydroxyapatite in FortrOss resembles the size, shape, and chemistry of native bone, boney tissue has a great affinity for nanOss and recognizes it as native tissue. This mimicry of native bone makes nanOss superior to other calcium phosphates on the market.'

'The FortrOss carrier is a collagen based bioscaffold processed to provide an osteopromotive effect. Pioneer's patented E-Matrix technology provides the unique open structure for bone growth and repair,' said Dr Ron Hill, vice president of research and development at Pioneer.

The combined nanotechnology-based osteoconduction and osteopromotive E-Matrix scaffold of FortrOss positions Pioneer to impact significantly the dynamic field of bone and tissue repair. FortrOss is expected to be released in the USA later this year.

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