RTI Surgical Receives Regulatory Clearances for nanOss Bioactive in Australia, Europe
RTI Surgical received regulatory clearance from the Australian Therapeutic Goods Administration for nanOss® Bioactive bone void filler in Australia, as well as CE Mark for nanOss Bioactive Loaded and nanOss Bioactive 3D in Europe. The products will be distributed by LifeHealthcare in Australia and independent distributors in the EU.
nanOss Bioactive bone graft substitute is composed of nano-structured hydroxyapatite granules in an open structured engineered collagen carrier.
nanOss Bioactive Loaded is a closed system in a pre-filled mixing syringe, while nanOss Bioactive 3D comprises nano-structured hydroxyapatite granules suspended in a porous gelatin-based foam matrix.
Pioneer Surgical Technology launched nanOss Bioactive Loaded in 2011, having acquired the technology with its purchase of Angstrom Medica in 2007. Pioneer announced the 1st human use of nanOss Bioactive 3D in 2012.
RTI completed its acquisition of Pioneer Surgical in 2013, and relaunched nanOss Bioactive 3D in 2014.
Sources: RTI Surgical, Inc.; ORTHOWORLD Inc.