Inion's BioRestore glass fibre bone graft substitute:
This article was originally published in Clinica
Finnish firm Inion has received 510(k) clearance from the US FDA for its BioRestore bone graft substitute. The product, made from bioactive glass fibres, is designed to fill bony voids resulting from surgery or traumatic injury. The implant accelerates the formation of new bone, while gradually degrading over six months to allow the bone to fill the void. BioRestore is now approved for use in dental and cranio-maxillofacial applications, but is also being reviewed by the FDA for use in orthopaedic trauma indications. The US market for synthetic bone graft substitutes is estimated at around $158m, claimed the Tampere firm. Inion hopes to gain CE-marking for BioRestore during the second half of 2007 and plans to launch the product in Europe soon after.