RepRegen, the 'smart biomaterials' company, has submitted StronBone to the US Food and Drug Administration for 510(k) clearance.
RepRegen claims CE marked StronBone bioactive glass with Strontium is the first product that is being commercialized from company’s repair and regeneration platform of ‘smart’ biomaterials for bone and other hard tissue.
RepRegen has discovered that the addition of Strontium ‘turbocharges’ the bioactivity of bioceramic technology, which enables development of enhanced products to repair and regenerate bone and other hard tissue.
RepRegen CEO Ian Brown said RepRegen’s advanced biomaterials represent a leap forward in designing superior products for tissue repair and regeneration by supporting and enhancing natural cellular growth and tissue regeneration in vivo.
RepRegen chairman Stephen Rietiker said the business opportunities ahead of RepRegen are significant and the company’s ‘smart’ biomaterials related to its hard tissue platform are of great interest to a significant number of orthopaedic companies with whom we are in discussions.