XPAND Biotechnology BV has developed a new generation of orthopaedic materials: the EpitaxOs bone regeneration material. EpitaxOs (TRL 6) is unique:a) it seduces the body to form boneb) is as effective as the golden standard autograft without its disadvantages (extra operative procedure, pain, limited quantity available)c) it is superior to other synthetic bone graft materials, allograft, growth factors and cell-based technologiesd) it is available in abundant quantities e) it increases the quality of life for patients as the use of EpitaxOs has no adverse effects on the patient. The innovative property of EpitaxOs is its patented surface nano-structure, which induces the formation of bone by attracting the patient’s own stem cells to the defect site and stimulate them to make autologous bone (in situ bone tissue regeneration). Similar to autograft and growth factors and unlike other synthetic materials, EpitaxOs is a true bone inducing material, but generates bone much fasterEpitaxOs is targeted at the €4 billion spinal market and the €200 million dental market. The exceptional bone inducing properties of EpitaxOs put it in a unique position to replace autograft, (processed) allograft and growth factors.The CHARME project aims at bringing EpitaxOs from technological maturity level TRL6 to a successful commercial/ production launch at level TRL 8/9 (in 2017). The objectives are:1. Development of a commercial scale production infrastructure2. Regulatory submission of EpitaxOs in key markets3. Providing evidence-based data to demonstrate product superiority and facilitate product launch & market acceptance4. Establishment of a marketing channel and development of a strategy for commercialisation of EpitaxOs The endpoints of the CHARME project will be EpitaxO, a commercial scale infrastructure, to manufacture EpitaxOs, regulatory submission, approval in Europe, clinically relevant study data, a marketing channel, plan for the commercialisation.