06 Oct Orthogem’s TriPore Putty given CE Mark
Orthogem is a British medical device company, founded in 2001 and based in Nottingham’s BioCity. Orthogem manufactures its patented synthetic bone graft, TriPore, in Nottingham and makes its products available via specialist distributors in multiple territories.
Orthogem’s TriPore Putty has been given its CE Mark, allowing Orthogem to promote TriPore Putty across the EU. This is a project Orthogem initiated four years ago focusing on the need to improve the handling characteristics of Putty products already available on the market.
This journey has been particularly challenging, due to changes in the medical device regulation which occurred in 2016. These changes significantly increased the regulatory hurdles to overcome, however, we are proud to announce our success. TriPore Putty provides Orthogem with the opportunity to access the spine surgery market across the EU, which has the potential to be transformational for the company.
TriPore was developed based on the observation that the microstructure of Synthetic Bone Grafts (SBGs) was essential to produce an environment to allow bone regeneration. TriPore’s macro, midi and microstructure supports bone formation (osteogenesis). The microstructure of TriPore is optimal for osteogenic activity and is created by Orthogem’s unique manufacturing process.
Unlike other ceramic bone grafts, TriPore’s structure allows for osteocyte formation throughout the entire ceramic body and not just at the graft surface. Other ceramic bone grafts have been shown to either be absorbed too quickly or to not fully resorb. TriPore remodels at the same rate as the bone heals, supporting the body’s natural healing process. TriPore Putty is TriPore HA granules combined with an aqueous gel to create a putty.