Orthogem, a UK based company specialising in the research and development of synthetic bone products, has been granted FDA clearance to sell its advanced synthetic bone graft TriPore in the US, following earlier success with European CE Mark registrations.
TriPore is different from other synthetic bone grafts (SBG’s) and represents a new generation ready to challenge the gold standard of autograft and expensive BMP biologics. Orthogem designed TriPore with a unique structure to provide the most favourable environment for osteogenic cells to form new bone. In meeting the design criteria, Orthogem developed and patented TriPore as a platform technology capable of being produced in many forms for specific clinical applications using a completely new and patented manufacturing process. Extensive pre‐clinical studies show that TriPore outperforms traditional SBG’s without the need for the added complexity of additional chemical or physical modification.
Mr Nick Birch, UK spine surgeon and clinical advisor to Orthogem, commented that ‘’ TriPore achieves rapid and sustainable bone growth throughout the ceramic implant resulting in a robust and viable implant site with graft resorption at the same rate as new bone formation”.
Orthogem TriPore technology forms the core of an exciting and comprehensive product development pipeline.
John Cucchi, Orthogem’s CEO, said that ‘’ with the 510k clearance for the first of the TriPore pipeline of products we are confident of building on our successful signing of marketing partners in Europe and attracting quality US distribution partners who will benefit from a high performance SBG to complement their portfolios’’.
ENDS
26th July 2007
For information on Orthogem and TriPore please contact
Mr John Cucchi or Dr. Wei‐jen Lo CEO CSO
+44 7983 336 051 +44 7906 001 281
Orthogem Ltd, Biocity, Pennyfoot Street, Nottingham, NG1 1GF, England
www.orthogem.com