This approval enables the company to market its line of bioresorbable implants for bone and/or soft tissue repair in the EU. Orthomimetics’ family of products was developed during a groundbreaking collaboration between the University of Cambridge and the Massachusetts Institute of Technology.
Chondromimetic is a novel off-the-shelf implant that helps to support the repair of defects involving both articular cartilage and bone – defects that can result from sports injuries, surgical intervention and other trauma. Articular cartilage damage and subsequent degeneration of the underlying bone are known to be a major cause of arthritis in young individuals.
CE-mark approval enables the company to market Chondromimetic in Europe, and comes earlier than originally forecast at the time of the company’s December 2006 Series A financing. Orthomimetics will immediately launch a comprehensive post-market clinical-trial program for Chondromimetic, and is currently negotiating distribution agreements for key European territories. The company will pursue additional approvals in other global territories throughout 2009.
Commenting on the CE Mark approval, Dr Andrew Lynn, CEO of Orthomimetics, said:
“Orthomimetics is extremely pleased to be able to make Chondromimetic available for surgeons and patients in Europe. This approval is the result of a tremendous amount of hard work on the part of our surgeon advisors, scientific collaborators, and – most of all – our professional, dedicated team. We look forward to making Chondromimetic a clinical and commercial success.”