The innovative idea is starting from wood to repair bone defects and provide patients the opportunity to return faster to normal life with their own bone completely regenerated.
GreenBone is transforming the treatment landscape for surgically created bone defects (like non-union) or osseous defects resulting from traumatic injury to the bone, in the extremities and pelvis.
Project development has been conducted in compliance with MDD93/42/EC, MDR 745/2017 and QSR FDA requirements.
Preclinical studies confirmed biocompatibility and safety of GreenBone scaffold material in conformity to ISO10993 Standards Series for long term implants.
Robust evidence of safety and new bone formation has been achieved in a sheep study with large bone loss in load bearing bone.
Production process has been set up in compliance with ISO13485:2016 to produce bone substitutes in different shapes and sizes.
Two multinationals first in man pre-market clinical studies in patients with non-loaded (iliac crest) and load-bearing long bone (extremities) defect (2 cm plus) are ongoing to meet the requirements of the MDR 745/2017.
We are working to complete the conformity process to obtain CE-Mark within the next 12 months.
Future development will be in bone infection, bone cancer, spine fusion and other applications.