Periodic Reporting for period 3 - GreenBone (The Holy Grail in Bone regeneration)
Periodo di rendicontazione: 2024-09-01 al 2025-08-31
Regeneration of bone defects is an important and unsolved problem in the orthopaedic practice with high social costs, high incidence in the population and a high economic impact on the healthcare system. Current procedures often show lack of vascularization and aeration of the materials. Bone healing is typically slow, over 25% of non-unions require multiple and painful surgeries, long hospitalization and recovery time and patients’ pain is rarely completely relieved. In addition, the risk of complications such as deep infection, non-union and amputation is high, 52%, 66% and 6.6%, respectively.
The GREENBONE project was conceived to address a critical need in spinal surgery: the development of a biomimetic bone graft that combines mechanical strength with regenerative capacity. GREENBONE’s objective was to bring to market a disruptive bone substitute—b.Spine—based on a proprietary biomaterial platform derived from rattan wood. This material mimics the structural, chemical, and morphological properties of human bone, offering multimodal osteogenic potential: osteoconduction, osteoinduction, and osteogenesis. The project aimed to validate this innovation through rigorous preclinical and clinical studies, culminating in CE certification.
The pathway to impact was carefully designed to navigate regulatory complexities and ensure market readiness. Clinical trials demonstrated a 100% spinal fusion success rate at 12 months, outperforming benchmarks and confirming the product’s efficacy and safety.
The GREENBONE project was conceived to address a critical need in spinal surgery: the development of a biomimetic bone graft that combines mechanical strength with regenerative capacity. GREENBONE’s objective was to bring to market a disruptive bone substitute—b.Spine—based on a proprietary biomaterial platform derived from rattan wood. This material mimics the structural, chemical, and morphological properties of human bone, offering multimodal osteogenic potential: osteoconduction, osteoinduction, and osteogenesis. The project aimed to validate this innovation through rigorous preclinical and clinical studies, culminating in CE certification.
The pathway to impact was carefully designed to navigate regulatory complexities and ensure market readiness. Clinical trials demonstrated a 100% spinal fusion success rate at 12 months, outperforming benchmarks and confirming the product’s efficacy and safety.
GREENBONE project successfully completed the development and validation of b.Spine a biomimetic bone graft for spinal fusion. The team overcame regulatory and technical challenges, achieving CE mark readiness through rigorous preclinical and clinical testing. Clinical trials demonstrated 100% fusion success at 12 months, confirming the device’s safety and efficacy. The project also advanced b.Putty a moldable variant with superior in vitro performance, now patented. All technical objectives were met, including process validation, usability testing, and regulatory documentation. The innovation remains aligned with the original scope, offering a disruptive solution for spinal surgery based on Greenbone’s proprietary biomaterial platform
In general terms there are many different products that can fill a bone defect, but they have widely different effectiveness. BMPs and autograft (gold standard) are the only class of solutions that are osteo-inductive and as such are the only true competitors to Greenbone. Autograft is the gold standard, still it presents some disadvantages: pain and donor site morbidity, cost of harvest and the amount and quality of available bone. Other class are synthetic materials, allografts and its derived Demineralized Bone Matrices (DBMs) that are all only osteoconductive, hence Greenbone is an order of magnitude more effective than these solutions. Allograft and DBMs have been used but have risk of infection and the required high-thermal sterilization process removes their ability to make bone. They are further complicated by availability, quality of available bone, need for stringent control and expensive licenses. All synthetics are sintered materials which reduces the ability to make bone.
The results from the clinical study showing the performance of Greenbone solution for spinal surgery as aligned to Autograft would define a new state of the art for synthetic scaffold. Further uptake and success will require effort in terms of dissemination activities, brand positioning and access to market. Ad-hoc case report may be needed to push and sustain the clinical evidence required to ensure traction on the market. Similarly, clinical effort on the trauma line should be positively affecting the overall perception of the common technological platform.
The results from the clinical study showing the performance of Greenbone solution for spinal surgery as aligned to Autograft would define a new state of the art for synthetic scaffold. Further uptake and success will require effort in terms of dissemination activities, brand positioning and access to market. Ad-hoc case report may be needed to push and sustain the clinical evidence required to ensure traction on the market. Similarly, clinical effort on the trauma line should be positively affecting the overall perception of the common technological platform.