Periodic Reporting for period 2 - GreenBone (The Holy Grail in Bone regeneration)
Periodo di rendicontazione: 2023-09-01 al 2024-08-31
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. We want to bring from bench to bed-side the new gold standard of bone regeneration, a material which challenges the properties of autograft and surpasses other commercially available products but without the known complications. Simply a material which effectively and consistently generates bone with great handling properties at a reasonable price.
Greenbone has developed an innovative not-sintered biomaterial inspired by nature. By exploiting our patented biomorphic thermochemical process, we transform Rattan wood largely available in nature into a synthetic, acellular and resorbable 3D bone regenerative scaffold that mimics the chemical composition and pore structure of natural human bone and triggers bone regeneration safely and effectively.
GreenBone is a cost-effective and easy-to-use Class III ceramic medical device and will help physicians to restore mobility, reduce pain and improve the quality of life of their patients.
The team has been able to develop a product line to extend the use of the platform to the spinal application which represent 50% of the total market. The first solution is currently in Clinical Study while the second one is approaching the IN-VIVO testing and will enter the Clinical Study by the end of 2024.
GreenBone is a cost-effective and easy-to-use Class III ceramic medical device and will help physicians to restore mobility, reduce pain and improve the quality of life of their patients.
The team has been able to develop a product line to extend the use of the platform to the spinal application which represent 50% of the total market. The first solution is currently in Clinical Study while the second one is approaching the IN-VIVO testing and will enter the Clinical Study by the end of 2024.
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.