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Background



Bone defects result from high-energy traumatic events, bone tumour, bone infection, from the treatment of complex non-unions and in surgery procedures like spine fusions or joint replacements. All very challenging conditions in orthopaedic practice.

Current therapy of bone defects usually implies the use of bone grafts and/or biocompatible materials that enhance bone biology and the migration of cells from the surrounding tissues to fill the gap.

Autograft (autologous bone) and Allograft (cadaver bone) are the treatment most currently used for large bone loss, but all treatments have significant disadvantages such as harvesting process peri-operative and post-operative complications and morbidity, low efficacy of frozen or freeze dried allograft, the potential of immunogenicity, and the hazard of microbial contamination. Accordingly with scientific literature , there is not any ideal bone substitute with the necessary osteoinductive, osteoconductive and mechanical properties.

our product

GreenBone Bone Substitute



GreenBone is a synthetic, acellular, reabsorbable, new generation bone substitute, being suitable for surgical reconstruction of bone defects. GreenBone is indicated to bone gaps and voids that are not intrinsic to the stability of the bone structure, caused by trauma, non-union or surgically induced defects in the extremites and the pelvis. Future development will be in bone infection, bone cancer, spine fusion and other applications.

implant

References:
1. Arner JW, Santrock RD. A historical review of common bone graft materials in foot and ankle surgery. Foot Ankle Spec. 2014 Apr;7(2):143-51.
2. Bhatt RA, Rozental TD. Bone graft substitutes. Hand Clin. 2012 Nov;28(4):457-68.
3. Boyan BD, McMillan J, Lohmann CH, Ranly DM, Schwartz Z. Basic information for successful clinical use with special focus on synthetic graft substitutes. In: Laurencin CT, editor.Bone graft substitute. Philadelphia: ASTM Int; 2002. P.231 -59.
4. Campana V, Milano G, Pagano E, Barba M, Cicione C, Salonna G, Lattanzi W, Logroscino G. Bone substitutes in orthopaedic surgery: from basic science to clinical practice. J Mater Sci Mater Med. 2014 Oct; 25(10):2445-61.
5. Giannoudis PV, Einhorn TA, Marsh D. Fracture healing: the diamond concept. Injury. 2007 Sep;38 Suppl 4:S3-6. 6. Lewandrowski KU, Gresser JD, Wise DL, Trantol DJ. Bioresorbable bone graft substitutes of different osteoconductivities: a histologic evaluation of osteointegration of poly(propylene glycol-co-fumaric acid)-based cement implants in rats. Biomaterials. 2000 Apr;21(8):757-64.
7. Miron RJ, Zhang YF. Osteoinduction: a review of old concepts with new standards. J Dent Res. 2012 Aug;91(8):736-44.
8. Pryor LS, Gage E, Langevin CJ, Herrera F, Breithaupt AD, Gordon CR, Afifi AM, Zins JE, Meltzer H, Gosman A, Cohen SR, Holmes R. Review of bone substitutes. Craniomaxillofac Trauma Reconstr. 2009 Oct;2(3):151-60.


GreenBone is a patented technology (WO 2012/063201, WO 2017/021894).
 
 
 

Naturally Better

At ISTEC-CNR (Institute of Science and Technology for Ceramics), a nature-inspired project led by Anna Tampieri’s team prompted a screen for plants that have a similar internal structure to bone: Rattan (a bamboo-like plant) resulted the best candidate with an internal 3D architecture that incorporates xylem-transporting channels, which mimic the way blood vessels run through bone. GreenBone bone substitute is designed to mimic the chemical composition (calcium phosphate phases plus ions) and porous architecture of natural bone substitute and it is suitable for the natural process of bone regeneration. This is why is defined as biomimetic scaffold. The porosity of the GreenBone bone substitute which acts like the harversian channels throughout the whole graft, permits an extensive vascularization and biologic fluids exchange. This architecture is one of the most important features of the product which differentiates GreenBone from the other available bone substitute in the market lacking of a hierarchical structure similar to the natural bone structure. It is obtained through a unique manufacturing process that transforms Rattan wood to the biomimetic GreenBone bone substitute while—crucially— preserving its natural porosity architecture. The images below represent the bone structure and the GreenBone material structure (CT scan of a GreenBone hollow cylinder bone substitute).

Innovative solution

GreenBone is a biomimetic bone substitute designed to mimic the chemical composition (calcium phosphate phases plus ions) and porous architecture of natural bone and is suitable for the natural process of bone regeneration. GreenBone aims to be the new gold standard for bone reconstruction surgery, endowed with properties never achieved so far in the same bone graft. Preclinical in-vitro and in-vivo studies confirmed GreenBone profile:
• Osteointegration, osteoconduction, osteoinduction;
• 3D porosity mimicking bone harversian channels;
• Biocompatible and safe;
• Resorbable;
• Enhance bone regeneration;
• Suitable to be cutted and shaped by the surgeons to best fit the gap or void;
• Used in combination with adequate postoperative immobilization if required;
• Suitable to be soaked with biological fluids like blood and bone marrow.

GreenBone: Osteointegration, Osteoconduction, Osteoinduction

In a load bearing large bone loss sheep study (Assaf-Harofeh Medical Center Israel and Rizzoli Orthopedic Institute Italy) GreenBone has successfully showed extraordinary results:

a) safe in all animals,
b) complete physiological healing and regeneration achieved in 6 months,
c) osteotomy line not visible any more,
d) histological and morphological analyses confirmed new bone tissue physiology,
e) mechanical assessment showed a well advance remodelling and maturation process,
f) new blood vessel formation.

The study has confirmed GreenBone unique Osteointegration, Osteoconduction and Osteoinduction properties.

Finally, complete biocompatibility without any risk of immunogenicity, infections or inflammation have been demonstrated accordingly with EU standards and US guidelines.

Bone regeneration in large bone defects resulting from trauma or other diseases remains an unsolved problem in trauma and orthopaedic practice with high economic impact on both healthcare system and social costs.

The Global Orthopedic Biomaterials market is expected to grow from US$23.6 billion to US$30.6 billion in 2022, with the biomaterial used only for tissue reconstruction increasing from US$4,7 billion in 2017 to reach nearly US$7.2 billion by 2022 [TechNavio analysis].

Autograft (self-transplanted bone) is still the gold standard solution able to regenerate large bone defects or voids. The identification of synthetic bone substitutes that behaves like transplanted bone is a major goal to achieve.

GreenBone bone substitute is a new generation acellular, biomimetic, resorbable and regenerative bone substitute. It is indicated for use in the treatment of surgically created osseous defects or osseus defects resulting from traumatic injury to the bone, in the extremities and pelvis.

Future development will be in bone infection, bone cancer, spine fusion and other applications.

GreenBone bone substitute can be produced in any size and shape to solve all the problems and medical needs experienced every day in bone grafting by orthopaedic surgeons.

Considering current and future applications GreenBone aims at >500M US$ in EU+USA peak sales.

 

Rattan why?

If wood was good enough for George Washington’s teeth, it’s good enough for our bones. This is one of the most widespread and enduring myth but visionary to the future.

At ISTEC-CNR in Faenza a team of researchers led by Anna Tampieri looking for materials that could one day be used to replace bone in grafts and implants, suggested that certain types of wood could inspire the generation of innovative biomaterial with the qualities doctors look for in a biocompatible bone substitute. Indeed, the remarkable biomechanical properties of bone depend on its hierarchically organized structure, from the molecular to nano-, micro-, and macro-scales, which makes it able to constantly adapt to ever-changing mechanical needs. In this regard, only scaffolds endowed with the right chemistry and the required hierarchically organized structure can exhibit complex biomechanical performances, yielding regeneration of well-organized bone. Natural woods show behaviors similar to bones in terms of elasticity, lightness, and strength. In this regard, the researchers cleverly thoughts, some woods could be transformed into porous devices acting as scaffolds and exhibiting pore size and organization that are suitable to mimic the biomechanical characteristics of human bone. This concept inspired new designs for bone grafts and implants to become the gold standard in reconstructive orthopaedic surgery. Rattan, a naturally renewable palm that grows in the tropical regions of Africa, Asia and Australasia was chosen… and the journey started. The children’s novel The Adventure of Pinocchio (the wooden puppet that become a real boy) written by Carlo Collodi (1883) is getting real.

Bioinspired Structural Materials


Nature’s hierarchical materials

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