NEWS & INSIGHTS

The GreenBone bone substitute achieves CE certification

30 January 2020

GreenBone Ortho

GreenBone received CE mark approval for the GreenBone Bone SubstituteTM

Faenza, January 30, 2020. GreenBone Ortho srl announced today that it has received CE mark approval for its nature-inspired biomimetic GreenBone Bone SubstituteTM. Lorenzo Pradella, CEO of GreenBone, states: “The CE mark is a major milestone for GreenBone. The CE mark certifies that GreenBone has successfully completed the development of the product and of its Quality System, which guarantees that all product design and production processes are in line with the ISO13485: 2016 and MDD 93/42 requirements. We believe this achievement will boost GreenBone bone substitute to become a most useful, cost-effective bone reconstructive solution.”

The GreenBone Bone SubstituteTM is a nature-inspired biomimetic graft mimicking the chemical composition (not-sintered calcium phosphate phases) and the 3D porous architecture of natural
bone. Derived from biomorphic transformation of rattan wood, it is endowed with osseointegration, osteoconduction and osteoinduction properties as needed for an effective and physiological healing also of large bone damages. The bone graft can be shaped by surgeons to achieve the best fit of the osseous defect.

The unmet need of a new generation bone substitute, able to provide a unique solution for large bone defects, is significant. The goal is to provide orthopedics and trauma surgeons with the most innovative nature-inspired solution to offer patients the opportunity to have their own natural bone regenerated. Every year, millions of patients undergo orthopedic surgeries where bone grafts are used to reconstruct different skeleton defects. All available solutions, including bone transplant (autograft), which is still the gold standard, have well known limitations. The GreenBone Bone
SubstituteTM will offer physicians and patients a new solution to avoid these surgical and postoperative complications in surgically created bone defects or osseous defects resulting from traumatic injury to the bone, in the extremities and pelvis. Future development will be in the spinal surgery and other skeleton defects and diseases affecting many patients. GreenBone is expected to enable patients a faster return to normal life with their own bone completely regenerated with a significant reduction of health care and social costs. For further information, please contact: Lorenzo Pradella of GreenBone Ortho srl

email: lorenzo.pradella@greenbone.it

TO THE EDITORS

GREENBONE™ ORTHO S.R.L.
Sede legale e amministrativa via Albert Einstein 8, 48018 Faenza (RA) Italy
Tel. +39 0546 46666 | www.greenbone.it | mail: info@greenbone.it | pec: erminetechnologysrls@legalmail.it
C.F./P.I. 02493440396 | R.E.A. RA-206894

About GreeenBone

GreenBone Ortho s.r.l., located in Faenza (Emilia Romagna, Italy) is a medical device company founded in 2014 to develop and market new generation of 3D bone substitutes inspired by nature, to address unmet needs of large bone defects in orthopedic reconstructive surgery. GreenBone mission is committed to work closely with international center of excellence and orthopedic surgeons to meet their needs and provide the highest quality, cost-effective and easy to use products. to improve quality of life of severe patients suffering from traumatic, chronic and degenerative conditions affecting bone . For more information about GreenBone please visit www.greenbone.it.

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