BONEGRAFT A product line of osteoplasty materials for the regeneration of bone tissue

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Project objective

Creation of a line of implantable medical devices for restoration of bone defects for use in dentistry and traumatology.

Project description

The project is aimed at creating a new line of medical products based on biological matrix with fully preserved native 3D organization possessing increased osteo - and biointegration; optimal biodegradation rate; high biocompatibility; lacking immunoreactivity on the part of the recipient; having high osteoconduction ability and pronounced osteogenic potential in osteosynthesis and bone grafting.

The scientific and technical basis of this project, determining its innovation, includes:

  • The use of technology for obtaining native unreconstructed collagen type I from various sources. The resulting collagen matrix has a fully preserved 3D organization corresponding to that in a living organism;
  • Use of unreconstructed collagen type I as a universal matrix for components with pronounced osteoinductive properties;
  • Use of supercritical fluid technologies for highly effective purification, sterilization of medical products from native collagen and osteogenic factors without changing their activity and structure.
The products of the line have the following features:

  • high biocompatibility (absence of immunoreactivity on the part of the recipient);
  • high degree of osteoconduction (due to the possibility of control during the manufacture of the internal structure and porosity of the material);
  • expressed osteogenic potential (due to a complex of osteoinductive factors);
  • high resistance to biodegradation (due to the use of type I non – reconstructed collagen as the matrix).

Project description

Material BoneGraft is highly purified cell-free unreconstructed native collagen matrix of xenogenic origin with fully preserved three-dimensional structure and preserved native amorphous form of hydroxyapatite and calcium phosphate. The material has a porous structure, very similar to the structure of autogenous bone, and, in the course of gradual resorption, it is replaced with a new bone.

Application areas

BoneGraft is recommended for filling of uninfected bone defects and bone augmentation in dentistry, orthopedics, traumatology, reconstructive surgery and oncology in the following cases:

  • augmentation/reconstruction of alveolar ridges;
  • filling post-extraction tooth holes;
  • in implantology: in the preparation of sites for installation of the implant; filling in the cracks in the bone and sinus lift; lifting of the sinus base (subantral augmentation); filling of alveolar defects to maintain the level of the alveolar bone to improve the condition following orthopedic treatment; filling of extraction defects to create the base for a dental implant;
  • in periodontology: for filling bone defects; membrane support during regulated tissue regeneration; filling of pathological bone pockets, as well as defects at the level of bi-and trifurcation of teeth; augmentation of atrophied maxillary sinus; filling of bone defects caused by fractures, bone cysts, other multigrid bone defects of alveolar processes and facial bones of the skull;
  • bone resorption defects: defects after cystectomy of bone cyst;
  • defects after resection of the root apex;
  • defects after surgical removal of impacted teeth;
  • reconstruction of bone structures in combination with metal structures, including revision arthroplasty;
  • filling large bone defects;
  • filling bone defects after osteotomy and bone resections;
  • filling of bone defects after resection for neoplastic lesions.

Benefits of the project

Due to the fact that BoneGraft contains Type 1 collagen preserved in the process of production, the material acts as a support (a three-dimensional matrix) for the growth of autologous osteoid cells present in the bone wound. The presence of nanocrystalline hydroxyappatite in the composition of the material delays its resorption in conditions of a non-inflamed bone wound, with normal "unoxidized" pH values. Nanoscale hydroxyapatite in native form is an ideal osteoconductive material, and the preserved porous structure acts as a matrix for fibroblasts and osteoblasts. A pronounced inflammatory reaction with the formation of purulent exudate shifts the pH values in the wound, resulting in accelerated resorption of hydroxyappatite, while protease (enzymatic) resorption of chemically unstable collagen occurs at an accelerated rate.

Patents/licenses/certificates

Certificates of quality management system ISO 9001-13485 for the implementation of research and development in the field of natural and technical sciences, i.e. development of devices, chemically and biologically active substances and medical products based on biological and artificial materials for regenerative medicine

Patent of the Russian Federation for the invention "Bioresorbable biological matrix for replacement of bone tissue defects and method of its production"

Application for the Patent of the Russian Federation for the invention "Method of purifying bone and skin matrix with the use of supercritical fluid"

Application for the Patent of the Russian Federation for the invention "Method of obtaining and using highly purified native bone mineral matrix in the form of segments and granules with osteoinductive properties for the replacement of bone defects"

PCT "Method for purifying bone and skin matrix with the use of supercritical fluid"

PCT "Method for the preparation and application of highly purified native bone mineral matrix in the form of segments and pellets with osteoinductive properties for the replacement of bone defects»

The application for the trademark "Матрифлекс"

The application for the trademark "Matriflex"

The application for the trademark "БОНГРАФТ"

The application for the trademark "BONEGRAFT"

Project is supported by

  • Skolkovo Fund
    Skolkovo Fund
  • Kaluga Pharmaceutical Cluster
    Kaluga Pharmaceutical Cluster

Project status

Pre-clinical trials and pre-registration procedures