FlexiOss

New bone defect filler for regenerative medicine

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Description

How does FlexiOss® work?

FlexiOss®, a so-called „artificial bone”, after implantation undergoes an integration with a patient’s bone tissue in a beneficial manner and is slowly remodelled and replaced with natural bone tissue. This eliminates the necessity of reoperation in order to remove the implanted biomaterial. Thus, the patient’s stress and pain are limited to the minimum.

FlexiOss® is a modern implantable biomaterial of the third generation:

flexioss-bone

Biphasic (hydroxyapatite-polymeric), bioactive, supporting the regeneration of bone tissue and a potential drug carrier.

The combination of two main compounds of the composite was obtained by polymer gelling into the structure of irreversible, collagen-like triple helix – the conformation which does not evoke the appearance of local inflammation processes and enables the entrapment of HAP granulate.

What makes FlexiOss® unique

Surgical handiness Surgical handiness allows to fit the composite during the operation to the shape of individual bone defects by cutting or bending.
Can be milled In a dry state, FlexiOss® can be milled which enables the personalization of the composite implant.
Faster ossification High specific surface area (due to the high microporosity of granules), high ionic reactivity (adsorption of calcium and phosphate ions from surroundings liquid which allows to increase the rate of mineralization within the implantation site and increase the rate of new bone tissue formation).
Minimizes the risk of viruses and prions contamination Application of carbohydrate polymer to produce FlexiOss® composite minimizes the risk of viruses and prions contamination. Curdlan undergoes gelling, forming the structure of irreversible, collagen-like triple helix – the conformation which is neutral for macrophages and does not evoke the appearance of local inflammation.
High soaking capacity FlexiOss® exhibits high soaking capacity. This simplifies the nutrient supply to the biomaterial within the implantation site and removal of metabolic degradation products, thus increasing the rate of bone tissue regeneration. Before the implantation, it can be soaked in a solution of antibacterial drugs, thus minimizing the risk of perioperative infections and implant rejection. Due to its properties, it can be also soaked in, for example, platelet-rich plasma (PRP) and solution of growth factors (commercial or isolated from patient’s blood). Thus, the biomaterial may resemble (in its properties) very expensive bone-substitutes containing BMP-2-type growth factors.
Can be easily stored and transported. Can be easily stored and transported.

The exceptional properties of FlexiOss® mentioned above result from its unique composition (hydrogel-like carbohydrate polymer and highly microporous hydroxyapatite ceramics) which does not appear in other bone-substituting biomaterials, neither commercial nor experimental ones.

Main Individual properties of FlexiOss® are as follows:

  • flexible after soaking (plastic and bendable)
  • bio-compatible with natural bone tissue
  • mechanical parameters similar to those of cancellous bone
  • actively supports bone reconstruction process
  • absorbs blood and medicine solutions
  • positively affects bone tissue regeneration process
  • ionic reactive / bioactive
  • non-toxic material
  • can be used for defects of up to 7 cm in length
  • non-animal material (lowering risk of pathogen transmission and appearance of allergic reactions)
  • easy to carry and store

Application

The innovative implantable FlexiOss® material allows effective treatment of bone defects, as big as 5-7 cm in length, although it is not intended to be used in load-bearing areas. It is designed in particular to repair the defects resulting from traffic accidents, located in long bones and defects after the removal of bone tumours and post-infective cysts. FlexiOss® is designated for orthopaedics, musculoskeletal trauma, dentistry, and veterinary surgery.

FlexiOss® can be also potentially used in the therapy of bone defects resulting from osteoporotic bone tissue fractures.

FlexiOss® can be used in dentistry for the treatment of dental cysts and oronasal fistulae. Besides, the biomaterial can be also used as a bioactive filling of titanium and polyester scaffolds used in implantological surgery.