New bone defect filler<br> designated for <br>regenerative medicine

New bone defect filler
designated for
regenerative medicine

Strona główna – English

About the product

FlexiOss®Vet is a modern implantable biomaterial of third generation:    Biphasic (hydroxyapatitepolymeric), bioactive, supporting the regeneration of bone tissue and a potential drug carrier.           

The combination of two main compounds of composite was performed 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.

After implantation undergoes an integration with patient’s bone tissue in 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 is limited to the minimum.

Available in 3 sizes: 1 cm, 3 cm and 5 cm.

Flexible after soaking: plastic and bendable.

Properties

flexible after soaking
(plastic and bendable)
bio-compatible with
natural bone tissue
mechanical parameters similar
to those of cancellous bone
actively supports bones
reconstruction process
absorbs blood
and medicine solutions
positively influences the 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 pathogens transmission and appearance
of allergic reactions)
easy to carry and store

Surgical handiness

Surgical handiness, which allows to fit it during the operation to the shape of individual bone defects by cutting or bending.

Can be milled

In a dry state, FlexiOss®Vet 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 undegoes 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®Vet exhibit high soaking capacity. This simplify 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 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.

Studies

The biomaterial was subjected to preliminary preclinical evaluation on patients of Animal Surgery Clinic of Veterinary Medicine Faculty, University of Life Sciences in Lublin, Poland. The bone replacement material was used for filling bone defects resulting from the teeth extraction and for the treatment of oronasal fistulae in dogs and cats. In the implantation site, the composite remained perfectly fitted and its presence did not induce any inflammatory reactions. Its effectiveness as a bone replacement material was confirmed by X-ray images..

Illustration 1
The procedure of cat’s oronasal fistula filling and X-ray evaluation directly after the implantation [A] and 1 month after the implantation [B].

IIllustration 2
The procedure of dog’s oronasal fistula filling – removal of the luxated canine tooth and filling of the fistula with biomaterial.

Illustration 3
Treatment of oronasal fistula in a dog – X-ray before canine tooth luxation [A], after tooth extraction [B], 6 months [C] and 12 months [D] after composite implantation.

Illustration 4
Determination of bone density after the composite implantation using microcomputing tomography technique (pQCT). Control image directly after the implantation (time 0) [A], image taken 1 month after the implantation [B], 3 months after the implantation [C], and 6 months after the implantation [D].

Illustration 5
Histological images suggesting integration of the implant with surrounding bone tissue. Image C presents the magnification of the fragment of image B. Image D shows the bone tissue remodelling.

PThe composite was also tested as a bone replacement material for filling defects in the tibiae of laboratory rabbits. The composite remained excellently fitted in the implantation site and its presence did not induce any inflammatory reactions. The results indicated its biocompatibility with the surrounding bone tissue. Histological evaluation unequivocally showed that the process of bone tissue formation appeared in the implantations site, which was confirmed by the presence of bone cells and laminae, collagen fibres and Haversian canals.

Illustration 6
A, B, C, D – surgical implantation of bone replacement material into the tibiae in rabbits.

Publications

Borkowski L., Lübek T., Jojczuk M., Nogalski A., Belcarz A., Palka K., Hajnos M., Ginalska G. Behavior of new hydroxyapatite/glucan composite in human serum, Journal of Biomedical Materials Research Part B: Applied Biomaterials’ 2018 Feb 6 [Epub ahead of print].

Borkowski L., Kiernicka M., Belcarz A., Pałka K., Hajnos M., Ginalska G. Unexpected reaction of new HAp/glucan composite to environmental acidification: Defect or advantage? Biomed. Mater. Res. B Appl. Biomater. 2017, 1 05(5), 1178-1190.

Borkowski L., Sroka-Bartnicka A., Drączkowski P., Ptak A., Zięba E., Ślósarczyk A., Ginalska G. The comparison study of bioactivity between composites containing synthetic non-substituted and carbonate-substituted hydroxyapatite. Mater. Sci. Eng. C Mater. Biol. Appl. 2016, 62, 260-267.

Belcarz A., Ginalska G., Pycka T., Zima A., Ślósarczyk A., Polkowska I., Paszkiewicz Z., Piekarczyk W. Application of β-1,3-glucan in production of ceramics-based elastic composite for bone repair. Centr. Eur. J. Biol. 2013, 8, 534-548.

Contact

Medical Inventi S.A.
ul. Nałęczowska 14
20-701 Lublin
woj. lubelskie, Polska
biuro@medicalinventi.pl
NIP: 946-262-83-41
REGON: 060772285
KRS: 0000544357

Sales and Marketing, Export
Aleksandra Machowska
aleksandra.machowska@medicalinventi.pl
tel. +48 881 750 883

Quality Department
Katarzyna Siwiec
katarzyna.siwiec@medicalinventi.pl
Olga Kruk
olga.kruk@medicalinventi.pl
tel. +48 881 550 883

Administration, EU projects
Aleksandra Gańska
aleksandra.ganska@medicalinventi.pl
tel. +48 667 330 883

Konto bankowe mBank
97 1140 1094 0000 2789 8000 1001

Sąd Rejonowy Lublin-Wschód w Lublinie z siedzibą w Świdniku
VI Wydział Gospodarczy Krajowego Rejestru Sądowego
Kapitał zakładowy: 267 721,50 zł

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