1. What are Biomaterials?
Biomaterials can be conceived as being compounds used in clinical medicine to replace biological systems.
2. What is the function of biomaterials?
Generally speaking, the aim of biomaterials is to help injured tissue to repair, through a mechanism of induction and conduction
3. Which materials can be classified as biomaterials?
All classes of materials can be used as biomaterials, so we can have metallic, ceramic, organic, etc. biomaterials.
4. What is the basic feature of biomaterials?
Biomaterials are characterized by their biocompatibility, i.e. they are inert from the biological point of view, not causing any harmful effect on the organism.
5. What is Gen-ox®?
Gen-ox® is the family of liophylized bovine bones, which is divided into organic/inorganic, cortical/spongy, blocks/granular, micro/macrogranular (for details see instructions and printed sheet "basic explanations").
6. What is the function of Gen-ox®?
The lyophilized bones are osteoconductor and inductor materials, which are for filling a cavity, guiding the bone tissue in its repair by means of osteoconduction and induction.
7. What is Gen-pro®?
Gen-pro® is the family of proteins and its main product is the BMP protein.
8. What is the function of the BMP protein?
BMP is an English acronym which means "Bone Morphogenetic Protein". These proteins are factors of bone growth and act on the primitive and undifferentiated mesenchymal cells, inducing them to be transformed into osteoblasts, which start the process of bone neoformation.
9. What is Gen-derm®?
Gen-derm® is the family of membranes of biological barriers.
10.
What is the function of Gen-derm®?
The biological membrane is constituted of decalcified bovine bone cortex in the form of a lamina. This Biomaterial acts mechanically preventing the invagination of soft tissue inside the bone cavity, theoretically exerting the function of periosteum. The re-absorption time of the biological membrane is approximately 4 thru 9 months.
11. What is Gen-col®?
Gen-col® is the family of collagens and the main product is granulated collagen.
12. What is the function of granulated Collagen?
Granulated Collagen is indicated as auxiliary material in the aglutination of implantable Biomaterials, allowing a homogeneous mass to be obtained, for the perfect molding of the surgical cavity. It is also indicated as hemostatic material or a vehicle of other Biomaterials.
13. What is Gen-phos®?
Gen-phos® is the family of hydroxyapatites, which is divided into the versions cola, granules and blocks.
14. What is the function of Gen-phos®?
Hydroxyapatite is the osteoconductor synthetic graft which are for filling a cavity, guiding the bone tissue in its neoformation. With this same indication we have Gen-ox®, which has the advantage of being a natural graft and available in the cortical/spongy and organic/inorganic versions.
15. What is the origin of these Biomaterials?
Except for the Gen-phos® family, al the other Genius® Biomaterials are of bovine origin. The Biomaterials are obtained from oxen confined with the age of 12 thru 15 months, free of anabolizants, hormones and heavy metals. The BMPs are obtained from bone cortex of the bovine fetus.
16. How are the products validated?
In order to validate these products, chemical and biological analyses are performed, such as (ashes, pH, thermogravimetric analysis, chemical analysis, dosage of heavy metals, x-ray diffraction, spectrometry, cytotoxicity), contents of protein, sweep microcospy. These tests were performed by the Analytic Center of the Chemistry Institute of Unicamp of electronic sweep microscopy – reports available in the Ditec.
17. Has the product been tested clinically?
At first in the dental area, where the results obtained proved the excellence of the product.
18. Are there tests in other medical areas?
Yes, the product is being tested by several universities, some of them overseas, in the areas of Orthopedics, Traumatology, Oncology, Neurosurgery, Dentistry, Oral and Maxilo Facial Surgery and the Spine. The tests also aim to discover new applications and produce literature in the specific areas.
19. Are the products registered in the Ministry of Health?
Yes, all the products are registered in the Ministry of Health.
20. Does the packaging meet international requirements?
Yes, the packaging was developed complying with all the requirements of the official Brazilian, American and European Pharmaceutical Codes.
21. Are all the products supplied already sterilized?
Yes, all the products are sterilized by Gamma ray, and are ready for use. The cycle applied is validated chemically and biologically.
22.
How is it stored and what is the vality?
The product must be stored at an ambient temperature between 15º - 25º C, far from the sun and heat. The validity period is 2 years from the date of manufacture, both of which appear on the internal and external labels of the products.
23. What is the purpose of the "Patient and Protocol" labels?
These labels provide basic information for the traceability of the product. They contain the code, volume, name of the product in 3 languages, manufacturing lot, date of manufacture, date of validity, RMS and biologist in charge. The label "Patient" must be delivered to him or her, whereas the "Protocol" must be attached to the patient records, thereby ensuring the final traceability of the product.
24. Can the products be re-sterilized?
No, in order to re-sterilize the products the manufacturer must be asked.
25. How are the products used?
In the instructions which accompany all the products there is: name of the product, description, properties/action, indications, posology, contra indications, instructions of use, conditions of use, adverse reactions, stability, presentation, sterilization and storage. Before using the products it is of paramount importance to read the instructions. If you still have any queries, contact the factory or its representative.
26. Can I use possible leftovers of Biomaterials?
No, after these materials have been hydrated, they lose their stability.
27. As it is a new product can I suggest or try new applications?
Yes, clearly, respecting the nature of the product. We really expect that there will be countless other applications, and count on the professionals of each area for this.