Valid from May 2021 MinerOss™ A An allograft that offers an alternative treatment option to autologous graft. Bone tissue augmentation inspiring excellence in oral reconstruction
Safety aspects Serological testing Virus Test Specification Hepatitis B virus (HBV) HBsAg, HBcAb*, NAT negative Hepatitis C virus (HCV) Ab, NAT negative Human immunodeficiency virus Ab, NAT negative Human T-Lymphotropic virus (HTLV 1/2) Ab, NAT negative Bacteria Test Specification Treponema pallidum (Lues) CMIA, TP Ab negative Only tissue of donors who have been tested negative enters the Allotec® process. * negative for active infection (in case of positive HBcAb C+TBA performs further investigations) The Allotec® process Independent validation of the critical viral inactivation steps of the process Step 6 Double packing and final sterilization by gamma-irradiation guarantees a 5-year shelf-life at 5–30 °C. Step 4 An oxidative treatment further denatures persisting soluble proteins, thereby eliminating potential antigenicity. Step 3 A treatment with alternating durations of diethyl ether and ethanol leaches out cellular components and denatures noncollagenic proteins, thereby inactivating potential viruses. Step 5 Freeze-drying preserves the natural structure of the tissue and maintains a residual moisture of <10 %, allowing quick rehydration and easy handling. Step 1 After crude removal of surrounding soft tissue, fat and cartilage, the donor tissue is brought into its final shape. Step 2 The defatting of the donor tissue allows moderate penetration of solvents during subsequent processing.
Manufacturing process of MinerOss™ A High safety standards After thorough donor anamnesis, maximum safety is assured via a series of strict serological testing combined with C+TBA‘s Allotec® purification procedure and radiological sterilization. First, serology and nucleic acid tests (NAT) are performed to identify infections before antibodies are detected in the blood. Potential viruses are inactivated, and bacteria destroyed during Allotec® purification procedure where non-collagenic proteins are denatured. An oxidative treatment is then used to denature persisting soluble proteins and eliminate potential antigenicity. Finally, the tissue undergoes dehydration via a lyophilization technique that facilitates the sublimation of frozen water from solid phase to gas phase. This stage preserves the material’s structural integrity. The lyophilization process is an accepted and well document procedure that preserves structural properties while improving graft incorpo- ration. [7, 8] The microscopic pores within the material ensure rapid rehydration of the tissue. The final sterilization by gamma irradiation guarantees a sterility assurance level (SAL) of 10-6 while ensuring structural and functional integrity of the product and its packaging. The success factors of the manufacturing process The Allotec® process Wet chemical by Allotec® processing of the granules, blocks and struts Ultrasound bath Purification with volatile reagents Oxidative treatment Explantation from femoral heads (patients undergoing hip surgery) or diaphysis (post-mortem donors) Written consent Donor screening (risk analysis) Serological testing (Ab screening and NAT test) Lyophilization and gamma-sterilization 5-years shelf-life at 5–30 °C High safety standards SEM picture of MinerOss™ A at 500-fold magnification showing microporous structure. SEM picture of MinerOss™ A at 100-fold magnification showing macroporous structure.
MinerOss™ A human bone substitute Fast graft incorporation and complete remodeling potential [1–5] The scientific evidence shows that allografts are the second best option to patient‘s own bone compared to other bone substitutes. [1] MinerOss™ A is a processed allogenic bone tissue that offers proven, reliable, and predictable surgical outcomes comparable to autologous bone harvested from intra-oral donor sites. MinerOss™ A is an allograft predominantly derived from human donor femoral heads post hip replacement surgery. The donor tissue is thoroughly inspected and undergoes a strict serological screening protocol. Thanks to its natural bone composition consisting of mineralised human collagen, MinerOss™ A shows a high biologic regeneration capability in combination with natural remodelling. Therefore MinerOss™ A is an excellent alternative to autologous bone, meaning that there is no need for an intraoral surgical donor site, which reduces morbidity for the patient. MinerOss™ A undergoes high safety standards in its production process and guarantees a 5-year shelf life at room temperature (5–30 °C). Living donors – femoral heads: MinerOss™ A Cancellous Granulate, MinerOss™ A Cortico-cancellous Granulate and MinerOss™ A Cancellous Block Post-mortem donor – diaphysis: MinerOss™ A Cortico-cancellous Block and MinerOss™ A Cortical Strut
Blocks (10x10x20 mm and 10x10x10 mm) Granulates Strut (25x10x1 mm) Product characteristics of MinerOss™ A Proprietary tissue processing maintains tissue integrity Bone from human donors (living donors: femoral heads, post-mortem donors: diaphysis) Natural bone composition – mineralized human collagen High biologic regeneration capability and natural remodeling [4] High safety standards 5 years shelf-life at room temperature (5–30 °C) Histological structure of MinerOss™ A Histology of biopsy harvested 7 months after block augmentation [3, 5, 6] The allogenic bone can be recognized by the empty cavities of the osteocytes and is embedded in newly formed bone matrix. 500 µm Allogenic bone (asterisk) embedded in newly formed bone. New bonematrix is lined by osteoblast (arrows) showing ongoing bone formation. 200 µm
Ideal for following indications Regeneration and augmentation Large bone defects where one bone wall is maintained can be restored to replace missing or inadequate bone tissue, or for filling or stabilizing bone defects by using MinerOss™ A in combination with collagen membrane. Regeneration of periodontal osseous defects Regeneration after cyst and root tip resections Regeneration of extraction sockets Regeneration of gaps between alveolar wall and dental implants Sinus augmentation Regeneration of gaps around block grafts Horizontal augmentation of alveolar ridges Three dimensional (horizontal and/or vertical) augmentation of alveolar ridges Regeneration of extraction sockets Filling the socket with MinerOss™A in combination with collagen membrane regenerates bone and so retains the volume and shape of the bone over time. Regeneration of periodontal osseous defects A tooth with a good prognosis can be retained by regenerating lost bone, with the support of biomaterials such as MinerOss™ A in combination with collagen membrane. Regeneration of gaps between alveolar wall and dental implants MinerOss™ A is applied to the defect to support bone regeneration.
The alternative bone-tissue graft High patient acceptance – shorter treatment times Shorter surgery time The ready-to-use allograft shortens surgery time by eliminating the need for a donor site. Lower patient morbidity and less pain for the patient Avoiding a donor site eliminates the postoperative pain associated with a second procedure. Unlimited availability It is predominantly derived from human donor femoral heads post hip replacement surgery. No clinical difference in final incorporation compared to autologous bone [3, 5, 6] The scientific evidence shows that allografts are the second best option to patient‘s own bone compared to other bone substitutes [1]
Headquarters CAMLOG Biotechnologies GmbH | Margarethenstr. 38 | 4053 Basel | Switzerland Phone +41 61 565 41 00 | Fax +41 61 565 41 01 | info@camlog.com | www.biohorizonscamlog.com MinerOss™ A is manufactured by C+TBA. Allotec® is a registered trademark of C+TBA. MinerOss™ is a trademark of BioHorizons Camlog. BioHorizons® is a registered trademark of BioHorizons. Not all products shown or described in this literature are available in all countries. As applicable, BioHorizons productsare cleared for sale in the European Union under the EU Medical Device Directive 93/42/EEC and the human tissues and cells Directive 2007/47/EC. We are registered to ISO 13485:2016, the international quality management system standard for medical devices, which supports and maintains our product licenses with Health Canada and in other markets around the globe. Original language is English. ©BioHorizons. All rights reserved. Rights to changes reserved · M-0372-FLY-EN-GLO-BHCL-00-082021 References [1] Schmitt et al. Clin Oral Implants Res. 2013, 24, 576. [2] Solakoglu et al. Clin Implant Dent Relat Res. 2019, 21, 1002-1016. [3] Kloss et al. Clin Case Rep. 2020, 8, 5. [4] Wen et al. J. Periodont. 2019, 1, 734. [5] Kloss et al. Clin Oral Implants Res. 2018, 29, 1163 [6] Tunkel et al. Clinical Case Reports 2020, 00:1-13. [7] Trajkovski et al. Materials 2018, 11(2). [8] Barbeck et al. Materials 2019, 12, 3234. Ordering information MinerOss™ A Responsible tissue bank Cells+Tissuebank Austria gGmbH | Magnesitstr. 1 | 3500 Krems an der Donau | Austria Phone +43 (0) 2732 76954 0 | Fax +43 (0) 2732 76954 40 | vigilanz@ctba.at Art.-No. Volume Particle size BM1007.1005 0.5 cm3 250–1000 µm BM1007.1010 1.0 cm3 250–1000 µm BM1007.1020 2.0 cm3 250–1000 µm BM1007.1040 4.0 cm3 250–1000 µm MinerOss™ A Cancellous Granulate Art.-No. Volume Particle size BM1008.1005 0.5 cm3 250–1000 µm BM1008.1010 1.0 cm3 250–1000 µm BM1008.1020 2.0 cm3 250–1000 µm BM1008.1040 4.0 cm3 250–1000 µm MinerOss™ A Cortico-cancellous Granulate Art.-No. Product size BM1010.1010 10x10x10 mm BM1010.1020 10x10x20 mm MinerOss™ A Cancellous Block Art.-No. Product size BM1010.1000 25x10x1 mm MinerOss™ A Cortical Strut Art.-No. Product size BM1009.1010 10x10x10 mm BM1009.1020 10x10x20 mm MinerOss™ A Cortico-cancellous Block 25 x 10 mm (Cortical)
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