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MinerOss A Family

MinerOss® A Family: The alternative to autologous bone New: MinerOss A is now available as particulate with hyaluronic acid

Clinical cases Horizontal ridge augmentation in the posterior mandible using MinerOss® A cortical plate Dr. Moritz Boeddinghaus, Herne, Germany A significant horizontal bone gain was observed at six months. The panoramic X-ray of a 67-year-old female patient showed bone loss in the edentulous region 45–46. Digital volume tomography confirmed the horizontal bone deficit in regions 45 (left) and 46 (right). Unsalvageable teeth 43 and 44 were extracted. A narrow alveolar ridge was visible after healing. The significant horizontal bone loss extending from region 43 to 46 was evidenced after flap elevation. For lateral bone augmentation following the shell technique, two cortical plates were fixed by osteosynthesis screws (occlusal view). Buccal view of the cortical plates fixed against the jaw. The gap between the shell and the alveolar ridge “the biological container” was first filled with autologous bone ... ... then a layer of volume-stable xenogeneic bone substitute was added on top of the defect. Well-perfused vital bone had formed after 6 months, suitable for implant placement. Panoramic X-ray after the placement of implants and insertion of the healing abutments showed stable bone conditions around the implants shoulders. Aesthetically shaped emergence profiles around the implants in regions 43, 45, and 46 were obtained after nine months.

After a thorough screening of donor history, a series of stringent serological tests (including exclusion of hepatitis B virus, hepatitis C virus, human immunodeficiency virus, and Treponema pallidum (syphilis)) combined with the Allotec purification process using C+TBA and gamma irradiation ensure maximum safety. During the purification process, potentially present viruses are inactivated and bacteria destroyed. Furthermore, non-collagenous proteins are denatured, thus eliminating potential antigenicity. The Allotec process eliminates potential pathogens without destroying the natural bone structure The Allotec® process High safety standards Step 6 Double packing and final sterilization by gamma-irradiation guarantees a sterility assurance level (SAL) of 10-6. Step 4 An oxidative treatment denatures persisting soluble proteins, thereby eliminating potential antigenicity. The insoluble collagen matrix of the bone remains intact. Step 3 A treatment with diethyl ether and ethanol leaches out the cellular components and denatures non- collagenic proteins, thereby inactivating potential viruses. Step 5 Freeze-drying preserves the structural integrity of the tissue and maintains a residual moisture of < 10 %, allowing quick rehydration and easy handling. Step 1 The tissue is coarsely cleaned to remove soft tissue, fat, and cartilage. It is then mechanically shaped into its final form, such as granules or blocks. Step 2 Ultrasonic treatment removes residual tissues and fat from the bone’s porous structure and improves the penetration of cleansing agents during subsequent steps. The Allotec process in video: www.camlog.de/allotec-prozess Histology of MinerOss A Taken 7 months after block augmentation MinerOss A particles () are surrounded by newly formed bone () / The latter is lined by osteoblasts (), which indicates ongoing osteoid synthesis (Dr. Christian Hilscher, Friedberg, Germany). 200 µm

For the following indications: Regeneration and augmentation Preservation of extraction sockets Regeneration of missing bone tissue around dental implants Horizontal augmentation of the alveolar ridge Sinus augmentation 3D augmentations (horizontal and/or vertical) of the alveolar ridge Regeneration of periodontal osseous defects Regeneration after cysts and root tip resections Features of the human bone substitute material Rapid integration and natural remodeling MinerOss A is a human allograft primarily derived from the femoral heads of patients undergoing hip replacement surgery. The donated tissues are thoroughly inspected and are subject to strict serological screening at the Cells+Tissuebank Austria (C+TBA). The Allotec process is used to clean and sterilize the tissues, yielding MinerOss A as cancellous or cortico-cancellous particulate, blocks, or cortical plates. A new formulation of granules mixed with sodium hyaluronate (hereinafter “MinerOss A + HYA”) is also available. The cancellous variant supports revascularization and the supply of vital cells, thus promoting rapid regeneration. The cortico-cancellous formulation ensures higher volume stability when reconstructing extensive bone defects. Product Features Allografts processed from voluntarily donated human tissues Advanced processing preserves the tissue integrity Natural bone composition – the native collagen is retained in the material6, 7 High regenerative capacity and natural remodeling4 Osteoconductive properties supported by a three-dimensional pore network and rough surface Shelf life: five years at ambient temperature (5–30°C) Studies demonstrated that allografts are comparable to autologous bone in terms of regenerative potential and physiological remodeling, unlike bone substitutes of xenogeneic or synthetic origin.1–5 Since the proprietary Allotec process preserves the native collagen in the material,6, 7 MinerOss A exhibits high regenerative capacity combined with a natural remodeling behavior.4 MinerOss A is therefore a predictable alternative to autologous bone grafting. Clinical Evidence A comparative clinical study demonstrated that MinerOss A produced significantly higher amounts of new bone in lateral sinus lift than bovine bone mineral.8 The rapid turnover of MinerOss A shortens the reentry time and enables implant placement after 3–4 months.9, 10 MinerOss A completely remodels into patient’s bone; histological monitoring revealed well-vascularized lamellar bone without any avital remnants.3 Using MinerOss A in bone augmentation procedures ensures excellent regenerative capacity4 and lower patient burden.11 Particulate Cortical Plate

Hyaluronic acid is a natural polysaccharide found in the extracellular matrix of various tissues. It plays a crucial role in maintaining tissue hydration and regulating cellular processes such as proliferation, differentiation, and signaling.12 Product Features Innovative combination MinerOss A + HYA combines allogeneic bone granules with sodium hyaluronate (NaHyA) – a salt of hyaluronic acid. Exceptional fluid binding capabilities Sodium hyaluronate exhibits exceptional fluid binding capabilities due to the numerous hydrophilic groups in its molecular structure, such as hydroxyl (-OH) and carboxylate (-COO-) groups.13 Improved handling and precise application Sodium hyaluronate enables quick and easy preparation of the “sticky bone” upon hydration, thereby improving the handling and application of the bone substitute material.14, 15 Unique composition MinerOss A + HYA contains up to 20 times more hyaluronic acid than other commercial products. This results in better stickiness and malleability after hydration.16 Allografts mixed with hyaluronic acid Properties Application example “Hydration MinerOss A + HYA“: www.camlog.com/mineross-a-hya The hydration of MinerOss A + HYA Only few drops to the sticky allograft To achieve adequate consistency, a 1.0 ml syringe can be used to accurately measure the volume of the hydration solution. The consistency should be sticky and dry rather than runny. Withdraw approximately 0.8 ml of saline solution and add it dropwise to 1.0 cm3 of MinerOss A + HYA. Mix thoroughly to form the sticky bone. Particulates with hyaluronic acid New Clinical Evidence 85 % of the surveyed clinicians rated the application of the sticky bone as “easier” or “much easie” compared to conventional particles.14, 17 The preparation of the sticky bone was rated 8.9 on a scale of 1 (most difficult) to 10 (easiest).14 On a scale of 1 to 10, clinicians rated the soft tissue healing within the first two weeks as 8.8.14, 17

Clinical case Reconstruction of a compromised socket in the aesthetic zone using cortico-cancellous granules and A-PRF plugs Priv. Doz. Dr. Dr. Frank Kloss, Lienz, Austria The implant was placed subcrestal according to the manufacturer’s protocol. A healing abutment was then inserted. Preoperative situation: Radiological examination revealed unsalvageable tooth (# 21) with fully resorbed buccal bone plate. Following atraumatic tooth extraction, the socket was meticulously debrided to remove inflammatory tissue and remaining periodontal ligament tissues. The cortico-cancellous granules were hydrated with sterile saline. The socket was subsequently filled with the allograft particulates ... ... and sealed with A-PRF plugs, which were adapted by sutures. Excellent soft tissue conditions were observed after four months. The successful integration of the MinerOss A particles was confirmed by radiography, yielding an alveolar ridge with adequate dimensions for implant placement. Further, the mucoperiosteal flap elevation revealed a fully vascularized bone, suggesting a high remodeling of MinerOss A into patient bone. Post-operative panoramic radiography confirmed the correct implant positioning. The final prosthetic restoration consisting of zirconia was mounted 3 months after implant placement. Radiographical control (CBCT) showed stable bone conditions around the implant one year after placement.

Bilateral sinus floor elevation and lateral augmentation Prof. Dr. Dr. Daniel Rothamel, Mönchengladbach, Germany Postoperative X-ray control showed good distribution of bone graft material on both sides of the sinus and in the buccal areas. After a 6-month healing period, two SCREW-LINE implants (3.8 and 4.3 mm) were placed on each side. The postoperative examination after exposure shows stable bone conditions around the implants. Similarly, the pericardium collagen membrane was used to stabilize the augmentation site and further fixed by pins and sutures. The flap closure was achieved by alternating backstitch and single interrupted sutures made of absorbable Vicryl. Identical procedure with lateral augmentation and sinus floor elevation was conducted in right side sinus. As previously observed in the digital volume tomography, the preparation of the Schneiderian membrane revealed the presence of Underwood‘s septa. The sinus cavity was filled with the bone substitute. A pericardium membrane (Argonaut®) was tacked bucally and used to cover the defect. Mattress sutures beneath the palatal mucosa ensured good immobilization of the augmentation site. The 75-year-old female patient requested implant-supported prosthesis in the upper jaw. Satisfactory soft-tissue conditions were present, yet the maxilla suffered severe horizontal bone deficit. Bovine bone (CeraOss®) mixed with MinerOss A® + HYA was hydrated with saline to form the sticky bone graft with advantageous consistency.

Responsible tissue bank Cells+Tissuebank Austria gGmbH | Magnesitstr. 1 | 3500 Krems an der Donau | Austria Phone +43 2732 76954 0 | Fax +43 2732 76954 40 | vigilanz@ctba.at 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.bhclgroup.com MinerOss® A is manufactured by C+TBA. CeraOss® and Argonaut® are manufactured by botiss biomaterials GmbH. All product names, whether or not appearing in large print or with the trademark symbol, are trademarks of BioHorizons Inc. or CAMLOG Biotechnologies GmbH, its affiliates, related companies or its licensors, unless otherwise noted. Allotec® is a registered trademark of C+TBA. Products are approved for sale in the European Union in accordance with pharmaceutical legislation, the Medical Device Directive 93/42/EEC (and where applicable, Regulation 2017/745), and the Human Tissues and Cells Directive 2004/23/EC, respectively. We are certified to ISO 13485:2016, the international quality management system standard for medical devices, which is used to manage our product licenses with Health Canada and in other markets worldwide. Rights to changes reserved · M-2271-FLY-EN-INT-BHCL-00-102025 Ordering information MinerOss A Family 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 BM1008.2005 0.5 cm3 1000–2000 µm BM1008.2010 1.0 cm3 1000–2000 µm BM1008.2020 2.0 cm3 1000–2000 µm BM1008.2040 4.0 cm3 1000–2000 µm MinerOss® A Cortico-cancellous Granulate MinerOss® A Cancellous Granulate 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 BM1007.2005 0.5 cm3 1000–2000 µm BM1007.2010 1.0 cm3 1000–2000 µm BM1007.2020 2.0 cm3 1000–2000 µm BM1007.2040 4.0 cm3 1000–2000 µm Art. No. Product size BM1010.1000 25 × 10 × 1 mm MinerOss® A Cortical Plate Art. No. Product size BM1009.1010 10 × 10 × 10 mm BM1009.1020 10 × 10 × 20 mm MinerOss® A Unicortical Block Art. No. Product size BM1010.1010 10 × 10 × 10 mm BM1010.1020 10 × 10 × 20 mm MinerOss® A Cancellous Block MinerOss® A Cancellous Granulate + HYA Art. No. Volume Particle size BM1017.1005 0.5 cm3 250–1000 µm + HYA BM1017.1010 1.0 cm3 250–1000 µm + HYA BM1017.1020 2.0 cm3 250–1000 µm + HYA BM1017.2005 0.5 cm3 1000–2000 µm + HYA BM1017.2010 1.0 cm3 1000–2000 µm + HYA BM1017.2020 2.0 cm3 1000–2000 µm + HYA Art. No. Volume Particle size BM1018.1005 0.5 cm3 250–1000 µm + HYA BM1018.1010 1.0 cm3 250–1000 µm + HYA BM1018.1020 2.0 cm3 250–1000 µm + HYA BM1018.2005 0.5 cm3 1000–2000 µm + HYA BM1018.2010 1.0 cm3 1000–2000 µm + HYA BM1018.2020 2.0 cm3 1000–2000 µm + HYA MinerOss® A Cortico-cancellous Granulate + HYA 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):886-893. 4 Wen et al. J Periodontol. 2020. 91(2):215-222. 5 Kloss et al. Clin Oral Implants Res. 2018, 29, 1163. 6 Trajkovski et al. Materials 2018, 11(2):215. 7 Barbeck et al. Materials 2019, 12, 3234. 8 C hávarri-Prado et al. Int J Periodontics Restorative Dent. 2024, 44:309-319. 9 Barone et al. Int J Periodontics Restorative Dent. 2024;44(6):685-696. 10 Kloss et al. Int J Implant Dent. 2024. 10(1):42. 11 Heimes et al. CIDRR. 2024. 26(1):170-182. 12 Garantziotis et al. Matrix Biol. 2019, 78-79:1-10. 13 Necas et al. Vet Med-Czech. 2008, 53(8):397-411. 14 Data on File. Limited Market Release. Users Feedback on Handling and Initial Healing Period 08/2023. 15 Data on File. Limited Market Release. Clinical Case Documentation. 16 Data on File. Marktforschung - Hyaluronsäure Hyaluronsäure-haltige Spritzen 01/2025. 17 Data on File. Entwicklungsbericht: Hyaluronat-Mix Evaluierung Produkteigenschaften 3: „Bone Paste-CTBA“. 03/2024.

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