naturesQue SemOss B

Xenohybrid bovine bone substitute material

naturesQue SemOss B is a xenohybrid bone substitute material with a coating of a co-polymer mix and collagen fragments. The combination of different material classes compensates for the limitations of the individual elements and amplifies their positive properties. This combination produces a resorbable bovine bone substitute material. To apply the material, the granules are moistened with blood so that the positive properties of the coating can develop effectively.


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naturesQue SemOss B – a new concept for a bovine bone substitute material and its components


Bovine bone matrix

  • Femoral heads with a high proportion of cancellous bone
  • Porous raw material with naturally perfect design features for osseointegration and remodeling


Chemical purification procedure

  • Unchanged crystalline structure in the bone matrix
  • Removal of organic components

Finishing procedure to enhance the matrix properties

  • Enhances the elastic mechanical properties
  • Increases colonization by cells in the bone matrix

Safety

naturesQue SemOss B is a safe bone substitute material and satisfies the requirements of Directive 93/42/EEC Annex 2 Section 4 and Regulation 722/2012.

Structure and design

The porosity of naturesQue SemOss B is determined by the large spaces in the cancellous bone. The trabecular architecture is retained and creates the perfect design for the migration of osteoblasts, the growth of blood vessels, and remodeling.

Scanning electron microscopy image of naturesQue SemOss B granules.

Application—The recommended rehydration with (patient) blood




The bovine bone matrix of naturesQue SemOss B is reinforced by a surface coating. Denatured collagen fragments create an environment suitable for cell colonization. The first weeks are characterized by cell migration and colonization of the surface of naturesQue SemOss B. At the same time the co-polymer mix is degraded, making the mineral bone matrix fully accessible.

For the positive properties of the surface coating of naturesQue SemOss B to develop, naturesQue SemOss B must be moistened with blood. This ensures that important biological molecules from the blood bind to the surface and contribute to formation of new bone in direct contact with the bone substitute material.

Biological conditioning

The hydration with blood develops the positive properties of the coating.
The bone substitute material is permeated by blood in the defect. Local microcoagulation of the blood in the augmentation material initiates a signal cascade and creates the conditions for the integration of naturesQue SemOss B.

Apply: Hydration with blood

Binding of biological molecules to the surface

  • Surface conditioning with the serum components of the blood
  • Very good cell adhesion to the RGD motifs of the denatured collagen fragments
  • Stable bone bed

Avoid: Hydration with saline

Extraction of the denatured collagen fragments from the co-polymer film

  • Missing binding sites for cells as a result of the extraction of the denatured collagen fragments from the co-polymer film
  • Connective tissue boundary layer between new bone and bone substitute material
  • Insufficient stability in the bone bed

Co-polymer mix of poly(L-lactide) & poly(ɛ-caprolactone)

  • Increased resistance of
    naturesQue SemOss B
  • Protects the mineral bone matrix against premature resorption during the inflammatory phase after the surgical procedure
  • Gives naturesQue SemOss B plastic properties for outstanding handling

Porcine denatured collagen fragments

  • Immobilized short biomolecules
  • Contain the RGD sequence (Arg-Gly-Asp) that promotes cell adhesion and forces the start of bone formation

Resorption profile

As a result of the natural crystalline structure of the bone mineral that is left after processing, the xenogeneic bone matrix of naturesQue SemOss B is completely resorbable.

The finishing treatment with a co-polymer mix protects the bone matrix against premature resorption and improves its elastic mechanical properties. The collagen fragments are an attractive substrate for cellular adhesion and encourage the wettability of the surface of naturesQue SemOss B.

naturesQue SemOss B is completely resorbed within 1–2 years as part of the remodeling and replaced by the patient’s own bone. The co-polymer mix in the finishing coating of naturesQue SemOss B is degraded over an average of 18 weeks, an optimal time frame during which good bone formation and tissue integration can be expected.


Resorbable bovine bone substitute material

  • The mineral structure of the bovine bone matrix remains unchanged during production. The natural crystalline network can thus be completely degraded during remodeling by osteoclasts

Radiopacity

  • After application, naturesQue SemOss B is less opaque due to the low density and very open, porous structure. During bone healing and remodeling the opacity increases as new mineralized bone is formed in the defect region

naturesQue SemOss B put into context

Origin
  • Bovine bone
  • Co-polymer mix
  • Porcine collagen
Composition
  • Mineral phase of the cancellous bone
  • Poly(L-lactide) and poly(ɛ-caprolactone)
  • Porcine collagen fragments
Processing
  • Removal of the organic phase
  • Reinforcement/Finishing treatment:
  • Application of the co-polymer mix and the collagen fragments
  • Screening, packaging, sterilization
Application
  • Mix with patient blood
  • Insert into the defect using sterile instruments
  • Avoid mixing with aqueous solutions (NaCl, saline)
Consistency/Feel
  • Dry: hard and solid
  • Moistened with blood: slightly plastic, can be modeled because the granules adhere to one another
Resorption
  • Resorbable; resorption profile depends on the individual condition of the patient
  • Mechanical load in the augmentation area after 6 months at the earliest

Publications naturesQue SemOss B

Ghiretti C, Grottoli F, Cingolani A, Perale G. Clinical Case Employing Two different Biomaterials in Bone Regeneration. Journal of applied sciences 2020; 10,4516:1-9*
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Boffano M, Ratto N, Conti A , Pellegrino P, Rossi L, Perale G, Piana R. A Preliminary Study on the Mechanical Reliability and Regeneration Capability of Artificial Bone Grafts in Oncologic Cases, With and Without Osteosynthesis. Journal of Clinical Medicine 2020; 9, 1388:1-11*
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Cristalli MP, La Monaca G, Pranno N, Annibali S , Iezzi G, Vozza I. Xeno-Hybrid Composite Scaffold Manufactured with CAD/CAM Technology for Horizontal Bone-Augmentation in Edentulous Atrophic Maxilla: A Short Communication. Appl. Sci. 2020, 10, 2659: 1-12*
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Barbeck M, Jung O, Xiong X, Krastev R, Korzinskas T, Najman S, Radenkovic M, Wegner N , Knyazeva M, Walther F. Balancing Purification and Ultrastructure of Naturally Derived Bone Blocks for Bone Regeneration: Report of the Purification Effort of Two Bone Blocks. Materials 2019; 12, 3234:1-13*
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Perale G, Monjo M, Ramis JM, Øvrebø Ø, Betge F, Lyngstadaas P, Haugen HJ. Biomimetic Biomolecules in Next Generation Xeno- Hybrid Bone Graft Material Show Enhanced In Vitro Bone Cells Response. Journal Clinical Medicine 2019;8, 2159:1-20*
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Grottoli CF, Cingolani A, Zambon F, Ferracini R, Villa T, Perale G. Simulated Performance of a Xenohybrid Bone Graft (SmartBone®) in the Treatment of Acetabular Prosthetic Reconstruction. Journal of Functional Biomaterials 2019;10, 53:1-16*
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Ferracini R, Bistolfi, A, Garibaldi R, Furfaro V, Battista A, Perale G. Composite Xenohybrid Bovine Bone-Derived Scaffold as Bone Substitute for the Treatment of Tibial Plateau Fractures. Journal of applied sciences 2019, 9(13), 2675: 1-11*
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Facciuto E, Grottoli DF, Mattarocci M,  Fusto Illiano F, Compagno M, Ferracini R, Perale G. Three-Dimensional Craniofacial Bone Reconstruction With SmartBone on Demand. The Journal of Craniofacial Surgery 2019;30(3):739-741*
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Grottoli CF, Ferracini R, Compagno M, Tombolesi A, Rampado O, Pilone L, Bistolfi A, Borrè A, Cingolani A. Perale G. A Radiological Approach to Evaluate Bone Graft Integration in Reconstructive Surgeries. Journal of applied sciences 2019;9,1469:1-14*
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Perale G, Roato I, Belisario DC, Compagno M, Mussano F, Genova T, Veneziano F, Pertici G, Ferracini R. Adipose-derived stromal vascular fraction shows marked bone-regenerative potential on a xenohybrid bone scaffold. In Orthopaedic Proceedings. 100:114*
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Abuelnaga MS, Elbokle NN, Khashaba MN. Evaluation of custom made xenogenic bone grafts in mandibular alveolar ridge augmentation versus particulate bone graft with titanium mesh. OMX.9(2):62-73*
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Cingolani A, Grottoli CF, Esposito R, Villa T, Rossi F, Perale G. Improving Bovine Bone Mechanical Characteristics for the Development of Xenohybrid Bone Grafts. Current Pharmaceutical Biotechnology. 2018;19(12):1005-1013*
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Haugen HJ, Lyngstadaas SP,Rossi F,Perale G. Bone grafts: which is the ideal biomaterial? J Clin Periodontol. 2019;1–11*
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Mandelli F, Perale G, Danti S, D’Alessandro D, Ghensi P. Clinical and histological evaluation of socket preservation using Smartbone®, a novel heterologous bone substitute: a case series study. Oral & Implantology.2018;11(2):87-94*
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Pertici G, Grottoli CF. Dental and Maxillo-Facial reconstructions adopting innovative customized biomaterial. Data on file IBI S.A (2018)*
Abstract

Cingolani A, Casalini T, Caimi S, Klaue A, Sponchioni M, Rossi F, Perale G. A Methodologic Approach for the Selection of Bio-Resorbable Polymers in the Development of Medical Devices: The Case of Poly(L-lactide-co-“-caprolactone). Polymers 2018, 10, 851
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Mayer Y, Ginesin O, Khutaba A, Machtei EE, Giladi HZ. Biocompatibility and osteoconductivity of PLCL coated and noncoated xenografts: An in vitro and preclinical trial. Clin Implant Dent Relat Res. 2018;20:294–299
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Roato I, Belisario DC, Compagno M, Mussano F, Genova T, Veneziano F, Pertici G, Perale G, Ferracini R. Bone regenerative potential of Adipose-derived Stromal Vascular Fraction on a xenohybrid bone scaffold. Poster Contribution*
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Roato I, Belisario DC, Compagno M, Verderio L, Sighinolfi A, Mussano F, Genova T, Veneziano F, Pertici G, Perale G, Ferracini R. Adipose-Derived Stromal Vascular Fraction/Xenohybrid Bone Scaffold: An Alternative Source for Bone Regeneration. Stem Cells Int. 2018;4126379:1-11*
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Pertici G, Grottoli CF, Molinari S, Perale G. Innovative Bone Substitute for Dental and Maxillo-Facial Applications. Data on file IBI S.A (2018)*
Abstract

Roato I, Belisario DCv Compagno M, Lena A, Bistolfi A,Maccari L, Mussano F,Genova T,Godio L, Perale G, Formica M, Cambieri I, Castagnoli C, Robba T, Felli L, Ferracini R. Concentrated adipose tissue infusion for the treatment of knee osteoarthritis: clinical and histological observations. International Orthopaedics. 2019;43:15–23*
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Perale G, Grottoli CF, Molinari S, Pertici G, Bistolfi A, Ferracini R. Hybrid Scaffold for Bone Reconstructive Surgery. Data on file IBI S.A (2018)*
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Piana R, Boffano M, Pellegrino P, Ratto N, Rossi L, Perale G. Treating femoral chondrosarcoma with high mechanical performances bio-hybrid bone graft: a case report. Materials Science and Engineering Congress. 2018*
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Piana R, Boffano M, Pellegrino P, Ratto N, Rossi L, Perale P. Treating femoral chondrosarcoma with high mechanical performances bio-hybrid bone graft: a case report. Journal:Materials Science and Engineering Congress. 2018*

Facciuto E, Grottoli CF, Mattarocci M, Illiano F, Pertici G, Perale G. Personalized Bone Implant.24th Congress of the European Association for Canio Maxillo facial Surgery. 2018*
Abstact

Schiavo A, Samorì M, Apicella C. Avance en la regeneración ósea en odontología mediante Smart-Bone®. A propósito de un caso. 2018*

Pertici G, D’Alessandro D, Danti S, Milazzo M, Perale G. Scaffold ibrido a base di idrossiapatite bovina, poliesteri alifatici e collagene denaturato per rigenerazione ossea: uno studio istologico. 5° Convegno Nazionale FORM. Forum On Regenerative Methods: materiali e metodiche di rigenerazione tissutale in medicina rigenerativa. Roma, 10-11 maggio 2018. Riassunti. Roma: Istituto Superiore di Sanità; 2018 (ISTISAN Congressi 18/C1)*.
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Michele B, Nicola R, Pietro P, Stefano M, Andrea F, Elena B. Ugo A, Raimondo P. A new bone graft for bone tumors: preliminary results. EMSOS 2018 Congress, Amsterdam. 2018
Abstract

Stacchi C, Lombardi T, Ottonelli R, Bertoni F, Perinetti G, Traini T. New bone formation after transcrestal sinus floor elevation was influenced by sinus cavity dimensions: A prospective histologic and histomorphometric study. Clinical Oral Implants Research. 2018;1–15*
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Roato I, Lena A, Belisario DC, Compagno M, Mussano F, Genova T, Godio L, Veneziano F, Perale G, Bistolfi A, Formica M, Cambieri I, Castagnoli C, Robba T, Felli L, Ferracini R. Treatment of knee osteoarthritis with concentrated adipose tissue infusion: clinical results and histological observations. EORS 2018, Munich
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Perale G, Roato I, Belisario DC, Compagno M, Mussano F, Genova T, Veneziano F, Pertici G, Ferracini R. Adipose-derived stromal vascular fraction shows marked bone regenerative potential on a xenohybrid bone scaffold. EORS 2018, Galway, Ireland
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Roato I, Belisario DC, Compagno M, Verderio L, Sighinolfi A, Mussano F, Genova T, Veneziano F, Pertici G, Perale G, Ferracini R. Bone regenerative potential of adipose-derived stromal vascular fraction on a xenohybrid bone scaffold. Calcified Tissue International and Musculoskeletal Research, Springer.2018*
Abstract

Roato I, Belisario DC, Compagno M, Verderio L, Sighinolfi A, Mussano F, Genova T, Veneziano F, Pertici G, Perale G, Ferracini R. Adipose-Derived Stromal Vascular Fraction/Xenohybrid Bone Scaffold: An Alternative Source for Bone Regeneration. Stem Cells International. 2018;1-11*
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Piana R, Boffano M, Pellegrino P, Rossi L, Perale G. Treating aneurysmal bone cysts with high mechanical performances bio-hybrid bone grafts without osteosynthesis devices --case report. 2018*
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Spinato S, Galindo-Moreno P, Bernardello F, Zaffe D. Minimum Abutment Height to Eliminate Bone Loss: Influence of Implant Neck Design and Platform Switching. The International Journal of Oral & Maxillofacial Implants.2017;1-7*
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Secondo F, Grottoli CF, Zolino I, Perale G, Lauritano D. Positioning of a contextual implant along with a sinus lift anchored with a block of heterologous bone. ORAL & Implantology. 2017;11(4):457-467*
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Milazzo M, D’Alessandro D, Stefanini C, Pertici G, Perale G, Danti S.SmartBone®: una nuova alternativa per la ricostruzione dei tessuti ossei. 2017*
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Facciuto E, Grottoli CF, Mattarocci M, Illiano F, Perale G, Pertici G.3D complex Custom-Made Bone Reconstruction with Innovative Biomaterial. Congress SICMFS 2017, Napoli.2017*
Abstract

Martini M, Zazzetta A. New frontiers in bone regeneration: bone graft on-demand. Poster at AEEDC Duabi, UAE. 2017*
Poster

Mahesh L., Aran Shetty D., Shukla S Socket Preservation Using a Small Particulate Xenograft: A Case Report.The Journal of Implant & Advanced Clinical Dentistry. 2017:9(4):2-17*
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Poonia N, Morales H, Mahesh L. Management of a Failed Implant Site with Guided Bone Regeneration, Reimplantation, and Root Submergence Technique. International Journal of Oral Implantology and Clinical Research. 2016; 7(2):1-3*
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D’Alessandro D, Perale G, Milazzo M, Moscato S, Stefanini C, Pertici G, Danti S. Bovine bone matrix/poly(L-lactic-co-e-caprolactone)/gelatin hybrid scaffold (SmartBone) for maxillary sinus augmentation: A histologic study on bone regeneration. International Journal of Pharmaceutics. 2017;523:534-544*
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Perale G. Biohybrid materials: inspired by nature to repair bones. eCM Meeting Abtsracts 2016, Collection 4; eCM XVII (page 35)*
Abstract

Ekwueme EC, Patel JM, Freeman JW, Danti S. Applications of Bioresorbable Polymers in the skeletal systems (cartilages, tendons, bones). Bioresorbable Polymers for Biomedical Applications - Pages 391-422 Woodhead Publishing Series in Biomaterials: Number 120 Edited by Giuseppe Perale and Jons Hilborn. 2016
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Zollino I, Carusi G, Carinci F, Perale G. Positioning of a Contextual Implant Along with a Sinus Lift with Smartbone® Microchips of Composite Heterologous-Synthetic Bone. Indian Journal Stomatology 2015;6(2):59-62*
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Milazzo M, D’Alessandro D, Danti S, Stefanini C,.Pertici G, Perale G. Bone matrix/copolymer/gelatin scaffold (SmartBone®) as a biomimetic graft for sinus lift procedure in dental surgery 10th World Biomaterials Congress, Montréal, Canada. 2016*
Abstract

Laffranchi L, Buffoli B, Boninsegna R, Zotti F, Savoldi F, Fontana P, Bonetti S, Visconti L, Rodella LF, Paganelli C. Reinforced bioactive bone chip scaffold for bone regeneration: experimental study. Dental Materials 3 0 S ( 2 0 1 4 ) e1–e180
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Grecchi F, Perale G, Candotto V, Busato A, Pascali M, Carinci F. Reconstruction of the zygomatic bone with SmartBone®: Case Report. Journal of biological regulators & homeostatic agents. 2015;29(3 S1): 42-47*

Pertici G, Carinci F, Carusi G, Epistatus D, Villa T, Crivelli F, Rossi F, Perale G. Composite polymer-coated mineral scaffolds for bone regeneration: from material characterization to human studies. Journal of biological regulators & homeostatic agents. 2015;29 (3 S1):136-148
Abstract

Industrie Biomediche Insubri SA. SmartBone®on Demand™ applied to a post humoral large spheno-orbital reconstruction. 2014*
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Pertici G, Rossi F, Casalini T, Perale G. Composite polymer-coated mineral grafts for bone regeneration: material characterisation and model study. Annals of Oral & Maxillofacial Surgery. 2014;14:2(1):4*
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Pertici G, Grecchi F, Perale G. Custom-made bone grafts for reconstructive maxillo-facial surgery: a case study. European Cells and Materials Vol. Scandinavian society for biomaterials annual meeting Upsala. 2013;26 (S2):24*
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Rossi F, Santoro M, Perale G. Polymeric scaffolds as stem cell carriers in bone repair. Journal of Tissue Engineering and Regenerative Medicine. 2013
Abstract

Pertici G, Müller M, Rossi F, Villa T, Carusi G, Maccagnan S, Carù F, Crivelli F, Perale P. SmartBone®: a new scaffold for regenerative medicine.1st International Conference on Design and PROcesses for MEdical Devices-PROMED 2012: 2-4 May, Padenghe sul Garda–Brescia (Italy)*

Maccagnan S, Perale G, Cappelletti T, Pertici G. Microextrusion as a way for combining performance, functions and quality.1st International Conference on Design and PROcesses for MEdical Devices-PROMED. 2012: 2-4 May, Padenghe sul Garda–Brescia (Italy)

Perale G, Pertici G, Motroni A, Livi L, Busato A, Grecchi F. SmartBone® On Demand™: an innovative custom-made bone graft for reconstructive surgery. 1st International Conference on Design and PROcesses for MEdical Devices–PROMED. 2012:2-4 May, Padenghe sul Garda–Brescia (Italy)*

Pertici G, Carusi G, Perale G. SMARTBONE: a new composite bone substitute for reconstructive surgery. Second 30 Bologna lnternational Symposium and Workshop. 2012*
Abstract

Perale G. New regeneration technologies for bone and cartilage. ISPE. 2011
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Pertici G, Müller M, Maccagnan S, Perale G. Bioresorbable Bioactive Matrix For Bone Reconstruction. 2011

Pertici G, Müller M, Maccagnan S, Rossi F, Perale G. Innovative Bone Scaffold For Reconstructive Oral Surgery. 2011
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Pertici G, Müller M, Rossi F, Villa T, Carusi G, Maccagnan S, Carù F, Crivelli F, Perale G. Bioresorbable bioactive bone scaffold: A new scaffold for regenerative medicine. European Symposium on Biomaterials and Related Areas EuroBioMat. 2011
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Industrie Biomediche Insubri SA. Bone regeneration technology. OrthoTec Europe. 2010
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Pertici G, Müller M, Perale G. Bioresorbable bioactive matrix for bone regeneration. Tissue Engineering Part A, 16(8): A-10 & International Tissue Engineering Congress BONE-TEC 2009 -Hannover (Germany)

Pertici G, Müller M, Crivelli F, Perale G. Stem cells, biomaterials and nanotechnologies in regenerative medicine. JOINT CONFERENCE OF THE CZECH AND SLOVAK NEUROSCIENCE SOCIETIES. 2019
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Bardelli S, Minonzio G, Aita G, Pertici G, Albertini V, Vigetti D, Gola M, Moccetti T, Tallone T, Soldati G. Clinically optimized cell culture conditions in combination with a new 3D scaffold for human mesenchymal stem cell bone tissue engineering. Regenerative medicine, 2009; 4(6):70-71; World Conference on Regenerative Medicine, Leipzig (Germany)
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Tallone T, Minonzio G, Pertici G, Aita G, Bardelli S, Gola M, Albertini V, Soldati G. New defined cell culture conditions in combination with a new 3d-scaffold for mscs bone tissue engineering. 22nd European Conference on Biomaterials ESB. 2009 Lausanne (Switzerland)

Pertici G, Perale G, Maccagnan S, Müller M. Novel composite 3d scaffold for bone tissue engineering. 22nd European Conference on Biomaterials ESB 2009 - 07-11th September, Lausanne (Switzerland)
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Pertici G, Müller M, Perale G. Bioresorbable bioactive bone matrix: a new 3d scaffold for tissue engineering in reconstructive maxillo-facial surgery. The 7th International Stem Cell School in Regenerative Medicine, 2-4 Nov., Prague (Czech Republic)
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*Smartbone® is a trade name from Industrie Biomediche Insubri SA and identical to naturesQue SemOss B