naturesQue SemOss B

Ksenohibridni goveđi nadomjesni koštani materijal

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naturesQue SemOss B je ksenohibridni nadomjesni koštani materijal s premazom od mješavine kopolimera i fragmenata kolagena. Kombinacija različitih klasa materijala kompenzira ograničenja pojedinih elemenata i poboljšava njihova pozitivna svojstva. Ova kombinacija stvara resorptivni nadomjesni koštani materijal goveđeg podrijetla. Za primjenu, granule se navlaže krvlju kako bi se pozitivna svojstva premaza mogla učinkovito razviti.


Preuzmite brošuru za liniju proizvoda

Dokumentirana edukacija pacijenata o augmentaciji kosti

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naturesQue SemOss B – novi koncept za goveđi nadomjesni koštani materijal i njegove gradivne blokove

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Matrica goveđe kosti

  • Glave femura s visokim sadržajem spužvastog tkiva
  • Porozni inicijalni materijal s prirodno savršenim značajkama dizajna za urastanje kosti i remodeliranje
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Kemijski postupak pročišćavanja

  • Nepromijenjena kristalna struktura u koštanom matriksu
  • Uklanjanje organskih komponenti
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Proces usavršavanja za poboljšanje svojstava matrice

  • Jača elasto-mehanička svojstva
  • Povećava kolonizaciju stanica u koštanom matriksu
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Sigurnost

naturesQue SemOss B siguran je nadomjesni koštani materijal i ispunjava zahtjeve Direktive 93/42/EEC Dodatak 2 odjeljak 4 i Uredbu 722/2012.

Struktura i dizajn

Poroznost naturalsQue SemOss B karakteriziraju veliki prostori volumena spužvaste kosti. Trabekularna arhitektura ostaje netaknuta i pruža savršen dizajn za migraciju stanica koje tvore kost, urastanje krvnih žila i remodeliranje.

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Skenirajuća elektronska mikroskopska snimka granula naturalsQue SemOss B.

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Primjena – preporučena rehidracija krvlju (pacijenta).

Matrica goveđe kosti naturalsQue SemOss B ojačana je površinskim premazom. Denaturirani fragmenti kolagena stvaraju pogodno okruženje za kolonizaciju stanica. Prvi tjedni obilježeni su migracijom stanica i kolonizacijom površine naturalsQue SemOss B. U isto vrijeme, mješavina kopolimera se razgrađuje i mineralna koštana matrica postaje potpuno dostupna.

Kako bi se razvila pozitivna svojstva površinskog premaza naturesQue SemOss B, naturalsQue SemOss B mora se navlažiti krvlju. Na taj se način važne biološke molekule iz krvi vežu na površinu i pridonose stvaranju nove kosti u izravnom kontaktu s koštanim nadomjeskom.

Biološko kondicioniranje

Pozitivna svojstva premaza razvijaju se hidratacijom krvlju.
Koštani nadomjesni materijal natapa se krvlju u defekt. Zbog lokalne mikrokoagulacije krvi u augmentatu pokreće se signalna kaskada i stvaraju preduvjeti za integraciju prirodnog SemOss B.

Primjena: natapanje krvlju

Vezanje bioloških molekula na površinu

  • Kondicioniranje površine serumskim komponentama krvi
  • Vrlo dobro prianjanje stanica na RGD motive fragmenata denaturiranog kolagena
  • Stabilno koštano ležište

Izbjegavati: vlaženje s NaCl

Ekstrakcija fragmenata denaturiranog kolagena iz kopolimernog filma

  • Nedostaju vezna mjesta za stanice ekstrakcijom fragmenata denaturiranog kolagena iz kopolimernog filma
  • Granični slojevi vezivnog tkiva između nove kosti i koštanog nadomjeska
  • Nedovoljna stabilnost u ležištu kosti
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Kopolimerna mješavina poli-L-laktida i poli-ɛ-kaprolaktona

  • Povećana otpornost naturalsQue SemOss B
  • Zaštita mineralne koštane matrice od preuranjene resorpcije tijekom upalne faze nakon operacije
  • Daje NaturalsQue SemOss B plastična svojstva za izvrsno rukovanje

Fragmenti denaturiranog svinjskog kolagena

  • Imobilizirane kratke biomolekule
  • Sadrži RGD sekvencu (Arg-Gly-Asp), koja potiče staničnu adheziju i ubrzava početak stvaranja kosti

Profil resorpcije

Zbog prirodne kristalne strukture minerala kosti, ksenogenska koštana matrica naturalsQue SemOss B potpuno se resorbira.

Završna obrada mješavinom kopolimera štiti koštanu matricu od prerane resorpcije i poboljšava njezina elasto-mehanička svojstva. Fragmenti kolagena su pogodan supstrat za staničnu adheziju i potiču mogućnost vlaženja površine naturalsQue SemOss B.

naturesQue SemOss B potpuno se resorbira unutar 1 – 2 godine tijekom remodeliranja i zamjenjuje ga vlastita kost pacijenta. Mješavina kopolimera u završnom premazu naturesQue SemOss B razgrađuje se u prosjeku za 18 tjedana, što je optimalno vrijeme u kojem se može očekivati dobro formiranje kosti i integracija u tkivo.

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Resorptivni ksenohibridni goveđi koštani nadomjesni materijal

  • Mineralna struktura matrice goveđe kosti ne mijenja se tijekom proizvodnje. Osteoklasti mogu u potpunosti razgraditi prirodni kristalni agregat tijekom remodeliranja.

Radiološka neprozirnost 

  • Nakon apliciranja, naturesQue SemOss B blago je neproziran zbog niske gustoće i vrlo otvorene porozne strukture. Tijekom cijeljenja i remodeliranja kosti, neprozirnost se povećava stvaranjem nove, mineralizirane kosti u području defekta.

naturesQue SemOss B u kontekstu

Podrijetlo
  • Goveđa kost
  • Mješavina kopolimera
  • Svinjski kolagen
Sastav
  • Mineralna faza spužvaste kosti
  • Poli-L-laktid i poli-ɛ-kaprolakton
  • Fragmenti denaturiranog svinjskog kolagena
Obrada
  • Uklanjanje organske faze
  • Ojačanje/završni tretman: Nanošenje mješavine kopolimera i fragmenata denaturiranog kolagena
  • Procjeđivanje, pakiranje, sterilizacija
Primjena
  • Pomiješajte s krvlju pacijenta
  • Umetnuti u defekt sterilnim instrumentima
  • Miješanje s vodenom otopinom (NaCl, fiziološka otopina) treba izbjegavati.
Konzistencija
  • Suh: tvrd i čvrst
  • Navlažen krvlju: malo plastičan, može se modelirati jer se granule lijepe jedna za drugu
Resorpcija
  • Resorptivan, profil resorpcije ovisi o individualnom stanju pacijenta.
  • Mehaničko opterećenje u području augmentata najranije nakon 6 mjeseci

Publikationen 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)*
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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)*
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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
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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*
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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)*
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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*
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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
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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
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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*
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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