Inion BioRestore Bridging the Gap 2.11.2015 Types of Bone Grafts - PowerPoint PPT Presentation

Inion BioRestore ™ Bridging the Gap 2.11.2015

Types of Bone Grafts  Allograft Donor bone  Autograft Bone taken from the patient’s own body, e.g., hip or ribs  Synthetic graft HA TCP Bioactive glass → Inion BioRestore ™

Key Market Trends & Drivers  The United States is the largest and leading market worldwide, while emerging nations (i.e. China, India and Brazil) are forecasted to fuel growth in the coming years.  A series of factors drive the higher demand for bone graft or bone graft substitute products  The increasing number of spinal fusion procedures in private healthcare  Rising incidence of knee and hip related problems in the elderly  Developments in dental implant materials technology and the rise in dental implant procedures  Synthetic bone grafts increasingly replace conventional autografts and allografts  Growing understanding among patients and physicians about the advantage of synthetic over cadaveric allograft  `` Strict regulatory norms governing clinical trials and approvals ´´ Cited from Bone Grafts: A Global Strategic Business Report published by Global Industry Analysts. INC Cited from www.implantpracticeus,com by Dr. Kamran Zamanian, PhD, and Stephen Teng, iData Research, Inc.

How Bone Grafts work? Four ways for bone grafts (or bone graft substitutes) to help repair a defect in the bone Osteoinduction A chemical process in which Osteogenesis molecules contained within the The formation of new bone graft (bone morphogenetic by the cells contained within proteins, BMP) convert the the graft patient’s cells into cells capable of forming bone Osteoconduction Osteostimulation A physical effect whereby the An active stimulation of graft matrix configures a osteoblast proliferation and scaffold on which cells in the differentiation recipient form new bone Cited from http://www.surgeryencyclopedia.com/A-Ce/Bone-Grafting.html

How Bone Grafts work? Four ways for bone grafts (or bone graft substitutes) to help repair a defect in the bone Growth factors: Autograft or allograft Osteoinduction bone: A chemical process in which Osteogenesis molecules contained within the The formation of new bone graft (bone morphogenetic by the cells contained within proteins, BMP) convert the the graft patient’s cells into cells capable of forming bone Inion BioRestore, Inion BioRestore: HA and TCP fillers: Osteoconduction Osteostimulation A physical effect whereby the An active stimulation of graft matrix configures a osteoblast proliferation and scaffold on which cells in the differentiation recipient form new bone Cited from http://www.surgeryencyclopedia.com/A-Ce/Bone-Grafting.html

What is Inion Biorestore™? A synthetic bone graft substitute  Made of degradable bioactive glass  Composed of fibers welded together to form an interconnected, fully open 3D structure  Biocompatible and safe to use  Gradually resorbed and replaced by new bone within 6 months in vivo  An advantageous alternative to harvesting autograft bone and use of allograft bone in a variety of surgical procedures

How does Inion BioRestore™ work? SiO 2 rich layer 1-2µm Silica disolution Silicic acid - Si(OH) 4 Rapid ion exchange Condensation and polymerization of an amorphous Silica-rich layer (PO 4 ) 3- Ca 2 ACP + Ca 2 (PO 4 ) 3- + Further dissolution of the Further dissolution of the glass, formation of ACP layer glass, formation of HCA layer. New Bone growth

Histological Response of Inion BioRestore™ Bony tissue formation inside the 3D structure Scaffold material Bony tissue formation inside a degraded fibre

Indications Inion BioRestore™ can be used for:  orthopaedic trauma, dental indications and cranio- maxillofacial surgery for bony voids or gaps that are not intrinsic to the stability of the bony structure AND  in spine surgery for filling defects associated with spinal stabilisation and fusion.

Contraindications The Inion BioRestore™ implants are NOT intended for use in and are contraindicated for:  Active or potential infection  Patient conditions including:  Use of medication known to affect the skeleton like chronic anticoagulant therapy (e.g., heparin).  A systemic metabolic disorder known to adversely affect bone healing and mineralisation (e.g. poorly controlled insulin-dependent diabetes, renal osteodystrophy , Paget’s disease), other than primary osteoporosis.  Any existing condition or disease that will interfere with good soft tissue and bone healing.  Defects requiring graft material to exceed the volume of 30 cm³ .  Limited blood supply  When patient cooperation cannot be guaranteed e.g. alcoholism, drug abuse, and psychiatric problems

Advantages  Not only osteoconductive but also osteostimulative  The highly porous and fully open structure enables better flow of fluid, cells and nutrients, and allows formation of new bone both outside in and inside out  Controlled and significantly faster resorbtion and replacement by bone than in case of other commercially available products (e.g., HA and other bioactive glass products)

Advantages  Synthetic origin excludes risks of disease transmission and overcomes the limitations in quantity and quality of available bone graft  Donor site morbidity is avoided as no autograft needs to be taken or in case autograft is used through filling the donor site defect with Inion BioRestore ™  Easy to use  Recent studies suggest that bioactive glasses have antibacterial properties* * Gorriti et al., Advanced Engineering Materials 2009; 11(7): B67-B70 Lindfors et al., Bone 2010;47:212-218 Lindors et al., J Biotechnol Biomaterials 2011;1:111 Leppäranta et al., J Mater Sci: Mater Med 2008;19:547-551 Munukka et al., J Mater Sci: Mater Med 2008;19:27-32 Prabhakar and Kumar, Indian J Dent Res, 2010 Jan-Mar; 21(1): 30-4

Preparation Technique • The Inion BioRestore ™ Morsels should be wet with patient’s blood or marrow, or sterile saline or water before application • Place the Inion BioRestore ™ Morsels in contact with the desired fluid to soak up the fluid in a sterile basin or other suitable container • The open porous structure of Inion BioRestore ™ Morsels will allow the fluid to immediately permeate into the implant * While either sterile saline or water can be used, osseous regeneration may occur more rapidly by using the patient’s osteogenic blood or marrow obtained by scoring the surface or drilling into the cortical bone at the surgical site

Key Features and Selling Points  Key features  Bioglass fibres welded together to form an interconnected, fully open 3D structure  HCA layer formed on surface during degradation  Fully degrades and is replaced by bone in 6 months in vivo  Key indication / use  Fill bony voids or gaps that are not intrinsic to the stability of the bony structure  Not for load bearing indications without appropriate additional fixation  Key benefits and selling points  Fully biodegradable bioactive scaffold (Increased level of osteoblast activity and differentiation due to increased levels of alkaline phosphatase)  Bone grows not only from the outside of the defect to its insides (osteoconductivity), but also throughout the defect (osteostimulativity)  Antibacterial properties of bioactive glasses*  Easy to use *Lepparanta et.al. Antibacterial effect of bioactive glasses on clinically important anaerobic bacteria in vitroJ Mater Sci: Mater Med. 2008;19(2):547-551 Munukka et al. Bactericidal effects of bioactive glasses on clinically important aerobic bacteria. J Mater Sci: Mater Med. 2008;19(1):27-32

Clinical Experience  Inion BioRestore ™ has been successfully used in 82 spinal fusion cases (26 anterior cervical and 56 posterior lumbar fusions) in 5 hospitals in the USA .  The operations have been done between May 2013 and December 2014  20 cases in 2013  20 cases during the first half of 2014 and 42 during the second half of 2014  The ease of implantation was rated by surgeons as “very easy” and “easy” 50 42 40 Case number 40 30 20 10 0 0 0 Very Easy Easy Difficult Very Difficult

Clinical Experience  In the posterior lumbar fusions (56 cases) and anterior cervical fusions (26 cases), Inion BioRestore ™ was used as bone graft extender or independently. 60 19 Case Number Inion BioRestore™ 45 2 Inion BioRestore™ + allograft 30 35 20 Inion BioRestore™ + autograft 15 6 0 The posterior The anterior lumbar fusions cervial fusions  The volume of used Inion BioRestore ™ Morsels and the related case number Volume (cc) 1.5 4.5 9.0 18 Case No. In posterior lumbar fusions - 41 14 1 In anterior cervical fusions - - 4 22  No problems or complications reported

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