BIOACTIVE BASICS. Bioactive materials elicit a controlled action and reaction in the physiological environment.

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2 BIOACTIVE BASICS Bioactive materials elicit a controlled action and reaction in the physiological environment. Bioglass is a glass ceramic composed of silicon dioxide (SiO 2 ), sodium oxide (Na 2 O), calcium oxide (CaO) and phosphorus pentoxide (P 2 O 5 ). It is a bioactive material shown to be osteostimulative and elicit a specific biological response at the material surface. What is Osteostimulation? Osteostimulation is defined as an accelerated bone formation process characterized by the active stimulation of osteoblast proliferation and differentiation in an osseous defect. This stimulatory action has been demonstrated during in vivo tests of the Bioglass particulate to be more rapid than simple osteoconduction. 4, 5 These tests are supported by in vitro cell culture tests which demonstrate the mechanisms of cell stimulation as a result of cellular 1, 2, 6, 7 interaction with the ionic dissolution products released from the Bioglass particulate during its absorption. The Power of Bioactive Glass Attracts osteoblasts and stimulates increased 1, 2, 3 protein production

3 THE POWER OF BIOACTIVE GLASS Bioactive Ion Release Osteoblast Proliferation Bioglass is composed of calcium, phosphorous, silicon, and sodium oxides which are minerals that naturally occur in the body. As Bioglass resorbs and comes in contact with bodily fluids, it releases these constitutive ions.6, 7 The release of bioactive ions attracts osteoblasts to the scaffold and activates increased protein production.1, 3 Bioglass has been shown to stimulate the proliferation of human osteoblasts and help accelerate bone formation.1, 2, 11 Hydroxycarbonate Apatite Layer Formation Early Vascularization Once ions are released from the Bioglass, a hydroxycarbonate apatite layer forms on the surface of the matrix, creating an ideal surface for cellular attachment and entrapment of growth factors.3, 6, 7, 10 Hyaluronic acid is shown to promote early vascularization which may lead to earlier bone growth.8, 9

4 IMPLANT OVERVIEW Confirm is an osteostimulative and osteoconductive bioactive bone void filler available in two different forms gel and crunch. Confirm Gel Composition: Bioglass, hyaluronic acid, glycerol Sterile-packed in a syringe Available in three sizes: 2, 5, and 10cc Uniform Bioglass particle sizes Confirm Crunch Composition: Bioglass, hyaluronic acid, glycerol Sterile-packed in a syringe Available in three sizes: 2, 5, and 10cc Mixture of Bioglass particle sizes For more information about Confirm Bioactive or other Bone Bank orthobiologic solutions, visit BoneBank.com

5 PRODUCT SPECIFICATIONS Ease of Use Confirm does not require special handling procedures prior to use. Confirm implants must be combined with autogenous graft material and bone marrow aspirate (BMA) in the following product:autograft:bma ratios: Gel 3:1:1 and Crunch 10:2:1. Storage Confirm Bioactive is temperature sensitive and must be stored at room temperature (15 C-30 C; 59 F-86 F) in a clean, dry place. This product is stable at room temperature; no refrigeration or freezing is required. Part No. Description Size S Confirm Gel, 2cc 2cc S Confirm Gel, 5cc 5cc S Confirm Gel, 10cc 10cc S Confirm Crunch, 2cc 2cc S Confirm Crunch, 5cc 5cc S Confirm Crunch, 10cc 10cc REFERENCES 1. Xynos ID, Edgar AJ, Buttery LDK, Hench LL, Polak JM. Ionic products of bioactive glass dissolution increase proliferation of human osteoblasts and induce insulin-like growth factor II mrna expression and protein synthesis. Biochem. Biophys. Res. Commun. 2000; 276: Xynos ID, Hukkanen MV, Batten JJ, Buttery LD, Hench LL, Polak JM. Bioglass 45S5 stimulates osteoblast turnover and enhances bone formation in vitro: implications and applications for bone tissue engineering. Calcif. Tissue Int. 2000; 67: Ducheyne P, Qiu Q. Bioactive ceramics: the effect of surface reactivity on bone formation and bone cell function. Biomaterials 1999; 20: Oonishi H, Kushitani S, Yasukawa E, Iwaki H, Hench LL, Wilson J, Tsuji E, Sugihara T. Particulate bioglass compared with hydroxyapatite as a bone graft substitute. Clin Orthop. 1997; 334: Fujishiro Y, Hench LL, Oonishi H. Quantitative rates of in vivo bone generation for bioglass and hydroxyapatite particles as bone graft substitute. J Mater Sci Mat Med. 1997; 8: Vrouwenvelder WC, Groot CG, de Groot K. Histological and biochemical evaluation of osteoblasts cultured on bioactive glass, hydroxyapatite, titanium alloy and stainless steel. J. Biomed Res. 1993; 27: Bosetti M, Cannas M. The effect of bioactive glasses on bone marrow stromal cells differentiation. Biomaterials. 2005; 26(18): Sasaki T, Watanabe C. Stimulation of osteoinduction in bone wound healing by high-molecular weight hyaluronic acid. Bone. 1995; 16: West DC, Hampson IN, Arnold F, Kumar S. Angiogenesis induced by degradation products of hyaluronic acid. Science. 1985; 14: Hench LL. The story of bioglass. J. Mater. Sci. Mater. Med. 2006; 17(11): Gerhardt LC, Boccaccini AR. Bioactive glass and glass-ceramic scaffolds for bone tissue engineering. Materials, 2010; 3(7):

6 Distributed by: Bone Bank Allografts An AATB certified tissue bank 4808 Research Drive San Antonio, TX BBBRC Rev B