Bacterin Biologics Product Guide

Transcription

1 Bacterin Biologics 2015 Product Guide

2 Contents Welcome to Bacterin Biologics 3 Product Codes Reference 4 BacteRinse Process 7 OsteoSponge 8 OsteoSponge SC 11 OsteoSelect DBM Putty 13 OsteoWrap OrbitalWrap HD 15 OsteoSTX 16 3Demin 17 BacFast 18 Precision-Milled & Traditional Allografts 19 Bacterin is ISO 13485:2003 certified, registered with the FDA, accredited by the AATB, and has state licensures where required. All current licenses and certifications can be found at bacterin.com hmatrix ADM & hmatrix PR ADM 20 Sports Medicine 21 Need More Info? 22 Circle of Life 23 2 bacterin.com

3 Welcome to Bacterin Biologics Bacterin upholds the highest levels of safety, efficacy, and quality with every product. About Bacterin Bacterin is a biotechnology organization focused on biologic-based applications for orthopedic and reconstructive surgical procedures. We take pride in our role as stewards of the gift of donation and the dimensional healing that occurs with both, patients and donor families. We thank you for the role you play in the Circle of Life and invite you to learn more about the Value Bacterin has to offer. Advanced Processing Technologies Bacterin has developed a patented demineralization technology that is engineered to preserve the native growth factors inherent bone. These growth factors are essential for the tissue regeneration process in the patients body. Bacterin has additional patent-pending methods focused on demineralization of tissue, designed to extend more desirable handling characteristics for the surgeon and clinical benefits for the patient. Our BacteRinse Process is also utilized ensuring all allografts are processed aseptically using progressive methods, and finalized with low-dose gamma irradiation. Proven Clinical Efficacy Clinical efficacy is of considerable importance to Bacterin and the continuum of care we strive to provide on behalf of our donors for the patients. Our products have been featured in various publications yielding results as high as 97.5% fusion rates. We take pride in knowing the science in our allografts provides the best possible outcomes for patients. Safety Patient safety is of the utmost importance. There have been many scientific advances in irradiation technologies that have minimized the effects on allograft integrity. 100% of Bacterin allografts and biologic devices are sterilized via low-dose gamma irradiation in the final packaging, with a sterility assurance level of 10-6 (SAL 10-6 ). This is commonly referred to as device level sterility and is accomplished using FDA approved, validated methods. bacterin.com 3

4 Bacterin Biologics Product Codes Call Point Legend FA Foot and Ankle H Hip UE Upper Extremity S Spine K Knee PR Plastic and Reconstructive C Cranio-Maxillofacial W Wound OsteoSponge Filler FA H S UE C OsteoSponge Block FA K H S UE OsteoSponge Filler Fine 0.5cc 1 4 mm Chips OsteoSponge Filler Fine 1.0cc 1 4 mm Chips OsteoSponge Filler Fine 2.5cc 1 4 mm Chips OsteoSponge Filler Fine 5.0cc 1 4 mm Chips OsteoSponge Filler Fine 10.0cc 1 4 mm Chips OsteoSponge Filler Fine 15.0cc 1 4 mm Chips OsteoSponge Filler Fine 30.0cc 1 4 mm Chips OsteoSponge Filler 1.0cc 4 10 mm Chips OsteoSponge Filler 2.5cc 4 10 mm Chips OsteoSponge Filler 5.0cc 4 10 mm Chips OsteoSponge Filler 10.0cc 4 10 mm Chips OsteoSponge Filler 15.0cc 4 10 mm Chips OsteoSponge Filler 30.0cc 4 10 mm Chips OsteoSponge Filler 5.0cc Syringe OsteoSponge Filler 10.0cc Syringe OsteoSponge Filler 15.0cc Syringe OsteoSponge Block 8 mm OsteoSponge Block 8 mm 10 pack OsteoSponge Block 10 mm OsteoSponge Block 12 mm OsteoSponge Block 14 mm OsteoSponge SC FA K OsteoSponge SC 6 mm OsteoSponge SC 8 mm OsteoSponge SC 10 mm OsteoSponge SC 12 mm OsteoSponge Disc FA C PR OsteoSponge Strip FA H S UE C OsteoSponge Strip mm OsteoSponge Strip mm OsteoSponge Strip mm OsteoSponge Strip mm OsteoSponge Strip mm OsteoSponge Strip mm OsteoSponge Strip mm OsteoSponge Strip mm OsteoSponge Strip mm OsteoSponge Strip mm 2 pack OsteoSponge Strip mm 4 pack OsteoSponge Strip mm 4 bacterin.com OsteoSponge Disc, 10 mm OsteoSponge Disc, 12 mm OsteoSponge Disc, 14 mm OsteoWrap OrbitalWrap HD FA H S UE C PR OsteoWrap mm OsteoWrap mm OsteoWrap mm OsteoWrap mm OsteoWrap mm OsteoWrap mm OsteoWrap mm OsteoWrap mm OrbitalWrap HD mm OrbitalWrap HD mm

5 3Demin Cortical Fibers FA K H S UE OsteoSTX S Demin Cortical Fibers 2.5 cc Demin Cortical Fibers 5.0 cc Demin Cortical Fibers 10.0 cc OsteoSTX 50 mm 10 per pack OsteoSTX 100 mm 10 per pack OsteoSTX 200 mm 10 per pack 3Demin Boats FA K H S UE Traditional Allografts FA H S UE Demin Boat mm 2 pack Demin Boat mm 2 pack 3Demin Strips FA K H S UE Demin Strip mm 2 pack Demin Strip mm 2 pack Demin Strip mm 2 pack Precision-Milled Allografts S BacFast HD Facet Dowel, 5 mm BacFast HD Facet Dowel, 6 mm Cervical Spacer, Lordotic, 5 mm Cervical Spacer, Lordotic, 6 mm Cervical Spacer, Lordotic, 7 mm Cervical Spacer, Lordotic, 8 mm Cervical Spacer, Lordotic, 9 mm Cervical Spacer, Lordotic, 10 mm OsteoSelect DBM Putty FA H S UE OsteoSelect DBM Putty 0.5cc OsteoSelect DBM Putty 1.0cc OsteoSelect DBM Putty 2.5cc OsteoSelect DBM Putty 5.0cc OsteoSelect DBM Putty 10.0cc OsteoSelect DBM Putty 2.5cc Syringe Ilium Tricortical Block 6 mm Ilium Tricortical Block 7 mm Ilium Tricortical Block 8 mm Ilium Tricortical Block 9 mm Ilium Tricortical Block 10 mm Ilium Tricortical Block 11 mm Ilium Tricortical Block mm Ilium Tricortical Block 15 mm Ilium Tricortical Block mm Ilium Tricortical Block mm Ilium Tricortical Strip 40 mm Ilium Tricortical Strip 45 mm Ilium Tricortical Strip 50 mm Ilium Tricortical Strip 55 mm Ilium Tricortical Strip 60 mm Cancellous Crushed mm 5cc Cancellous Crushed mm 15cc Cancellous Crushed mm 30cc Cancellous Crushed 4 10 mm 5cc Cancellous Crushed 4 10 mm 15cc Cancellous Crushed 4 10 mm 30cc Unicortical Block 5 mm Unicortical Block 6 mm Unicortical Block 7 mm Unicortical Block 8 mm Unicortical Block 9 mm Unicortical Block 10 mm Fibula Segment mm Fibula Segment mm Femoral Cortical Strut 200 mm Split OsteoSelect DBM Putty 5.0cc Syringe OsteoSelect DBM Putty 10.0cc Syringe bacterin.com 5

6 hmatrix ADM FA W Sports Medicine FA K hmatrix Dermis 2 1 cm, Thin hmatrix Dermis 4 2 cm, Thin hmatrix Dermis 5 4 cm, Thin hmatrix Dermis 7 5 cm, Thin hmatrix Dermis 10 5 cm, Thin hmatrix Dermis 2 1 cm, Medium hmatrix Dermis 4 2 cm, Medium hmatrix Dermis 5 4 cm, Medium hmatrix Dermis 7 5 cm, Medium hmatrix Dermis 10 5 cm, Medium hmatrix Dermis 2 1 cm, Thick hmatrix Dermis 4 2 cm, Thick Achilles Tendon w/bone Block Anterior Tibialis Tendon Posterior Tibialis Tendon Gracilis Tendon Hemi-Patella Tendon Semitendinosus Tendon Whole Patella Tendon w/quad Whole Patella Tendon w/o Quad Hemi-Patella Tendon w/quad Peroneus SportMatrix ADM 12 1 cm, Medium hmatrix Dermis 5 4 cm, Thick hmatrix Dermis 7 5 cm, Thick hmatrix Dermis 10 5 cm, Thick hmatrix Dermis 4 2 cm, Thin, Meshed hmatrix Dermis 5 4 cm, Thin, Meshed hmatrix Dermis 7 5 cm, Thin, Meshed hmatrix Dermis 10 5 cm, Thin, Meshed hmatrix PR ADM PR hmatrix PR - Dermis 16 6 cm, Thin hmatrix PR - Dermis 16 8 cm, Medium hmatrix PR - Dermis cm, Medium hmatrix PR - Dermis 20 8 cm, Medium hmatrix PR - Dermis cm, Medium Pericardium and Fascia Lata FA W hmatrix Fascia Lata 30 30mm hmatrix Fascia Lata 50 40mm hmatrix Fascia Lata 70 50mm hmatrix Fascia Lata mm Pericardium 30 30mm Pericardium 40 40mm Pericardium 50 40mm Pericardium 70 50mm Pericardium mm Pericardium mm 6 bacterin.com

7 The BacteRinse Proprietary Process Aseptic Recovery of Donor Tissue Tissue recovery takes place in prequalified settings Direct tissue sampling at time of recovery Donor Screening Exceeds FDA and AATB Standards Extensive microbiological testing on all recovered donor tissues Serological testing using the latest NAT (Nucleic Acid Testing) techniques v Aseptic Processing to Prevent Introduction of Microbial Bioburden Utilization of ISO 5 cleanrooms Processing staff wears full isolation PPE We process each graft in ISO 5 (Class 100) cleanrooms using the highest level of manual craftsmanship to consistently meet our product specifications for the surgical needs of medical providers. Bacterin has engineered its processing methods to effectively clean and decontaminate allograft tissue while minimizing exposure of the extracellular matrices to potentially damaging treatment steps. This preserves the osteoinductive potential of our DBM allografts and maintains the biomechanical integrity of our soft tissue grafts. Meticulous Cleansing of Tissue Lysing of cellular components Removal of bone marrow and blood elements Validated, Rigorous Disinfection of Tissue Proven log reduction against a panel of representative microbes Effective removal of processing reagents Validated Sterilization with an SAL of 10-6 Low dose, low temp ASNI/AAMI/ISO VD MAX or Method 2B bacterin.com 7

8 OsteoSponge Features 100% human demineralized cancellous bone OsteoSponge can be cut to perfectly fit any cage Osteoconductive, interconnected porosity Osteoinductive potential Elastic, compressible handling characteristics Radiolucent to allow for accurate follow-up Sterility assurance level (SAL) year shelf life, room-temperature storage OsteoSponge Benefits OsteoSponge is a novel form of demineralized bone matrix (DBM) made from 100% bone. Derived from trabecular bone, OsteoSponge provides a natural scaffold for cellular ingrowth and exposes bone-growth-inducing proteins to the healing environment. The malleable properties of OsteoSponge enable it to fill and conform to irregular bony defects. Due to its shape memory characteristics, OsteoSponge will expand to completely fill a void after graft placement. The unique mechanical and biological properties make OsteoSpongean ideal bone graft for use with all non-weight bearing applications where fusion is desired. The compressible characteristics of OsteoSponge OsteoSponge Strip OsteoSponge Block 8 bacterin.com

9 OsteoSponge absolutely works. I haven t worked with a product that is as reliable and easy to work with as OsteoSponge. Dr. Kevin Stevenson, MD The Science OsteoSponge is processed with a validated method which includes a patented demineralization step engineered to preserve growth factors native to cancellous bone. The efficacy and saftey of this processing method has been clinically proven. When utilized in TLIF procedures in the lumbar spine, OsteoSponge has demonstrated fusion rates equivalent to historical controls without any reported complications.1 OsteoSponge has been successfully utilized in foot and ankle fusion procedures. Both retrospective2 and prospective3 data indicate that OsteoSponge can produce Figure 1 fusion rates equivalent to or higher than historic controls. Reported pain and function outcomes were statistically improved over historical controls. Growth factors found in bone TGF-(Beta) 1-5 PDGF AA,AB,BB BMP 1-12 IGF 1,2 FGF 1 Girasole, G. et al,. (2013) Transforaminal lumbar interbody fusion rates in patients using a novel titanium implant and demineralized cancellous allograft bone sponge. International Journal of Spine Surgery. 7: e95-e Brigido, S.A. et al., (2013) A Retrospective Analysis Evaluating Allogenic Cancellous Bone Sponge for Foot and Ankle Arthrodesis. The Journal of Foot and Ankle Surgery. 52: Figure 2 3 Protzman, N.M. et al., (2014) Biologic Augementation of Foot and Ankle Arthrodesis With an Allogenic Cancellous Sponge. Orthopedics. March 37(3): e230-e236. Figures 1 and 2 (above) Neovascularization, osteoid formation, and new bone growth has been consistently observed in subcutaneous and intramuscular implants of OsteoSponge. These results suggest that in addition to providing an excellent natural scaffold for cellular ingrowth To see full, published articles regarding the clinical efficacy of Bacterin biologics, please visit bacterin.com. and proliferation, OsteoSponge also contains growth factors. bacterin.com 9

10 OsteoSponge Competitive Comparison Few allografts on the market achieve similar clinical efficacy as OsteoSponge, without compromising patient safety and ease of use Osteoinductive Response in Animal Model Contains Bioavailable BMPs Sterile (SAL) 10-6 Trabecular Bone Structure Interconnected Porosity Osteoconductive Easily Loaded With BMA Room Temperature Storage Cervical Spine Indication Posterior Spinal Fusion Indication OsteoSponge (Bacterin) Infuse (Medtronic) OsteoCel Plus (NuVasive) Trinity Elite (MTF/Orthofix) Chronos (DePuy) Vitoss (Stryker) Actifuse (Baxter) Crushed Cancellous PRP (Autologous) Bacterin was the first tissue bank to market an allograft specifically designed for its compressible handling characteristics, osteoconductivity, and osteoinductive potential. If you aren t using OsteoSponge, you aren t using the original ideal bone graft. 10 bacterin.com

11 OsteoSponge SC Features Slightly contoured for ease of placement Osteoconductive, interconnected porosity Osteoinductive potential Elastic, compressible handling characteristics Radiolucent to allow for accurate follow-up Sterility assurance level (SAL) year shelf life, room-temperature storage OsteoSponge SC Benefits OsteoSpnge SC OsteoSponge SC is sterile, radiolucent, has a 5-year shelf life at room temperature, and is characterized by malleable handling properties, making it an excellent alternative to autologous bone or synthetic materials to effectively, safely, and efficiently repair subchondral defects in the knee or other articulating joints. Published clinical data confirm the results of a large animal study demonstrating restoration of the subchondral bone and a healthy joint environment. OsteoSponge SC Surgical Instrumentation Kit Available Upon Request Side View Shows the Tapered Shape of OsteoSpnge SC bacterin.com 11

12 OsteoSponge Block OsteoSponge Strip OsteoSponge Block 8mm OsteoSponge Strip mm OsteoSponge Block 8mm 10 pack OsteoSponge Strip mm OsteoSponge Block 10mm OsteoSponge Strip mm OsteoSponge Block 12mm OsteoSponge Strip mm OsteoSponge Block 14mm OsteoSponge Strip mm OsteoSponge Strip mm OsteoSponge Strip mm OsteoSponge Filler OsteoSponge Filler Fine 0.5cc 1 4 mm Chips OsteoSponge Strip mm OsteoSponge Filler Fine 1.0cc 1 4 mm Chips OsteoSponge Strip mm OsteoSponge Filler Fine 2.5cc 1 4 mm Chips OsteoSponge Strip mm - 2 pack OsteoSponge Filler Fine 5.0cc 1 4 mm Chips OsteoSponge Strip mm - 4 pack OsteoSponge Filler Fine 10.0cc 1 4 mm Chips OsteoSponge Strip mm OsteoSponge Filler Fine 15.0cc 1 4 mm Chips OsteoSponge Filler Fine 30.0cc 1 4 mm Chips OsteoSponge Filler 1.0cc 4 10 mm Chips OsteoSponge Filler 2.5cc 4 10 mm Chips OsteoSponge Filler 5.0cc 4 10 mm Chips OsteoSponge Filler 10.0cc 4 10 mm Chips OsteoSponge Filler 15.0cc 4 10 mm Chips OsteoSponge Filler 30.0cc 4 10 mm Chips OsteoSponge Filler 5.0cc Syringe OsteoSponge SC 6 mm Defect OsteoSponge Filler 10.0cc Syringe OsteoSponge SC 8 mm Defect OsteoSponge Filler 15.0cc Syringe OsteoSponge SC 10 mm Defect OsteoSponge SC 12 mm Defect OsteoSponge Disc OsteoSponge Disc, 10 mm OsteoSponge Disc, 12 mm OsteoSponge Disc, 14 mm OsteoSponge SC See the unique handling characteristics of OsteoSponge, and other Bacterin biologics at: bacterin.com/videos 12 bacterin.com

13 OsteoSelect DBM Putty Features Osteoinductive Osteoconductive Sterility assurance level (SAL) 10-6 OsteoSelect DBM Putty Exceptional handling characteristics Sterile, room-temperature storage Will not dissipate upon direct irrigation Contains 74% demineralized bone matrix (DBM) by dry weight OsteoSelect DBM Putty Benefits OsteoSelect DBM Putty is engineered with the surgeon in mind. With exceptional handling characteristics, OsteoSelect DBM Putty can be easily molded into any shape and compressed into bone voids. Taking the design a step further, Bacterin has validated a low-dose, low-temperature gamma sterilization process to provide maximum osteoinductive potential while still imparting device-level sterility. Every lot of OsteoSelect DBM Putty is tested for osteoinductivity after gamma sterilization in an animal model. Indications OsteoSelect DBM Putty is indicated for use as a bone void filler and bone graft substitute for voids or gaps that are not intrinsic to the stability of the bony structure. OsteoSelect DBM Putty is indicated for treatment of surgically created osseous defects or osseous defects from traumatic injury to the bone. OsteoSelect DBM Putty can be used as follows: Extremities Posterolateral Spine Pelvis OsteoSelect DBM Putty OsteoSelect DBM Putty 0.5 cc OsteoSelect DBM Putty 1.0 cc OsteoSelect DBM Putty 2.5 cc OsteoSelect DBM Putty 5.0 cc OsteoSelect DBM Putty 10.0 cc OsteoSelect DBM Putty in a syringe OsteoSelect DBM Putty 2.5 cc syringe OsteoSelect DBM Putty 5.0 cc syringe OsteoSelect DBM Putty 10.0 cc syringe bacterin.com 13

14 OsteoSelect DBM Putty Competitive Comparison OsteoSelect DBM Putty is a highly competitive product in the demineralized bone matrix space, providing many benefits to the surgeon and the patient. Osteoconductive 100% lot testing for osteoinductive potential animal model (in vivo) Sterile R (SAL) 10-6 Osteoinductive potential tested after sterilzation Room Temp Storage OsteoSelect DBM Putty (Bacterin) Progenix (Medtronic) DBX (DePuy Synthes) N/A Grafton (Medtronic) N/A Accell (Integra) Dynagraft II (Integra) The Science OsteoSelect DBM Putty utilizes a proprietary process engineered to preserve the growth factors found in cortical bone and provide the highest degree of safety (SAL 10-6 ) This validated proprietary method consistently demonstrates its efficacy in vivo as every lot of OsteoSelect DBM Putty is proven to induce bone formation in a validated pre-clinical model after terminal sterilization. OsteoSelect DBM Putty has been shown to be equivalent to autograft when used as a bone graft substitute in a pre-clinical, un-instrumented posterior spinal fusion model. 1 OsteoSelect DBM Putty has also been shown to be superior to a commercially available synthetic bone void filler. 2 1 Kiely, P.D. et al., (2014) Evaluation of a new formulation of demineralized bone matrix putty in a rabbit posterolateral spinal fusion model. The Spine Journal. September 14(9): Schallenberger et al., (2014) Comparison of the Osteogenic Potential of OsteoSelect Demineralized Bone Matrix Putty to NovaBone Calcium-Phosphosilicate Synthetic Putty in a Cranial Defect Model. The Journal of Craniofacial Surgery. March 25(2): bacterin.com

15 OsteoWrap & OrbitalWrap HD Features Demineralized cortical bone sheet Radiolucent to allow for accurate follow-up assessment of bone formation Osteoconductive & osteoinductive potential Flexible handling characteristics OsteoWrap Sterility assurance level (SAL) year shelf life, Room-temperature storage OsteoWrap Benefits OsteoWrapis 100% human cortical bone demineralized through a proprietary process that makes the graft flexible while maintaining allograft integrity. In addition to its unique handling characteristics, OsteoWrapcan be easily sized with a scalpel or scissors, and it may be sutured in place. The versatility of the OsteoWrapallograft makes it an ideal scaffold for use in spine, neuro, cranio-maxillofacial, reconstructive, and general orthopedic surgical procedures, to provide additional structural support as an overlay graft. OrbitalWrap HD Benefits OrbitalWrap HD is a unique and cost-competitive biologic solution that alleviates the need for permanent implants. This low-profile graft can be easily contoured over a defect in the patient s orbital floor. If desired, OrbitalWrap HD can be used in conjunction with traditional implants. Designed to have similar attributes to OsteoWrap, OrbitalWrap HD is slightly less flexible. OrbitalWrap HD OsteoWrap OrbitalWrap HD OsteoWrap mm OsteoWrap mm OsteoWrap mm OsteoWrap mm OsteoWrap mm OsteoWrap mm OsteoWrap mm OsteoWrap mm OrbitalWrap HD mm OrbitalWrap HD mm bacterin.com 15

16 OsteoSTX Features Osteoconductive Osteoinductive potential Sterility assurance level (SAL) 10-6 Flexible handling characteristics Sterile, room-temperature storage Easily cut to size, available in multiple lengths Conveniently distributed in packs of 10 OsteoSTX Benefits OsteoSTX are demineralized cortical sticks processed from donated human bone. Our proprietary demineralization technology gives the osteoconductive scaffold flexible handling characteristics and osteoinductive properties. When combined with BMA, OsteoSTX provide all of the necessary elements for bone regeneration. OsteoSTX are designed for posterolateral spine surgery applications including single- and multi-level fusions, as well as deformity procedures. OsteoSTX OsteoSTX 50 mm 10 per pack OsteoSTX 100 mm 10 per pack OsteoSTX 200 mm 10 per pack OsteoSTX can be easily cut to size 16 bacterin.com

17 3Demin Features Osteoconductive Osteoinductive potential Sterility assurance level (SAL) 10-6 Exceptional handling characteristics Sterile, room-temperature storage Will not dissipate upon direct irrigation 100% human demineralized cortical bone 3Demin Benefits 3Demin Boat Bacterin s 3Demin Technology utilizes demineralized cortical bone fibers that are entangled and shaped into sizes engineered to compliment specific surgical applications. This unique process creates an interconnected graft material that contains BMPs and other growth factors necessary for the promotion of new bone formation. 3Demin allografts are flexible upon hydration and each allograft has a sterility assurance level of 10-6 via low-dose gamma sterilization. 3Demin allografts are also available as loose cortical fibers in three volume options. 3Demin Strip 3Demin Cortical Fibers 3Demin Cortical Fibers Demin Cortical Fibers 2.5 cc Demin Cortical Fibers 5.0 cc Demin Cortical Fibers 10.0 cc 3Demin Boats Demin Boat mm 2 pack Demin Boat mm 2 pack 3Demin Strips Demin Strip mm 2 pack Demin Strip mm 2 pack Demin Strip mm 2 pack bacterin.com 17

18 Precision-Milled Allografts BacFast HD BacFast HD BacFast HD Surface via a Scanning Electron Microscope (SEM) at a magnification of 22x BacFast HD is a facet stabilization dowel designed with a focus on osteoconductivity and preventing graft migration, making it an ideal graft to be used as a complement to common spinal fusion procedures as it preserves the posterior spine. Utilizing Bacterin s proprietary demineralization technology, BacFast HD is hyper-demineralized to expose the growth factors and BMPs inherent to cortical bone. With the benefits of HD technology and increased collagen surface area, BacFast HD also provides the graft with osteoinductive properties without compromising the structural integrity of the graft. Cervical Interbody Spacers Precision-Milled Cervical Spacer Precision-Milled Allografts offer the support your patient needs. We have a cervical footprint that is 12 mm 14 mm with varying heights and 7 degree lordosis. Cervical spacers feature ridged contact surfaces to help reduce the incidence of graft migration. The central lumen is ideal for press-fit placement of OsteoSponge blocks for great fusion results. BacFast HD on Inserter Instrumentation Surgical Kits available upon request Precision-Milled Allografts BacFast HD Facet Dowel, 5 mm BacFast HD Facet Dowel, 6 mm Cervical Spacer, Lordotic, 5 mm Cervical Spacer, Lordotic, 6 mm Cervical Spacer, Lordotic, 7 mm Cervical Spacer, Lordotic, 8 mm Cervical Spacer, Lordotic, 9 mm Cervical Spacer, Lordotic, 10 mm 18 bacterin.com

19 Traditional Allografts Traditional Allografts In addition to Bacterin s proprietary allograft portfolio, select traditional allografts are available. These matrices are used for multi-disciplinary applications including: Spine, Neuro, Trauma, Foot and Ankle, Sports Medicine, Cranio-Maxillofacial, and Plastic/Reconstructive Procedures. Unicortical Block Traditional Allografts Ilium Tricortical Block 6 mm Ilium Tricortical Block 7 mm Ilium Tricortical Block 8 mm Ilium Tricortical Block 9 mm Ilium Tricortical Block 10 mm Ilium Tricortical Block 11 mm Ilium Tricortical Block mm Ilium Tricortical Block 15 mm Ilium Tricortical Block mm Ilium Tricortical Block mm Ilium Tricortical Strip 40 mm Tricortical Block Ilium Tricortical Strip 45 mm Ilium Tricortical Strip 50 mm Ilium Tricortical Strip 55 mm Ilium Tricortical Strip 60 mm Cancellous Crushed mm 5cc Cancellous Crushed mm 15cc Cancellous Crushed mm 30cc Cancellous Crushed 4 10 mm 5cc Cancellous Crushed 4 10 mm 15cc Cancellous Crushed 4 10 mm 30cc Unicortical Block 5 mm Unicortical Block 6 mm Unicortical Block 7 mm Femoral Cortical Strut, Split Unicortical Block 8 mm Unicortical Block 9 mm Unicortical Block 10 mm Fibula Segment mm Fibula Segment mm Femoral Cortical Strut 200 mm Split bacterin.com 19

20 hmatrix ADM Features Sterility assurance level (SAL) 10-6 Superior strength * Flexible matrix for precise placement Decreased inflammatory response * hmatrix ADM and hmatrix PR ADM are distributed as a frozen product 5 year shelf life (with proper storage conditions) hmatrix Q Code Q4134 hmatrix PR ADM hmatrix ADM hmatrix ADM and hmatrix PR ADM Benefits hmatrix Acellular Dermis (ADM) and hmatrix PR ADM are allografts derived from donated human skin. The dermis is processed using a proprietary method to remove the cells minimizing the chance of an immunologic response. The natural collagen and elastin matrix is ideal for neovascularization and cellular proliferation and has the potential to expedite the healing process. Because it is processed from human donors, the risk of inflammation is significantly reduced relative to products of animal origin. Suture Retention Strength of hmatrix ADM and hmatrix PR ADM * Test results demonstrate an average suture retention strength of 310 Newtons (n = 12) for hmatrix ADM 200 and hmatrix PR ADM compared to 229 Newtons (n = 10) for a leading competitive product. Overall, 150 hmatrix ADM and hmatrix PR ADM were 35% stronger than the leading competitor (P = 0.002) 100 with more consistent suture retention strength. 50 Barber FA, Herbert MA, Coons DA (2006) Tendon Augmentation Grafts: Biomechanical Failure Loads and Failure Patterns. Arthroscopy: The Journal of Arthroscopic and Related Surgery. Vol 22, No 5 (May): hmatrix ADM & Competitor * Data on File at Bacterin. hmatrix PR ADM 20 bacterin.com

21 hmatrix ADM hmatrix Dermis 2 1 cm, Thin hmatrix Dermis 4 2 cm, Thin hmatrix Dermis 5 4 cm, Thin hmatrix Dermis 7 5 cm, Thin hmatrix Dermis 10 5 cm, Thin hmatrix Dermis 2 1 cm, Medium hmatrix Dermis 4 2 cm, Medium hmatrix Dermis 5 4 cm, Medium hmatrix Dermis 7 5 cm, Medium hmatrix Dermis 10 5 cm, Medium hmatrix Dermis 2 1 cm, Thick hmatrix Dermis 4 2 cm, Thick hmatrix Dermis 5 4 cm, Thick hmatrix Dermis 7 5 cm, Thick hmatrix Dermis 10 5 cm, Thick hmatrix Dermis 4 2 cm, Thin, Meshed hmatrix Dermis 5 4 cm, Thin, Meshed hmatrix Dermis 7 5 cm, Thin, Meshed hmatrix PR ADM hmatrix PR - Dermis 16 6 cm, Thin hmatrix PR - Dermis 16 8 cm, Medium hmatrix PR - Dermis cm, Medium hmatrix PR - Dermis 20 8 cm, Medium hmatrix PR - Dermis cm, Medium Pericardium and Fascia Lata hmatrix Fascia Lata mm hmatrix Fascia Lata mm hmatrix Fascia Lata mm hmatrix Fascia Lata mm Pericardium mm Pericardium mm Pericardium mm Pericardium mm Pericardium mm Pericardium mm hmatrix Dermis 10 5 cm, Thin, Meshed Sports Medicine Sports Medicine allografts are an excellent replacement option for deficient or torn cruciate ligament reconstructions and revisions. Benefits of Bacterin s Sports Medicine allografts include consistent, superior quality and precise measurements. As with all of Bacterin s allografts, safety and efficacy are an absolute priority. All tendons are distributed sterile via low-dose gamma irradiation. Hemi-Patella Tendon Achilles Tendon Sports Medicine Achilles Tendon w/bone Block Anterior Tibialis Tendon Posterior Tibialis Tendon Gracilis Tendon Hemi-Patella Tendon Semitendinosus Tendon Whole Patella Tendon w/ Quad Whole Patella Tendon w/o Quad Hemi-Patella Tendon w/quad Peroneus SportMatrix 12 1 cm bacterin.com 21

22 GPO Affiliations As part of our commitment to provide you with the most cost savings, we have partnered with Group Purchasing Organizations nationwide. Please contact our Customer Service Department at or for more information. Bacterin is Just a Click Away If you are a Bacterin Distributor or Materials Manager and would like access to our Online Customer Service Portal, please contact our Customer Service Department for an application. Our portal will provide you with easy access for submitting online orders, a training calendar, and available downloads such as published papers, whitepapers, technique guides, instructions for use, and educational videos. We look forward to adding you as part of our online community and making access to information available at the click of a button. Bacterin Reimbursement Hotline Bacterin s Reimbursement Hotline is dedicated to providing answers to all your reimbursement questions. It also serves as a resource for obtaining accurate billing information and reimbursement support for Bacterin products. hmatrix Q Code Q4134 Distributors Like what you see and want to become a distributor for Bacterin? Or if you have a recommendation for a Distributor that you enjoy working with, please contact us at bacterin. com/contact/distributors. Returns For information regarding returns, please contact our Customer Service Department at cs@bacterin.com or Not all products qualify MONDAY FRIDAY. 9AM 4PM CENTRAL. 22 bacterin.com

23 Patients Quality of Life is Greatly Enhanced Surgical Implantation of Tissue Hospital Accepts Tissue The Gift of Donation with Family Consent Recovery and Transfer of Tissue Tissue is Shipped via a Validated Carrier Bacterin Sterilely Processes and Packages Tissue Honoring the Gift At Bacterin, we are honored to be stewards of the gift of donation. Our respect for representing the wishes of the donor drives every decision we make. Bacterin serves a role throughout the entire process, from overseeing donor recovery to manufacturing, ensuring the highest possible graft quality and consistency, and distribution to our customers. In turn, this attention to detail in the recovery process, donor screening, and processing of our allografts reflects our respect not only for the donor, but extends to the recipient as well. Bacterin values the role you play in the Circle of Life. If you would like more information please visit: Donate Life America Bacterin is a proud supporter of Donate Life America and the Donate Life Rose Parade Float. Each year Bacterin, along with our recovery partners, sponsors hundreds of dedication roses, and in recent years memorial floragraph portraits of organ, eye, and tissue donors honored and displayed on the Donate Life Rose Parade Float. bacterin.com 23

24 600 Cruiser Lane Belgrade, MT P: F: B 04/ Bacterin International, Inc. All Rights Reserved. BacFast, hmatrix, OrbitalWrap, OsteoLock, OsteoSelect, OsteoSponge, OsteoWrap, and BacteRinse are registered trademarks of Bacterin International, Inc. 3Demin, SportMatrix, and OsteoSTX are trademarks of Bacterin International, Inc. Records on file at Bacterin International, Inc.