ORTHOPEDIC Bone & Skin Tissue Products

Transcription

1 ORTHOPEDIC Bone & Skin Tissue Products DBM Products SurFuse TM Demineralized Bone Matrix - Gel / Putty ExFuse TM Demineralized Bone Matrix with Cancellous Bone - Gel / Putty BellaFuse TM Inserter Demineralized Bone Matrix - Inserter BellaFuse TM Demineralized Bone Matrix - Flexible Sheet MaxiGen TM Demineralized Bone Matrix with Calcium Sulfate - Putty /FDBA Products D-Sure TM Block / Chip Demineralized Cancellous Bone - Sponge Block / Chip OsteoGrow TM Demineralized Cortical Bone - Chip Pedi-Stick TM Demineralized Cortical Bone - Stick SureChip TM Cancellous Bone - Chip Synthetic Products AlloHA TM Hydroxyapatite from Human Bone OssCA TM Synthetic Bone of Dibasic CA ADM AlloCover TM Acellular Dermal Matrix - Sheet Demineralized Bone Matrix CNU 15.0kV 12.6mm x µm Cancellous Bone CNU 15.0kV 12.6mm x µm Cortical Bone CNU 15.0kV 12.6mm x µm

2 The Global Leader of Bio Engineering Hans R&D Center HansBiomed Head Office Establishment: September 1999 Primary Manufacturing Goods: Allograft Tissue / Silicone Polymer Medical Devices / Bio Technology Location: 807, 55, Seongsuil-ro, Seongdong-gu, Seoul, Korea Company Website: Family Website: (Periodontal) (Breast Implant) (Face Lifting) HansBiomed Daeduk Institute Establishment: June 2002 Total Area: 11,337 m 2 Total Floor Area: 2,500 m 2 Location: 64, Yuseong-daero 1628beon-gil, Yuseong-gu, Daejeon, Korea HansBiomed USA Branch Office Establishment: March 2011 Primary Manufacturing Goods: Bone&Skin Products Location: 140 Sylvan Ave Suite #204 Englewood Cliffs, NJ 07632, USA 2

3 3F bone - Dressing room - Production preparation room - Raw material storage room - Air conditioning room - Bone processing room - Bone pulverization room - Primary packaging room - Freeze-drying control room - Production room - Final packaging room - Storage for final products - Office & Archive 2F skin - Reagent preparation room - E.O. sterilization room - Production preparation room - Storage for sterilizing equipments - SureDerm production room - Micronized production room - Freeze-drying room - Product packaging room 1F silicone - Dressing room - Clean shower C/S - Production preparation room/raw material storage - Production room No. 1 - Mandrel storage - Washing room - Shell storage/patch room - Production room No.2 - Q.C. facilities - Storage for final products - Final packaging room 3 Orthopedic Bone Products

4 Safety, Trust, Innovation Hans Achievement FDA MFDS ISO was founded in 1993 with the specialized business project titled wound healing and scar prevention. Thanks to our young researchers creativity and hard work, we could secure the core technologies that are soon applied to manufacture the cutting-edge medical products. These products manufactured at the Hans Daeduk R&D Center are being exported to over 25 countries around the world. Top 5 World-class Product Company Korea s Largest Tissue Engineering Research Institute First FDA Registered Facility in ASIA 4

5 Established the First Domestic Tissue Bank First KOSDAQ-Listed biocompany First 510(K) Clearance in ASIA (DBM) 5 Orthopedic Bone Products

6 Excellent Biocompatibility and Bone Formation Orthopedic Allograft Bone Cancellous Allograft - FDBA: Freeze Dried Bone Allograft The structure of Open trabecular of Cancellous particle, like of host bone, contains mineral structure and collagen, so that it accelerates cells to be settled and a bone to be remodeled. Also this product creates ideal environment for fast revascularization and remodeling, as a result, healthy bones can be formed. Osteogenic progenitor cells from new blood vessels are differentiated into Osteoblast and cause a new bone around Trabecular of the grafted bone to be settled, and at the same time Osteoblast absorbs the grafted bone until the grafted bone substitutes with a new bone. This process, creeping substitution, helps to form healthy and strong bone. Cortical Allograft - FDBA: Freeze Dried Bone Allograft Cortical Bone is a compact type of bone tissue that used for supporting volume of bone for such procedures as sinus lift, ridge augmentation, and socket extraction. It provides fine lamellar structure and is effectively remodeled into natural bone. Absorption of cortical particles proceed with revascularization and enlarge canal space is filled with migrated oestoblasts. Then, healthy and strong bone is formed. Bone Block Allograft - FDBA: Freeze Dried Bone Allograft Compared to the particle form of allograft, this block form of bones are ideal for recovering volume of Ridge, which has high absorbability. Cancellous bone parts of allograft are remodeled into a new bone through fast revascularization. In addition, the cortical bone parts provide framework for mechanical strength and forms part of healthy and strong bone by remodeling process, which ultimately facilitates the dental implantation. This block bone allograft eliminates the need of autologous bone extraction and therefore it decreases a possibility of secondary pains and complications from it. This then leads to a shorter period of patient s recovery. DBM Allograft - Demineralized Bone Matrix DBM are demineralized bone matrix retaining growth factor and other proteins such as BMP, without lipid and mineral contents, so that it can form healthy and high quality new bone through its osteoinductive and osteoconductive potential. DBM is basically composed of demineralized bone particles and liquid carrier to helps the action of growth factor and to enhance its handling. (Demineralized Freeze Dried Bone Allograft) are referred to the bone powder before this mixing process. 6

7 Cortical VS Cancellous Bone Cross section pictures of bone Cortical Cancellous (Demineralized Freeze Dried Bone Allograft) 7 Orthopedic Bone Products

8 DBM Products Product Contents Type Size Gel Putty 1 cc 3 cc 5 cc 8 cc 10 cc Cancellous Bone Gel Putty 1 cc 3 cc 5 cc 8 cc 10 cc Inserter Inserter containers and even different sizes of products can be produced upon your request DBM Flex DBM+Cortical Flex Cortical Bone Flexible Sheet 20 x 40 x 2.5 mm 25 x 25 x 2.5 mm 25 x 50 x 2.5 mm 25 x 100 x 2.5 mm Calcium Sulfate Putty 3 cc 5 cc 8 cc 10 cc 15 cc 20 cc 8

9 DBM Products - SurFuse TM Demineralized Bone Matrix - Gel / Putty - ExFuse TM Demineralized Bone Matrix with Cancellous Bone - Gel / Putty - BellaFuse TM Inserter Demineralized Bone Matrix - Inserter Demineralized Bone Matrix CNU 15.0kV 12.6mm x µm - BellaFuse TM Demineralized Bone Matrix - Flexible Sheet - MaxiGen TM Demineralized Bone Matrix with Calcium Sulfate - Putty

10 Demineralized Bone Matrix - Gel / Putty SurFuse TM Gel and Putty are strong mixture of DBM. They help forming normal healthy bone by stimulation of Mesenchymal Cell proliferation. Moreover, osteoblasts are formed by differentiation of Mesenchymal Cell proliferation. SurFuse TM Gel is injectable and easy to implant. The viscosity of Gel phase maintains the interface of graft surface. SurFuse TM Putty has the unique form called putty. It can be changed into any forms freely and fit into bone defect or between bone structures. Moreover, SurFuse TM Putty can be made into more matrixes with the mix of patient s bone or bone marrow. Demineralized cortical bone matrix without lipid or mineral components Growth factors, such as BMP, helps bone regeneration through osteoinduction Enhanced convenience of use by viscosity attained from contents Patent for Composite of Bone-regeneration (Apply # : ) Characteristics - High DBM contents - No need of rehydration - Osteoinduction - Osteoconduction - Change into any sizes and forms freely - Easy use with high viscosity - Excellent biocompatibility Application - Compensation and reconstruction of autograft bone - Reconstruction of maxillofacial defect - Spine fixation with adequate materials - Bone fixation and filling in various sizes and forms of bone defect - Spinal fusions - Oncology - Joint revision - Long bone trauma - Distal fractures - Small bone procedure - Craniomaxillofacial 10

11 Gel Putty Injectable Syringe Type Ex. Putty Ex. Putty Putty Gel 1. Remove protective cap from syringe end. 2. Simply, implant the paste onto the treatment site. Shape the paste into a desired form before implantation. * Rehydration is not required Specification Product Cat No. Size Particle Size Type Contents SG1 1 cc SurFuse TM Gel SG3 SG5 SG8 3 cc 5 cc 8 cc 200~850 µm Gel SG10 10 cc Product Cat No. Size Particle Size Type Contents SP1 1 cc SurFuse TM Putty SP3 SP5 SP8 3 cc 5 cc 8 cc 200~850 µm Putty SP10 10 cc 11 Orthopedic Bone Products

12 Demineralized Bone Matrix with Cancellous Bone - Gel / Putty Cancellous ExFuse TM Gel and Putty is DBM(Demineralized Bone Matrix) to which Cancellous Bone Chip is added. It helps to form normal healthy bone by stimulation of Mesenchymal Cell proliferation. Moreover, osteoblasts are formed by differentiation of Mesenchymal Cell proliferation. It is easy to implant, because it is made into a Putty type and a Gel type like SurFuse TM. Using allograft bone, patients do not need to have secondary operation. Therefore, it helps reduce pain and give quick healing. Cancellous Demineralized cortical bone matrix without lipid or mineral components Growth factors, such as BMP, helps bone regeneration through osteoinduction Cancellous Open trabecular(fibrous and rod-shape supporting tissue in the body) structure assembles natural bone in a way that it has identical mineral structure and collagen. It then facilitates cells to be settled and promotes bone remodeling. Enhanced convenience of use by viscosity attained from contents Patent for Composite of Bone-regeneration (Apply # : ) Characteristics - Containing Cancellous Bone - No need of rehydration - Osteoinduction - Osteoconduction - Change into any sizes and forms freely - Easy use with high viscosity - Excellent biocompatibility Application - Compensation and reconstruction of autograft bone - Reconstruction of maxillofacial defect - Spine fixation with adequate materials - Bone fixation and filling in various sizes and forms of bone defect - Spinal fusions - Oncology - Joint revision - Long bone trauma - Distal fractures - Small bone procedure - Craniomaxillofacial 12

13 Gel Putty Injectable Syringe Type Ex. Putty Ex. Putty Putty Gel 1. Remove protective cap from syringe end. 2. Simply, implant the paste onto the treatment site. Shape the paste into a desired form before implantation. * Rehydration is not required Specification Product Cat No. Size Particle Size Type Contents EG1 1 cc ExFuse TM Gel EG3 EG5 EG8 3 cc 5 cc 8 cc 200~850 µm Gel Cancellous Bone EG10 10 cc Product Cat No. Size Particle Size Type Contents EP1 1 cc ExFuse TM Putty EP3 EP5 EP8 3 cc 5 cc 8 cc 200~850 µm Putty Cancellous Bone EP10 10 cc 13 Orthopedic Bone Products

14 Demineralized Bone Matrix - Inserter Inserter BellaFuse TM Inserter is demineralized human allograft bone product which has 50% of bone content which is effective for promoting bone formation. The BellaFuse TM Inserter Bone Graft component is used to fill the ALIF, Cervical and Lumbar Fusion Device. The purpose of demineralization is to stimulate bone formation. BellaFuse TM Inserter in a cage acts as a scaffold for the formation of new bone that the protein stimulates and is aseptically processed and provided in a sterile, single patient use package. BellaFuse TM Inserter will be customized to fit any cages and offers excellent handling and time-saving convenience for optimum bone regeneration. Clinicians will benefit from the pre-shaped, which is packaged in a handy container for easy delivery. In addition, the BellaFuseTM Inserter maintains its form and resists migration in a fluid environment. Demineralized cortical bone matrix without lipid or mineral components Growth factors, such as BMP, helps bone regeneration through osteoinduction added to flexible bone sheet enhances its easy of use Characteristics - High contents (Over 50%) - No need of rehydration - Osteoconductive ability - Osteoinductive ability - Customizable Size and Shape - Excellent biocompatibility Application - Compensation and reconstruction of autograft bone - Reconstruction of maxillofacial defect - Spine fixation with adequate materials - Bone fixation and filling in various sizes and forms of bone defect - Spinal fusions - Oncology - Joint revision - Long bone trauma - Distal fractures - Small bone procedure - Craniomaxillofacial 14

15 * containers and even different sizes of products can be produced upon your request. Cervical Lumbar ALIF Pre-shaped to fit into any cage [Lumbar Case] Specification Product Cat No. Type Contents BIC BIC Cervical BellaFuse TM Inserter BIL BIL BIL Lumbar BIA BIA ALIF is committed to provide you the top of the line products with the most advanced biological technology under your brand. You order and we are able to fit your needs that may include package designs, containers and even different sizes of products can be produced upon your request. 15 Orthopedic Bone Products

16 Demineralized Bone Matrix - Flexible Sheet BellaFuse TM Flexible Bone Sheet is flexible type of DBM which has higher content of allograft bone (over 50%) and is mixed with gelatin. Therefore it has excellent ability for bone regeneration. Additionally, it can be used without rehydration and can be shaped or cut any bone defect area. Demineralized cortical bone matrix without lipid or mineral components Growth factors, such as BMP, helps bone regeneration through osteoinduction added to flexible bone sheet enhances its easy of use Characteristics - High contents (Over 50%) - No need of rehydration - Osteoconductive ability - Osteoinductive ability - Sheets are easily handled (DBM Flex, DBM+Cortical Flex) - Provides great Graft-to-host interface - Excellent biocompatibility Application - Span small spaces between bone fragments - Place over or pack into defects where bone formation is needed - Compensation and reconstruction of autograft bone - Reconstruction of maxillofacial defect - Spine fixation with adequate materials - Bone fixation and filling in various sizes and forms of bone defect 16

17 Flexible Sheet Flexible Bone Sheet Type 1. BellaFuse TM is a flexible DBM strip and is easily bent to both sides. 2. No rehydration is required prior to use and BellaFuse TM can be easily cut into or bent to desired size for implantationa desired form before implantation. Specification Product Cat No. Size Type Contents DBF24 20 x 40 x 2.5 mm BellaFuse TM DBM Flex DBF25 DBF50 25 x 25 x 2.5 mm 25 x 50 x 2.5 mm Flexible Bone Sheet DBF x 100 x 2.5 mm Product Cat No. Size Type Contents BellaFuse TM DBM + Cortical Flex CDF24 CDF25 CDF50 CDF x 40 x 2.5 mm 25 x 25 x 2.5 mm 25 x 50 x 2.5 mm 25 x 100 x 2.5 mm Flexible Bone Sheet Cortical Bone 17 Orthopedic Bone Products

18 Demineralized Bone Matrix with Calcium Sulfate - Putty CA (Calcium Sulfate) MaxiGen TM is composed of demineralized bone matrix(dbm) and Calcium sulfate(cs) in a carrier. MaxiGen TM consists of medical grade calcium sulfate and demineralized bone matrix(dbm), provides optimal osteoinductivity and osteoconductivity. Demineralized bone matrix(dbm) stimulates new bone growth, and calcium sulfate supplies mechanical support for bone remodeling. Also carrier facilitates easy handling. Surgeons will custom blend the contents of MaxiGen TM to control the structural consistency depending on the condition of surgical sites. Calcium Sulfate Demineralized cortical bone matrix without lipid or mineral components Growth factors, such as BMP, helps bone regeneration through osteoinduction CA Medical grade calcium sulfate has excellent robustness and hardness With using -Na, it maintains its position in the injected site for a certain period Enhanced convenience of use by viscosity attained from contents Patent for Composite of Bone-regeneration (Apply # : ) Characteristics - High contents - Calcium sulfate provides robustness and hardness - Osteoconductive ability - Osteoinductive ability - Highly cohesive gives great injectability and handle-ability - Excellent biocompatibility Application - Compensation and reconstruction of autograft bone - Reconstruction of maxillofacial defect - Bone fixation and filling in various sizes - Fractures 18

19 Type 1. Type 2. Putty Easy Handling Putty Type +CA+ Mixing Bowl Saline MexiGen TM 1. Empty the powder ( + Calcium Sulfate + ) contained in brown glass bottle and saline into the mixing bowl. 2. Mix them well using a spatula provided. 3. Shape the mixture into a desired size and form. * Desired amount of mixture can also be injected using a syringe provided Specification Product Cat No. Size Particle Size Type Contents MGP03 3 cc MaxiGen TM Putty MGP05 MGP08 MGP10 MGP15 5 cc 8 cc 10 cc 15 cc 150~850 µm Putty Calcium Sulfate MGP20 20 cc 19 Orthopedic Bone Products

20 / FDBA Products Product Contents Type Size Demineralized Cancellous Bone Block 10 x 10 x 10 mm 12 x 12 x 12 mm 14 x 14 x 14 mm 10 x 10 x 20 mm 12 x 12 x 22 mm Demineralized Cancellous Bone Chip 5 cc 10 cc Demineralized Cortical Bone Chip 3 cc 5 cc 10 cc Demineralized Cortical Bone Stick ø 3.5 x 30 mm Cancellous Bone Chip 3 cc 5 cc 10 cc 15 cc 30 cc 20

21 / FDBA Products - D-Sure TM Block / Chip Demineralized Cancellous Bone - Sponge Block / Chip - OsteoGrow TM Demineralized Cortical Bone - Chip Cortical Bone Matrix CNU 15.0kV 12.6mm x µm - Pedi-Stick TM Demineralized Cortical Bone - Stick - SureChip TM Cancellous Bone - Chip

22 Demineralized Cancellous Bone Block Demineralized Cancellous Bone Chip Block Chip D-Sure TM Block and D-Sure TM Chip are elastic like a sponge D - Sure TM Block Block D - Sure TM Chip Chip

23 Demineralized Cortical Bone - Chip Demineralized Cortical OsteoGrow TM has osteoconductive and osteoinductive properties, it provides the full spectrum of factors needed to promote bone healing. It is used in void filling, fracture repair, spinal fusions, arthrodesis and more. All tissue grafts are collected aseptically and processed in a steriled, clean room with class100. The DBM consists of cortical bone that has been ground to particle sizes of 1.5 ~ 3.3mm and demineralized. The demineralization procedure utilizes methods that have been shown to leave the matrix and endogenous bone growth factors in place. OsteoGrow TM is conveniently packaged for individual case management. Demineralized cortical bone matrix without lipid or mineral components Growth factors, such as BMP, helps bone regeneration through osteoinduction Advantages - As effective as autograft in long term outcomes. - Completely natural biological repair fuses with, and eventually replaced by, the recipient s own bone. - Reduces OR time and is cost effective. - Reduces patient pain and other morbidity(no need to obtain autograft). - Demineralization exposes the native bone growth factors in the matrix so they are immediately available when implanted (bypasses resorption as the first step in bone healing). Application - Compensation and reconstruction of autograft bone. - Reconstruction of maxillofacial defect - Spine fixation with adequate materials - Bone fixation and filling in various sizes and forms of bone defect Specification Product Cat No. Size Particle Size Type Contents OsteoGrow TM Chip OGC3 OGC5 OGC10 3 cc 5 cc 10 cc 3 ~ 5 mm Chip Demineralized Cortical Bone 24

24 Demineralized Cortical Bone - Stick Demineralized Cortical Pedi-Stick TM is made of cortical bone composed of 100% demineralized allograft bone for improving osteoinduction and osteoconduction. In addition to that, it is used by the cutting edge freeze dried technology of for long-term storage and packaged for individual case management. Demineralized cortical bone matrix without lipid or mineral components Growth factors, such as BMP, helps bone regeneration through osteoinduction Pedi-Stick TM is easy to use as its syringe type Application - Spinal fixation for Osteoporosis patient After inserted Pedi-Stick TM then it is crushed and spread into the screw thread. Afterwards Pedi-Stick TM particles prevent to loosen and falling the screws. After fusion in the screw thread, it increases the bone density with new bone formation. - Pedicle screw revision - Spondylosyndesis (stimulate the synostosis by Osteoinduction) For interbody fusion, inset between the cages For lateral fusion, easy to use - Kyphoplasty After Kyphoplasty, fill up the pedicle hole. Specification Product Cat No. Size Particle Size Type Contents Pedi-Stick TM Stick PDS30 ø 3.5 x 30 mm 200~850 µm Stick Demineralized Cortical Bone 25 Orthopedic Bone Products

25 Cancellous Bone - Chip Cancellous Cancellous Bone offers an osteoconductive scaffold for promoting bone regeneration. Used either alone or as part of a composite bone graft, cancellous bone supplies a natural scaffold facilitating the attachment of osteogenic precursor cells. Cancellous Bones have good osteoconductive properties and are very well suited to fill defects in the bony structure. Due to their natural origin and optimal porosity, cancellous bone is readily remodeled by the human body and are replaced by new host bone. Cancellous Open trabecular(fibrous and rod-shape supporting tissue in the body) structure assembles natural bone in a way that it has identical mineral structure and collagen. It then facilitates cells to be settled and promotes bone remodeling. Cancellous Characteristics - 100% Allograft Cancellous Bone Chip - 3-dimensional lattice structure enables a fast revasculation - Osteoconductive ability - Osteoinductive ability - Excellent biocompatibility Application - Bony void filler of the extremities and pelvis to prevent fractures - Bone graft extender(extremities, spine, pelvis) with autograft or allograft - Surgically created osseous defects or osseous defects created from traumatic injury to the bone - Improved healing of fracture and nonunions Specification Product Cat No. Size Particle Size Type Contents BC03 3 cc SureChip TM Chip BC05 BC10 BC15 5 cc 10 cc 15 cc 4~10 mm Chip Cancellous Bone BC30 30 cc 26

26 Synthetic Product - AlloHA TM Hydroxyapatite from Human Bone - OssCA TM Synthetic Bone of Dibasic CA Cancellous Bone CNU 15.0kV 12.6mm x µm

27 Hydroxyapatite from Human Bone AlloHA is made from mineral powder of human bones. The main component of human bone minerals is hydroxyapatite, and essential elements for bone growth - sodium, magnesium and potassium ions- are included at the same ratio as present in the body and it ultimately provides the best micro-environment for new bone formation. AlloHA is the next-generation bone substitute with its excellent osteoinductive and osteoconductive abilities. Hydroxyapatite from Human Bone AlloHA Human Bone Interconnected Pore Structure and Increased Inner Surface Area Porous structure has characteristic similar to human bone and provides enough space for new bone formation and proliferation of blood vessels. Large internal surface area provides the best environment for angiogenesis and osteogenesis. Scaffold promotes new bone formation through migration of bone cells. Comparison of component AlloHA with other Synthetic materials 1,400 AlloHA(Hydroxyapatite from Human Bone) 1,200 Hydroxyapatite(Synthetic) 1,000 TCP(Synthetic) Ca (mg/kg) P (mg/kg) Fe (mg/kg) K (mg/kg) Mg (mg/kg) Na (mg/kg) Sodium, magnessium, phosphorus, potassium ions and iron are included at the same ratio as present in the body and it ultimately provides the best micro-environment for new bone formation. AlloHA is the next generation bone substitute with its excellent osteoinductive and osteoconductive abilities. * AlloHA is derived from human bone mineral (Ca/P=1.72) which is suitable as biomaterial according to KFDA regulation : 1.5~2.0 Interconnected Pore Structure - Stabilizes bone structure and maintains its volume Interconnected pore structure stabilizes bone structure and preserves its volume for a long period of time. 28

28 Interconnected Pore Structure / Crystaline Structure Crystalline micro-structured surface supports adhesion of osteoblasts. Enables absorption of the blood, angiogensis and new bone growth through its structure. In accordance with patients medical condition and expectation Variety of Product Line-up optimized for different indications Mixcubes Block Putty Specification Product Cat No. Size Particle Size Type Contents AHCR500 5 cc AlloHA TM Mixcubes AHCR1000 AHCR cc 15 cc 4~10 mm Mixcubes Hydroxyapatite AHCR cc AlloHA TM Block AHAB111 AHAB112 AHAB122 1x1x1 cm 1x1x2 cm 1x2x2 cm N/A Block Hydroxyapatite AHPU cc AHPU cc AlloHA TM Putty AHPU100 AHPU300 AHPU500 1 cc 3 cc 5 cc 200~850 µm DBM Putty Hydroxyapatite DBM AHPU800 8 cc AHPU cc 29 Orthopedic Bone Products

29 Synthetic Bone of Dibasic CA OssCA is formulated with Dibasic Calcium Phospate (DCP), which shows excellent biocompatibility and promotes bone regeneration. Outstanding Cell Adhesion Ability and Resorption Rate Calcium Phosphate Cells attached to OssCA well OssCa helps osteoblast to form new bone by releasing calcium and phosphate (CA-P). OssCar is biocompatible material with great cell adhesion property which makes bone forming cells easily attach. It makes acidic environment that promotes solubility of BMPs. Comparison of Emission ratio between Ca and PO OssCA(Dibasic CA) Hydroxyapatite (Synthetic) B-TCP Ca PO 4 Dibasic calcium phosphate, which is major content of OssCA, dissolves slowly and provides 300-fold more calcium and phosphate ions than either tricalcium phosphate(tcp) or hydroxyapatite(ha). Excellent Biological Absorption OssCA (Dibasic Calcium Phosphate) Transplant After 6~12 weeks Hydroxyapatite(Synthetic) Transplant After 6~12 weeks Bone OssCA Bone Bone Bone (Synthetic) HA Bone HA HA HA HA HA HA HA HA HA HA HA HA Bone Bone HA HA HA HA HA OssCA is 100% Dibasic Calcium Phosphate. It absorbs quickly and new bone formation occurs. Hydroxyapatite(Synthetic) doesn t absorb quickly and remain itself at the grafted area for period of time. 30

30 Comparison of BMP(Bone Morphogenic Protein) Vitalization OssCA provides a moderately acidic environment which promotes solubility of endogenous bone morphogenic proteins (BMPs). Growth Factors (including BMPs) may remain available to bone healing in a moderately acidic environment. OssCA activates Growth Factors indirectly so that it can promote osteoinductive ability. 0 Control OssCA TM TCP -ك Hydroxyapatite (No Mineral) * References: LeGeros R. Biodegradation and bioresorption of calcium phosphate ceramics. Clin Mater. 1993; 14(1): In accordance with patients medical condition and expectation Variety of Product Line-up optimized for different indications Crush Block Flexible Sheet Specification Product Cat No. Size Particle Size Type Contents OCC10 10 cc OssCA TM Crush OCC15 OCC20 15 cc 20 cc 4~10 mm Crush Calcium Phosphate OCC30 30 cc OCB111 1x1x1 cm OssCA TM Block OCB112 OCB122 1x1x2 cm 1x2x2 cm N/A Block Calcium Phosphate OCB222 2x2x2 cm OssCA TM Flexible Sheet OCF25 OCF50 OCF100 25x25 mm 25x50 mm 20x100 mm 200~850 µm Flexible Sheet Calcium Phosphate 31 Orthopedic Bone Products

31 ADM Product - AlloCover TM Acellular Dermal Matrix Acellular Dermal Matrix CNU 15.0kV 12.6mm x µm

32 Acellular Dermal Matrix AlloCover TM is acellular human dermis, which is intended for the repair or replacement of damaged soft tissue. AlloCover TM can be used as a substitute for autograft with its equal usage, effect and safety while it solves donor site trauma followed by autograft. AlloCover TM is processed human skin by a special process of high technology. Main purpose of this technological process is to be easily transplanted without rejection by eliminating the immune response. When healing completed, AlloCover TM eventually becomes the patient s own tissue. General Human Skin De-epidermal Acellular AlloCover Characteristics - Provides the same effect and safety as an autograft while reduces donor site trauma - No reactivity: Graft remodels like autogenous tissue - No migration: Graft integrates into surrounding tissue - Cost effective: Graft reduces surgery time - Easy to use: 10minutes rehydration is the only requirement before operation, No test required - Multiple usage: Can be used for a variety of surgical procedures with its own elasticity - Long shelf life: 2years under refrigeneration Specification Product Cat No. Size AVG Thickness Application AlloCover TM SLS (Small Ligament Surgery) AlloCover TM HAD (High Demand Augmentation) AlloCover TM SDC (Skin Defect Covering) AC x 40 mm 1.0~1.39 mm AC x 50 mm 1.0~1.39 mm AC x 100 mm 0.6~0.99 mm Small Ligament reinforcement of the hand and foot Rotator Cuff Achilles Tendon Quadriceps Patella Tendon Capsular Reinforcement Tendon, Rotator Cuff Augmentation Large Area Chronic Acute Defect Wound 33 Orthopedic Bone Products

33 Bone & Skin Products Product Composition Commercially available forms Claimed mechanism of action Gel Putty D B M Cancellous Bone Gel Putty Inserter Inserter Cortical Bone Flexible Sheet Calcium Sulfate Putty F D BA Demineralized Cancellous Bone Sponge Block Sponge Chip Osteoconduction Biocompatibility Osteoinduction / Demineralized Cortical Bone Chip D F D B A Demineralized Cortical Bone Stick Cancellous Bone Chip S yn t h e ti c Hydroxyapatite from Human Bone Synthetic Bone of Dibasic CA Mixcubes Block Putty Crush Block Flexible Sheet A D M Acellular Dermal Matrix Sheet Biocompatibility 34

34 Distributors around the globe Partner with Us Quick Response for your market needs, as the first tissue bank listed in KOSDAQ, develops and produces a variety of human tissue allograft products. We have received US FDA 510(k) clearance to ensure the safety and quality of our products, and to ultimately provide you with only the safe and high quality allograft products. Please do not miss this opportunity to meet best products and services by becoming our partner. Should you have any questions or inquiries, please do not hesitate to contact us. We will be more than happy to respond to any of your questions. 35 Orthopedic Bone Products

35 807, 55, Seongsuil-ro, Seongdong-gu, Seoul, Korea T F HansBiomed Daeduck Institute 64, Yuseong-daero 1628beon-gil, Yuseong-gu, Daejeon, Korea T F Rev