Bone & Membrane. Catalogue Biologic Regenerative Products ALLOGRAFTS BONE SUBSTITUTES BONE GRANULES & BLOCKS RESORBABLE MEMBRANES

Transcription

1 Bone & Membrane Biologic Regenerative Products Catalogue 2016 ALLOGRAFTS BONE SUBSTITUTES BONE GRANULES & BLOCKS RESORBABLE MEMBRANES

2 PTFE Surgical Sutures Bone & Membrane Biologic Regenerative Products Office: Orders: El Dorado Hills Blvd Suite 501, El Dorado Hills, CA 96762

3 CONTENTS 2016 BONE GRAFTS PENTOS OI Proven to form bone Page 6 4 C-GRAFT PUTTY & C-BLAST PUTTY Demineralized Bone Matrix Page 7 RAPTOS Allograft bone particulates and bone blocks Page 8 ECLIPSE Synthetic resorbable bone substitute Page 9 MEMBRANES NEOMEM Resorbable Bovine Collagen Membrane Page NEOMEM FLEXPLUS Resorbable Porcine Collagen Membrane Page 12 NEODERM Natural elasticity of human acellular dermis Page info@ibsofamerica.com

4 Versatile Grafting Solutions Regenerative properties CMC CC CMC Description PentOS OI Putty PentOS OI Putty is made from 100% human bone without any additional diluent or carriers to diminish its osteoinductive properties. EVERY lot used to manufacture PentOS OI products is verified to be osteoinductive and histologically demonstrates all five elements of bone formation. C-Graft Putty Demineralized Bone Matrix in CMC - a natural, plant derived, carrier for superior handling. C-Blast Putty A composite graft product that combines osteoinductive and osteoconductive cancellous particles in CMC - a natural, plant derived carrier for superior handling. Characteristics 100% bone Verified to be osteoinductive Osteoconductive Excellent handling characteristics Resists irrigation Sterilized using low-dose gamma irradiation Ready to use Stored at room temperature with natural CMC carrier Excellent handling Great pricing Ready to use Open bore syringe Osteoinductive and osteoconductive Demineralized Bone Matrix () with Cancellous Bone and CMC carrier Excellent handling Great pricing Open bore syringe Applications Periodontal defects Implant site development Coronal defects around immediate implants Extraction site repair Implant dehiscence defects Sinus lift procedures Moderate localized ridge defects Periodontal defects Extraction site repair Implant site development Sinus lift procedures Coronal defects around immediate implants Sockets Preservation Extraction site repair Implant dehiscence defects Sinus lift procedures Moderate localized ridge defects Mixing options May be used alone or mixed with Raptos allograft bone and/or Eclipse synthetic bone. May be used alone or mixed with Raptos allograft bone and/or Eclipse synthetic bone. May be used alone or mixed with cortical bone (Raptos) in larger defect sites. Availability Putty in a syringe. 0.5 cc, 1 cc, 2.5 cc and 5 cc Putty in a syringe. 0.3 cc, 0.5cc, 1 cc and 3 cc Putty in a syringe. 0.3 cc, 0.5cc, 1 cc and 3 cc Demineralized Bone Matrix CMC Carboxymethylcellulose carrier RPM Reverse Phase Medium CC Cancellous Chips

5 Versatile Grafting Solutions ALLOGRAFT ALLOGRAFT SYNTHETIC Regenerative properties Raptos Allograft Cancellous, cortical, cortico-cancellous and demineralized irradiated bone particulates that offer an osteoconductive scaffold for bone regeneration. Premium Blend This cortical mineralized/demineralized blend combines two of the most popular allograft particles used in dentistry, all in a single vial or syringe! PentOS OI Flex Demineralized, osteoinductive 100% cortical bone veneer graft. When hydrated the veneer graft becomes pliable and easily adapts to graft sites that would be difficult to treat with particulate or putty grafts. Eclipse Synthetic resorbable bone substitute that uses the mineral building blocks naturally found in human bone. Granules: 80%ß-tcp - 20%HA Putty: HA + ß-tcp + Hydrogel Description Osteoconductive scaffold Remodels completely to host bone Mineralized graft material Osteoinductive demineralized Cortical veneer 1 mm thick Can be fixated with screws Freeze-dried Sterilized using low-dose gamma irradiation Has a shelf-life of 5 years from the date of sterilization Macro and Micro pores allow complete remodeling Completely remodels to host bone while preserving volume (12-18 months*) Characteristics Mineralized component in a composite graft As a graft extender Osseous defects Onlay grafting for the repair of shallow bone defects or bone loss To augment thin or missing bone over root form implants Orbital floor repair Cases where it is difficult to place particulate grafts Ridge preservation Extraction site repair Sinus lifts procedures Ridge augmentation Osseous defects Periodontal defects Applications May be used alone or mixed with Putty for osteoinductive potential. May be used alone or in combination with other graft materials. May be used alone or mixed with Putty for osteoinductive potential. Mixing options Available in syringes in a variety of sizes. 10x10 mm 15x15 mm 17x10 mm Granules available in vials or syringes. Putty available in syringes. Availability * Resorption and bone regeneration times are estimates as each patient and case is unique.

6 100% Bone. Proven to form Bone. Every Lot. PENTOS OI ALLOGRAFTS MUST DEMONSTRATE ALL FIVE ELEMENTS OF BONE FORMATION BEFORE THEY ARE RELEASED FOR USE. Post sterilization in-vivo testing on each lot must demonstrate the presence of new bone, bone marrow, osteocytes, cartilage and chondrocytes within 28 days otherwise we can t call it PentOS OI. In-vitro tests of PentOS OI demonstrate levels of BMP-2 up to 19 times the native levels in the control. 1 NEW BONE New bone is the final step in the maturation of the product. 2 BONE MARROW The presence of bone marrow indicates the ability of the product to differentiate into osteoblasts, chondrocytes, cartilage and new bone. 3 OSTEOCYTES Osteocytes are derived from osteoblasts, or bone forming cells, and are essentially osteoblasts surrounded by the products they secreted. 4 CARTILAGE Cartilage is replaced by bone during ossification in the higher vertebrates. It is indicative that the bone formation is forthcoming. 5 CHONDROCYTES A Chondrocyte is a unique cell type in articular cartilage tissue and is essential for cartilage formation and functionality. It arises from mesenchymal stem cells. PentOS OI Putty 100% Allograft Putty. PentOS OI Putty is made from 100% human bone without any additional diluent or carriers to diminish its osteoinductive properties. EVERY lot used to manufacture PentOS OI products is verified to be osteoinductive and histologically demonstrate all five elements of bone formation. Proven to form bone. Every time. It s that simple! Available syringe sizes: 0.5cc, 1cc, 2.5cc and 5cc PentOS OI Flex 100% Allograft Flexible Veneer Graft PentOS OI Flex is a 1 mm thick osteoinductive, demineralized cortical bone graft. When hydrated, this veneer graft becomes pliable and easily adapts to graft sites that would be difficult to treat with particulate or putty grafts. These characteristics make PentOS OI Flex ideally suited for onlay grafting for the repair of shallow bone defects or bone loss. Available sizes: 10x10mm, 15x15mm and 17x10mm PentOS OI Sponge 100% Allograft Compressible Bone Matrix PentOS OI Sponge is made of cancellous and demineralized bone, it is available as strips or blocks. Strips: 20x10x10mm and 20x15x7mm Blocks: 10mm³ and 12mm³ 6

7 with or without cancellous chips. Demineralized Bone Matrix () Putty + CMC CMC Demineralized Bone Matrix Putty + CMC + Cancellous bone chips Cancellous CMC CMC CARRIER Natural Plant Derived Carrier Carboxymethylcellulose (CMC) A polysaccharide hydrogel derived from linters of the cotton seed Commonly used in food, cosmetics and pharmaceutical preparations Excellent biocompatibility does not interfere with cell mediated bone formation Odourless, tasteless and nontoxic High viscosity physiologically inert carrier which maintains its interface at the graft site Malleable - can be molded and placed into any shaped defect Excellent dimensional stability does not significantly shrink nor expand Will not migrate from the graft site Resorbs slowly in harmony with new bone formation allowing for cellular and vascular infiltration Haemostatic effect when grafted into a bleeding site FDA classifies CMC as GRAS (generally regarded as safe) Features Quality products Excellent handling Great pricing Ready to use Room temperature storage Open bore syringes E-beam sterilization Double sealed blister packaging AVAILABLE IN 0.3 cc SYRINGES Common applications Sockets Preservation Extraction site repair Implant dehiscence defects Sinus lift procedures Moderate localized ridge defects Available syringe sizes: 0.3 cc 0.5 cc 1 cc 3 cc 7

8 All your bone allografts... under one wing! RAPTOS IRRADIATED BONE PARTICULATES, A NATURAL SCAFFOLD FOR BONE REGENERATION. RAPTOS allograft mineralized bone grafts offer an osteoconductive platform for bone regeneration and Raptos demineralized particles offer an osteoinductive boost. Used either alone or as part of a composite bone graft, allograft bone particulates supply a natural framework facilitating the attachment of osteogenic precursor cells. Premium Blend - This Cortical Mineralized/Demineralized blend combines two of the most popular allograft particles used in dentistry, all in a single syringe! SAFETY INFORMATION Each donor is thoroughly evaluated using medical/ social history questions, medical records, blood tests, culture results, physical examination and autopsy reports (when performed). This process is used to ensure the donor is suitable for donation by allowing to recognize and exclude potential diseases or medical conditions that are unacceptable. Specific lab tests are performed for Syphilis, Hepatitis B and C, HIV and other viruses. All of the donor chart information is evaluated by individuals trained in tissue banking, prior to the processing of the tissue. Tissue grafts are rinsed and soaked in various solutions to minimize transmission of bacteria and viruses. Processing and packaging of the tissue are performed using aseptic technique and occur in a clean room. As an added margin of safety, a low dose gamma irradiation after final packaging of the musculoskeletal grafts is utilized. AATB accredited source and mandatory CTO registered with Health Canada. Syringes Granule size CANCELLOUS CORTICAL CORTICO- CANCELLOUS DEMINERALIZED PREMIUM BLEND µm.25cc.5 cc 1 cc.25cc.5 cc 1 cc.25cc.5 cc 1 cc.25cc.5 cc 1 cc.25cc.5 cc 1 cc 8

9 The science of balanced bone regeneration. SYNTHETIC RESORBABLE BONE SUBSTITUTE GRANULES & PUTTY For patients who express concerns with allografts and xenografts Completely remodels to host bone 25 years of clinical experience ECLIPSE GRANULES & PUTTY 100% SYNTHETIC - COMPLETELY TRANSFORMS TO NATURAL BONE Using the mineral building blocks naturally found in human bone, Eclipse goes a step beyond the realm of everyday hydroxyapatite (HA) and tricalcium phosphate (TCP) with its unique combination of micro and macroporosity technology. 70% overall porosity 2/3 macroporosity 1/3 microporosity Granules: Eclipse Granules, a 100% synthetic (20% HA, 80% TCP), costeffective bone graft matrix used as an alternative to biologic osteoinductive products. Putty: Eclipse Putty is an innovative and moldable bone graft, composed of Hydroxyapatite (HA), Beta Tricalcium Phosphate (ß-TCP) and a hydrogel. Microporosity (pores <10μm) allows the diffusion of biological fluids, by the capillary action, into the three-dimensional matrix. Inside the fine pores of the matrix, biological fluids dissolve ß-TCP producing calcium phosphate ions that are released back into the biological fluids. This saturation of ions leads to precipitation of apatite crystal identical to that of the natural bone minerals. Shortly afterwards, this process creates a surface that promotes bone cell adhesion. MICRO MACRO Granules ( mm) available in syringes of 0.5cc & 1.0cc or in vials of 0.25cc, 0.5cc & 1.0cc Granules ( mm) available in vials of 2.0cc Putty available in syringes of 0.5cc & 1.0cc Macropores (300 to 600 μm) promote a deep invasion of osteogenic cells by osteoconduction. Through the same resorption and formation cycle as the natural bone remodeling process, new bone increases progressively at the expense of the MBCP. 9

10 A wide variety of membrane options BOVINE PORCINE ALLOGRAFT Description Neomem Resorbable collagen membrane derived from highly purified type I collagen fibres from bovine Achilles tendon. Neomem FlexPlus Single layer collagen membrane derived from porcine peritoneum. Neoderm Acellular human dermis in thicknesses of and mm. Characteristics Cell occlusive Allows nutrient transfer Optimized flexibility and rigidity Either side can be placed towards the soft tissue or bone Easily trimmed and placed, wet or dry Gamma irradiated to sterilize Fixated with sutures or tacks Nonpyrogenic Suture pull out strength between 290g and 350g High suture pull out strength Excellent draping Lower inflammation 3-4 month resorption Easy handling Human derived dermal grafts that are decellularized to remove cellular components and preserve the biological properties that promote revascularization and repair. Neoderm acelluar dermis, has the natural elasticity of human skin. Neoderm is minimally processed to remove epidermal and dermal cells while preserving the extracellular matrix of the dermis. The grafts are freeze-dried and sterilized. GTR GBR GTR GBR Replacement of damaged or inadequate tissue for the repair, reinforcement, or supplemental support of soft tissue defects. Applications Resorption 26 to 38 weeks 3 to 4 months 3 to 4 months (thin) 4 to 6 months (thick) Availability 15x20, 20x30 & 30x40 mm 15x20, 20x30 & 30x40 mm 10x10, 10x20, 10x40 & 20x40 mm in either thin ( μm) or thick ( μm) GTR Guided Tissue Regeneration GBR Guided Bone Regeneration

11 The standard in membrane technology. NEOMEM MEMBRANE IS A TYPE 1 BOVINE COLLAGEN MATRIX INDICATED FOR USE IN GUIDED TISSUE PROCEDURES TO ENHANCE WOUND HEALING. Advantages Higher mechanical strength for membrane stabilization in situ using either sutures or resorbable tacks. Longer in vivo stability and resorption time, weeks, for sustained function. Optimized flexibility and rigidity for better space maintenance which allows for desired tissue in-growth. Either side of the Neomem can be placed towards the soft tissue or bone. Easily trimmed and placed, wet or dry. NEOMEM RESORPTION RATE Available in convenient sizes 15x20 mm 20x30 mm 30x40 mm NeoMem is sterilized by irradiation and packaged in double pouches. EXCEPTIONAL CLINICAL PERFORMANCE Suture pull out strength between 290g and 350g Cell occlusive - retards epithelium down growth Macromolecular pore size allows nutrient transfer WHY MAKE NEOMEM YOUR MEMBRANE OF CHOICE? Highly purified type I collagen fibres derived from bovine Achilles tendon Nonpyrogenic Excellent safety profile Easy in situ placement 11

12 Strong performance with a supple touch. NEOMEM FLEXPLUS - Native porcine peritoneum Neomem FlexPlus is a single layer collagen membrane derived from porcine peritoneum. Suture pullout testing has shown this membrane to be biomechanically strong yet conformability evaluations demonstrate the ability to adapt to the contour of the surgical site. Neomem FlexPlus hydrates quickly and handling characteristics make surgical placement easy. It can be repositioned easily and placed wet or dry and with either side up. Additionally, in-vitro testing of Neomem FlexPlus shows low tissue inflammation and foreign body giant cell response. INFLAMMATION SCORE Bio-Gide Neomem FlexPlus 4 weeks 8 weeks 12 weeks 16 weeks GIANT CELLS SCORE Bio-Gide Neomem FlexPlus 4 weeks 8 weeks 12 weeks 16 weeks *Published in Science, Technology, Innovation, Feb. 1-5, 2015 All trademarks are the property of their respective owners. Compared to Bio-Gide : Stronger Neomem FlexPlus has 3 times the suture pull out strength compare to Bio-Gide and resorption time of 3-4 months. Neomem FlexPlus can be repositioned once placed. Supple Lack of memory means that Neomem FlexPlus drapes and conforms to the defect site and since both sides are the same, it is easy to place. Better Initial Resorption Rate Compared to Bio-Gide, Neomem FlexPlus s initial in-vivo resorption profile suggests that Neomem FlexPlus is more stable. Less Inflammation In-vivo testing also demonstrates that Neomem FlexPlus produced a lower level of early inflammation than Bio-Gide and Neomem FlexPlus shows a lower level of giant cell response. Advantages: High suture pull out strength Excellent draping Lower inflammation 3-4 month resorption Easy handling Available in convenient sizes: 15x20, 20x30 & 30x40 mm 12

13 Natural elasticity of human acellular dermis. NEODERM IS HUMAN ACELLULAR DERMIS, WHICH HAS NATURAL ELASTICITY. These human derived dermal grafts that are decellularized to remove cellular components and preserve the biological properties that promote revascularization and repair. Neoderm acellular dermis, has the natural elasticity of human skin. Neoderm is minimally processed to remove epidermal and dermal cells while preserving the extracellular matrix of the dermis. The grafts are freeze-dried and sterilized providing 5 years of shelf life at room temperature. Neoderm can be used to replace damaged or inadequate tissue for the repair, reinforcement, or supplemental support of soft tissue defects. Neoderm is available in a variety of sizes and thickness, and can be shaped with scissors or a scalpel. Neoderm is ideal for the replacement of damaged or inadequate tissue for the repair, reinforcement, or supplemental support of soft tissue defects. NEODERM IS MANUFACTURED BY CELLRIGHT TECHNOLOGIES CellRight Technologies is a biotech company that specializes in regenerative medicine and is dedicated to the development of innovative osteobiologic and wound care scaffolds that enhance healing opportunities of defects created by trauma and disease. CellRight s goal is to continually develop exceptional human biologics matrices that accelerate neovascularization and cell infiltration of damaged tissues, including orthopedics, neurosurgery, foot & ankle, craniomaxillofacial, trauma, reconstruction and dental defects. Resorption 3 to 4 months (thin) 4 to 6 months (thick) Available in convenient sizes in either thin ( µm) or thick ( µm) 10x10 mm 10x20 mm 10x40 mm 20x40 mm 13

14 Biologic Regenerative Products RAPTOS Mineralized Cortico-Cancellous Blend 0.025cc Syringe ( microns) CCBO2S cc Syringe ( microns) CCBO2S cc Syringe ( microns) CCBO2S-10 RAPTOS Mineralized Cortico-Cancellous Blend 0.5cc Vial ( microns) CCBO cc Vial ( microns) CCBO cc Vial ( microns) CCBO cc Vial ( microns) COR cc Vial ( microns) COR10-20 C-Blast Putty + Cancellous Bone 0.03cc Syringe CB-P03 0.5cc Syringe CB-P05 1.0cc Syringe CB-P10 3.0cc Syringe CB-P30 C-Graft Demineralized Bone Matrix 0.03cc Syringe CG-P03 0.5cc Syringe CG-P05 1.0cc Syringe CG-P10 3.0cc Syringe CG-P30 HeliMEND Collagen Resorbable Membrane* 15mm x 20mm mm x 30mm mm x 40mm Resorbs in 4-8 weeks HeliTAPE Collagen Resorbable Membrane* 2.5cm x 7.5cm - 10 pack Resorbs in days HeliCOTE Collagen Resorbable Membrane* 1.9cm x 3.8cm - 10 pack Resorbs in days HeliPLUG Collagen Resorbable Membrane* 1.0cm x 2.0cm - 10 pack Resorbs in days NEOMEM Collagen Resorbable Membrane* 15mm x 20mm N mm x 30mm N mm x 40mm N3040 Resorbs in weeks NEODERM Acellular Human Dermis* 10mm x 10mm 0.5mm thick R 10mm x 20mm 0.5mm thick R 10mm x 40mm 0.5mm thick R 20mm x 40mm 0.5mm thick R Resorbs in 3-4 months 10mm x 10mm 1.0mm thick R 10mm x 20mm 1.0mm thick R 10mm x 40mm 1.0mm thick R 20mm x 40mm 1.0mm thick R Resorbs in 4-6 months Also Available: Socket Preservation Kits (Bone, Membrane, Sutures) PTFE Surgical Sutures Order Today: InnoBioSurg of America El Dorado Hills, Blvd STE 501, El Dorado Hills, CA

15 Price & Fee List 2016 Bone Grafting PentOS OI Putty 0.5cc syringe $ cc syringe $ cc syringe $475 PentOS OI Flex 10X10 $120 17X10 $240 15X15 $280 PentOS OI Sponge 20x10x10 - Strip $1,700 20x15x7 - Strip $1,190 10mm 3 - Block $525 Block 12mm 3 - Block $785 C-Graft Putty 0.3cc $89 0.5cc $ cc $ cc $455 C-Blast Putty 0.3cc $99 0.5cc $ cc $ cc $465 Raptos allograft particles (syringe) Cortical, Cancellous, Blend or Demineralized 0.25cc syringe $34 0.5cc syringe $54 1.0cc syringe $78 Raptos allograft particles (vial) Cortical, Cancellous, Blend or Demineralized 0.5cc - Granules $54 1.0cc - Granules $78 2.0cc - Granules $117 Raptos Premium Blend Cortical Mineralized/Demineralized Blend 0.5cc vial $56 1.0cc vial $80 2.0cc vial $ cc syringe $36 0.5cc syringe $56 1.0cc syringe $80 Eclipse Putty 0.5cc syringe $95 1.0cc syringe $175 Eclipse Granules 0.25cc vial $55 0.5cc vial $75 1.0cc vial $99 2.0cc vial $ cc syringe $85 1.0cc syringe $135 Neomem 15x20mm $92 20x30mm $115 30x40mm $165 Membranes Neomem FlexPlus 15x20mm $92 20x30mm $115 30x40mm $165 Neoderm 1cmx1cmx0.5mm $89 2cmx1cmx0.5mm $132 4cmx1cmx0.5mm $199 4cmx2cmx0.5mm $265 1cmx1cmx1mm $89 2cmx1cmx1mm $132 4cmx1cmx1mm $199 4cmx2cmx1mm $265 Your order request can be made by calling, ing or faxing our customer service desk. We will send your order confirmation, invoice and shipping information automatically to the address we have on file for your account. All currencies are expressed in US Dollars. Applicable taxes and shipping fees are not included. Prices and fees are subject to change without notice. Office: Orders: El Dorado Hills Blvd Suite 501, El Dorado Hills, CA 96762