INNOVATE INVOLVE INVENT. Innovasis Bone Products

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1 INNOVATE INVOLVE INVENT Innovasis Bone Products

2 Company Overview Innovasis is a rapidly growing company engaged in the research, development, manufacturing, and marketing of spinal implant devices and related products. Innovasis offers a spinal product line with implants and instruments that address the major pathologies and focus areas of traditional spinal surgery. Major spinal pathologies include deformities, degenerative conditions, trauma and tumors; all of which can result in severe back pain and sometimes paralysis. These can occur in all areas of the spine, from the cervical region down through the thoracic, lumbar and sacral regions. Spinal implants are aimed at restoring mechanical and neurological function by readjusting vertebral positioning until bone fusion occurs. Innovasis is fully committed to providing surgeons and distributors with training, support and excellent customer service, thus ensuring the establishment of a strong and long term strategic partnership. Innovate. Innovasis is committed to the constant innovation of spinal implants and other related products. Working collectively with surgeons, we are constantly improving our instruments and products to better suit surgeons and optimize surgical outcomes. Involve. Our success is contingent upon one thing: Collaboration. Without it, we wouldn t be any different than everyone else. We firmly believe in order to make the best and most innovative products, both surgeons and developers must be involved in the process. After all, it s in the hands of the surgeons that our devices are used in lifechanging procedures every day. Invent. Innovasis strives to invent new and effective tools that will give professionals a more competitive advantage and provide patients with solutions to their medical needs. We are committed to the development of the most reliable spinal implants and related surgical solutions on the market. Company Overview

3 Innovasis partners with HansBiomed Corporation to provide human bone implant products. All donors utilized for Innovasis bone products are sourced in the USA and are traceable for each unit. The Innovasis bone products are processed, including sterile packaging, by HansBiomed prior to placing in the final packaging for Innovasis. HansBiomed is registered with the US FDA for HCT/P, is licensed where required by states (including New York and California) and has been accredited by AATB. About Hans Biomed As the first in Asia to successfully commercialize human skin and bone implant products, HansBiomed Corp. manufactures and conducts research on human tissue products, and is approved by Korea Food & Drug Administration (KFDA) and US FDA. HansBiomed Corp. has received the World-Class Product Award (organized by the Korean Ministry of Commerce, Industry and Energy) given to the company with the best export performance in the industry. HansBiomed exports human skin and bone implant products to the world including Asia and USA. Most of the human implant tissues are imported due to the lack of Korean domestic supply. By establishing the Hans Daeduk R&D Center in the Daeduk Valley equipped with the biggest production line and research facilities in Asia, HansBiomed Corp. is setting up a production system to meet a high demand and to provide high-quality products in a timely manner. Domestic and overseas branch offices are being established for efficient export activities while expanding the network of authorized retail stores across the European and the US market. Company Overview The core biological tissue engineering technology of HansBiomed Corp. has been recognized by the Korean government and receives annual research funds support for new product development and the expansion of research resources. HansBiomed Corp., as a leading bio-venture company, is moving forward to protect the public health and to become one of the world s top bio-companies with international competitive power.

4 INNOVATE / INVOLVE / INVENT INNOVATE INVOLVE INVENT DEMINERALIZED BONE MATRIX Putty 5cc / 10cc INNOVATE INVOLVE INVENT DEMINERALIZED BONE MATRIX Putty INNOVATE / INVOLVE / INVENT Innovasis DBM Putty is a demineralized bone matrix with superior osteoinductive and osteoconductive properties. The mixture aids in the natural healing process by stimulating mesenchymal cell differentiation and promoting new bone growth. With tremendous handling characteristics, Innovasis DBM is provided as a ready-to-use, off the shelf product with no premixing preparation or thawing and is stored at room temperature. Carboxymethyl Cellulose will resist irrigation in a fluid environment. Additionally, all lots are tested to verify osteogenic characteristics and biological efficacy. Characteristics Application High DBM content Osteoinduction Osteoconduction Changes into any size and forms freely Easy use with high viscosity Excellent biocompatibility Compensation and reconstruction of autograft bone site Bone & spine fixation with adequate materials Ability to fill various forms and sizes of bony defects Product Size REF DBM Part. Size DBM Putty L00008 Rev A 5cc AXDBMP5 L00013 Rev A 34.00% 150~850 µm 10cc AXDBMP10 L00014 Rev A INNOVASIS, INC. 614 East 3900 South Salt Lake City, Utah Office: Fax:

5 INNOVATE / INVOLVE / INVENT INNOVATE INVOLVE INVENT CANCELLOUS BONE CHIP INNOVATE INVOLVE INVENT CANCELLOUS BONE CHIP INNOVATE / INVOLVE / INVENT Cancellous Bone Chip 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 Application Cancellous Bone Chip 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 defect created from traumatic injury to the bone Improved healing of fracture and nonunions Structural Scaffold Cancellous Bone is a strong bone graft material that can provide structural support to the bony defect where synthetic bone graft substitutes are limited. Cancellous allograft tissue is slightly less rigid but still provides structural support to the bony defect. Product Size REF Cancellous Bone Chip Cancellous Bone 15cc AXCBC15 100% Part Size 4~10 mm INNOVASIS, INC. 614 East 3900 South Salt Lake City, Utah Office: Fax: L00018 Rev A L00018 Rev A

6 INNOVATE / INVOLVE / INVENT INNOVATE INVOLVE INVENT CANCELLOUS SPONGE INNOVATE INVOLVE INVENT CANCELLOUS SPONGE INNOVATE / INVOLVE / INVENT Innovasis Cancellous Sponge is a unique graft material derived from trabecular bone that has compressible and elastic, sponge-like properties. Our proprietary demineralization process revolutionizes the handling properties of bone while maintaining natural growth factors. Innovasis Cancellous Sponge is a perfect solution for filling bony defects. The unique mechanical and biological properties make Innovasis Cancellous Sponge an ideal bone graft for use with anterior spinal devices, in arthrodesis or in fracture sites. Application Cancellous Sponge Spinal fusion and general orthopedic surgeries Any bony defect area where the malleable bony void filler is needed A scanning electronic microscope image demonstrates the open structure and large surface area. Product Size REF INNOVASIS, INC. Cancellous Sponge 10X10X10 L00010 Rev A 12X12X12 L00011 Rev A AXCSB10 AXCSB East 3900 South Salt Lake City, Utah Office: Fax: L00017 Rev A 14X14X14 L00012 Rev A AXCSB14

7 DBM Putty DBM Putty is a demineralized bone matrix with superior osteoinductive and osteoconductive properties. The mixture aids in the natural healing process by stimulating mesenchymal cell differentiation and promoting new bone growth. The superior handling characteristics allow for easy implantation, freely forming into bony defects or fusion sites. The viscosity of the putty will maintain the shape and interface of the graft surface creating new autograft bone. DBM Putty is provided as a ready-to-use, off the shelf product with no premixing preparation or thawing and is stored at room temperature. Carboxymethyl Cellulose will resist irrigation in a fluid environment. All lots are tested to verify osteogenic characteristics and biological efficacy. Innovasis bone products provide a natural and safe environment for advanced healing. Every Batch Verified for Osteogenic Efficacy U.S. Sourced Tissue Procurement Indicated for Spinal Fusions and Bony Defects/Voids Competition Table DBM Putty Product Distributor Carrier % DBM (Weight) Terminal Sterility Osteoinductive Testing DBM Putty Innovasis Carboxymethyl Cellulose 34 Yes Every Lot In Vivo DBX Putty Synthes Sodium Hyaluronate 32 No Every Lot In Vivo Grafton Putty Medtronic Glycerol 17 No Random Lots in Vivo Optium Putty DePuy Glycerol 20 Yes Every Lot In Vitro InterGro Paste Biomet Lecithin Every Lot In Vitro Optefil Paste Exactech (RTI) Porcine Gelatin 24 Yes Every Lot In Vivo AlloMatrix Putty Wright Medical Calcium Sulfate 40 Yes Every Lot In Vitro STIMUBlast Putty Arthrex RPM 36 Yes Every Lot In Vivo

8 Licenses & Certifications Our products follow strict federal laws and guidelines set forth by the United States Food and Drug Administration (FDA) and industry standards. Additionally, we are licensed by and follow regulations set forth by the States of New York, California, Maryland, Illinois and Florida. Our superior level of allograft processing begins with rigorous donor screening and meticulous donor recovery procedures, certified laboratory testing, validated tissue cleaning, sterile packaging, and a meticulous quality assurance procedures. Licenses & Certifications

9 Donor Screening & Analysis Donor Screening & Analysis Our donor screening and recovery partners meet or exceed all industry standards. Following donation consent, our extensive evaluation process includes: A detailed potential donor screening and evaluation process to review medical history as well as any lifestyle or behavioral issues which may disqualify donation. Individuals identified with risk factors for or clinical evidence of relevant communicable diseases and disease agents (RCDADS) such as AIDS, viral Hepatitis, Sepsis, etc., are ruled out as potential donors or are later disqualified if subsequent investigation reveals high risk markers. An on-site review of the potential donor's relevant medical records to evaluate other rule out conditions. A physical assessment of each donor candidate just prior to tissue recovery to confirm donor identity, evaluate the accuracy of medical and social history collected, and to look for signs/symptoms of other disqualifying conditions or risk factors.

10 Tissue Sterilization & Processing Our process requires aseptic handling of all tissue throughout processing and is based on a scientifically validated sterilization method which results in a Sterility Assurance -6 Level (SAL) of 10 in accordance with the ISO Method 1. This validated process is designed to protect the biomechanical properties of each allograft while virtually eliminating patient risk. Extreme care is taken to ensure donor tissues are recovered, processed and packaged appropriately so that the donor gift materializes in the most beneficial way for transplant recipients. Providing safe, sterile human allograft tissue is the primary goal of our processing efforts. Stringent tissue donor screening, recovery, storage and shipping guidelines are followed to best preserve the allografts for their intended function. Tissue Processing & Sterilization

11 Certified Laboratory Testing In accordance with FDA and recognized standards, donor specimens are collected and sent to an independent laboratory certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) to test for the infectious diseases and antibody or antigen markers listed below: Human Immunodeficiency Virus Type I Ab HIV I Antibody HIV I Nucleic Acid Test Human Immunodeficiency Virus Type II Ab HIV II Antibody Human T-Lymphotrophic Virus Type I HTLV I Antibody Human T-Lymphotrophic Virus Type II HTLV II Antibody Certified Laboratory Testing Hepatitis B Virus HBc Antibody (total) HBs Antigen Hepatitis C Virus HCV Antibody HCV Nucleic Acid Test Syphilis Rapid Plasma Reagin Test FTA Confirmation

12 Quality Assurance The donor tracking, documentation, tissue processing, allograft packaging, storage and shipping processes ensure the availability of safe, high quality allografts. A three-level pre-processing review is performed by procurement and processing center quality assurance staff and medical director. The following items are carefully reviewed and documented: Donor qualification Medical/behavioral risk profile Review of consent/authorization to recover tissues for transplantation Review of recovery process/time frames/reconciliation of refrigeration times/recovery site assessment/recovery sequence Completion of recovery record Receipt/reconciliation of tissue recovered Supplies/materials used in recovery/lot numbers and expiration dates Blood sample assessment/qualification Infectious disease testing results Procurement microbiology results Information sharing with other agencies who participated in recovery or receipt of recovered tissues Pathology/autopsy results if performed Tissue receipt records - Verification of Shipment parameters - Reconciliation of tissues shipped vs. received Processing records - SOP requirements have been met - Supplies used - Visual product/packaging inspection - Traceability of tisses received - Irradiation sterilization parameters - Residual Moisture results acceptable Completion of quality assurance investigations Completion of production technical review Inventory data entry Final labeling Quality Assurance

13 INNOVASIS, INC. 614 East 3900 South Salt Lake City, Utah Office: Fax: Innovasis, Inc LCM06 Rev B