BioDOptix® Native human amnion

Growth FactorsbFGF + +

EGF + +

G-CSF + +

PDGF-AA + +

PDGF-BB + +

PLGF + +

TGF-ß + +

TGF-ß1 + +

InterleukinsIL-4 + +

IL-6 + +

IL-8 + +

IL10 + +

Tissue Inhibitors of MetalloproteasesTIMP-1 + +

TIMP-2 + +

TIMP-4 + +

H&E stained tissue demonstrating normal amnion architecture with intact epithelium, compact layer and fibroblast layer.

Histology of BioDOptix® (Magnified image of BioDOptix® Amniotic Allograft Membrane)

Amnion epithelial cells

Fibroblast layer Compact

layer

The science behind human placental tissueHuman amniotic membrane has been used to treat a variety of wounds for over 100 years1 and the first reported use for ocular surface defects was reported in 1940 by De Roth.2 Research has shown that placental tissues can promote new tissue formation, reduce scar tissue formation, modulate inflammation and pain and may have antimicrobial effects.3-15

The native human amniotic membrane is composed of:• A three-dimensional architecture to support reconstruction of damaged tissue.• Growth factors, as well as other proteins, cytokines and peptides

BioDOptix preserves the key components of native human amniotic membrane using the Dryflex® processing technology. Laboratory analyses and assays demonstrated that this process:• Preserves the continuous, intact epithelium, basement membrane, compact and

fibroblast layers of the amniotic tissue, as illustrated in the histology section on the right.16

• Maintained the presence of cytokines and growth factors with particularly high quantities of EGF, PDGF, TGF-, and TIMPs 1 and 2.16

You are focused on healing.

We are focused on improving your clinical experience.

BioDOptix® amniotic extracellular matrix is a dehydrated membrane allograft derived from human amniotic tissue that is intended for use in ocular tissue repair.

BioDOPTIX®

A M N I O T I C E X T R A C E L L U L A R M A T R I X

References: 1. Davis JW. Skin Transplantation. Johns Hopkins Med J 1910;15:307–96. 2. De Roth A. Plastic repair of conjunctival defects with fetal membranes. Arch Ophthalmol. 1940; 23: 522-5. 3. Hao Y, Ma DH, Hwang DG, et al. Identification of antiangiogenic and anti-inflammatory proteins in human amniotic membrane. Cornea 2000;19(3):348–52. 4. Fetterolf DE, Snyder RJ. Scientific and clinical support for the use of dehydrated amniotic membrane in wound management. Wounds 2012(10):299–307. 5. Solomon A. Suppression of interleukin 1alpha and interleukin 1beta in human limbal epithelial cells cultured on the amniotic membrane stromal matrix. Br J Ophthalmol 2001;85(4):444–9. 6. Kim JS, Kim JC, Na BK, et al. Amniotic membrane patching promotes healing and inhibits proteinase activity on wound healing following acute corneal alkali burn. Exp Eye Res 2000;70(3):329–37. 7. Tseng SCG, Li D-Q, Ma X. Suppression of transforming growth factor‐beta isoforms, TGF‐ß receptor type II, and myofibroblast differentiation in cultured human corneal and limbal fibroblasts by amniotic membrane matrix. J Cell Physiol 1999;179(3):325–35. 8. Lee S-B, Li D-Q, Tan DT, et al. Suppression of TGF-ß signaling in both normal conjunctival fibroblasts and pterygial body fibroblasts by amniotic membrane. Curr Eye Res 2000;20(4):325–34. 9. Adzick NS, Longaker MT. Scarless fetal healing: Therapeutic implications. Ann Surg 1992;215(1):3–7. 10. Cuttle L, Nataatmadja M, Fraser JF, et al. Collagen in the scarless fetal skin wound: Detection with Picrosirius-polarization. Wound Repair Regen 2005;13(2):198–204. 11. Aagaard-Tillery KM, Silver R, Dalton J. Immunology of normal pregnancy. Semin Fetal Neonatal Med 2006;11(5):279–95. 12. Chen EH, Tofe AJ. A literature review of the safety and biocompatibility of amnion tissue. J Impl Adv Clin Dent 2010;2(3):67–75. 13. Bailo M, Soncini M, Vertua E, et al. Engraftment potential of human amnion and chorion cells derived from term placenta. Transplantation 2004;78(10):1439–48. 14. Liu J, Sheha H, Fu Y, et al. Update on amniotic membrane transplantation. Expert Rev Ophthalmol 2010;5(5):645–61. 15. Werner S, Grose R. Regulation of wound healing by growth factors and cytokines. Physiol Rev 2003;83(3):835–70. 16. Data on file.

USA 800-654-2873 n 888-980-7742 faxInternational +1 609-936-5400 n +1 609-750-4259 faxintegralife.com/contact

United States, Canada, Asia, Pacific, Latin America

Availability of these products might vary from a given country or region to another, as a result of specific local regulatory approval or clearance requirements for sale in such country or region. n Non contractual document. The manufacturer reserves the right, without prior notice, to modify the products in order to improve their quality.n Warning: Applicable laws restrict these products to sale by or on the order of a physician.n Consult product labels and inserts for any indication, contraindications, hazards, warnings, precautions, and instructions for use.

For more information or to place an order, please contact:

BioDOptix, DryFlex, Integra and the Integra logo are registered trademarks of Integra LifeSciences Corporation or its subsidiaries in the United States and/or other countries. ©2017 Integra LifeSciences Corporation. All rights reserved. Printed in USA. 0840400-1-EN

BioDOptix is regulated by the FDA under 21 CFR Part 1271 and Section 361 of the Public Health Service Act.