Three layers of protection and preservation

BioDFence® G3 is a dehydrated, tri-layer amnion, chorion, amnion allograft providing enhanced handling characteristics for surgical application where in vivo adjustments and manipulation are required.

BioDFence® G3Placental Tissue Membrane

† As compared to BioDDryFlex® Amniotic Tissue Matrix* Preclinical results are not necessarily indicative of clinical outcomes.** Retention of growth factor configuration as demonstrated through ELISA testing, data on file

BioDFence® G3 Placental Tissue MembraneThree layers of protection and preservation

Three layers of protection and preservation:1. Stronger† tri-layer placental membrane that lasts 15*

2. G3 is associated with decreased post-op complications in an animal study16*

3. An easy-to-use, non-side-specific membrane that can be repositioned in vivo

BioDFence G3 details:1. For use as a tissue barrier in soft tissue repair

2. Retains the bioactive growth factors found in native placental tissues**

3. The tri-layer configuration is able to hold a suture15

4. Dehydrated and terminally sterilized with a 5-year shelf life at room temperature

Amnion

Chorion

Amnion

Retains the composition of unprocessed human placental membrane*Laboratory analysis and assays demonstrate that DryFlex®

processing helps preserve the structure and growth factors of

the amnion and chorion layers of the placental membrane.

G3 increases cell migration*As shown in a scratch assay, cell migration was greater in the G3

group compared to the control group (basal media).

The science behind BioDFence® G315* (G3)

CELL MIGRATION IMAGES

Hematoxylin and Eosin (H&E) stained tissue demonstrating normal placental architecture with intact epithelium, compact layer and fibroblast layer

BIODFENCE G3 HISTOLOGY

*Preclinical results are not necessarily indicative of clinical outcomes.

Human placental membrane has been used in the treatment of

a variety of wounds for over 100 years.1 Research has shown that

native placental tissue is immune privileged, can help promote

angiogenesis and new tissue formation, reduce scar tissue

formation, modulate inflammation and pain, and may have

antimicrobial effects.2-14

The placental membrane is composed of:

• Collagen, elastin, fibronectin and proteoglycans that provide

a three-dimensional architecture to promote reconstruction

of damaged tissue

• Regenerative growth factors, such as PDGF, VEGF, TGF-ß,

FGF and IGF, as well as other proteins, anti-inflammatory

cytokines and peptides that promote tissue repair

Why placental tissue? STRUCTURE OF THE PLACENTAL MEMBRANE

AM

NIO

NC

HO

RIO

N

Epithelium

Compact layer

Fibroblast layer

Spongy layer

Cellular layer

Reticular layer

Trophoblast layer

Basement membrane

Basement membrane

Amnion

Amnion

Chorion

(-) Control G3

0 hours

27 hours

(+) Control

Laboratory assessment demonstrates that the G3 tri-layer

membrane is thicker than the leading 2-layer membrane product.

After processing, G3 still maintains the extracellular matrix proteins

(ECM) found in native placental tissues.

Laboratory assessment demonstrates that the G3 membranes last

longer than the leading placental product (dHACM, MiMedx). The

enzyme degradation assay represents an accelerated lab-scale

environment in which scaffolds will break down.

G3 is thicker than the leading amnion/chorion product15*

G3 lasts longer in an enzyme degradation assay15*

Placental Product ThicknessAE, 1-layer 12µm +/- 6 µm

dHACM, 2-layer 45µm +/- 15 µm

G3, 3-layer 55µm +/- 20 µm

0

2

4

6

The enzyme test used is collagenase that is naturally found in the body

ENZYME DEGRADATION

Tim

e to

100%

Deg

rada

tion

(Hou

rs)

AE1-layer

dHACM2-layer

G33-layer

100%

25%

AmnioExcel® Amniotic Allograft Membrane dHACM G3

H&E

Collagen I*

Collagen III*

AE AmnioExcel, Integra LifeSciences (amnion)

dHACM MiMedx® (amnion/chorion)

G3 BioDFence G3, Integra (amnion/chorion/amnion)

Amnion

ChorionAmnion

Amnion

Amnion

Chorion

*Immunohistochemistry stains for collagens type I and III (brown)

*Preclinical results are not necessarily indicative of clinical outcomes.

50 μm

Prospective randomized study comparing BioDFence G3 (G3) to

a leading barrier product (Seprafilm) using an intra-abdominal

peritoneal adhesion rat model

G3 is associated with decreased post-operative complications in an animal study16*

G3 was associated with fewer post-operative complications and preserved the tissue planes better than Seprafilm® Adhesion Barrier, by helping to provide a more appropriate environment for tissue repair.16*

*Preclinical results are not necessarily indicative of clinical outcomes.

COMPARATIVE ANIMAL STUDYGrowth and histological assessment of post-operative complications

Adhesion scores Control (n=5) Seprafilm® (n=10) G3 (n=10)Total 11 10.5 9**Gross total 9 7 6§

Cecum involved, % 75 50 25**†

Vascularity 3 3 2

Strength 3 3 3

Histology total 3 3 3

Inflammation 1 1 1

Fibrosis 2 2 2

Adhesions, n 4 3 2**‡

Post hoc p values between controls. G3 and Seprafilm groups are represented by the following:**p ≤ 0.01 G3 improved compared with control.†p ≤ 0.05 G3 improved compared with Seprafilm.‡p ≤ 0.01 G3 improved compared with Seprafilm.§p ≤ 0.09 G3 improved compared with Seprafilm.

A histological grading rubric was used, with a lower score indicating fewer complications.

References: 1. Davis JW. Skin Transplantation. Johns Hopkins Med J. 1910;15:307–396. 2. Hao Y, Ma DH, Hwang DG, et al. Identification of antiangiogenic and anti-inflammatory proteins in human amniotic membrane. Cornea. 2000;19(3):348–352. 3. Fetterolf DE, Snyder RJ. Scientific and clinical support for the use of dehydrated amniotic membrane in wound management. Wounds. 2012(10):299–307. 4. 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):444–449. 5. 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):329–337. 6. 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):325–335. 7. 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):325–334. 8. Adzick NS, Longaker MT. Scarless fetal healing: therapeutic implications. Ann Surg. 1992;215(1):3–7. 9. 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. 10. Aagaard-Tillery KM, Silver R, Dalton J. Immunology of normal pregnancy. Semin Fetal Neonatal Med. 2006;11(5):279–295. 11. 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. 12. Bailo M, Soncini M, Vertua E, et al. Engraftment potential of human amnion and chorion cells derived from term placenta. Transplantation. 2004;78(10):1439–1448. 13. Liu J, Sheha H, Fu Y, et al. Update on amniotic membrane transplantation. Expert Rev Ophthalmol. 2010;5(5):645–661. 14. Werner S, Grose R. Regulation of wound healing by growth factors and cytokines. Physiol Rev. 2003;83(3):835–870. 15. Data on file. 16. John P Kuckelman, Human-Derived Amniotic Membrane Is Associated With Decreased Postoperative Intraperitoneal Adhesions in a Rat Model, Dis Colon Rectum. 2018 Apr;61(4):484-490.

BioDFence® Ordering Information

BioDFenceG3, BioDDryFlex, and AmnioExcel are products regulated by the FDA under 21 CFR Part 1271 and Section 361 of the Public Health Service Act.

Integra LifeSciences Corporation intends to use reasonable efforts to provide accurate coding information, but this information should not be construed as providing clinical advice, dictating reimbursement policy or substituting for the judgment of a practitioner. It is always the Provider’s responsibility to determine and submit appropriate codes, charges and modifiers for services that are rendered. Integra LifeSciences Corporation assumes no responsibilities or liabilities for the timeliness, accuracy and completeness of the information contained herein. Since reimbursement laws, regulations and payor policies change frequently, it is recommended that providers consult with their payors, coding specialists and/or legal counsel regarding coverage, coding and payment issues.

USA 800-654-2873 n 888-980-7742 faxintegralife.com

United States

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:

AmnioExcel, BioDDryFlex, BioDFence, DryFlex, Integra and the Integra logo are registered trademarks of Integra LifeSciences Corporation or its subsidiaries in the United States and/or other countries. All other trademarks and trade names are the property of their respective owners. ©2020 Integra LifeSciences Corporation. All Rights Reserved. Printed in USA. 0M 1743965-1-EN

*Two, 15 mm discs

Reference Description Reference Description

DF-020015 MIS Tube* DF-020206 2.0 cm x 6.0 cm

DF-020152 1.5 cm x 2.0 cm DF-020404 4.0 cm x 4.0 cm

DF-020202 2.0 cm x 2.0 cm DF-020306 3.0 cm x 6.0 cm

DF-020203 2.0 cm x 3.0 cm DF-020408 4.0 cm x 8.0 cm

DF-020204 2.0 cm x 4.0 cm DF-020606 6.0 cm x 6.0 cm

General Use: BioDFence G3 is intended for use as a wound covering. This product is an allograft tissue intended for homologous use as a protective barrier covering during the repair of soft tissue wounds at the direction of a physician.

BioDFence® G3Placental Tissue Membrane