Geistlich Derma-Gide®

Advanced Wound Matrix

DISRUPTYOUR

EXPECTATIONS

Upper compact layer: mimics basement membrane, supports growth factor binding and preservation, supports keratinocyte migration, provides mechanical protection of the wound site, allows suturing

Geistlich Derma-Gide ®

after hydration

Lower porous layer: shown to modulate matrix metalloproteinase (MMP) activity, provides optimal structure for cell migration and attachment, able to absorb wound fluid

Acellular bilayer scaffold derived from porcine extracellular matrix (100 % veterinary certified).

Designed specifically to support wound healing.1,2

EXPECT Advanced Design

Geistlich Derma-Gide® Advanced Wound Matrix

The Geistlich Process

Extractrenders the source material acellular

Purifyremoves antigens, lipids and unwanted proteins

Refinereassembly and three dimensional organization of the extracellular matrix into the proprietary bilayer design

Can one treatment innovation DISRUPT your EXPECTATIONS for the better?EXACTLY

Avoiding disruptions is a cornerstone of successful wound care, but sometimes to embrace innovation you have to change your way of thinking. It’s time to DISRUPT and RAISE your EXPECTATIONS with Geistlich Derma-Gide®. Geistlich Derma-Gide® Advanced Wound Matrix supports the management of diverse wounds with a novel bilayer design that optimizes the body’s own healing potential. In your hands, solutions like Geistlich Derma-Gide® become as indi vidual as you are. Like a fingerprint – and EXACTLY like no other.

“The fingerprint represents the uniqueness of Geistlich Pharma and the Geistlich family. We constantly strive to support our customers and patients and our relentless pursuit of being: EXACTLY like no other.”

Dr. Andreas GeistlichPresident of the Board of Directors 5th Generation Family Member since the Company was founded.

In an IRB approved 10 patient retrospective study1, the authors assessed the clinical effectiveness and healing characteristics of the Geistlich Derma-Gide®. Additional data was collected on the average cost to treat each patient as well as unique handling and performance characteristics of the product.

Initial observation 5 weeks Initial observation 5 weeks

EXPECT Performance

EXPECT Scientific Evidence*

In a chronic wound situation the physiological balance between metalloproteinases (MMPs) and growth factors is disturbed. This is associated with inadequate cell migration and proliferation, which results in stalled healing.3,4 Geistlich Derma-Gide® supports the rebalancing of these factors.1 In vitro studies led to the discovery of the following clinically relevant characteristics:

* Performance in in vitro studies may not be representative of performance in humans

Time to closure1

› Average time to complete wound closure was 2.7 weeks

› Average wound size was 3.3 cm2

Cost to closure1

› Average cost to treat the patients in the cohort was $1,203

Healing rate1

› At study conclusion, complete wound closure was achieved for 90% of the wounds (9/10 patients)

$

Geistlich Derma-Gide® supporting the healing process.

4 cm² Diabetic Foot UlcerPatient information63 year old Female with Diabetes mellitus | 2cm x 2cm plantar Diabetic Foot Ulcer with wound edge maceration and exposed cartilage and tendon | Wagner grade 2 | 6 months of unsuccessful treatment with Standard of Care | healing after 4 weeks of Geistlich Derma-Gide® treatment

15 cm² Diabetic Foot UlcerPatient information43 year old Male with Diabetes mellitus | 5 cm × 3 cm distal Diabetic Foot Ulcer with exposed bones, Wagner grade 2 | 2 months of unsuccessful treatment with Standard of Care | significant progression/healing after 5 weeks of Geistlich Derma-Gide® treatment

Growth Factor Binding and PreservationThe Geistlich Derma-Gide® matrix maintains growth factors in an active state in situ, which is necessary for wound healing.Geistlich Derma-Gide® was incubated with healing-related growth factors or control solutions and extensively washed. After 0h or 72h the matrix was cultured with cells and the effect on cell activity was measured by gene expression. An equally strong activity was measured at both time points for TGF-β1, bFGF and VEGF, which are important for vascularization, reepithelialization, and tissue formation.

lp

th

0h

72h

0h

72h

0h

72h

0h

72h

1 10010

Gene Expression [Fold difference to control]

Cell activity assay

Coating + washing

Control Group

GrowthFactors

0h

72h

0h

72h

CONTROL

bFGF

TGF-β1

VEGFCase Example 2Case Example 1

Matrix Metalloproteinase (MMP) ActivityGeistlich Derma-Gide® is shown to modulate MMP activity.MMP-1, 2, and 9, which are most abundant in chronic wounds, were analyzed after 2h incubation with Geistlich Derma-Gide® in the supernatant. MMPs alone served as the control. Geistlich Derma-Gide® led to lower activity of MMP-1 (55% reduction, upper panel), MMP-2 (96% reduction, middle panel) and MMP-9 (66% reduction, lower panel) 2h after incubation compared to the control, therefore demonstrating modulation of MMP activity in this in vitro study.

Test:MMP + Geistlich Derma-Gide®

Control:MMP

Activity [%]

Control

Test

Control

Test

Control

Test

0 20 40 60 80 100

2h

MeasureMMP activity

MMP-1

MMP-2

MMP-9

Cell MigrationGeistlich Derma-Gide® provides optimal structure for cell migration and attachment.Human epidermal keratinocytes were seeded in Boyden chamber wells. In the lower compartment either basal medium (negative control), Geistlich Derma-Gide® or growth factor supplements (positive control) were added. After 12h the cell number in the lower compartment of each well was quantified. The well containing Geistlich Derma-Gide® was found to contain a number of cells equivalent to the positive control.

0 1 2 3

Test solution

Permeablemembrane

Cell culture well

Cells Migrated cells [cell index]

CONTROL

GEISTLICHDERMA-GIDE®

POSITIVE CONTROL(growth supplements)

12h

Migrated cell number analysis

Excellent soaking capacity. Geistlich Derma-Gide® may be applied on a freshly debrided wound.

Ready to use, with no pre-treatment, rinsing or pre-hydrating required.

Naturally conforms and adheres to the defect site as soon as hydrated.

Can be easily sutured and trimmed using standard surgical instruments.

Geistlich Derma-Gide® can be applied as is when used with VAC therapy. Fenestration, if required, should be performed in a dry state.

Preparation of the wound bedPrior to applying the Geistlich Derma-Gide® the affected skin site must be carefully debrided, cleaned and disinfected to ensure the wound edges contain viable tissue.

Product preparation

Open the lid after taking the inner blister out of the outer blister.

Trim the device to the wound size in its dry state.

Product applicationApply Geistlich Derma-Gide® in its dry state. Apply the product with the compact layer facing upward and the porous, soft layer toward the wound bed.

Once applied, ensure that Geistlich Derma-Gide® is completely hydrated either with wound exudate or sterile saline.

Application of secondary dressings

Geistlich Derma-Gide® should be covered with a non-adhesive dressing in order to prevent desiccation. Apply subsequent dressings in accordance with standard treatment protocols.

EXPECT Ease of Handling

An Advanced Wound Matrix that is EXACTLY like no other

Geistlich Derma-Gide® is available in a wide variety of sizes and shapes in order to minimize trimming and shaping and to optimize the overall cost when treating

patients with chronic wounds.

For more information please visit: www.derma-gide.com

HCPCS Q4203 High Cost Category

Advanced Wound Matrix

Product Size Total cm² Re-Order Number

12 mm Disk 1.1 500477

14 mm Disk 1.5 500478

16 mm Disk 2.0 500479

18 mm Disk 2.5 500480

1.5 cm x 2 cm 3.0 500425

2 cm x 2 cm 4.0 500474

2 cm x 3 cm 6.0 500426

2 cm x 4 cm 8.0 500475

3 cm x 4 cm 12.0 500427

Convenient Clinical Application2Excellent Handling Characteristics2

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ManufacturerGeistlich Pharma AGBahnhofstrasse 40CH-6110 Wolhusen, SwitzerlandPhone +41 41 492 55 55Fax +41 41 492 56 39

Distributed byGeistlich Pharma North America Inc.202 Carnegie CenterPrinceton, NJ 08540 USAPhone toll-free 877 485 2968www.derma-gide.com

Caution: Federal law restricts this device to sell by or on the order of a licensed health care provider.

Product availability may vary from country to country.

Longevity › Founded in 1851 in Zurich › Two sites in central Switzerland,

10 subsidiaries and distribution in over 90 countries

Stability › 100% family owned › Since its founding the company has

focused on sustainable, independent success through its own strengths

› Ability to think in long-term perspectives

Commitment › Collaborations with >100 universities › Extensive research has resulted in

more than 1,000 scientific publications confirming the efficacy of Geistlich biomaterials

EXACTLY

How can you measure a company like Geistlich?

Partnership › Three Foundations supported

by the Geistlich family: The Osteology, OrthoRegeneration Network, and the OsteoScience Foundations are completely independent non-profit organizations that link science with practice in regeneration

› Founded to promote research as well as education for the benefit of patients worldwide

Trusted Clinical Solutions › Every 15 seconds a Geistlich product

is used somewhere in the world › More than 10 million patients

have been treated with Geistlich regenerative products over the last 30 years

References

1 Data on file 2 Instructions for Use, Geistlich Derma-Gide®

3 Krishnaswamy et al. 20174 Armstrong et al. 2002