AmnioFix® InjectabledHACM (dehydrated human amnion chorion

membrane)

• Uses Include:– Tendinopathies– Fasciitis– Ulcer perimarginal and intramarginal adjunctive use– Bursitis, neuritis, capsulitis

• Mix with sterile saline and inject– See Instructions for Use included with product for

full application guidelines

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Where MiMedx® Sources Its Amnion and Chorion

SB299.004

MiMedx® Separates the Amniotic Sac from the Placenta and the Chorionic Plate

MiMedx® only uses the Amnion and Chorion Membrane from the Amniotic Sac to Create EpiFix® and AmnioFix®

Fresh Amnion/Chorionvs. PURION® Processed Amnion/Chorion

Cytokine Fresh* PURION® Processed**

PDGF-AA

PDGF-BB

TGF-α

TGF-β1

bFGF

EGF

GCSF

IL-1ra**

IL-4,6,8,10

VEGF**

PLGF

Inhibitor Fresh* PURION® Processed**

TIMP-1

TIMP-2

TIMP-4

* Determined by ELISA Assay (N=15) Cytokine/inhibitor test completed by a 3rd party laboratory, data on file

5

** Koob T, Rennert R, Zabek N, Massee M, Lim J, Temenoff J, Li W, Gurtner G. “Biological properties of dehydrated human amnion/chorion composite graft: implications for chronic wound healing.” Int Wound J 2013: doi: 10.1111/iwj.12140

25+ PEER REVIEWED, PUBLISHED, CLINICAL &

SCIENTIFIC JOURNAL ARTICLES ON dHACM

50+ ARTICLES ON VARIOUS dHACM APPLICATIONS

100+ POSTERS PRESENTED BY INDEPENDENT

PRACTITIONERS

Plantar Fasciitis RCT†

• Significant improvement in plantar fasciitis symptoms was observed in patient receiving micronized dHACM injections

• Micronized dHACM show statistical significance values over control in the following tests; AOFAS Hindfoot, Wong-Baker FACES pain, and SF36v2 Physical and Mental

† Zelen C, Poka A, Andrews J. “Prospective, Randomized, Blinded, Comparative Study of Injectable Micronized Dehydrated Amniotic/Chorionic Membrane Allograft for Plantar Fasciitis—A Feasibility Study.” Foot & Ankle International XX(X) 1–8, October 2013.

* Hansen M, Anderson J. “Chronic and Refractory Plantar Fasciitis Treatment with Single-Dose Dehydrated Amniotic Allograft Injection.” Poster presentation, Annual Scientific Conference of the American Foot and Ankle Surgeons 2013.

Variable Average Range

Age (yr) 46 27-68BMI 30.2 19.6-46.8History of Pain (mos) 10.5 7-16

Baseline Pain Rating (0-10) 6.9 6-8Prior Corticosteroid Injections 3.6 3-5

Variable % Patients

Corticosteroid Injection 100

NSAIDS 100

Physical Therapy 100

Orthodics 100

Medrol Pack or OPC Cream 80

Night Splints 70

Cam Walker 20

Table 1. Patient Demographics

Table 2. Prior Therapies

Pre-Injection Ultrasound Post-Injection Ultrasound

Fascia decreased in overall thickness by 19% with one injection of dHACM Powder(N=10)

0

1

2

3

4

5

6

7

8

9

10

Baseline Week 2 Week 4 Week 6 Week 8 Week 16

Pai

n s

cale

ou

t o

f 1

0

dHACM PowderRate of Pain Reduction (n=10)

0.0

2.0

4.0

6.0

8.0

10.0Overall Pain Reduction

-94%-96%-86%

-96%

-62%

% Pain Reduction from Baseline

Pai

n s

cale

ou

t o

f 1

0

Baseline 2 4 6 8 16

Weeks

In the following study, inflammation reduction was measured using standardized methods including pain scale and ultrasound.

Inflammation Reduction in Plantar FasciitisUsing dHACM Powder*

• 30 yo male • Worsening infrapatellar knee pain • basketball injury 12 months ago• MRI after 6 months

• Partial thickness tear patellar tendon origin

• Recalcitrant to conservative Tx• Anti-inflammatory Meds• >30 sessions of PT• No injections

Partial Thickness Tear Patellar Tendon Origin

Injection Resultsat 5 weeks

Pre-Injection Post-Injection

Courtesy of Dr Rahul Desai, MD

Injection Results

POST at 5 weeksPRE

Courtesy of Dr Rahul Desai, MD

Brief Comparison Between PRP and dHACM

PRP1, 2 dHACMGrowth Factors• Transforming Growth Factor Beta (TGF-b)• Platelet Derived Growth Factor (PDGF)• Insulin-like Growth Factor (IGF)• Fibroblast Growth Factor (FGF)• Epidermal Growth Factor (EGF)• Vascular Endothelial Growth Factor (VEGF)• Hepatocyte Growth Factor (HGF)Cytokines• Tissue inhibitor of metalloproteinase- 4 (TIMP-4)Adhesive Proteins• Fibronectin• Fibrinogen• Vitronectin• Thrombospondin-1• Laminin

Growth Factors

• Epidermal Growth Factor (EGF)

• Fibroblast Growth Factor (FGF)

• Platelet Derived Growth Factor (PDGF)

• Transforming Growth Factor Beta (TGF-b)

• Vascular Endothelial Growth Factor (VEGF)

Cytokines

• Defensins

• Endothelins

• Interleukins

• Interleukin -1 α, 1 β , 6, 8, 10

• Interleukin -1 Receptor antagonist

• Matrix metalloproteinase-1, 2, 9

• Tissue inhibitor of metalloproteinase-1 , 2, 3, 4 (TIMP-1, 2, 3, 4)

Adhesive Proteins

• Fibronectin

• Fibrillin

• Laminins

Extra Cellular Matrix

• Elastins

• Collagen I, IV, V, VII

1 Sanchez- Gonzalex, D J; Mendez-Bolaina, E; Tejo-Bahena, Platelet-Rich Plasma Peptides: Key for Regeneration. Int J Pept. 2012; 2012: 532519.2 Boswell, S G; Cole, B J; Sundman, E A; Karas, V; Fortier, L A, Platelet-Rich Plasma: A Milieu of Bioactive Factors. Arthroscopy. vol 28, 3, 2012 pp 429-439.3 Hao Y; Ma DH; Hwang DG; Kim WS; Zhang F "Identification of antiangiogenic and antiinflammatory proteins in human amniotic membrane." Cornea. (19)3. 01-MAY-2000. pp 348-52.

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