Company Presentation September 2018
Introduction Leading Developer and Marketer of R egenerative and Therapeutic Biologics bas ed on a P lacental Technology P latform Addres s ing Multiâ&#x20AC;?Billion Dollar Market Opportunities in Wound Care, S urgical and Mus culos keletal P ain P roven S afety P rofile; More than 1 Million Allograft Units S hipped; Over 100* Is s ued and Allowed P atents <Include Key Financial Highlights >
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Placental Technology - Amniotic and Umbilical Membranes
Barrier properties 1 Modulates inflammation2 R educes s car tis s ue formation2 Immunologically privileged3 Contains es s ential growth factors 4 Enhances wound healing5
1 Tao H, Fan H. Implantation of amniotic membrane to reduce pos tlaminectomy epidural adhes ions . Eur S pine J . 2009 Aug; 18(8):1202-12. 2 Ts eng S C, Li DQ, Ma X. S uppres s ion of trans forming growth factor-beta is oforms , TGF-beta receptor type II, and myofibroblas t differentiation in cultured human corneal and limbal fibroblas ts by amniotic membrane matrix. J Cell P hys iol. 1999 J un;179(3):325-35. 3 Hao Y, Ma DH, Hwang DG, Kim WS , Zhang F. Identification of antiangiogenic and antiinflammatory proteins in human amniotic membrane. Cornea. 2000 May;19(3):348-52. 4 Koob TJ , R ennert R , Zabek N, Mas s ee M, Lim J J , Temenoff J S , Li WW, Gurtner G. Biological properties of dehydrated human amnion/chorion compos ite graft: implications for chronic wound healing. Int Wound J . 2013 Oct;10(5):493-500. 5Zelen CM, S erena TE, Denozière G, Fetterolf DE. A pros pective randomized comparative parallel s tudy of amniotic membrane wound graft in the management of diabetic foot ulcers . Int Wound J . 2013 Oct;10(5):502-7.
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Delivering Innovative Technologies in Regenerative Medicine
Placental Tissue Amniotic
Umbilical
Disc
Amniotic Fluid
Collagen Fiber*
Bone Tissue
Modulate Inflammation
Protective Environment
Protective Environment
Protect & Cushion
Mimics Native Tissue
Physiological Bone
Reduce Scar Tissue
Replace or Supplement Damaged or Inadequate Integumental Tissue
Replace or Supplement Damaged or Inadequate Integumental Tissue
Provide Lubrication for Enhanced Mobility
Biomechanics for Tendon and Ligament Repair
Moldable
Enhance Healing
Reduce Inflammation
Flowable Wet Field Integrity
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*In Development – not for sale in U.S.
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Delivering Innovative Technologies in Regenerative Medicine
Injection s ites : glabellar complex, periorbital area, cheeks , nas olabial folds , mouth, lips , chin, and jaw. US market - $3 billion by 2026, driven primarily by high patient demand. Increas ingly men and younger patients
MedTech 360 â&#x20AC;&#x201C; Aesthetic Injectables 2018
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MiMedx Cosmetic Filler Product for wrinkles and Scar Depressions
Material: S mall particulate placental ECM (includes Amnion, Chorion, Umbilical Cord, and Dis c) R econs tituted with s aline during injection
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Proprietary PURIONÂŽ Processing
5-year
Unique, Specifically Developed Process
Shelf-life
On-theShelf Storage
Dehydration
Biologic & Structural Integrity
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Gentle
Terminal Sterilization
Dehydrated Amnion/Chorion – Bioactive proteins
226 Natural Bioactive Proteins Preserved in PURION® Processed Amnion/Chorion1-4 1. Koob TJ , et al. A P rimer on Amniotic Membrane R egenerative Healing. 1s t ed. Grand R apids , MI: MiMedx/Color Hous e Graphics . 2015. 2. Koob TJ , R ennert R , Zabek N, Mas s ee M, Lim J J , Temenoff J S , Li WW, Gurtner G. Biological properties of dehydrated human amnion/chorion compos ite graft: implications for chronic wound healing. Int Wound J . 2013 Oct;10(5):493-500. 3. Koob TJ , Lim J J , Mas s ee M, Zabek N, Denozière G. P roperties of dehydrated human amnion/chorion compos ite grafts : Implications for wound repair and s oft tis s ue regeneration. J Biomed Mater R es B Appl Biomater. 2014 Aug;102(6):1353-62. 4. Koob TJ , Lim J J , Mas s ee M, Zabek N, R ennert R , Gurtner G, Li WW. Angiogenic properties of dehydrated human amnion/chorion allografts : therapeutic potential for s oft tis s ue repair and regeneration. Vas c Cell. 2014 May 1;6:10.
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Placental ECM
PURION PLUS PROCESS
RECOVER PLACENTA, AMNION/CHORION, UMBILICAL CORD
DISC
SEROLOGICAL AND MICROBIAL TESTING
ACU (amnion/chorionACU/umbilical)
LIVE BIRTH
PURION PLUS PROCESS Delivers vital growth factors /cytokines and extracellular matrix (ECM) components ideal for healing large tunneling wounds and voids . 9
Placental ECM â&#x20AC;&#x201C; Proliferation Studies
Incubate
Combine
Basal Medium
Human Dermal Fibroblasts
AmnioFill Treatment
Cell Culture Dish
72 Hours
RESULTS: P roduct s timulates proliferation of Human Dermal Fibroblas ts TRANSLATION:
The bioactive components in amniotic tis s ue are pres erved through proces s ing P roduct can s upport the growth of cells neces s ary to facilitate ECM depos ition 10
Count Cells
In Vivo Testing - Rat Study; Product Vs Juvederm
POST-OP
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DAY 1
200 mg/ml dis c +ACU
150 mg/ml Dis c only
J uvederm
J uvederm
150 mg/ml dis c + ACU
150 mg/ml dis c + ACU
In Vivo Testing - Filler Volume Measurements (Interim Results)
150 mg/ml ACU 12
200 mg/ml ACU
150 mg/ml Disc
Juvederm
98 days
84 days
70 days
56 days
42 days
28 days
14 days
7 days
24 hours
500.00 450.00 400.00 350.00 300.00 250.00 200.00 150.00 100.00 50.00 0.00 0 days
Volume, mm3
Dermal Filler Volume
Human Case Examples: Case # 1 â&#x20AC;&#x201C; Marionette line injection
Pre Injection
1cc of product was injected No unintended reaction, burning, or itching No inflammation reaction, no rednes s After 1 month
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Human Case Examples: Case # 1 – Marionette line injection
Before Filler Injection One month after injection: Increas e in Collagen-like material content (green) and elas tin-like material (blue) Two months after injection: S table collagen and elas tin levels , with s light increas e in elats in levels
Green – Collagen-like; Blue – Elas tin-like; Yellow- Fibrous ; Black – Loos e s kin
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Testing Summary
Well es tablis hed s afety data from comparable configurations Animal tes ting (R at model) â&#x20AC;&#x201C; in progres s Limited launch: S afety conclus ions Longevity of fill: to be as certained â&#x20AC;&#x201C; 9 months ?
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