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Dermavest overview

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Review of the technology behind Dermagraft, so you can see how dermagraft will help you close wounds.

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Dermavest overview

  1. 1. AND Placental Disc Umbilical Cord Amnion/Chorion Dermavest ® Human Placental Connective Tissue Matrix
  2. 2. Through the course of gestation the human placenta maintains an environment for cell protection, proliferation and activity that plays a signifcant role in the development of mankind’s most important asset. The key to maintaining these optimum conditions is the ability of the structural attachment proteins, growth factors and cytokines of the placental tissue extra Dermavestis processed by gently decontaminating the placental tissue while preserving important cell attachment proteins, growth factors and cytokines that have been proven to have therapeutic value. The tissue is freeze-dried to remove moisture, pressed into a pad and sealed in a foil pouch. cellular matrix to migrate cells to where they need to be and enable them to respond constructively to the surroundings to which they are presented. Although many of the proteins and growth factors in the human placenta are known to science, many still perform important functions and have yet to be identifed. Product Description www.aedicell.com
  3. 3. The Difference is Processing Normal, healthy full term pregnancies FDA inspected tissue bank 3 Year room temperature shelf life Lyophilize & Validated 17kGy Irradiation Decontaminate & Capture Amnion/Chorion Umbilical Cord AND Placental Disk Gently Grind www.aedicell.com
  4. 4. Particularized Pad is Easy to Apply for an increased rate of enzymatic digestion of the graft and a more efcient transport of cell stimulatory cytokines and growth factors to the wound bed. Additionally, the particularized pad makes it extremely easy to work with in relation to thin membrane products that may need to be maneuvered into specifc As a particulate pressed together into a pad, the result is a more porous, open structure than a contiguous membrane scafold. This increase in porosity logically allows for easier cell infltration and thus attachment. Additionally, the larger surface area resulting from a particulate pad allows for increased contact with wound fuids. Presumably this allows www.aedicell.com orientations and that can roll up of of the surface of the wound. By reason, the easy administration of Dermavestas compared to contiguous membrane products, make them ideal candidates for deep or tunneled wounds.
  5. 5. Exposed Surface Area Enables Cell Migration cells/exudate Amnion/Chorion cells/exudate Plurivest/Dermavest “By far the easiest skin substitute to use” www.aedicell.com
  6. 6. In recent years, application of human amnion and chorion derived products have expanded to the treatment of chronic ulcers and soft tissue applications. Dermavestis the only product on the market that combine human tissue sourced from the amnion, chorion, umbilical cordAND placental disc. The protein profles of Dermavestis unlike anything that is being ofered in the market today. In Vitro studies demonstrate that Dermavestsupports the proliferation of type-1 collagen, fibroblasts and mesenchymal stem cells. Research shows amnion and chorion products to elicit a markedly diferent profle of proteins than the other classes of skin substitutes including porcine intestinal submucosa, cadaver skin and collagen based wound coverings. It stands to reason that with the addition of placental disc tissue, Dermavestwill drive a novel therapeutic response in the varied In Vivo environments to which they are applied. Innovative Technology www.aedicell.com
  7. 7. Profile of ECM and Cytokine and Growth Factors Relative (by protein) mass per cm2 product PlurivestChorion Dermavest ECM Laminin/Fibronectin Interleukin (10, 4, 6 ,8) VEGF Amnion www.aedicell.com
  8. 8. Mesenchymal Stem Cell Growth in Culture (72 hours) MSC’S are key to efective wound healing Moore MC, PandolfV, McFetridge PS, “Novel human-derived extracellular matrix induces in vitro and in vivo vascularization and inhibits fibrosis“, Biomaterials 2015 May; 49; 37-46 0. 2500. 5000. 7500. 10000. 12500. Control Placental Membrane Scaffold ugDNA (counts/minute) Control Dermavest Control = Culture media and 3-d collagen gel. Treatment = Control mixed with Dermavest. www.aedicell.com
  9. 9. Angiogenesis(Diabetic Rat Model) DermavestControl Placental Disc ECM is known to induce vascularization Moore MC, PandolfV, McFetridge PS, “Novel human-derived extracellular matrix induces in vitro and in vivo vascularization and inhibits fibrosis“, Biomaterials 2015 May; 49; 37-46 www.aedicell.com
  10. 10. Bacterial Resistance Staph Aureus 4 hour co-culture Negative Control (Cotton Bandage) Positive Control Acticoat 7 Silver Dressing >99.9% reduction Dermavest 55% reduction Placental Disc extracts are known to be antimicrobial Chakraborty PD, Bhattacharyya D, In vitro inhibition of microbes by human placental extract, Current Science, March 2005; 88 (5); 782-786 www.aedicell.com
  11. 11. Dermavest applied www.aedicell.com
  12. 12. Diabetic Ulcer Statistics 1. Dermavest data compiled from two case series presented at the society of advanced wound care (SAWC) annual meeting. 2. SOC Study 1data derived from Snyder RJ, Cardinal M, Dauphinee DM, Stavosky J, “A Post-hoc Analysis of Reduction in Diabetic Foot Ulcer Size at 4 Weeks as a Predictor of Healing by 12 weeks “, Ostomy wound Management 2010; 56 (3); 44-50. 3. SOC study 2 data derived from Zelen CM, Serena TE, Denoziere G, Fetterolf D “A prospective randomized comparative parallel study of amniotic membrane wound graft in the management of diabetic foot ulcers”, International Wound Jrnl 2013; doi: 10.1111/rwj.12097. 0% 20% 40% 60% 80% 100% Dermavest/Plurivest SOC study 1 (a and b) SOC study 2 % cases 4 week PAR > than 50%. *p-value calculated DV vs SOC using 1-sided test for 2 proportions Dermavest/ Plurivest SOC study 1 (a & b) SOC study 2 #Wounds 10 250 12 Duration-weeks mean (stdev) 42 (11.3) 671 16.7 (15.5) Size-cm2 mean (stdev) 4.74 (5.3) 2.531 3.4 (2.9) Age mean (stdev) 60.5 (11.3) 55.31 61.7 (10.3) # Cases PAR > 50% 8 142 4 1 only study b data available www.aedicell.com
  13. 13. VenousUlcerStatistics 1. Dermavest data compiled from two case series presented at the society of advanced wound care (SAWC) annual meeting. 2. SOC Study 1 data derived from Gelfand JM, Hoffstad O, Margolius D, “Surrogate Endpoints for the Treatment of Venous Leg Ulcers”, J Invest Dermatol 119:1420-1425, 2002 3. SOC study 2 data derived from Serena TE, Carter MJ, Lam TE, DSabo MJ, and DiMarco DT “A Multicenter, randomized, controlled clinical trial evaluating the use of dehydrated human amnion/chorion membrane allografts and multilayer compression therapy vs. multilayer compression therapy alone in the treatment of venous leg ulcers” Wound Rep Regeneration 2014; 22; 688-693. 0% 20% 40% 60% 80% Dermavest/Plurivest SOC study 1 SOC study 2 % cases 4 week PAR > than 40%. *p-value calculated DV vs SOC using 1-sided test for 2 proportions Dermavest /Plurivest SOC study 1 SOC study 2 #Wounds 13 25,406 31 Wound Duration (weeks) mean (median) 85 (72) 16 16.7 (15.5) Size wound (cm2) mean (stdev) 3.73 (4.4) 3.2 6.3 (5.3) Age mean (median) 66 (68) 68.5 63.6 (61.1) # Cases PAR > 40% 9 12,542 10 www.aedicell.com
  14. 14. www.aedicell.com 2017 HOPD Medicare Reimbursement Example Graft Sizecoverage to 4.0 cm2 Email or Call for benefits analysis (dvhotline@aedicell.com, (877) 614-2355). national average, high tier bundled payment for CPT 15271 = $1429 Plurivest 1.5 x 1.0 cm Spreads to cover up to 2 sqr cm $350 $1120.34 $285.80 Dermavest 1.5 x 1.0 cm Spreads to cover up to 4 sqr cm $550 $1120.34 $285.80 Competitors $450 (1.5 cm2) to $1,100 $1120.34 $285.80
  15. 15. national average, high tier bundled payment for CPT 15271 = $1429 Dermavest 2 x 3 cm Spreads to cover up to 14 sqr cm $925 $1120.34 $285.80 Competitors $1,100 (6.0 cm2) to $2,200 $1120.34 $285.80 www.aedicell.com 2017 HOPD Medicare Reimbursement Example Graft coverage from 6.0 to 14 cm2 * Chasing CoPays to return < ≈20% of the bundle.
  16. 16. www.aedicell.com Bryan@DrKentner.com sales@DrKentner.com (215)696-3674 Reimbursement Consulting dvhotline@aedicell.com (877) 614-2355 AEDMKT-012

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