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
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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
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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
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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. Exposed Surface Area Enables Cell Migration
cells/exudate
Amnion/Chorion
cells/exudate
Plurivest/Dermavest
“By far the easiest skin substitute to use”
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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
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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
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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.
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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
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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
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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
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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
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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. 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
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2017 HOPD Medicare Reimbursement Example
Graft coverage from 6.0 to 14 cm2
* Chasing CoPays to return < ≈20% of the bundle.
