Orcel vs apligraf v4
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Transcript of Orcel vs apligraf v4
Comparisons Between OrCel and Apligraf
Comparative Histological ProfilesComparative Histological Profiles
Apligraf OrCel
Fully Differentiated andStratified Keratinocytes
Partially Differentiated, Non-Stratified “Wound Healing”
(Migrating & Replicating) Keratinocytes
Low Density Dermal Fibroblasts, Many Undergoing Apoptosis
Medium Density, Vigorously Growing Dermal Fibroblasts
(15% “Dividing” Cells)
In Vitro expression of KGF and GMCSF by cultured LSE and ORCEL
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1000
1000000
KGF GM-CSF
Cyt
oki
ne
Ou
tpu
t P
er u
nit
Are
a, p
g/c
m2/
day LSE
ORCEL
Living Skin Equivalent (LSE) is a generic name for Apligraf
Output, OrCel vs. Apligraf
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1000
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100000
bFGF GM-CSF HGF KGF-1 VEGF IL-1a MMP-9 PGE-2
Cyt
oki
ne
Pro
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ity,
pg
/cm
2 /d
ay
OrCel Apligraf
Pro-mitotic Pro-Inflammatory
OrCel in Donor Site Healing(Independent Physician Evaluation:
Donor Site Treated with both OrCel & Apligraf)
OrCel
ApligrafOrCel: Faster healing, less inflammation
Days to100% Healing
(Median)
OrCel
Standard of Care
DONOR SITESDONOR SITES
Pivotal: 2/01
Based on Photography
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2222 Days
15 Days
PMA Claims
•Accelerated healing
•Less Scarring
•Reduced time to recropping
OrCel OrCel ™™ Heals Heals Wounds FasterWounds Faster
47%
23%
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60
Diabetic Foot Ulcers Pilot Trial
% of Patients Achieving 100% Wound Closure
By 12 Weeks
OrCel
OrCel
Standard of Care
Standard Of Care
Summary of OrCel® vs. Apligraf® FeaturesFeature OrCel® Apligraf®
Shape/Size Square 6.5 x 6.5 x 0.09 cm (42 cm2) Round 75mm diam x 0.75mm (44cm2)
Matrix Preformed porous cross-linked bovine collagen sponge, very pliant
Contracted, dense, stiff bovine collagen gel
Keratinocytes (K) Immature mono-/bilayer (submerged culture condition)
Stratified multilayer (air interface culture condition)
Fibroblasts (F) Healthy vigorously dividing Dormant or apoptotic
Cell type ratio Nominal ~90% F ~10% K Nominal ~30% F ~70% K
Cytokine profile F (& F/K co-culture) dominated; activated “wound healing” profile
K (& F/K co-culture) dominated; normal skin steady state dormant profile
Ease of use Semi-auto thaw/rinse (~20 min) & direct application
Remove from dish, cut to size, fenestrate (~20 min)
Shelf life 7 mo (clin. trial); expect 12 – 18 mo 10 days in sealed pkg.
Current reimbursement
$1,100./42 cm2 $1,200/44 cm2
Summary: OrCel® vs. Apligraf® Data
• Pilot ORCEL (fresh) VLU trial data achieved closure in 12 weeks (59% vs. 36%) comparable to adjusted (Cox) Apligraf results at 6 months (56.8% vs. 39.8%); pivotal ORCEL (cryopreserved) clinical data are similar (50% vs. 31%).
• Pilot ORCEL DFU trial data achieve results within 12 weeks (47% vs. 23%) comparable to Apligraf (56% vs. 39%) at 12 weeks (SOC differed)
• ORCEL is easier to apply• ORCEL, since cryopreserved, has far superior shelf life (7-
12 months+ (projected) vs. 10 days) and can also be stored at the clinical site for “off-the-shelf” availability