Transcript Traditional Biomaterials - Rose

LifeCell Corporation
• Branchburg, NJ
• www.lifecell.com
• 1994: Commercial introduction of
AlloDerm®
• > 40,000 patients treated to date
• Currently ~120 employees
LifeCell Corporation Financials
 Product sales
•
•
•
2001: $26.6M
2002: $24.3M
2003: $28.0M
 Stock price:
•
•
•
•
6/30/99: $4.125
3/00: $12.62
4/01: $1.25
4/1/03: $8.50
 Operating Income
•
•
•
2001: ($1.52M)
2002: $1.40M
2003: $2.08M
One year performance vs. NASDAQ
AlloDerm® Tissue Processing
Technology
• Begin with donated skin purchased
from tissue banks
• Processing to remove epidermis (12
hours in 1 M NaCl)
• Processing to remove all cellular
components (1 hour in 0.5% SDS)
 eliminates the immune response in the
patient
AlloDerm® Tissue Processing
Technology
• Result: matrix of collagen, elastin,
intact basement membrane,
glycosaminoglycans (proteins)
• Matrix is then freeze-dried without
damaging the matrix protein
structure
 cryoprotectant: dextran, sucrose,
raffinose
AlloDerm® for grafting
Click to view
actual
size
Product Code
Size
Thickness
1000 /inch
mm
th
(No image available)
101010
nonmeshed*
7-20
0.18-0.50
101510
premeshed* 1:1
7-20
0.18-0.50
*Order by size (total cm required)
2
102009
2 cm × 4 cm
6-12
0.17-0.29
102010
2 cm × 4 cm
13-24
0.18-0.62
102020
3 cm × 7 cm
20-29
0.50-0.73
102025
4 cm × 5 cm
7-24
0.18-0.62
General Use of AlloDerm®
• Scaffold for growth of new tissue
• Patient’s cells repopulate and lay
down their matrix
• Vasculature grows in
• Graft becomes incorporated into
surrounding tissue and is eventually
indistinguishable from it
AlloDerm® Structure
Day 1
Day 7-10
Day 45
Day 90
Third Degree Burn Treatment
• Dermis is damaged (does not
normally regenerate - is replaced with
scar tissue)
• Standard treatment - full thickness
graft from unburned part of body
(often meshed)
• Creates donor site wound that is as
bad as (or worse than) the burn site
Burn Treatment with AlloDerm®
• Use AlloDerm® in place of full
thickness graft
• Still requires an ultra-thin autograft
(epidermis only) from the patient
 0.006” vs. 0.014”
Results with AlloDerm®
• Over time, graft is repopulated with
cells and blood vessels and becomes
part of surrounding skin
• Excellent cosmetic appearance
• Excellent range of motion - used
especially at joints
2.5 years post-op
Other Uses Currently Approved
• Plastic and Reconstructive Surgery
o
some ethical issues
• Periodontal Surgery
o
replaces gingiva rather than dermis
Regulatory Status
• Considered by FDA to be a banked
human tissue - not regulated by FDA
• Regulated by AATB - much easier
• Some new applications are being
considered devices by FDA - these
will be regulated
Other Products
• Repliform™ in urogynecology
• Incontinence treatment
• Bladder sling - lift and support the
neck of the bladder and provide
urethral support
• Pelvic floor reconstruction
• Partnership with Boston Scientific
• HUGE Market
Other Products
• Cymetra™
• Powdered form of AlloDerm® that
can be administered by injection
• Plastic surgery applications - acne
scar revision
• Incontinence treatment
Near Future Products
• Vascular grafts
• Treat harvested arteries using the
AlloDerm® process - develop an
acellular, freeze-dried tissue tube
• Used in coronary artery bypass surgery
replacing autografts (from leg veins)
• In large animal study phase (looks
good)
• HUGE market - no good alternative
Partnerships
• Wright Medical Technologies
-
Graft Jacket
Repair or replacement of damaged or
inadequate periosteum
Also for diabetic foot ulcers
• Stryker Corporation
-
AlloCraft DBM
Bone graft