LifeCell Corporation

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LifeCell Corporation

• Branchburg, NJ
• www.lifecell.com
• 1994 Commercial introduction of AlloDerm
• gt 40,000 patients treated to date
• Currently 120 employees

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LifeCell Corporation Financials

• Operating Income
• 2001 (1.52M)
• 2002 1.40M
• 2003 2.08M

• 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

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One year performance vs. NASDAQ
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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

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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

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AlloDerm for grafting
Click to view actual size Product Code Size Thickness Thickness
      1000th/inch mm
(No image available) 101010 nonmeshed 7-20 0.18-0.50
                101510 premeshed 11 7-20 0.18-0.50
  Order by size (total cm2 required) Order by size (total cm2 required) Order by size (total cm2 required) Order by size (total cm2 required)
                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
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General Use of AlloDerm

• Scaffold for growth of new tissue
• Patients cells repopulate and lay down their
  matrix
• Vasculature grows in
• Graft becomes incorporated into surrounding
  tissue and is eventually indistinguishable from it

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AlloDerm Structure
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Day 1 Day 7-10
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Day 45 Day 90
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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

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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

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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

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2.5 years post-op
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Other Uses Currently Approved

• Plastic and Reconstructive Surgery
• some ethical issues
• Periodontal Surgery
• replaces gingiva rather than dermis

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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

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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

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Other Products

• Cymetra
• Powdered form of AlloDerm that can be
  administered by injection
• Plastic surgery applications - acne scar revision
• Incontinence treatment

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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

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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