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SPMP12289 REV B JUN 2018 AlloDerm TM Regenerative Tissue Matrix (RTM) LifeCell timeline Advancing surgery and improving patients’ lives For over two decades, LifeCell , an Allergan affiliate has developed innovative products for use in a wide range of applications. Our success could not have been possible without the insight and guidance of healthcare professionals. 1986 1994 1998 2000 2002 2004 2006 2008 2009 2010 2011 2012 LifeCell Corporation formed burn treatment AlloDerm TM RTM dental challenging hernia repair breast reconstruction Strattice RTM EU breast plastic surgery with Strattice RTM AlloDerm TM RTM for breast reconstruction available in bilateral pairs Strattice Reconstructive Tissue Matrix (RTM) AlloDerm TM RTM Ready to use Tissue recovery Independent, FDA Registered 3rd Party Tissue Recovery Partners (TRP) obtain consent for procurement of the tissue Comprehensive medical and social history screening meets FDA and AATB criteria Donor blood sample is tested and must be found negative for infectious diseases including HIV and Hepatitis B & C Tissue samples are screened for microbial contaminants and must be free of pathogenic bacteria Allergan medical directors determine donor eligibility per AATB standards and FDA regulations Patented acellular process Non-damaging steps designed to: Remove cells on surface of skin Remove cells deep in the dermal tissue Non-damaging freeze-drying: Process creates an amorphous ice that retains the structural integrity of the complex microarchitecture of the dermis 1 Non-destructive drying and packaging for storage During conventional freeze-drying, hexagonal ice crystals form, disrupting the normal architecture of this layer and rendering the damaged matrix susceptible to inflammation and rejection, because the hosts immune system regards the fragmented subunits as individual foreign bodies. 1 40x magnification, Verhoeff-van Geison (stain for elastin) LifeCell quality and processing Final AlloDerm TM RTM product No cells detected Although donor tissues are screened for infectious diseases, the LifeCell patented acellular dermal matrix processing demonstrates >99.9% viral reduction No microbial pathogens detected Intact matrix and critical biochemical components check the history and processing head and neck reconstruction more than 2.5 million grafts to date LifeCell patented freeze-drying did not alter the matrix Conventional freeze-drying altered the matrix 2016 ARTIA TM Reconstructive Tissue Matrix
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SPMP12289 REV B JUN 2018

AlloDermTM Regenerative Tissue Matrix (RTM)

LifeCell™ timeline Advancing surgery and improving patients’ livesFor over two decades, LifeCell™, an Allergan affiliate has developed innovative products for use in a wide range of applications. Our success could not have been possible without the insight and guidance of healthcare professionals.

1986 1994 1998 2000 2002 2004 2006 2008 2009 2010 2011 2012

LifeCellCorporation formed

burntreatment

AlloDermTM RTM

dental

challenginghernia repair

breastreconstruction

Strattice™ RTM EU

breast plasticsurgery with

Strattice™ RTM

AlloDermTM RTM for breast

reconstruction available in

bilateral pairs

Strattice™

ReconstructiveTissue Matrix (RTM)

AlloDermTM RTMReady to use

Tissue recovery• Independent, FDA Registered 3rd Party Tissue Recovery Partners (TRP) obtain consent for procurement of the tissue• Comprehensive medical and social history screening meets FDA and AATB criteria• Donor blood sample is tested and must be found negative for infectious diseases including HIV and Hepatitis B & C• Tissue samples are screened for microbial contaminants and must be free of pathogenic bacteria• Allergan medical directors determine donor eligibility per AATB standards and FDA regulations

Patented acellular processNon-damaging steps designed to:• Remove cells on surface of skin• Remove cells deep in the dermal tissue

Non-damaging freeze-drying:• Process creates an amorphous ice that retains the structural integrity of the complex microarchitecture of the dermis1

• Non-destructive drying and packaging for storage

During conventional freeze-drying, hexagonal ice crystals form, disrupting the normal architecture of this layer and rendering the damaged matrix susceptible to inflammation and rejection, because the hosts immune system regards the fragmented subunits as individual foreign bodies.1

40x magnification, Verhoeff-van Geison (stain for elastin)

LifeCell™ quality and processing

Final AlloDermTM RTM product• No cells detected• Although donor tissues are screened for infectious diseases, the LifeCell™ patented acellular dermal matrix processing demonstrates >99.9% viral reduction• No microbial pathogens detected• Intact matrix and critical biochemical components

check the history and processing

head and neckreconstruction more than

2.5 million grafts to date

LifeCell™ patented freeze-dryingdid not alter the matrix

Conventional freeze-drying altered the matrix

2016

ARTIATM Reconstructive Tissue Matrix

check the out of package histology

1) LH Holton, D Kim, RP Silverman, ED Rodriguez, N Singh, NH Goldberg. Human acellular dermal matrix for repair of abdominal wall defects: review of clinical experience and experimental data. Journal of Long-term Effects of Medical Implants. 2005; 15(5)547-558.

Puros® Dermis is a registered trademark of Zimmer Dental, Inc. Mucograft® is a registered trademark of Ed. Geistlich Sohne Ag Fur Chemische Industrie. PerioDerm® is a registered trademark of Dentsply International Inc. SPMP12289 REV B JUN 2018

AlloDermTM RTM Human Dermis (100x, H&E stained)

100 µm

Puros® Dermis Mucograft® (Non-human extracellular matrix)

100 µm 100 µm 100 µm

PerioDerm®

43

2

1) Intact basement membrane2) Papillary dermis3) Basket weave configuration4) Reticular dermis

1) Cells2) Epidermis3) Papillary dermis4) Reticular dermis5) Basement membrane

1

2

3

4

5

2

1

1 1

2

1) Modified basement membrane, no undulation2) Cellular remnants

1) No basement membrane2) Modified collagen bundle

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2

1

1

1

1

2

1) Separation between collagen bundles2) Cellular remnants

1

AlloDermTM Regenerative Tissue Matrix (RTM)


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