This document discusses dermal fillers for facial rejuvenation. It presents information on EVOLENCE, a collagen-based dermal filler, including its benefits, composition, and safety profile. EVOLENCE uses collagen and Glymatrix technology to provide natural, long-lasting results of at least 12 months. Clinical studies demonstrated its safety, with no reported allergic reactions among over 30,000 injections. Histological examinations on rabbits found EVOLENCE remained intact for 24 months without degradation.

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Before & After Pictures
Case Studies

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Nasolabial Folds:Nasolabial Folds:
Before & Immediately After InjectionBefore & Immediately After Injection
Before After

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What Is the Ideal Filler?What Is the Ideal Filler?
Medical Point of ViewMedical Point of View
 Natural,Natural,
predictable resultspredictable results
 Minimal downtime/Minimal downtime/
immediate effectsimmediate effects
 Cost effectiveCost effective
 SafeSafe
 Long-lasting, butLong-lasting, but
also biodegradablealso biodegradable
Consumer Point of ViewConsumer Point of View
 Natural lookNatural look
 Instant gratificationInstant gratification
—lunch time—lunch time
procedure;procedure;
no/minimalno/minimal
downtimedowntime
 SafeSafe
 Long-lasting butLong-lasting but

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True Beauty, All Year LongTrue Beauty, All Year Long
EVOLENCEEVOLENCE
 True results – the benefit of collagenTrue results – the benefit of collagen
 True duration - Glymatrix™ technologyTrue duration - Glymatrix™ technology
provides results that last at least 12provides results that last at least 12
monthsmonths
 True science – Johnson & JohnsonTrue science – Johnson & Johnson
leadershipleadership

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 Indicated for the correction of soft tissueIndicated for the correction of soft tissue
contour deficiencies or deformitiescontour deficiencies or deformities
 Pre filled syringes of 1ml and 0,5mlPre filled syringes of 1ml and 0,5ml
 Storage at Room temperatureStorage at Room temperature
 EVOLENCE – 27G needleEVOLENCE – 27G needle
 EVOLENCE Breeze – 30G needleEVOLENCE Breeze – 30G needle
EVOLENCE & BreezeEVOLENCE & Breeze
1,2 : Data on file, Colbar lifescience

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Why collagen?Why collagen?
Collagen characteristics:Collagen characteristics:
 Collagen is the key structural biomaterialCollagen is the key structural biomaterial
 Collagen makes 70-80% of the dermisCollagen makes 70-80% of the dermis11
 Collagen is non-hydrophillicCollagen is non-hydrophillic
Collagen benefits:Collagen benefits:
 Predictable & natural resultsPredictable & natural results
 No need for touch up or over fillNo need for touch up or over fill
 Less edema, erythema, bruisingLess edema, erythema, bruising
 Ideal for modeling and sculpturingIdeal for modeling and sculpturing

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Why Porcine source?Why Porcine source?
 Provide the benefits of collagenProvide the benefits of collagen
 Extremely low immunogenicityExtremely low immunogenicity
 Closest to human collagenClosest to human collagen
 Well documented as safe biomaterial inWell documented as safe biomaterial in
medical devices and proceduresmedical devices and procedures

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Why Glymatrix technology?Why Glymatrix technology?
 True duration – at least 12 monthsTrue duration – at least 12 months
 Natural materials only – Collagen andNatural materials only – Collagen and
sugarsugar
 Same process as the natural glycation inSame process as the natural glycation in
the dermisthe dermis
 No toxicicity (different to BDDE andNo toxicicity (different to BDDE and

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EVOLENCEEVOLENCE DurationDuration
 Pre clinical study - Intracutaneous injections of EVOLENCE 30 intoPre clinical study - Intracutaneous injections of EVOLENCE 30 into
the dermisthe dermis
of the ears of 14 New Zealand rabbits in comparison with Zyplastof the ears of 14 New Zealand rabbits in comparison with Zyplast®®
and Zydermand Zyderm®®
. Histopathological examination indicated that. Histopathological examination indicated that
EVOLENCE is safe with no evidence of degradation at 1, 6, 12, andEVOLENCE is safe with no evidence of degradation at 1, 6, 12, and
24 months.24 months.
EVOLENCEEVOLENCE ZyplastZyplast®®
ZydermZyderm®®
1 Month1 Month
6 Months6 Months
1212
MonthsMonths
2424
MonthsMonths

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PT – Immediately after second treatment.
Baseline – 2 weeks after second treatment.
Clinical StudiesClinical Studies
EVOLENCE DurationEVOLENCE Duration
Randomized controlled study, intra individual comparison
Accepted for publication in Plastic & Reconstructive
Surgery,2007

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EVOLENCE BiocompatibilityEVOLENCE Biocompatibility
Indications ofIndications of
suitability andsuitability and
biocompatibility:biocompatibility:
 ResemblingResembling
staining patternstaining pattern
 One continuousOne continuous
main bulkmain bulk
 Integration ofIntegration of
fibroblastsfibroblasts
 No signs ofNo signs of
Pre clinical study - EVOLENCE
implant after 1 month (H&E)

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VascularizatiVascularizati
onon
FibroblastFibroblast
ss
EVOLENCE biocompatibilityEVOLENCE biocompatibility
Enlarged Histology ImageEnlarged Histology Image
Preclinical Study

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Hyaluronic Acid histologyHyaluronic Acid histology
Different histologicalDifferent histological
structure:structure:
 FenestratedFenestrated
appearanceappearance
 Clear interfaceClear interface
boundaryboundary
 no fibroblastsno fibroblasts
within HAwithin HA
Preclinical study - Hyaluronic acid
dermal implant after 1 month (H&E)

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EVOLENCE SafetyEVOLENCE Safety
 More than 700 patients injected withMore than 700 patients injected with
Evolence in clinical studies and post clinicalEvolence in clinical studies and post clinical
surveillance and followed up (for up to 2surveillance and followed up (for up to 2
years) : ZERO allergic reactionyears) : ZERO allergic reaction
 More than 30.000 syringes injectedMore than 30.000 syringes injected
worldwide : ZERO related hypersensitivityworldwide : ZERO related hypersensitivity
reportedreported
 More than 150.000 people received OSSIXMore than 150.000 people received OSSIX
( dental implant with collagen and glymatrix( dental implant with collagen and glymatrix
technology): No allergic reactiontechnology): No allergic reaction

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EVOLENCE SafetyEVOLENCE Safety
 Recently finished study in the US:Recently finished study in the US:
Two sequential skin testsTwo sequential skin tests
530 subjects injected530 subjects injected
No positive hypersensitivity response duringNo positive hypersensitivity response during
the study periodthe study period
No antibody elevationNo antibody elevation
 These results indicate thatThese results indicate that a skin testa skin test
before treatment with EVOLENCEbefore treatment with EVOLENCE
implant is not warrantedimplant is not warranted

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1.DeLustro, F., S.T. Smith, J. Sundsmo, G. Salem, S. Kincaid, and L. Ellingsworth.
Reaction to injectable collagen: results in animal models and clinical use. Plast.
Reconstr. Surg. 79:581-592, 1987.
2.1case out of 438 patients. Ref.: Lowe, N.J., C.A. Maxwell, P.L. Lowe, et al. Hyaluronic
acid skin fillers: adverse reactions and skin testing. J. Am. Acad. Dermatol. 45:930-3,
2001.
3.2cases out of 271 patients. Ref.: Lowe, N.J. Temporary dermal fillers- European
experiences. In Textbook of Facial Rejuvanation, chapter 16, pgs. 177-188.
4.Evolence Skin Test Study USA. 0 patients out of 530 patients. Upperbound rate of
0.58%. Data on file. ColBar LifeScience
1 2,32,3 4
Hypersensitivity Rate in Dermal Fillers
0.00%
1.00%
2.00%
3.00%
4.00%
5.00%
Skin test rate 3.00% 0.00% 0.00% 0.00%
Rate to treatment 1.30% 0.23% 0.74% 0.58%
Zyderm Hylaform Restylane Evolence1 2,3 2,3 4

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