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Before & After PicturesCase Studies

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Nasolabial Folds:Nasolabial Folds: Before & Immediately After Injection Before & 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, predictable Natural, predictable resultsresults

Minimal downtime/ Minimal downtime/ immediate effectsimmediate effects

Cost effectiveCost effective SafeSafe Long-lasting, but also Long-lasting, but also

biodegradablebiodegradable BiocompatibleBiocompatible

Consumer Point of ViewConsumer Point of View

Natural lookNatural look Instant gratificationInstant gratification

—lunch time —lunch time procedure; procedure; no/minimal no/minimal downtimedowntime

SafeSafe Long-lasting butLong-lasting but

non-permanent non-permanent cosmetic effectcosmetic effect

No pre-testNo pre-test

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True Beauty, All Year LongTrue Beauty, All Year LongEVOLENCEEVOLENCE True results – the benefit of collagen True results – the benefit of collagen True duration - Glymatrix™ technology True duration - Glymatrix™ technology

provides results that last at least 12 provides results that last at least 12 monthsmonths

True science – Johnson & Johnson True science – Johnson & Johnson leadershipleadership

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Indicated for the correction of soft tissue Indicated 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 in Well 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 and sugarNatural materials only – Collagen and sugar

Same process as the natural glycation in the Same process as the natural glycation in the dermisdermis

No toxicicity (different to BDDE and No toxicicity (different to BDDE and Glutaraldehyde)Glutaraldehyde)

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EVOLENCEEVOLENCE DurationDuration Pre clinical study - Intracutaneous injections of EVOLENCE 30 into the Pre clinical study - Intracutaneous injections of EVOLENCE 30 into the

dermis 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 EVOLENCE . Histopathological examination indicated that EVOLENCE is safe with no evidence of degradation at 1, 6, 12, and 24 months.is safe with no evidence of degradation at 1, 6, 12, and 24 months.

EVOLENCEEVOLENCE ZyplastZyplast®® ZydermZyderm®®

1 Month1 Month

6 Months6 Months

12 12 MonthsMonths

24 24 MonthsMonths

04/11/2304/11/23 1212N= 12 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,2007Monstrey et al

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EVOLENCE BiocompatibilityEVOLENCE Biocompatibility

Indications of suitability Indications of suitability and biocompatibility:and biocompatibility:

Resembling staining Resembling staining pattern pattern

One continuous One continuous main bulkmain bulk

Integration of Integration of fibroblasts fibroblasts

No signs of No signs of encapsulation encapsulation

Pre clinical study - EVOLENCE implant after 1 month (H&E)

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VascularizatiVascularizationon

FibroblastFibroblastss

EVOLENCE biocompatibility EVOLENCE biocompatibility Enlarged Histology ImageEnlarged Histology Image

Preclinical Study

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Hyaluronic Acid histologyHyaluronic Acid histology

Different histological Different histological structure: structure:

Fenestrated Fenestrated appearanceappearance

Clear interface Clear interface boundary boundary

no fibroblasts no 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 with More than 700 patients injected with

Evolence in clinical studies and post clinical Evolence in clinical studies and post clinical surveillance and followed up (for up to 2 surveillance and followed up (for up to 2 years) : ZERO allergic reactionyears) : ZERO allergic reaction

More than 30.000 syringes injected worldwide More than 30.000 syringes injected worldwide : ZERO related hypersensitivity reported : ZERO related hypersensitivity reported

More than 150.000 people received OSSIX More 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 during the No positive hypersensitivity response during the study periodstudy period

No antibody elevation No antibody elevation

These results indicate that These results indicate that a skin test before a skin test before treatment with EVOLENCE implant is not treatment with EVOLENCE implant is not warrantedwarranted

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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 .1 case 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 .2 cases 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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