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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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