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Reveal the Inner you
Regenerate Beauty through Collagen Stimulation
C 60
C 100
M 00
M 66
J 6
J 0
N 0
N 0
pantone 2985 C
pantone 286 C
2
Bone
reso
rptio
n
& rem
odeli
ng Fat loss
& redistribution
Dermal ageing
collagen lossM
uscle
tone
and at
rophy
• Facial muscles become more tensed and atrophic
• Contribute to facial sagging and droopiness
• Fat pads displacement
AGE
• Signifi cant loss of facial bone with age4
• Leads to biometric volume loss2-4
• Noticeable changes in the other layers of overlying soft tissue and skin1,3
• Fat pads loss and/or migration under muscular action leading to deep creases and contour defects1-6
• Accumulation of fat in some areas (e.g. under the lower eyelid, jaw, mouth) leading to the impression of permanent puffi ness
FACIAL AGEING PROCESS
BONE RESORPTION & REMODELLING
MUSCLE TONE & ATROPHY
FAT LOSS & REDISTRIBUTION
Facial ageing is a multifactorial process that affects different layers.
3
As the ageing skin loses its structural proteins (collagen and elastin), it becomes more lax and begins to sag, which contributes to a tired and aged look.
COLLAGEN MODIFICATIONS WITH AGEING
•Decrease in the level of collagen
• Changes in histological characteristics (collagen fi bres distribution)
• Changes in ultrastructure (collagen network disorganisation)
• Fragmentation of fi brils, fi broblast can no longer bind
COLLAGEN IN YOUTHFUL SKIN
DERMAL AGEING & COLLAGEN LOSS
COLLAGEN IN AGEING SKIN
CollagenProvides infrastructure forelastin and hyaluronic acid
ElastinHelps the skin retain its elasticity
Hyaluronic AcidWater binds to hyaluronic acid, keeping the skin moist
Well structured collagennetwork7
EPIDERMIS
DERMIS
SUBCUTANEOUSLAYER
Collagen networkdisorganisation7
DecreasedCollagen
DecreasedHyaluronic Acid
DecreasedElastin
EPIDERMIS
DERMIS
SUBCUTANEOUSLAYER
4
• Totally smooth polycaprolactone (PCL) microspheres 25-50 μm
• PBS*-based carboxymethylcellulose (CMC) gel-carrier
• Excellent safety profile and largely used in bioresorbable implants (sutures and orthopaedic implants dermal fillers, oral and maxillo-facial surgery) for several decades worldwide
• Used in numerous European (CE-certified) and US Food and Drug Administration (FDA) approved commercial bioresorbable products in cosmetic and pharmaceutical industries
Totally smooth polycaprolactone (PCL)
PCL microspheres homogenously suspended in a PBS*-based
carboxymethylcellulose CMC gel-carrier
STAT TM
Technology
Sustained Performance, Tunable Longevity and Total Bioresorbability
•Maintained correction over total duration of effect through one single injection •Different levels of action depending on patients' needs •Fully resorbable treatment with a predictable, controlled and tunable bioresorption and a high safety profile
PCL30% 70%
CMCGel carrier
PBS: Phosphate Buffered Saline
PCL & CMC
STATTM TECHNOLOGY: A unique manufacturing process with several benefits
THESE 3 FEATURES GIVE ELLANSÉTM UNIQUE ADVANTAGES
COMPOSITION
ELLANSÉTM: A TAILOR-MADE BIORESORBABLE COLLAGEN STIMULATOR8
5
ELLANSÉTM is an injectable implant, indicated for subdermal implantation in the face for the lasting correction of wrinkles and other facial ageing signs or conditions.
•Medical Device Class III8
•CE mark obtained in 2009 •Distributed in more than 80 countries
ELLANSÉTM comes in ready-to-use syringes: •2 x 1 ml syringes of ELLANSÉTM with 4 x 27G 3/4" needles •2 x 0.5 ml syringes of ELLANSÉTM with 4 x 27G 3/4" needles
ELLANSÉTM is available in 2 options -S and -M, that differ only in their duration of action. All the other product characteristics are identical for the entire product range.
CE MARK INDICATION
ELLANSÉTM: A TAILOR-MADE BIORESORBABLE COLLAGEN STIMULATOR8
6
MECHANISM OF ACTION9
2-in-1 actionImmediate fi lling
• CMC gel provides the immediate fi lling & wrinkle correction
Long-lasting volumisation through collagen stimulation
• PCL microspheres stimulate neocollagenesis
Before treatment When ELLANSÉTM is injected subcutaneously CMCgel provides immediate results
CMC gel is resorbed and PCL microspheres remain
PCL microspheres stimulate fi broblasts to produce new collagen
Overtime PCL microspheres are bioresorbed
Smooth and natural correction maintained throughout total duration of effect
1
3
5
2
4
6CMC: Carboxymethylcellulose; PCL: Polycaprolactone
7
PREDICTABLE AND CONTROLLED TOTAL BIORESORBABILITY10-13
Thanks to state-of-the art STATTM Technology : • Initial length of the PCL chains is the uniquely distinguishing characteristic of ELLANSÉTM
• Varying the length of the PCL chains is the basis of the different levels of longevity options which differ from 1 to 2 years* that you can adapt to your patient needs and expectations
• Fully resorbable product via hydrolysis
* Expected longevity in-vivo based on extrapolation of clinical data from –S and –M and accepted PCL degradation behaviour.
PCL chainsPCL microspheres
MECHANISM OF ACTION9
MICROSPHERES SIZE: 25-50 μm for the whole range
ELLANSÉTM provides an effect of different durations from 1 to 2 years*.
At injection Chain Scission Total BioresorptionBioresorption
1 YearELLANSÉTM -S
At injection Chain Scission Total BioresorptionBioresorption
2 YearsELLANSÉTM -M
PCL: Polycaprolactone
8
AREAS OF TREATMENT: ELLANSÉ™ RANGE
Sustained volumising capacity through collagen stimulation for natural and long-lasting results from 1 to 2 years*, ideal for volume restoration and contour defi nition.
Depth of InjectionELLANSÉTM is indicated for sub-dermal injections. For further injection techniques please refer to the ELLANSÉTM Injection Technique Guidelines (available upon request).Due to its cohesiveness, ELLANSÉTM is easy to shape and mold, enabling higher precision in the shaping and defi nition of treated areas.
Temples and Brow Area
Malar Augmentation Cheek
Cheek
Nasolabial Folds
Jaw Line
Nose Reshaping
Marionette Lines
Chin Defi nition
ELLANSÉTM
TREATMENT AREAS WHERE ELLANSÉTM -S and -M
NB: Glabella, lips, tear trough and eyelids are not recommended for the use of ELLANSÉTM
* Expected longevity in-vivo based on extrapolation of clinical data from –S and –M and accepted PCL degradation behaviour.
DERMIS
EPIDERMIS
SUB-DERMALTISSUE
PCL: Polycaprolactone
9
PROVEN NEOCOLLAGENESIS INDUCED BY ELLANSÉTM
13 months after ELLANSÉTM -M injection, PCL microspheres were surrounded with collagen deposition and a mild fi broblastic and histiocytic tissue response. Stainings were Haematoxylin & Eosin (A and B) and Martin-s Trichrome (C and D)
In rabbit tissue9
In human tissue14
ELLANSÉTM -M: 9 months post injection (rabbit) Haematoxylin & Eosin staining shows:Microspheres still round and intact during bioresorption processCollagen fi bres are stained red
ELLANSÉTM -M: 9 months post injection (rabbit) Picro Sirius Red (PSR), Polarised light shows:Red (arrows): collagen type IGreen (arrowheads): collagen type IIIConfi rmation of neocollagenesis
ELLANSÉTM -M: 21 months post injection (rabbit) Picro Sirius Staining, Polarised light shows :Red colour confi rming predominant presence of collagen type IType I collagen confi rms stable environment and long-term effi cacy
PCL: Polycaprolactone
10
ELLANSÉ™ offers clear advantages over the NASHA based dermal filler, both in terms of durability and efficiency15
PROVEN EFFICACY & SAFETY
High efficacy of ELLANSÉ™ - S and ELLANSÉ™ - M in nasolabial folds treatment with high safety over a 2 years period10
Investigator Evaluated Aesthetic Global Improvement Scale GAIS
Comparative clinical study of ELLANSÉ™ vs a NASHA hyaluronic acid for treatment of nasolabial folds15
Patie
nts
% w
ith Im
prov
emen
t
Patie
nts
% w
ith Im
prov
emen
t
ELLANSÉ™ -S
months months
3 6 9 12 15 18 24 3 6 9 12 15 18 24
ELLANSÉ™ -M
Of patients with at least improved results at 12 months
Improved Much Improved Very Much Improved
Of patients with at least improved results at 24 months
90%100%
100%
90%
80%
70%
60%
50%
40%
30%
20%
10%
0%
100%
90%
80%
70%
60%
50%
40%
30%
20%
10%
0%
35%
55%
10%
40% 45%
78%
11%
11%10%
20%
15%
20%10%
60%
45%
35%
45%
3,5%
51,7%
13,8%
62,8%
27,6%25,9%41,4%
50% 71%58%
50%
23%
77%
6%
44%31%
14%
7% 4%
5,2%
Improved Much Improved Very Much Improved
PCL: Polycaprolactone; HA: Hyaluronic acid
11
HIGH SAFETY PROFILE OF ELLANSÉ™
The unique smooth and spherical shape of ELLANSÉ™ microspheres :
• Is the basis for optimal biocompatibility as rough surfaces and irregular shaped microspheres have the propensity to induce adverse events, such as nodules, and result in decreased collagen deposition16-20
•Provide a safe, long-lasting and high quality tissue scaffold
SAFE PRODUCT COMPONENTS WITH A LONG SAFETY HISTORY
Perfectly Smooth
SEM Picture
Totally Spherical Microparticles
Light Microscopy Picture
High Quality Scaffold
Light Microscopy: Histology 2-weeks post intradermal injection
•Long-term and total bioresorption of ELLANSÉTM components through the normal metabolic pathways well documented
•PCL microspheres bioresorption demonstrated via radio-labeled bioresorption studies
of patients like to repeat ELLANSÉTM - S treatment
of patients like to repeat ELLANSÉTM - M treatment
•Total biocompatibility demonstrated via tests according to the ISO-10993 biocompatibility standard • 2-weeks implantation data clearly show the particles well-embedded in a healthy tissue environment and demonstrate excellent local tolerance
•In-house in-vitro resorption study of ELLANSÉTM Range PCL microspheres consistent with published literature data
SHORT-TERM SAFETY: Pre-Clinical Data7
IN-VITRO
LONG-TERM SAFETY: Scientific Evidence and Literature10, 13
HIGH PATIENT SATISFACTION10
ELLANSÉ™ -S & -M: Satisfaction using Visual Analogue Scale (VAS)15
75%
78%
At 24 months post-injection :Patient Satisfaction with ELLANSÉTM Treatment (mean)
Patient Satisfaction
Satisfaction 74% 81.7%
ELLANSÉTM- S12 Months
ELLANSÉTM- M24 Months
PCL: Polycaprolactone
12
ELLANSÉ™ ABILITY TO REGENERATE BEAUTY
ELLANSÉ™ -S Nasolabial Folds
ELLANSÉ™ -S Nasolabial Folds
ELLANSÉ™ -M Nasolabial Folds
After 12 Months
Courtesy of Marion Moers-Carpi, MD, Germany
Before Treatment
Courtesy of Marion Moers-Carpi, MD, Germany
After 24 MonthsBefore Treatment
Courtesy of Marion Moers-Carpi, MD, Germany
After 12 MonthsBefore Treatment
13
Courtesy of Ayham Al-Ayoubi, MD, London, UK
Before Treatment After Treatment
Before Treatment After 3 Weeks
Courtesy of Dr. Fab Equizi, Liverpool, UK
Before Treatment After 2 Months
Courtesy of Alida Harb, MD, Riyadh, Saudi-Arabia
ELLANSÉ™ -M Nose Reshaping
ELLANSÉ™ -M Nasolabial Folds, Cheeks and Marionette Lines
ELLANSÉ™ -M Cheeks and Submalar Augmentation
14
REFERENCES
1. Nicolau PJ, et al. Neocollagenesis after injection of a polycaprolactone based dermal fi ller in a rabbit. Eur J Aesth Med Dermatol 2013;3(1):19-26.
2. Moers-Carpi MM, et al. Polycaprolactone for the Correction of Nasolabial Folds: A 24-Month, Prospective, Randomized, Controlled Clinical Trial. Dermatol Surg 2013;39:457-463.
3. Murphy MR, et al. The ageing face consultation. In: Master Techniques in Facial Rejuvenation. Elsevier 2006;1-16.
4. Coleman SR, et al. The anatomy of the ageing face: volume loss and changes in 3-dimensional topography. Aesthet Surg J 2006;26(suppl 1):S4-S9.
5. Zimbler MS, et al. Anatomy and pathophysiology of facial ageing. Facial Plast Surg Clin North Am 2001;9:179-187.
6. Vleggaar D, et al. Dermatological implications of skeletal ageing: a focus on supraperiosteal volumization for perioral rejuvenation. J Drugs Dermatol 2008;7:209-220.
7. Le Louarn C. Botulinum toxin and the Face Recurve® concept: decreasing resting tone and muscular regeneration. Ann Chir Plast Esth 2007;52:165-176.
8. Donofrio LM. Fat distribution: a morphologic study of the ageing face. Dermatol Surg 2000;26:1107-1111.
9. Valenga Baroni, et al. Infl uence of ageing on the quality of the skin of white women- the role of collagen. Acta cirurgica Brasileira 2012; 27: 736-740
10. CE mark-Technical dossier (Whitepaper W113.05).
11. Pitt CG. Aliphatic polyesters II The degradation of Poly (DL-lactide), poly (ε-caprolactone), and their copolymers in vivo. Biomaterials 1981;2:215-220.
12. Varani J. Decrease collagen production in chronologically aged skin. Am J Pathol 2006;168: 1861-1868.
13. Woodruff MA, et al. The return of a forgotten polymer: polycaprolactone in the 21st century. Prog Polym Sci 2010;35(10):1217-1256.
14. Kim, et al. Neocollagenesis in human tissue injected with a polycaprolactone-based dermal fi ller. Journal of Cosmetic and Laser Therapy, 2014; Early Online: 1-3.
15. Galadari, et al. A randomized, prospective, blinded, split face, single center study comparing polycaprolactone to hyaluronic acid for treatment of nasolabial folds. The Journal of Cosmetic Dermatology.
16. Laeschke K. Biocompatibility of microparticles into soft tissue fi llers. Semin Cutan Med Surg 2004; 23(4):214-217.
17. Morhenn VB, et al. Phagocytosis of different particulate dermal fi ller substances by human macrophages and skin cells. Dermatol Surg 2002;28(6):484-490.
18. Anderson JM. Mechanism of infl ammation and infection with implanted devices. Cardiovasc Pathol 1993;2:33S-41S.
19. Matlage BF, et al. Tissue response to implanted polymers: The signifi cance of sample shape. J Biomed Meter Res 1976;10:391-397.
20. Nicolau PJ. Long-Lasting and permanent fi llers: Biomaterials infl uence over host response. Plast Reconstr Surg 2007;119:2271-2286.
15
REFERENCES
B&
A C
AS
ES
SINCLAIR is a pharmaceutical company with a renowned strong skin expertise:
• Provides best in class treatments in aesthetics to further support physicians in
their practice thanks to unique treatments to answer all patient needs at all
ages through minimally invasive procedures.
• Is dedicated to offering safe and effective solutions to achieve optimal results
with limited downtime.
• SINCLAIR treatments respect skin's own natural processes and contribute to
maintain the skin in good condition and to rejuvenate the face at all ages.
SINCLAIR COMMITMENT
Unique products
portfolio based on
physician and
patient needs
High quality training
program based on
physician practice
and expectations
Create added value in your daily practice
Optimi e aesthetics outcome to increase
your patients satisfaction
s
16
Reveal the Inner you
Easy to inject Immediate correction Sustained volumising capacity
through collagen stimulation9 Maintained correction
over total duration of effect
Easy to hold Long-lasting effect from 1 to 2 years*
Natural results from patients own collagen stimulation
High level of patient satisfaction10
* Expected longevity in-vivo based on extrapolation of clinical data from –S and –M and accepted Polycaprolactone (PCL) degradation behaviour.
Genop Healthcare (Pty) Ltd. PO Box 3911, Halfway House, 1685, South Africa.Co. Reg.No.: 1984/011575/07. www.genop.co.za. 02/2016/NS/60.