Ellansé Physicians Brochure

Regenerate BeautyThrough Collagen Stimulation

W288.01

W288.02-ELLANSE Physicians Brochure_vA01.indd 1 2/02/2016 10:42 am

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Bone

resorptio

n

& remod

eling Fat loss

& redistribution

Dermal aging

collagen lossMus

cle to

ne

and atroph

y

Facial aging is a multifactorial process that affects different layers.

Muscle Tone & Atrophy

• Facial muscles become more tensed and atrophic

• Contribute to facial sagging and droopiness

• Fat pads displacement

Bone Resorption & Remodeling

AGE

• Significant 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 Loss & Redistribution

• 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 puffiness

Facial Aging Process


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Dermal Aging & Collagen Loss

As the aging 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 Aging

• Decrease in the level of collagen

• Changes in histological characteristics (collagen fibers distribution)

• Changes in ultrastructure (collagen network disorganization)

• Fragmentation of fibrils, fibroblast can no longer bind

Collagen in youthful skin

EPIDERMIS

DERMIS

SUBCUTANEOUSLAYER

CollagenProvides infrastructure for elastin and hyaluronic acid

ElastinHelps the skin retain its elasticity

Hyaluronic AcidWater binds to hyaluronic acid, keeping the skin moist

Well structured collagennetwork7

Collagen loss in aging skin

DERMIS

SUBCUTANEOUSLAYER

EPIDERMIS

Collagen networkdisorganization7

Decreased Collagen

Decreased Hyaluronic Acid

Decreased Elastin


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ELLANSÉTM : A tailor-made bioresorbable collagen stimulator8

Composition

• Totally smooth polycaprolactone (PCL) microspheres 25-50 μm

• PBS*-based carboxymethylcellulose (CMC) gel-carrier

PCL & CMC

• Excellent safety profile and largely used in bioresorbable implants (sutures and orthopedic 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

STATTM Technology : A Unique Manufacturing Process with Several Benefits

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

These 3 features give ELLANSÉTM unique advantages

PCL

30% 70%

CMCGel carrier

*(Phosphate Buffered Saline)


5

ELLANSÉTM is an injectable implant, indicated for sub-dermal implantation, for the lasting correction of wrinkles and other connective tissue imperfections 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 4 options -S, -M, -L and -E that differ only in their duration of action. All the other product characteristics are identical for the entire product range.

CE Mark Indication


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Mechanism of Action9

2-in-1 actionImmediate filling

• CMC gel provides the immediate filling & wrinkle correction

Long-lasting volumization through collagen stimulation

• PCL microspheres stimulate neocollagenesis

Before treatment1 When ELLANSÉTM is injected subcutaneously CMCgel provides immediate results

2

CMC gel is resorbed and PCL microspheres remain

3 PCL microspheres stimulate fibroblasts to produce new collagen

4

Overtime PCL microspheres are bioresorbed

5 Smooth and natural correction maintained throughout total duration of effect

6


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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 4 years that you can adapt to your patient needs and expectations

• Fully resorbable product via hydrolysis

Microspheres size : 25-50 μm for the whole range

ELLANSÉTM provides an effect of different durations from 1 to 4 years.

At injection Chain Scission Bioresorption Total Bioresorption


2 Years

1 Year


3 Years


4 Years

ELLANSÉTM - S

ELLANSÉTM - M

ELLANSÉTM - L

ELLANSÉTM - E

PCL chainsPCL microspheres


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Areas of Treatment : ELLANSÉTM range

Sustained volumizing capacity through collagen stimulation for natural and long-lasting results from 1 to 4 years, ideal for volume restoration and contour definition.

Treatment areas where ELLANSÉTM-S, -M, -L and -E can be used

NB : Glabella, lips and eyelids are not recommended for the use of ELLANSÉTM

Depth of Injection

ELLANSÉTM 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 definition of treated areas.

SUB-DERMALTISSUE

DERMIS

EPIDERMIS

Temples and Brow Area

Malar Augmentation Cheek

Cheek

Nasolabial Folds

Jaw Line

Nose Reshaping

Marionette Lines

Chin Definition

ELLANSÉTM


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13 months after ELLANSÉTM - M injection, PCL microspheres were surrounded with collagen deposition and a mild fibroblastic and histiocytic tissue response. Stainings were Haematoxylin & Eosin (A and B) and Martin-s Trichrome (C and D)

Proven Neocollagenesis induced by ELLANSÉTM

In rabbit tissue9

In human tissue14

ELLANSÉTM-M : 9 months post injection (rabbit)

Haematoxylin & Eosin staining shows :

Microspheres still round and intact during bioresorption process

Collagen fibers are stained red


Picro Sirius Red (PSR), Polarized light shows :

Red (arrows): collagen type I

Green (arrowheads): collagen type III

Confirmation of neocollagenesis


Picro Sirius Staining, Polarized light shows :

Red color confirming predominant presence of collagen type I

Type I collagen confirms stable environment and long-term efficacy


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ELLANSÉTM offers clear advantages over the NASHA based dermal filler, both in terms of durability and efficiency15

Proven Efficacy & Safety

High efficacy of ELLANSÉTM - S and ELLANSÉTM - M in nasolabial folds treatment with high safety over a 2 years period10

Investigator Evaluated Aesthetic Global Improvement Scale GAIS

Comparative clinical study of ELLANSÉTM vs a NASHA hyaluronic acid for treatment of nasolabial folds15

100%

90%

80%

70%

60%

50%

40%

30%

20%

10%

0%

Patie

nts

% w

ith Im

prov

emen

t

10%

40%

55% 45%

15%

20%

45%

35%

10%

60%

10%

20%

11%

45%

11%

78%

ELLANSÉTM - S

3 6 9 12 15 18 24

months

35%

Much Improved Very Much ImprovedImproved Much Improved Very Much ImprovedImproved

12 months

90%

80%

70%

60%

50%

40%

30%

20%

10%

0%Pa

tient

s % w

ith im

prov

emen

ts

10,0%

40,0%

0,0%

35,0%

55,0% 45,0%

15,0%

20,0%

45,0%

35,0%

10,0%

60,0%

10,0%

20,0%

24 months

11,0%

35,0%

11,0%

78,0%Pa

tient

s %

with

Im

prov

emen

t41,4%

50% 63,8% 71%

4%

58%

14%27,6%25,9%

51,7%

13,8%

5,2%

7%

31%

50%

44%

6%

58,0%

77%

23%

ELLANSÉTM - M

3,5%

3 6 9 12 15 18 24

months

100%

90%

80%

70%

60%

50%

40%

30%

20%

10%

0%

100% 90%

Of patients with at least improved results at 12 months

100% 90%

Of patients with at least improved results at 24 months


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High Safety Profile of ELLANSÉTM

The unique smooth and spherical shape of ELLANSÉTM 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

LONG-TERM SAFETY : Scientific Evidence and Literature10, 13

High Patient Satisfaction10

ELLANSÉTM - S & -M : Satisfaction using Visual Analogue Scale (VAS)10

Patient Satisfaction with ELLANSÉTM Treatment (mean)

Patient SatisfactionELLANSÉTM - S

12 MonthsELLANSÉTM - M

24 Months

Satisfaction 74% 81.7%

At 24 months post-injection :

75% of patients like to repeat ELLANSÉTM - S treatment

78% 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

SHORT-TERM SAFETY : Pre-clinical Data7

• In-house in-vitro resorption study of ELLANSÉTM Range PCL microspheres consistent with published literature data

In-vitro


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ELLANSÉTM Ability to Regenerate Beauty

ELLANSÉTM - S Nasolabial Folds

Before Treatment After 12 Months

Courtesy of Marion Moers-Carpi, MD, Germany



ELLANSÉTM - M Nasolabial Folds


ELLANSÉTM - S Nasolabial Folds



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ELLANSÉTM - M Nose Reshaping

Before Treatment After 3 Weeks

Courtesy of Ayham Al-Ayoubi, MD, London, UK

Before Treatment After Treatment

ELLANSÉTM Cheeks and Submalar Augmentation

Courtesy of Dr. Fab Equizi, Liverpool, UK

ELLANSÉTM - M Nasolabial Folds, Cheeks and Marionette Lines


Courtesy of Alida Harb, MD, Riyadh, Saudi-Arabia


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References

1. Vleggaar D et al. Dermatological implications of skeletal ageing: a focus on supraperiosteal volumization for perioral rejuvenation. J Drugs Dermatol 2008;7:209-220.

2. 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.

3. Zimbler MS et al. Anatomy and pathophysiology of facial ageing. Facial Plast Surg Clin North Am 2001;9:179-187.

4. Murphy MR et al. The ageing face consultation. In: Master Techniques in Facial Rejuvenation. Elsevier 2006;1-16.

5. Le Louarn C. Botulinum toxin and the Face Recurve® concept: decreasing resting tone and muscular regeneration. Ann Chir Plast Esth 2007;52:165-176.

6. Donofrio LM. Fat distribution: a morphologic study of the ageing face. Dermatol Surg 2000;26:1107-1111.

7. Valenga Baroni et al, Influence of aging on the quality of the skin of white women- the role of collagen. Acta cirurgica Brasileira 2012; 27: 736-740

8. CE mark-Technical dossier (Whitepaper W113.05)

9. Nicolau PJ et al. Neocollagenesis after injection of a polycaprolactone based dermal filler in a rabbit. Eur J Aesth Med Dermatol 2013;3(1):19-26.

10. 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.

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 filler. 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 fillers. Semin Cutan Med Surg 2004; 23(4):214-217.

17. Morhenn VB et al. Phagocytosis of different particulate dermal filler substances by human macrophages and skin cells. Dermatol Surg 2002;28(6):484-490.

18. Anderson JM. Mechanism of inflammation and infection with implanted devices. Cardiovasc Pathol 1993;2:33S-41S.

19. Matlage BF et al. Tissue response to implanted polymers: The significance of sample shape. J Biomed Meter Res 1976;10:391-397.

20. Nicolau PJ. Long-Lasting and permanent fillers: Biomaterials influence over host response. Plast Reconstr Surg 2007;119:2271-2286.


15 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

Optimize aesthetics outcome to increase

your patients satisfaction


SINCLAIR PHARMACEUTICALS LTD.35, Rue d’Artois, 75008 Paris, France

Tel: +33 1 53 76 11 11 Fax: +33 1 53 76 12 12www.sinclairpharma.com

www.ellanse.com

Easy to inject

Immediate correction

Sustained volumizing capacity

through collagen stimulation9

Maintained correction

Easy to mold

from 1 to 4 years

Natural results from patients

own collagen stimulation

High level of patient satisfaction10

EXCLUSIVE DISTRIBUTORFOR ELLANSÉ™

+61 3 9702 3119www.austramedex.com


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