WHEN FRENCH TOUCH MEETS BEAUTY

Transcription

1 WHEN FRENCH TOUCH MEETS BEAUTY

2 , MADE IN FRANCE BY SINCLAIR is manufactured 100% in France by SINCLAIR PHARMA in its laboratory specialized in the research, development and manufacturing of Hyaluronic Acid (HA) dermal fillers, and ISO certified since The biocompatibility and performance of the entire range have been clinically demonstrated. complies with all safety standards required by health authorities and has been CE marked since It is registered and launched in more than 70 countries around the world. With more than 10 years of clinical use, 2.8 million syringes sold worldwide, has established itself among the leaders on the aesthetic market.

3 /03 IS A TAILOR - MADE RANGE OF «MADE IN FRANCE» HA DERMAL FILLERS, DESIGNED FOR WRINKLE CORRECTION, FACIAL CONTOURING AND VOLUME RESTORATION, COMBINING EASE OF INJECTION AND NATURAL AND LONG-LASTING RESULTS Perfectha is intended for reconstructive purposes in the treatment, for instance, of facial lipoatrophy, or morphological asymmetry associated with the aging process or other underlying conditions. Perfectha is for intradermal and subcutaneous application and is implanted in the areas of the face and hands to fill skin depressions and also for the augmentation of tissue volume.

4 THE E-BRID TECHNOLOGY: A STATE OF Use of high molecular weight and high purity Sodium Hyaluronate ENHANCED CROSS-LINKING PROCESS Elimination of impurities 2 ENHANCED CROSS-LINKING PROCESS CROSS-LINKING PARTICLE CREATION + Free HA BDDE Macromolecular Network Microgel Particles The Macromolecular Network is maintained in the resulting microgel particles.

5 /05 THE ART MANUFACTURING PROCESS CONTROLLED MIXING PROCESS Standardized pharmaceutical grade sterilization Extensive quality control 4 CONTROLLED MIXING PROCESS + CONTROLLED MIXING Microgel particles HA Polymer Solution Network MULTI STRUCTURED CONNECTIVE NETWORKS

6 MULTI-STRUCTURED CONNECTIVE NETWORKS MACROMOLECULAR NETWORK A combination of both physical and chemical bonds leading to a strong cross-linked network. HA POLYMER SOLUTION NETWORK Physical network made of entangled HA chains. It is a soft solution. INTERFACIAL NETWORK This interfacial network is created by the presence of entanglements between the outer region of the microgel particles and the neighbouring HA. FEATURES BENEFITS BENEFITS FOR PATIENTS Use of high quality, high molecular weight Sodium Hyaluronate PURE GEL Product with a high safety rating Tolerance Safe use Low risk of adverse events Degree of cross-linking RESILIENT MICROGEL NETWORKS Lifting and volumizing effect Slows down the gel degradation process Instant volumizing effect Filled cutaneous depressions Better / healthier looking Longer-lasting results Slows down the gel degradation process Longer - lasting results HA Polymer Solution Network CREATES A PROTECTIVE FLUID ENVIRONMENT Antioxidant effect Confers mobility to the microgel particles and thus ensures coherent flow and ease of injection Slows down the skin degradation process Less painful Interfacial Network PROVIDES BRIDGES BETWEEN NETWORKS Ensures coherent flow and ease of injection Less painful

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8 OPTIMAL GEL CHARACTERISTICS is made of cross-linked hyaluronic acid gel of non-animal origin at a concentration of 20 mg/ml in phosphate-buffered saline. S A F E T Y complies with safety standards for dermal fillers 2. It is a non-cytotoxic product 3 and proves to be a biologically safe product 2. Low Endotoxin level < 4 UI / ml ( routinely < 0.5 UI/ml ) Non-detectable BDDE residual content < 2 ppm Low Protein Load < 6 µg / ml showed greater than 90% cell viability 3. Cell toxicity was tested on fibroblast cell line. Cell viability was assessed neat and in 1/2 and 1/4 dilutions using 0.2g/ml HA filler. No significant cytotoxicity 3 Relative Cell Viability (%) CTL JUVEDERM ULTRA-XC PERLANE PERFECTHA DEEP 100% 80% 60% 40% 20% 0% References : 2- Technical file 1:4 DILUTION 1:2 DILUTION NO DILUTION 3- Park KY1, Kim HK, Kim BJ. Comparative study of hyaluronic acid fillers by in vitro and in vivo testing. J Eur Acad Dermatol Venereol May;28(5):565-8.

9 /09 products were tested on adherent macrophages and induced a very low release of IL - 8 (specific mediators of inflammation), around 50 pg / ml, evidencing that the products are devoid of inflammatory effect 4. LPS : positive controle ,00 IL-8 [pg/ml] , , , ,00 PERFECTHA is devoid of inflammatory effect ,00 0,00 Lps 1 µg/ml ,48 Lps 100 ng/ml 49598,48 Lps 10 ng/ml 17614,98 Lps 1 ng/ml 5296,16 STIMULUS Dilution of hyaluronan filler 4 IL-8 [pg/ml] 50 1:2 1:4 1:8 1:16 1:32 1:64 1:128 1:256 DEEP COMPLEMENT SUBSKIN DERM 2.8 million syringes sold worldwide and a very low adverse event rate % adverse events 5 References : 4- Koenig B., Analysis of IL-8 inducing potential from human effector cells. Evaluation of inflammatory potential of Perfectha product line by measurement of IL-8 release from adherent macrophages. Study Report, MMD, May Post-market survey from July 2012 to June 2016

10 E F F I C I E N C Y Studies conducted on Derm evidenced that 86% of patients showed «much improved» and «very much improved» appearances one week after treatment, according to the Global Aesthetic Improvement Scale (GAIS). Moreover, they proved that filling effects last even after 6 months as excellent results remained in the nasolabial folds in 57% of the patients, and in the lips in 45% 6. Percentage of satisfaction % 100 % 90 % 80 % 70 % 60 % 50 % 40 % 30 % 20 % 10 % 0 % 86% much improved and very much improved appearances 6 LIP CONTOUR NASOLABIAL FOLD L O N G L A S T I N G 7 days 90 days 180 days The E-BRID Technology enables the presence of a higher number of covalent bonds which help to minimize the effects of hyaluronidase and oxidation in the body, thus slowing down the enzymatic degradation and allowing the gel to stay longer in the skin 7.8. The HA Polymer Solution network acts as a protective environment also slowing down the gel degradation process. Degradation rate in vitro 7 (%) PERLANE PERFECTHA JUVEDERM DEEP ULTRA-XC 50% 40% 79% Reduction rate in vivo in humans at 6 months 8 (%) TEOSYAL GLOBAL ACTION DERM ESTHELIS BASIC 25% 12.5% 62.5% References : 6- Talarico S. et al. Evaluation of the safety and efficacy of a new filler with hyaluronic acid for the treatment of nasolabial folds and lip contour; Surg. Cosmet. Dermatol.2010;2(2): Park KY1, Kim HK, Kim BJ. Comparative study of hyaluronic acid fillers by in vitro and in vivo testing. J Eur Acad Dermatol Venereol May;28(5): Da Costa et al. Durability of Three Different Types of Hyaluronic Acid Fillers in Skin: Are There Differences Among Biphasic, Monophasic Monodensified, and Monophasic Polydensified Products?; Aesthet. Surg. J. 2016, 1-9

11 H I G H L I F T I N G A N D V O L U M I Z I N G C A P A C I T Y All gels are among the most elastic on the market, making post-injection results in terms of volume and lifting excellent 9. Providing the practitioner an immediate effect, reduces the risk of overcorrection and gives the desired volume with a small amount of gel. / G modulus (Pa) Juvederm Ultra 4 Teosyal Puresense Firstlines Belotero Balance Restylane Volyme Juvederm Ultra 3 Juvederm Volbella Restylane Kysse Art Filler Universal E A S Y T O I N J E C T Teosyal Puressense Kiss Restylane Lyft Juvederm Voluma Restylane Art Filler Volume Derm Thanks to its specific technology, allows a smooth injection given the low extrusion force needed to inject the gel, and the addition of HA Polymer Solution which acts as a lubricant agent. Moreover, the controlled particle size of and its thin wall needle enable the gel to have a regular flow, reducing any possible discomfort during injection. Subskin Deep Restylane Vital Subskin is as easy to inject as the reference monophasic product and 2.5 times easier than the reference biphasic product 10 Measurement of injectability 10 Extrusion force (Newtons) 22,5 8,7 8,0 BIPHASIC VOLUMIZER SUBSKIN MONOPHASIC VOLUMIZER 9- Internal data - Evaluation and comparison study of the G rheological properties of PERFECTHA with the main competitors HA-based dermal fillers. This study was conducted internally on a TA Instruments DHR-2 rheometer with a 25mm parallel-plate geometry. Frequency sweep tests were performed on samples between 0.1 and 100 rad/s at a 1% strain in order to match the gels Newtonian Plateau and using plate-plate geometry. 10- Internal Data: Material: Brookfield Texturometer CT with a TA51 probe. Extrusion speed: 12mm/s over distance of 15mm.

12 A TAILOR-MADE FINELINES COMPLEMENT INDICATIONS Superficial facial lines and skin depressions Periorbital lines Perioral lines Superficial facial lines and skin depressions Forehead finelines DEPTH OF INJECTION SUPERFICIAL DERMIS SUPERFICIAL DERMIS HA CONCENTRATION 20 mg / ml 20 mg / ml VOLUMINIZING CAPACITY + + VOLUME 0.5 ml 0.8 ml NEEDLES & CANNULAS 2 x 30 G 1/2 needle 2 x 30 G 1/2 needle

13 /13 RANGE OF FILLERS DERM DEEP SUBSKIN Medium facial lines and skin depressions Glabellar lines Lip contour MID-DERMIS Deep facial lines and skin depressions Lip volume Nose Nasolabial folds Marionette lines Oral commissures Cheekbones and chin moderate augmentation DEEP DERMIS Volume creation Facial contours Malar areas Chin and cheeks Nose bridge Hands SUBCUTANEOUS OR SUPRAPERIOSTEAL 20 mg / ml 20 mg / ml 20 mg / ml ml 2 x 30 G 1/2 needle 1 ml 2 x 27 G 1/2 needle 1 x 3 ml 3 x 1 ml 22G x 50mm needle + 22G x 50mm cannula 21G x 50mm needle + 21G x 50mm cannula

14 DIFFERENT PRODUCTS FOR DIFFERENT LAYERS is a range of gels made of a 20mg/ml HA concentration. Each gel has the same HA concentration, however the cross-linking within each gel influences the rheological properties enabling a range of gels to be produced. In particular, what differentiates gels is the particle size: the bigger the particles, the greater the volumizing effect, and the longer-lasting the results. Each gel is unique and designed to best meet specific needs: depending on the treated areas, the volume needed and the depth of injection required, a different variant will be used. SUBSKIN + DEEP DERM Volumizing capacity FINELINES COMPLEMENT - + FINELINES COMPLEMENT Particle size Resistance to enzymatic degradation DERM DEEP + SUBSKIN

15 SUBSKIN : THE IDEAL VOLUMIZER /15 ELASTIC AND VISCOUS ENOUGH TO: Be moldable, enabling you to shape your patients faces Remain in place after injection Perfectly restore or create volume, and redefine facial contours Injection depth: Subcutaneous or Supraperiosteal LONG LASTING RESULTS UP TO 18 MONTHS months Efficacity Results according to the Physician Evaluator Aesthetic Rating Very much improved Percentage of Satisfaction % 60% 50% 40% 30% 20% 10% 0% Much improved Improved No change Worse MONTHS 100% of patients rated as very much improved or improved 11 References : 11- J. Fares, A prospective study of evaluation of the results achieved with the application of Subskin, a new gel of hyaluronic acid non animal origin for malar and mental enhancement.

16 FULL - FACE TREATMENT CASE STUDY Valérie 42 years old BEFORE Valérie 42 years old AFTER ASSESSMENT Atrophy of the fat layers above the nasolabial fat pad which increases the nasolabial line and induces convexity of the jawline. TREATMENT GOAL Reduce the nasolabial folds by lifting the mid face laterally. TREATED AREA PRODUCT QUANTITY INJECTION DEPTH TECHNIQUE Cheek bones SUBSKIN 1 ml Subcutaneous Fanning Preauricular DEEP 0.4 ml right 0.2 ml left Deep dermis Retrograde Nasolabial folds DERM DEEP 0.4 ml right 0.2 ml left 0.6ml Mid - dermis Deep dermis Retrograde Multi-bolus Lip commissures FINELINES 0.4 ml Superficial dermis Retrograde Marionette lines, jawline & chin DEEP 1.8 ml Deep dermis Fanning The procedures featured were performed by Dr. Iñigo de Felipe, Dermatologist, Barcelona, Spain.

17 NATURAL - LOOKING RESULTS /17 Sécoura 51 years old BEFORE Treated areas: Glabellar lines Cheeks Nasolabial folds AFTER Products used: DERM SUBSKIN FINELINES DERM 0.5 ML 1 ML 0.4 ML 1 ML Joseph 32 years old BEFORE Treated areas: Bridge of the nose Tip of the nose Nasolabial angle AFTER Products used: DEEP DEEP DEEP 0.3 ML 0.3 ML 0.3 ML The procedures featured were performed by Dr. Iñigo de Felipe, Dermatologist, Barcelona, Spain.

18 NATURAL - LOOKING RESULTS Edwige 48 years old BEFORE Treated areas: Cheeks Nasolabial folds Jawline AFTER Products used: SUBSKIN DEEP SUBSKIN 1.5 ML 0.6 ML 0.8 ML Antonio 41 years old BEFORE Treated areas: Cheekbones Tip of the nose Nasolabial folds Jawline & zygomatic area AFTER Products used: SUBSKIN DEEP DEEP SUBSKIN 1 ML 0.3 ML 0.8 ML 2 ML The procedures featured were performed by Dr. Iñigo de Felipe, Dermatologist, Barcelona, Spain.

19 BY YOUR SIDE /19 A COMPLETE SET OF TOOLS TO SUPPORT YOU IN YOUR DAILY PRACTICE Injection technique videos Case studies Patient leaflets Patient follow-up books Waiting room video Posters Next visit reminders INFORMATION social networks are regularly updated with the latest information.

20 Sinclair Pharma, has been commited to skin expertise since 1971, and more recently to the development of a safe, minimally invasive and effective portfolio of aesthetic treatments including. SINCLAIR PHARMA Office Village, Chester Business Park Chester, CH4 9QZ United Kingdom PF-DB A