*Resilient Hyaluronic Acid

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Transcription:

*Resilient Hyaluronic Acid

TEOSYAL RHA* DYNAMIC AESTHETICS EXPAND YOUR POSSIBILITIES

FACIAL REJUVENATION High patient expectations 1,2 / High medical standards 1,2 Natural results Immediate and long lasting effect Minimal side effects Maximized tolerance Resistance and adaptability Natural results Easily injectable 3 Care about facial dynamism 2 1. Kantar Health. The European TEOSYAL PEN survey included 30 physicians and 236 patients. 42 patients had never received manual injection with a hyaluronic acid-based filler. Report n 40HB64. 2015. 2. Michaud T, et al. Facial dynamics and emotional expressions in facial aging treatments. Journal of Cosmetic Dermatology. 2014;1-13. 3. Breithaupt AD, et al. Next-generation dermal fillers and volumizers. Cosmet Dermatol. 2012;25:184-19.

TEOSYAL RHA 1 ST RESILIENT HYALURONIC ACID DEDICATED TO FACIAL DYNAMICS + INNOVATIVE PATENTED TECHNOLOGY exclusive crosslinking method Exclusive Preserved Network method Classical method Long hyaluronic acid chains Less BDDE* 5 Low MoD** (2-4%) 5 Fragmented hyaluronic acid chains More BDDE 4 High MoD** (5-10%) Dynamic structure: Maintains natural viscoelastic properties Rigid structure: Damages natural viscoelastic properties Enhance your patient s beauty by preserving facial dynamism * BDDE: 1,4-Butanediol Diglycidyl Ether ** MoD: degree of modification 4. Pomarède N, et al. Hyaluronic acid injection. Ann Dermatol Venereol. 2009;136 Suppl 6:S287-9. 5. TEOXANE Laboratories. Data on file, measurement by an independent laboratory of the HA Degree of Modification by 1 H NMR.

RHEOLOGICAL PARAMETERS DIRECTLY LINKED TO PHYSIOLOGICAL BENEFITS 2,6 Elasticity Cohesivity Viscosity Properties to consider when choosing the best possible product profile depending on the area treated Enhance your patient s beauty Malleability properties to avoid movement resistance Ability to fill expression lines while remaining undetectable Volumising capability while remaining undetectable For optimal results in each indication 2. Michaud T, et al. Facial dynamics and emotional expressions in facial aging treatments. Journal of Cosmetic Dermatology. 2014;1-13. 6. Dr. Gassia: http://en.anti-age-magazine.com/sustainable-aesthetic-medicine-optimising-the-long-term-treatment-of-facial-aging-using-injections-2/

TEOSYAL RHA UNIQUE RHEOLOGICAL PROFILE DEDICATED TO FACIAL DYNAMISM 7 THE DYNAMIC RHEOLOGY CONCEPT Two parameters taking real conditions into account Stretch : Assessing gel malleability and adaptability in the non-linear viscoelastic region + PATENTED MEASUREMENT METHODS developed with experts from the University of Grenoble, France Strength : Assessing structure resistance to compression and repeated small stress, like micromovements in the facial tissues Stretch Strength 10000 160000 140000 10 6.s -1 - log scale 1000 100 Wrinkle fillers Volumizers 120000 100000 80000 Dynamic G' - Pa 60000 10 40000 20000 1 A* B* C* D* E* F* RHA 1 RHA 2 RHA 3 RHA 4 0 COMPETITORS TEOSYAL RHA Well defined rheological profile of each product in order to meet the clinical needs TEOSYAL RHA : 4 products able to stretch and resist under repeated harsh stress conditions *A, B, C and D are commonly used competitors products to treat wrinkles. E and F are commonly used competitors volumizers. 7. TEOSYAL RHA keeps its mechanical properties on a large range of strain or stress contraints (dynamic G ) - Report Rheological characterizations of hyaluronic acid gels. Rheonova (University of Grenoble, France). Data on file - Patent pending

TEOSYAL RHA CLINICAL EFFICACY A IN AN 18-MONTH C Prospective, double-blinded, split face, randomized (side and order of injection), controlled trial 90 subjects with moderate to severe nasolabial folds (NLF) Improvement of WSRS scores for 100% of patients at 6 months (primary criterion) and on the long term WSRS score from D0 to M18 4 4 4 3 3 3 2 2 2 1 1 1 0 D0 D14M1 M6 M9 M12 M15 M18 0 D0 D14M1 M6 M9 M12 M15 M18 0 D0 D14M1 M6 M9 M12 M15 M18 TEOSYAL RHA 2 vs Juvederm Volift TEOSYAL RHA 3 vs Juvederm Ultra 4 TEOSYAL RHA 4 vs TEOSYAL PureSense Ultra Deep Better improvement on the long term Volume of the nasolabial fold from D0 to M18 (mm 3 ) 5 10 10 4 3 8 6 * 8 6 p=0.018 p=0.018 p=0.034 2 4 4 * 1 0 D0 D14M1 *p=0.045 M6 M9 M12 M15 M18 2 0 D0 D14M1 *p=0.041 M6 M9 M12 M15 M18 2 0 D0 D14M1 M6 M9 M12 M15 M18 TEOSYAL RHA 2 vs Juvederm Volift TEOSYAL RHA 3 vs Juvederm Ultra 4 TEOSYAL RHA 4 vs TEOSYAL PureSense Ultra Deep Population: both genders (39-70 years) with 2 symmetrical moderate (WSRS=3) to severe (WSRS=4) nasolabial folds Assessments: Primary criterion: WSRS score improvement from pre-injection, 6 months after the last injection session (Blinded Live Evaluator, BLE) Secondary criteria: variation of NLF volumes using PRIMOS 3D (Phaseshift Rapid in-vivo measurement of skin); Global Aesthetic improvement Scale (GAIS), FACE-Q satisfaction assessment. Safety: Common Treatment Reactions, patient s diaries, pain during injection (VAS), Adverse events

Y AND SAFETY HIGHLIGHTED H COMPARATIVE STUDY 8, l ) TEOSYAL RHA 2 vs Juvederm Volift (n=30) Moderate NLF : WSRS score before injection = 3 TEOSYAL RHA 3 vs Juvederm Ultra 4 (n=30) Severe NLF : WSRS score before injection = 4 TEOSYAL RHA 4 vs TEOSYAL PureSense Ultra Deep (n=30) Severe NLF : WSRS score before injection = 4 Evaluation at D0, D14, M1, M6, M9, M12, M15, M18 Preference of the physicians for TEOSYAL RHA products Percentage of very satisfied injectors (%) 100 90 80 70 60 50 40 30 20 Easiness of injection Easiness of product positioning Immediate result Result after massage - Fewer touch-up with TEOSYAL RHA products: 26.7% vs 35.6% TEOSYAL RHA Comparators Better GAIS* score at 12 months Proportion of patients much improved : - TEOSYAL RHA 2: 50.0% vs Juvederm Volift: 33.3% +16.7 points - TEOSYAL RHA 3: 44.8% vs Juvederm Ultra 4: 41.4% +3.4 points - TEOSYAL RHA 4: 60.0% vs TEOSYAL PureSense Ultra Deep: 50.0% +10.0 points Good safety profile** - Mild to moderate local common treatment reactions lasting less than 7 days Physicians and patients highly satisfied by TEOSYAL RHA products performance * GAIS = Global Aesthetic Improvement Scale ** Local inflammatory récations: bruising, erythema, induration, oedema, pain, haematomas, lumps/bumps and swelling, itching, temporary loss of sensitivity, dyschromia, abscesses, nodules, skin necrosis, migration of the implant. General manifestations: immediate hypersensitivity up to anaphylactic shock. 8. TEOXANE Laboratories. Quantitative and comparative safety and effectiveness analysis of three non-ce approved injectable dermal fillers in moderate and severe nasolabial folds treatment versus CE approved comparators. A randomized double-blinded within subject clinical trial. Final 18-months report. Independent CRO analysis. January 8th, 2016.

DYNAMIC SUPERFICIAL WRINKLES TEOSYAL RHA 1 Superficial wrinkles Face - Neck - Décolleté e.g. Bar code Courtesy of Prof. Giuseppe Sito 15 mg/ml of a mix of crosslinked and non-crosslinked HA 0.3% lidocaine 1.9% MoD* Mid dermis injection with a 30G needle + Injection techniques recommended by the Experts : - LINEAR THREADING - CROSSHATCHING FOR BAR CODE Dr. Sebagh, Facial Plastic Surgeon, France & UK «Excellent product, an innovation for very fine wrinkles and bar code very natural very discreet»

DYNAMIC MODERATE WRINKLES TEOSYAL RHA 2 Moderate wrinkles e.g. Forehead + Glabella Courtesy of Dr. Wolfgang Redka-Swoboda Dr. Galadari, Dermatologist, UAE «The filler becomes part of the dermal structure rendering it more natural especially in mobile areas where the skin stretches the likelihood of developing lumps like with other products decreases» 23 mg/ml HA 0.3% lidocaine 3.1% MoD* Mid dermis injection with a 30G needle Injection technique recommended by the Experts : - LINEAR THREADING TO FILL WRINKLES + * MoD: degree of modification

DYNAMIC SEVERE WRINKLES TEOSYAL RHA 3 Severe wrinkles e.g. Nasolabial folds + Marionette lines Courtesy of Dr. Wolfgang Redka-Swoboda 23 mg/ml HA 0.3% lidocaine 3.6% MoD* Deep dermis injection with a 27G needle Dr. Carey, Associate Professor of Dermatology, Canada «It works great on lines. It seems to take them away immediately, which is unusual» + Injection technique recommended by the Experts : - LINEAR THREADING TO FILL WRINKLES

VOLUME IN DYNAMIC EXTENDED AREAS TEOSYAL RHA 4 Volume in extended areas e.g. Cheeks + Contours of the face Courtesy of Dr. Wolfgang Redka-Swoboda Dr. Redka-Swoboda, General Surgeon, Germany «You ve got an aesthetic improvement without feeling the product in the skin and soft tissue That s great» Injection technique recommended by the Experts : - SANDWICH TECHNIQUE 23 mg/ml HA 0.3% lidocaine 4.1% MoD* Subcutaneous injection with a 27G needle + * MoD: degree of modification

In today s world, beauty is no longer a question of age. Women want their beauty to last into the future. That s why TEOXANE Laboratories specialise in the complex development of hyaluronic acid injectable gels with researchers driven by the culture of excellence and innovation as well as a total dedication to effectiveness and safety. Thanks to this approach, the hyaluronic acid gels we produce in our Genevabased laboratories are of the highest quality and purity. Mrs Valérie Taupin CEO & Founder, TEOXANE 500274/04 - October 2016 TEOSYAL RHA 1 to 4 are medical devices, class III, and are regulated health products bearing the CE marking (CE0086) under this regulation. For more information, please consult TEOSYAL RHA s instructions for use. TEOXANE SA Les Charmilles - Rue de Lyon, 105 CH 1203 Geneva, Switzerland www.teoxane.com