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RADIESSE® 1 The power of regenerative biostimulation1 RADIESSE® is a regenerative biostimulator1 that stimulates new collagen and elastin with the versatility to also provide immediate correction and sharpened contours – for up to 12 months or longer in most patients.1–6
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RADIESSE® 3 The ability to regenerate healthy skin7* RADIESSE® is the first and only FDA-approved calcium hydroxylapatite (CaHA) injectable aesthetic treatment that provides immediate results and long-term improvement to lines and wrinkles.5,6,28 Improves skin foundation8,9 • • Meaningfully rebuilds skin10 • Renews healthy-looking skin* tissue1,11 • • For individualized and personalized treatments activating the body’s own skin regeneration power to achieve long-lasting, natural-looking results and a youthful, refreshed appearance.2,5–7 3,4 3 * “Healthy-looking skin” is defined by regeneration of collagen I and III, elastin, proteoglycans, and angiogenesis.
4 RADIESSE® Collagen loss and on aging Discover the power of regenerative biostimulation1 to reach your patients individual aesthetic goals with RADIESSE® As the years go by, there are a number of intrinsic and extrinsic factors impacting the skin aging process. When younger, your patients’ skin is highly capable of repair, but this capability decreases with age. The dense collagen network of the skin gets looser, which deprives dermal fibroblasts of the mechanical stimulation needed to activate the skin-renewing processes.12,13 Other factors, such as lifestyle choices and sun exposure can have a aging including reduced skin quality and saggy skin.12,13 Young skin Aged appearance
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RADIESSE® 7 Your patient’s desires and fears Negative perceptions from society and treatment-related fears need to be addressed in a personalized approach Your patients are looking to bring out the best in themselves through aesthetic enhancements for beautification or to treat signs of aging – they demand a youthful, refreshed and natural appearance. While every patient’s needs and goals are unique, and every treatment has to be tailored specifically to them, there are several treatment fears that are common. 49 % Looking unnatural or fake14 32 % Negative connection with having treatments14 31 % Negative reaction from society 14
8 RADIESSE® Discover the power of regenerative biostimulation with RADIESSE®1 address unique patient needs for immediate 2–4 RADIESSE and flexibility to provide a wide range of personalized treatments.5,6 Global regenerative biostimulation RADIESSE® is recommended to be used for greater areas skin regeneration and skin quality enhancement.2,15–17 Focal regenerative biostimulation RADIESSE®+ Lidocaine is recommended to be used for focal collagen biostimulation for sharpened contours and defined focal areas of the face and more so for the jawline.18–20 Medical hands-on training through authorized Merz Aesthetics® trainers is key to exploring RADIESSE® can be used in a diluted form for more treatment versatility*5,6 * Refer to page 22 and full prescribing information for further information on indications for use and product composition.
Hands Mandibular angle and jawline Medial and lateral cheek Mid face & submalar cheek hollows Nasolabial folds Pre jowl sulcus Décolleté wrinkles
10 RADIESSE® RADIESSE® delivers through a unique, evidence-based regenerative pathway1 RADIESSE® is a regenerative biostimulator1 which provides an immediate li and long-term eect on skin regeneration for a more youthful appearence.1-4 Immediate activation of dermal fibroblasts Before RADIESSE® Restoring wrinkle fibroblast contractility Epidermis Dermis Subcutis Sunken skin appears as wrinkles and folds on the surface due to aging. Loss in volume, elasticity and firmness. signs of aging – smoothing of wrinkles and folds plus contouring. Gel matrix CaHA microspheres Collagen fibres Fibroblasts Elastin
RADIESSE® 11 RADIESSE® improves the structure of the skin at the cellular level, directly contacting fibroblasts that activate five key regenerative components of the skin’s extracellular matrix1,8,9 Regeneration of key components of the ECM • Collagen I and collagen III improve skin thickness, texture and tone21 • Elastin improves skin elasticity and firmness21 • Proteoglycans provide hydration and glow21 • Angiogenesis restores the skin’s vascular networks22 Natural restoration of the key components of the skin Stimulating neocollagenesis and neoelastogenesis Improving skin quality Epidermis Dermis Subcutis stimulate the “collagen factories” – fibroblasts – to produce collagen. Newly formed networks of collagen and elastin provide structural support and improvement of skin quality.
12 RADIESSE® Regenerative biostimulation with RADIESSE®:1 Fibroblasts Studies showed that RADIESSE® has a number of with younger looking structures for up to 12 months or more2,4 Fibroblast activation RADIESSE® restores the contractility of wrinkle fibroblasts to that of fibroblasts from normal 23 1.4 x+5 1.2 x+5 1.0 x+5 0.8 x+5 0.6 x+5 0.4 x+5 0.2 x+5 Wrinkle fibroblasts + RADIESSE® Untreated wrinkle fibroblasts e c r o f e l i t c a r t n o c t s a b o r b F i l 0 4 8 12 16 20 24 Time (hours) Contractile forces developed by human aged dermal fibroblasts in a GlaSbox® device incubated with RADIESSE®. Data are given as mean.
RADIESSE® 13 Clinically proven regeneration:1 Particles RADIESSE® is a regenerative biostimulator1 with a unique particle material, shape, size, and consistency that creates the foundation of a true regenerative response through a non-acute inflammatory mechanism of action.1,11,24 Crystalys Facetem Renu HArmonyCa Images from Merz Aesthetics®. Data on File. 2023. These unique microspheres elicit a regenerative response to stimulate younger-looking skin from within.1,2,4
14 RADIESSE® Regenerative biostimulation with RADIESSE®:1 Results Long-term neocollagenesis 4 weeks* 32 weeks† 78 weeks† CaHA microspheres Collagen * 40x magnification † 60x magnification in a canine model Study 1 Mean levels of collagen type I and type III expression RADIESSE®.8 ** * ** Histology slides demonstrate the deposition of new collagen around CaHA microspheres over an extended period of time. Collagen fibres stain red, while other tissue elements appear more yellow.25 Studies show that stimulates new collagen production, lasting up to 12 months or more in many patients.2,7,8 i n o s s e r p x e n e g a l l o c n a e M ) y t i s n e t n i i g n n a t s ( i 6 5 4 3 2 1 0 4.3 2.4 5.0 5.3 6.0 2.6 Baseline 4 months 7 months * p<0.05 ** p<0.00001 Type I Type III Study 2 Sustained collagen type I stimulation of 64% for structural tissue support and stability at 9 months.2 i n o s s e r p x e n e g a l l o c n a e M ) y t i s n e t n i i g n n a t s ( i 6 5 4 3 2 1 0 4.0 6.6 4 months 9 months
RADIESSE® 15 Stimulation of neoangiogenesis RADIESSE® treatment resulted in significant neoangiogenesis, which suggests improved blood flow and delivery of nutrients to the skin.2 e r o c s n a e M 4 3 2 1 0 1.0 3.5 4 months 9 months Elastin formation i n o s s e r p x e n i t s a e n a e M l ) y t i s n e t n i i g n n a t s ( i 6 5 4 3 2 1 0 2.8 5.2 4 months 9 months RADIESSE® showed a significant increase in stimulating the body’s own natural synthesis of elastin, improving structural strength and skin elasticity for at least 2
16 RADIESSE® Visible skin quality improvement:8 Results Treatment with RADIESSE® revitalizes key components of the skin, leading to significant improvements in skin thickness and improved skin elasticity.1,2,8,9,26 Skin thickness Thickness of the dermis at baseline and 8 ) m m ( h t p e D 2400 2000 1600 1200 800 400 0 * ** 1462.3 1642.8 1865.9 * p<0.01 vs baseline ** p<0.0001 vs baseline Baseline 4 months 7 months Skin elasticity treatment with RADIESSE®.8 ) % , f U / a U ( y t i c i t s a e n k S i l 80 70 60 50 40 30 20 10 0 57.0 66.0 73.0 Baseline 4 months 7 months
18 RADIESSE® Visible results with RADIESSE® Your patients will love the natural-looking a loyal one who continues the treatment and recommends it to others. 94% of patients would recommend the treatment 27 77 % of patients felt more confident27 70 % of patients satisfied with décolleté treatment 28 82 % of patients felt 27 93% of patients would continue regular treatments27 With RADIESSE®, you can let your patients enjoy the joint benefits of immediate correction and long-term skin regeneration.1,3,29
RADIESSE® 19 Before Patient injected with 9ml of RADIESSE® in the cheeks and jawline.* Before Patient injected with 9ml of RADIESSE® in the cheeks and jawline.* Before Patient injected with RADIESSE® in the cheeks.*
RADIESSE® 21 Numbers that speak for themselves Reasons to choose RADIESSE® - 20+ years of scientific and clinical experience with a well-established and favorable safety profile3,4,30 - 220+ peer-reviewed publications since 200528 - Available worldwide in over 85 countries28 - 98% patient satisfaction rate27 - 98% of patients willing to repeat treatment 27 - 15 million+ syringes sold worldwide since 200528
22 RADIESSE® RADIESSE® Regenerative biostimulation1 - the power of skin regeneration RADIESSE® is the treatment of choice when your patients. - Improves skin foundation8,9 - Meaningfully rebuilds skin10 - Renews healthy-looking skin* tissue1,11 * “Healthy-looking skin” is defined by regeneration of collagen I and III, elastin, proteoglycans, and angiogenesis. Product composition and characteristics5,6 Composition - 70% Carboxymethylcellulose (CMC) - 30% Calcium Hydroxylapatite (CaHA) - 70% Carboxymethylcellulose (CMC) - 30% Calcium Hydroxylapatite (CaHA) - 0.3% Lidocaine Hydrochloride Forms - 1.5 ml / 3.0 ml - 1.5 ml Indications (based on EU label) - treatment of nasolabial folds - augmentation of cheeks - treatment of nasolabial folds - augmentation of cheeks - hand augmentation to correct volume loss in the dorsum of the hands - restoration and/or correction of the signs of facial fat loss (lipoatrophy) in people with human immunodeficiency virus - diluted 1:2 with 0.9% sterile saline for injections is intended for the treatment of moderate and severe décolleté wrinkles.** - treatment of jawline - hand augmentation to correct volume loss in the dorsum of the hands - restoration and/or correction of the signs of facial fat loss (lipoatrophy) in people with human immunodeficiency virus Regulatory status - CE marked for Medical Devices - CE marked for Medical Devices Class III in Europe Class III in Europe ** Applicable for EU Region on Radiesse 1.5 ml only
RADIESSE® 23 Merz Aesthetics® as a trusted partner For Merz Aesthetics®, beauty and aesthetics is much more than an improved appearance. It’s about feeling better and living a better life with more confidence and a positive attitude. We believe each patient has their unique beauty, ideals, and expectations and they need to be treated that way. With over a century of experience, we firmly believe in innovation and trusted relationships to provide our patients with the best treatment possible. Backed by research, our product portfolio includes injectables, devices, and designed to provide trusted treatment results with a high standard of safety and efficacy. Ask your Merz Aesthetics® contact for more information or visit merzaesthetics.com References 1. Kim, J. Clin Cosmet Investig Dermatol. 2019;12:771–784. 2. Yutskovskaya, Y, et al. J Drugs Dermatol. 2014;13(9):1047–1052. 3. Van Loghem, J, et al. J Clin Aesthet Dermatol. 2015;8(1):38–49. 4. Bass, LS, et al. Aesthet Surg J. 2010;30(2):235–238. 5. RADIESSE®. Instructions for use. 2023. 6. RADIESSE® (+). Instructions for use. 2023. 7. Wollina, U, Goldman, A. Dermatol Ther. 2020;33(6):e14183. 8. Yutskovskaya, YA, Kogan, EA. J Drugs Dermatol. 2017;16(1):68–74. 9. González, N, Goldberg, DJ. Dermatol Surg. 2019;45(4):547–551. 10. Varani, J, et al. J Invest Dermatol. 2004;122(6):1471–1479. 11. Nowag, B. Presented at Aesthetic and Anti-Aging Medicine World Congress; 2019. 12. Varani, J, et al. Am J Pathol. 2006;168(6):1861–1868. 13. Fisher, GJ, et al. Arch Dermatol. 2008;144(5):666–672. 14. Kantar. Consumer study. 2021. 15. Zerbinati, N, Calligaro, A. Clin Cosmet Investig Dermatol. 2018;11:29–35. 16. Zerbinati, N, et al. Arch Dermatol Res. 2017;309(5)389–396. 17. Sundaram, H, et al. Dermatol Surg. 2010;36 (Suppl 3):1859–1865. 18. Muti, GF. J Drugs Dermatol. 2019;18(1):86–91. 19. Wasylkowski, V. Clin Cosmet Investig Dermatol. 2015;8:267–273. 20. Schachter, D, et al. J Drugs Dermatol. 2016;15(8):1005–1010. 21. Karamanos, NK, et al. FEBS J. 2021;288(24):6850–6912. 22. Jahani, M, et al. Adv Pharm Bull. 2020;10(4):490–501. 23. Courderot-Masuyer, C, et al. J Cosmet Dermatol. 2016;15(3):260–268. 24. Bagnenko, E, Povzun, S. Inject Methods Cosmetol. 2018;2:46–50. 25. Coleman, KM, et al. Dermatol Surg. 2008;34(Suppl 1):S53–S55. 26. Silvers, SL, et al. Plast Reconstr Surg. 2006;118(Suppl 3):34s–45s. 27. Moers-Carpi, M, et al. Dermatol Surg. 2007;33(Suppl 2):S144–S151. 28. Merz Aesthetics®. Data on File. 2023. 29. Fabi, SG, et al. J Drugs Dermatol. 2021;20(5):534–537. 30. Draoui, O. The story of calcium hydroxylapatite. In: van Loghem, J, ed. Calcium Hydroxylapatite Soft Tissue Fillers. 2021. All models and patients shown in this brochure are actual RADIESSE® patients.
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