Restylane“The Filler of the New Millennium”       Physician Name, MD
Introduction “How Happy are You with Your Appearance”?          -Consumer Poll in March 2003 • Nearly half gave a score of...
Epidemic of Aging • Increasing percentage of US population   aged 45 years or greater. • Population over 45 will increase ...
Facial Aging • Thinning of the dermis and atrophy of fat pads • Loss of elasticity • Greater visibility of bony landmarks,...
Aging in the Lower Face•   Increase prominence of the nasolabial folds•   Deepening of the nasolabial groove•   Ptosis of ...
The 4 “R”s of Facial Aesthetics • Resurface • Relax • Refill • Redrape
Recontouring with Fillers   Fillers provide patient with fuller, youthful face and        can soften the appearance of agi...
Permanent Fillers May CausePermanent Problems Think twice before you ask your doctor for a   permanent solution:      “For...
Science of Hyaluronic Acids
History of Hyaluronic Acid • 1934: Meyer and Palmer first isolated hyaluronic   acid from bovine vitreous humor • 1970s: F...
Hyaluronic Acid • Has a simple chemical structure and is   identical in all species and tissues; thus is   non-immunogenic...
Stabilization of HA• Unmodified HA has a half-life in the body of  24-48 hrs• Stabilization increases the length of time i...
Physiologic Functions of HA  • Important component of the extracellular space  • Maintains proper structure and tissue fun...
Concentration/Distribution of HA.    • Average concentration of HA in       human body: 200mg/kg     • Largest distributio...
Differences between Animal and Non-Animal Based HA Products • Source and Purity:    – NASHA™ products (from bacteria) are ...
Non-Animal Based HA Products• NASHA™ - Patented form of non-animal based HA  – Source: Bacteria (streptococcus) fermentati...
NASHA-based on three considerations • To provide pure hyaluronic acid • To stabilize the molecule by the minimum   possibl...
Isovolemic degradation • The NASHA-gel is slowly degraded over   time • Isovolemic degradation. The initial volume   of th...
Isovolemic degradation
Restylane“ The Filler of the New Millennium”•   Biocompatible      • Stable after injection•   Non-antigenic      • Non-mi...
INSTANTRESULTS
Restylane consumer presentation1
Restylane consumer presentation1
Restylane consumer presentation1
Restylane consumer presentation1
Restylane consumer presentation1
Restylane consumer presentation1
Restylane consumer presentation1
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Restylane filler presentation

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  • Copyright © 2003 Thomson Advanced Therapeutics Communications™ and Vanderbilt University School of Medicine. All rights reserved. The Science of Hyaluronic Acids
  • Copyright © 2003 Thomson Advanced Therapeutics Communications™ and Vanderbilt University School of Medicine. All rights reserved. History Hyaluronic acid was first isolated in 1934 by Karl Meyer and John Palmer from bovine vitreous humour. In 1942, Endre Balazs applied for a patent to use hyaluronic acid as a substitute for egg white in bakery products. He became a leading expert on HA and made many of the discoveries about it for many years. 1970s: HA is first used therapeutically. In the 1980s, Biomatrix, Inc., developed second-generation hyaluronic acid derivatives (hylans) through a process called cross-linking or stabilization. Because hylans are more stable than naturally occurring hyaluronic acid, they have greatly increased tissue residency. In 1986, modern nomenclature gave the name “hyaluronan” to hyaluronic acid. 1 1. Balazs EA, Denlinger JL. Clinical uses of hyaluronan. Ciba Found Symp . 1989;143:265-285.
  • Copyright © 2003 Thomson Advanced Therapeutics Communications™ and Vanderbilt University School of Medicine. All rights reserved. Introduction: Hyaluronic Acid HA is one of natures most versatile macromolecules. It has a simple chemical structure which is identical in all species and in all tissues. HA is found in all vertebrates and is biosynthesized by some bacteria. Thus, HA is a universal component of the extracellular space, where it has multiple properties and constitutes a matrix that supports the normal function of cells and tissues. The identical structure of HA from all sources makes it an ideal substance for use as a biomaterial in health and medicine. HA is highly hydrophilic. HA is rapidly metabolized (in vivo). The half-life in most tissues ranges from 0.5 to a few days. HA may be obtained by extraction or through biotech methods. Hyaluronic acid has been traditionally extracted from chicken combs and bovine vitreous humor. HA products of animal origin can contain impurities that can be associated with allergic reactions. HA is also synthesized by some bacteria. Today, hyaluronic acid can be produced using non-animal components through modern biotechnological methods, reducing impurities and the risk of allergic reactions. (Non-animal derived sources can also cause allergies if the protein load is too high.)
  • Copyright © 2003 Thomson Advanced Therapeutics Communications™ and Vanderbilt University School of Medicine. All rights reserved. Goals of Stabilization of HA Unmodified hyaluronic acid is rapidly cleared by the body (half-life, 24-48 hours). It is degraded in the lymph nodes and liver to CO 2 and H 2 O. In order to increase tissue residency, the HA molecule must be stabilized. This is achieved through a process of cross-linking. The goals of stabilizing the hyaluronic acid molecule are to increase tissue residency, viscosity and elasticity. At the same time, in order to retain the biocompatibility and biological properties of the molecule, the amount of modification should be minimal. Greater degrees of cross-linking reduce the biocompatibility of HA. Less biocompatible HA will degrade more quickly as it is not recognized by the body
  • Copyright © 2003 Thomson Advanced Therapeutics Communications™ and Vanderbilt University School of Medicine. All rights reserved. Physiologic Functions Hyaluronic acid is an important component of the extracellular space. HA helps maintain the structure and function of tissues by creating volume, lubrication tissues and affecting cell integrity, mobility and proliferation. Creating volume: Hyaluronic acid forms a random coil in tissue that holds water and allows passage of metabolites to and from cells. Lubricating cells: Physiologically, HA stabilizes intracellular structures by creating a elastoviscous matrix. Cell integrity, mobility and proliferation: HA network assists in cell differentiation, migration and wound repair. As a highly permeable compound, HA regulates transport of solutions and cell movement and function. Importance to the skin: Hyaluronic acid is most abundant in the skin, where its ability to bind with water creates volume. In addition to being highly hydrophilic, HA also maintains the viscoelasticity of the skin. Without HA, the skin would appear dry, withered and wrinkled. Concentrations of naturally occurring hyaluronic acid within the skin decrease with aging. 1 This decrease in the number of HA molecules means less opportunity for water molecules to bind which results in less hydration of the skin. Skin also loses its elasticity and becomes more susceptible to injury and infection.
  • Copyright © 2003 Thomson Advanced Therapeutics Communications™ and Vanderbilt University School of Medicine. All rights reserved. Concentration of HA Concentration of HA in tissues varies The average concentration in the human body is 200mg/kg. Thus a person weighing 60kg, contains about 121g of hyaluronic acid. Although the highest concentrations of hyaluronic acid are found in connective tissues, most HA is found in the skin (56%) Distribution of HA Average distribution of HA in tissues: Skin: 56% Connective Tissues: 27% Muscles: 8% Intestines: 1% Other: 8% The normal state of HA in tissues is a free polymer. In some tissues however, such as cartilage and tendons, HA is bound to large glycoprotein structures or in other tissues, to specific cell receptors.
  • Copyright © 2003 Thomson Advanced Therapeutics Communications™ and Vanderbilt University School of Medicine. All rights reserved. Summary: Differences between animal and Non-Animal Based HA Products NASHA ™ is not derived from animals hence there is no risk of transmitting diseases and minimal risk of allergic reactions. No pre-injection skin test is required. NASHA ™ is modified only slightly – 1% as compared to Hylaform ® – 20% NASHA ™ is less extensively cross-linked than Hylaform ® which increases its biocompatibility and tissue residency .
  • Copyright © 2003 Thomson Advanced Therapeutics Communications™ and Vanderbilt University School of Medicine. All rights reserved. Non-Animal Based Hyaluronic Acid Products NASHA ™ : Non-Animal Stabilized Hyaluronic Acid - Is a patented form of hyaluronic acid products Source of NASHA ™ is through a bacterial (streptococcus) fermentation process. The bacteria are cultured in a non-animal medium and the integrity of the HA producing cells is preserved. Purity of NASHA ™ : Non-animal base and h igh molecular weight (~1 million) combined with the manufacturing process reduces potential impurities to a very small and well-defined amount. Thus there is no need for allergy testing prior to patient administration. Stabilization of NASHA ™ is achieved by adding an organic solvent. This causes some of the HA molecules to link together (about 1%). Reduced amounts of cross-linking allow for the product to remain biocompatible. An insoluble gel with a 3-dimensional HA network is formed. Concentration: The concentration of HA in all Restylane products is 20mg/mL Degradation of NASHA ™ is unique as the product maintains its initial volume over time. This process is known as isovolemic degradation. Bead contains 5x more HA than needed to help maintain its volume. This excess of HA makes the gel bead last longer As the stabilization bridges (cross-links) disappear, water bonds in its place. As the product becomes less concentrated, it holds more water. The volume of the product continues to be maintained with the addition of water molecules. When completely degraded, the remaining HA fragments are metabolized and no trace of the product remains.
  • Copyright © 2003 Thomson Advanced Therapeutics Communications™ and Vanderbilt University School of Medicine. All rights reserved. One of NASHA's exclusive features is that it is long-lasting. As we all know a biodegradable implant normally shrink gradually upon degradation. The NASHA-gel have a unique property of maintaining the initial volume throughout the degradation phase. During the degradation phase the stabilizing bridges slowly disappears. Water takes the place of a disappearing stabilizing bridge and the less concentrated the gel becomes – the more water each molecule is able to bind. This means that the same volume can be maintained with less implant material. Finally the implant is fully degraded and no traces of the hyaluronic acid will be left in the tissue.
  • Copyright © 2003 Thomson Advanced Therapeutics Communications™ and Vanderbilt University School of Medicine. All rights reserved. One of NASHA's exclusive features is that it is long-lasting. As we all know a biodegradable implant normally shrink gradually upon degradation. The NASHA-gel have a unique property of maintaining the initial volume throughout the degradation phase. During the degradation phase the stabilizing bridges slowly disappears. Water takes the place of a disappearing stabilizing bridge and the less concentrated the gel becomes – the more water each molecule is able to bind. This means that the same volume can be maintained with less implant material. Finally the implant is fully degraded and no traces of the hyaluronic acid will be left in the tissue.
  • Copyright © 2003 Thomson Advanced Therapeutics Communications™ and Vanderbilt University School of Medicine. All rights reserved. In many publications and presentations these characteristics are mentioned when discussing dermal fillers. Usually not all criterias are mentioned at the same time but anything from four to all are commonly used. Many doctors mention several of these characteristics when speaking about the RESTYLANE product range. What they sometimes comment on, however, is long-lasting a non not too expensive. These are two very subjective criteria and the perception of what is long-lasting and expensive is very much up to each individual. It must be considered as a strong competitive advantage to fulfill all these criteria.
  • Copyright © 2003 Thomson Advanced Therapeutics Communications™ and Vanderbilt University School of Medicine. All rights reserved.
  • Copyright © 2003 Thomson Advanced Therapeutics Communications™ and Vanderbilt University School of Medicine. All rights reserved.
  • Copyright © 2003 Thomson Advanced Therapeutics Communications™ and Vanderbilt University School of Medicine. All rights reserved.
  • Copyright © 2003 Thomson Advanced Therapeutics Communications™ and Vanderbilt University School of Medicine. All rights reserved.
  • Copyright © 2003 Thomson Advanced Therapeutics Communications™ and Vanderbilt University School of Medicine. All rights reserved.
  • Copyright © 2003 Thomson Advanced Therapeutics Communications™ and Vanderbilt University School of Medicine. All rights reserved.
  • Restylane consumer presentation1

    1. 1. Restylane“The Filler of the New Millennium” Physician Name, MD
    2. 2. Introduction “How Happy are You with Your Appearance”? -Consumer Poll in March 2003 • Nearly half gave a score of 5 or less on a scale of 10 • Only 1 in 4 adults Americans consider themselves attractive • 30% indicate they would change something about their looks
    3. 3. Epidemic of Aging • Increasing percentage of US population aged 45 years or greater. • Population over 45 will increase 20% from 2000-2025 • 59.2 million people in America between the ages of 45-59 • Aging Baby Boomers will have substantial impact on aesthetic marketplace
    4. 4. Facial Aging • Thinning of the dermis and atrophy of fat pads • Loss of elasticity • Greater visibility of bony landmarks, blood vessels, wrinkles and furrows • Transverse forehead lines • Lowering of the eyebrows • Descent of the corners of the mouth • Ptosis of nasal tip
    5. 5. Aging in the Lower Face• Increase prominence of the nasolabial folds• Deepening of the nasolabial groove• Ptosis of commissure• Thinning of the lips• Flattening and lengthening of the upper lip• Lateral mandibular groove• Prejowl depression• Less defined cupids bow• Perioral rhytids
    6. 6. The 4 “R”s of Facial Aesthetics • Resurface • Relax • Refill • Redrape
    7. 7. Recontouring with Fillers Fillers provide patient with fuller, youthful face and can soften the appearance of aging• Permanent • Non-Permanent -Lasting over 12 months – Lasting under 12 -Non-degradable months -Remains in the tissues – Degradable -Appearance can become – Temporary in case distorted due to aging patient is not satisfied process – Side-effects usually -Long-term side effects: mild and transient Granulomas, asymmetry, lumpiness, migration – Animal vs. Non-animal -Must be removed if effect is undesirable
    8. 8. Permanent Fillers May CausePermanent Problems Think twice before you ask your doctor for a permanent solution: “Forever is a long, long time”
    9. 9. Science of Hyaluronic Acids
    10. 10. History of Hyaluronic Acid • 1934: Meyer and Palmer first isolated hyaluronic acid from bovine vitreous humor • 1970s: First used therapeutically in human medicine and surgery • First product containing HA (for use in eye surgery) and (treatment of osteoarthritis) • 1980s: Biomatrix, Inc. developed second- generation hyaluronic acid derivatives (hylans) through cross-linking (stabilization), greatly increasing tissue residency
    11. 11. Hyaluronic Acid • Has a simple chemical structure and is identical in all species and tissues; thus is non-immunogenic • Found in all vertebrates and synthesized by some bacteria • Ideal biomaterial substance of use as a filler • Highly hydrophilic – “Loves water” • Rapidly metabolized in the body
    12. 12. Stabilization of HA• Unmodified HA has a half-life in the body of 24-48 hrs• Stabilization increases the length of time it exists in the skin.• Modification should be minimal so that the body sees the material as native.• HA must be cross-linked to stabilize the molecule
    13. 13. Physiologic Functions of HA • Important component of the extracellular space • Maintains proper structure and tissue function by: – Creating volume through high water binding capability – Protecting and lubricating tissues, joints and tendons – Affecting cell integrity, mobility and proliferation – Filtration and regulation of protein distribution – Transportation of nutrients to and from cells • Importance of HA in the skin: – Maintains volume and viscoelasticity – HA concentrations decrease with age1 1. Longas MO et al. Carbohydr Res. 1987;159:127-136.
    14. 14. Concentration/Distribution of HA. • Average concentration of HA in human body: 200mg/kg • Largest distribution of HA is in skin: 56% 8% 1% 8% Skin Connective Tissue Muscle 56% Intestines 27% Other Distribution of HA
    15. 15. Differences between Animal and Non-Animal Based HA Products • Source and Purity: – NASHA™ products (from bacteria) are more pure than animal- based HA products (from chicken combs) – Animal based products may require skin testing • Stabilization: – NASHA™ product modified 1% – Hylaform® products modified 20% • Biocompatibility: – Due to lower degree of cross-linking, NASHA™ products are more biocompatible than Hylaform® products – Increased biocompatibility indicates longer tissue residency
    16. 16. Non-Animal Based HA Products• NASHA™ - Patented form of non-animal based HA – Source: Bacteria (streptococcus) fermentation process – Purity: Minimal and well-defined impurities – Stabilization: Achieved by adding small amount of organic solvent • Degree of cross-linking is 1% • Product remains biocompatible – Concentration: 20mg/mL of HA for all products – Degradation: Maintains initial volume through process of isovolemic degradation • Bead contains 5x more HA than needed for volume maintenance • As stabilization bridges (or cross-links) disappear, water bonds in its place • More volume is maintained with less product
    17. 17. NASHA-based on three considerations • To provide pure hyaluronic acid • To stabilize the molecule by the minimum possible modification-for longer duration and minimal tissue disturbance • High clinical performance as well as safe use with minimal side effects. The hyaluronic acid is virtually unchanged and therefore similar to native hyaluronic acid
    18. 18. Isovolemic degradation • The NASHA-gel is slowly degraded over time • Isovolemic degradation. The initial volume of the material is maintained throughout the degradation phase • The less concentrated the gel becomes – the more water each molecule is able to bind
    19. 19. Isovolemic degradation
    20. 20. Restylane“ The Filler of the New Millennium”• Biocompatible • Stable after injection• Non-antigenic • Non-migratory• Non-pyrogenic • Long-lasting but• Non-inflammatory resorbable• Non-toxic • Natural looking• Non-animal • Forgiving • Not too expensive
    21. 21. INSTANTRESULTS
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