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TRAINING MANUAL TRAINING MANUAL P3

ALGENESS® THE HISTORY 01

An all-natural alternative to Hyaluronic acid fillers has been the dream of many clinicians,

including Leonard Miller, MD, a noted plastic surgeon in the US.

As a result of his research of published papers and aesthetic contacts, Dr. Miller discovered

the wealth of data and information on agarose derived from red algae.

Armed with this knowledge and data, Dr. Miller identified the manufacturer of this filler

which is composed of highly purified agarose in an all natural formulation.

Advanced Aesthetic Technologies, Inc. was then formed to acquire this technology in late Advanced Aesthetic Technologies Inc. 2014 and launched Algeness® in 2015. is an USA based company developing bio-technologies in the aesthetic medical field. TRAINING MANUAL P5 01 INTRODUCTION

Algeness® is distinguished by its ability to instantly volumize soft tissue for a more defined MASTER YOUR RESULTS ® natural look with a technique we call “MASTER YOUR RESULTS®”.

Additionally, unlike all HA fillers, Algeness® injectable implant is fully biodegradable and

biocompatible. In our “MASTER YOUR RESULTS®” program, we instruct practitioners in A BREAKTHROUGH the art of the technique to maximize the unique properties of Algeness® for consistently IN FILLER’S TECHNOLOGY excellent outcomes that are achieved immediately with little to no migration over time. THE FIRST BIODEGRADABLE INJECTABLE IMPLANT

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WHAT IS ALGENESS ® ?

MASTER YOUR RESULTS ® 02 TRAINING MANUAL P9 Algeness® is a biomaterial consisting of a purified agarose

WHAT IS AGAROSE? WHAT IS ALGENESS ® ? THE SCIENCE

• Agarose is a neutral polysaccharide Chemically agarose is a polysaccharide of a long chain of disaccharide units formed by • Highly purified it does not contain any protein and is free from bacteria two rings of 6 atoms. On each ring there is one Oxygen and 5 Carbon atoms and one ring • It is free from toxicity to micro-organisms and free from impurities contains only one OH group, while the other contains three. • Agarose is safe and totally biocompatible to the 02 OH OH Stereochemical O structure HOW IS AGAROSE OBTAINED? O OH of agarose gel O O H incorporating water OH O HO molecules n

Red Algea Agar Agar

In presence of water Agarose forms hydrocolloids. TRANSFORMATION

A B C D Purification process

ELIMINATION Pure Agarose

OH OH O O OH O O H O OH HO PURIFICATION Agaropectin n

Charged with sulfated polymer

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WHAT IS A HYDROCOLLOID? AGAROSE VERSUS HA

A hydrocolloid is a substance in a colloidal state formed of water (usually polysaccharide molecules which form fibres that retain the water molecules). MOLECULAR STRUCTURE It has the ability to retain the which it comes into contact with (in the case of a hydrogel the liquid is constituted of water) and therefore can be considered as a polymer that possesses the cohesive properties of a solid and the diffusion transport Agarose HA 02 properties of a liquid. OH OH O Algeness® has these properties and has a sufficient low viscosity, to be easily extruded O OH O O through a very thin needles. H O OH HO Thanks to its particular molecular structure, in which agarose presents a three dimensional n

® lattice, the integration into the tissues is ideal and stable (no migration). Algeness act as a • Polysaccharide polymer • Polysaccharide polymer structural support to eliminate depressions in the deep layers of the skin. • Disaccharide made up • Disaccharide made up of For these biochemical, physical and structural features, the agarose gel acts as a structural of D-galactose d-glucuronic acid support of the tissues giving them three-dimensional support against the forces exerted on and 3 6-anhydro-l-galactose and D-N-acetylglucosamine them by gravity and movement.

VI

OSMOSE PROCESS

VIII

VII Agarose Extracellular matrix structure IX

III R I

V IV

II

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ALGENESS® VERSUS HA FILLERS RESORPTION PROCESS OF AGAROSE

Cross linked HA fillers

DESTRUCTION • Purified Agarose (100% natural) • Synthetic HA IN THE PENTOSE • Saline solution • Chemical cross linking agent BDDE, PEG, RAH… 02 > > > CYCLE • Degradation 100% by Macrophages • Degradation of HA by Hyaluronidase • No residue • No degradation of the cross linking chemicals

Macrophage’s action Transport into the Enzymatic action cells of the galactosidase Reticulo-endothelial system

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ALGENESS®

BENEFITS & INDICATIONS

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ALGENESS® A REAL SCIENTIFIC BREAKTHROUGH WHY IS ALGENESS ® A UNIQUE ALTERNATIVE?

• For the first time in aesthetic medicine history, a 100% natural, biocompatible and The agarose gel is physically removed from the site by macrophages and then biodegradable injectable implant is available for safe and mastered injection. transported to the endothelial reticulum system (found mainly in the liver and the spleen). • Algeness® is totally biocompatible to the human body, and does not contain cross-linked The galactans are degraded in the pentose cycle together with the macrophages, platelets, synthetic chemicals (like BBDE) associated with Hyaluronic acid (HA) fillers. and cells of the endothelial reticulum. • Non allergenic; Algeness® offers excellent tolerability with a negligible immunological 03 reaction. Compararison Collagen - HA - Algeness®

Ref: Agarose gel filler; Histologic study of biocompatibility and interaction with human cutaneous structures. Prof. Alessio Pirino, Dr. Giorgio Maullu. Department of Biomedical Sciences, CRISMENC, University of Sassari, Italy

ALGENESS® BENEFITS • Unique volumizer to compensate bone mass and subcutaneous volume loss with Less capsula immediate results. • Long lasting results over 12 months demonstrated by clinical studies. • Minimal irritation & inflammation due to the absence of foreign body reactions. • Extremely low migration out of the injection site especially important in the cheek area for lifting and volumizing. • Excellent shaping capabilities for a more defined youthful appearance. • Ideal injectable implant for non surgical face lifting and contouring.

Low ALGENESS® BENEFITS ALGENESS® PURE AND SAFE inflammatory • 100% natural and biocompatible • Chemical Free reaction • Non allergenic filler • No Granulomatous activity • 100% Biodegradable • No capsula • Unique physical properties of • No Inflammatory reaction viscosity and plasticity

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ALGENESS® PRODUCT RANGE 1% 1,5% 2,5% 3,5% Product LD HD VL DF Charm

Composition 1.0% Agarose 1.5 % Agarose 2.5% Agarose 3.5% Agarose 99% sterile saline 98.5% sterile saline 0.5% non cross-linked HA 0.4% non cross-linked HA 97% sterile saline 96.1% sterile saline

Indication augmentation Marionette lines, wrinkles, Medium-deep volumizing Deep volumetric filling 03 Marionette lines and furrows Wrinkles, furrows and folds Cheeks, jawline and chin Tear trough correction Cheeks, jawline and chin Nasolabial folds and contouring Nasolabial folds Malar-zygomatic arch Oral commissure Malar and Submalar Submalar Oro-mandibular folds Non-surgical rhinoplasty Non-surgical rhinoplasty

Technique Linear, Linear, Linear, Linear, Retrograde Retrograde Retrograde Retrograde Tunneling Tunneling Small

Injection Immediately Subcutaneous Deep hypodermis Deep hypodermis depth Subcutaneous above bone

Follow up After 7-10 days if After 7-10 days if After 7-10 days if After 7-10 days if additional corrections additional corrections additional corrections additional corrections are required are required are required are required

Duration 3 – 4 months or more 4 – 8 months or more 8 – 12 months or more 8 – 12 months or more

Volume 0.5 ml 1.4 ml 1.4 ml 1.4 ml

Needle size 30 G 30 G 27 G 27 G

Each box 2 disposable “full-use” 2 disposable “full-use” 2 disposable “full-use” 2 disposable “full-use” contains 0.5 ml double Luer Lock 1.4 ml double Luer Lock 1.4 ml double Luer Lock 1.4 ml double Luer Lock syringe syringe systems, 2 needles syringe systems, 2 needles systems, 2 needles per syringe, systems, 2 needles per syringe, per syringe, 2 Luer caps, per syringe, 2 Luer caps, 2 Luer caps, 1 ergonomic syringe 2 Luer caps, 1 ergonomic syringe 1 ergonomic syringe grip, 1 ergonomic syringe grip, grip, product insert. grip, product insert. product insert. product insert.

Shelf life 2 years 2 years 2 years 2 years

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INDICATIONS

TEMPLE

ZYGOMATIC ARCH NOSE CORRECTION MORPHOLOGICAL CHANGES LIP CONTOURS NASOLABIAL POINT MOUTH COMISSURE BETWEEN AND NOSE OF THE FACE DUE TO AGEING

JAW LINE LIP CONTOUR

CHIN

BEFORE INJECTING ALGENESS ®

Understanding of the Face Ageing process What can be done with Algeness® injectable implant?

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MORPHOLOGICAL CHANGES OF THE FACE DUE TO AGEING MORPHOLOGICAL CHANGES DUE TO AGEING

LAXITY OF THE CANTHAL TENDON 40 30 years 50 04 years years

20 60 LAXITY AND DESCENT OF years years THE ORBICULARIS OCULI

The cumulative effects of DESCENT OF THE LID-CHEEK JUNCTION AND WEAKENING • Gravity, OF THE ORBITAL SEPTUM

• Tissue laxity, DESCENT OF THE CHECK FAT PAD WITH • Fat redistribution, LAXITY OF THE OBITOMOLOAR LIGAMENT • Generalized volume loss, LAXITY OF THE SMAS COVERING are all factors in the sequence of aging. ZIGOMATICUS MUSCLES AND OTHER ELEVATORS OF THE UPPER LIP

DEEPENING OF THE NASOLABIAL FOLD

JOWL FORMATION

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MORPHOLOGICAL CHANGES DUE TO AGEING MORPHOLOGICAL AND PHYSIOLOGICAL ANALYSIS

• An accurate analysis of the patient’s face morphology and physiological state is necessary before any treatment. With ageing; • It helps to understand where the volume loss is the most visible. • Cells turnover decreases. • The skin thins and becomes 04 dehydrated. • It loses its elasticity. • Then wrinkles form on the face due 01 to pressure and muscular action, but especially because the skin is 01 FOREHEAD RHYTIDS (WRINKLES) 02 02 BROW PTOSIS permanently exposed. 04 03 03 SKIN LAXITY WITH HOODING UPPER LID

04 GLABELLAR FROWN 05 05 TEAR TROUGH DEFORMITY 06 06 BAGGING OF THE LOWER LID

07 PERIORAL RHYTIDS (WRINKLES) HISTOLOGY: YOUNG SKIN [A], MATURE SKIN [B] YOUNGER & OLDER SKIN 08 ELONGATION AND FLATTENING OF UPPER LIP; 07 THINNING OF VERMILLION 1 1 08 09 09 MARIONETTE LINES 2 EPIDERMIS 10 JOWLS 2 10 ELASTIC FIBER 11 CHIN PTOSIS 3 4 DERMIS 11 12 PLATYSMA BANDS COLLAGEN

HYPODERMIS YOUNGER SKIN OLDER SKIN 12 [A] [B]

[ 1 ] STRATUM CORNEUM [ 2 ] EPIDERMIS [ 3 ] PAPILLARY DERMIS [4 ] DERMIS

With ageing, all ANABOLIC TISSUE processes become CATABOLIC resulting in involution of all the functional anatomical structures.

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MORPHOLOGICAL AND PHYSIOLOGICAL ANALYSIS MORPHOLOGICAL CONSEQUENCES OF AGEING Areas where the volume loss is the most visible. 04 01  MALAR EMINENCE

1. SKIN QUALITY 02  HOLLOW (elastin, collagen, dehydration) 01 CHEEKS 03 2 . VOLUME LOSS 03  LOWER (collagen, fat, bone ) 02 04 EYELDS 3. WRINKLES (dynamic, static) 04  NASOLABIAL FOLD

05 05  PRE-MANDIBULAR CREASE

1. Fat pad shrinkage 2. Bone resorption 3. Muscular contraction

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MORPHOLOGICAL CONSEQUENCES OF AGEING MORPHOLOGICAL CONSEQUENCES OF AGEING

> FAT PAD SHRINKAGE > BONE RESORPTION Arrows indicate the areas of the facial skeleton susceptible to resorption with aging. 04

YOUTHFULL FACE AGING FACE

> FAT PADS

01 01 02 03 02 05 03 04 YOUNG FEMALE OLD FEMALE

SUPERFICIAL FACIAL FAT PADS DEEP FACIAL FAT PADS

01 INFRAORBITAL FAT 01 LATERAL SOOF 02 SUPERFICIAL 02 MEDIAL SOOF MEDIAL CHEEK FAT 03 FIXATION POINT 03 NASOLABIAL FAT 04 BUCCAL FAT 05 DEEP MEDIAL CHEEK FAT

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MORPHOLOGICAL CONSEQUENCES OF AGEING MORPHOLOGICAL AND PHYSIOLOGICAL ANALYSIS

• The right analysis will lead to the right injection strategy. > MUSCULAR CONTRACTION • Algeness® is a perfect volumizer to compensate facial bone’s resorption and fat pads shrinkage.

CORRUGATOR SUPERCILII 01 02 FRONTALIS 02

PROCERUS 03

TEMPORALIS 04 01 ORBICULARIS OCULI 05 04 05 LEVATOR LABII SUPERIORISS 06 03 01 BONE REMODELING MASSETER 07

ZYGOMATICUS MINOR 08 14 06 03 FUROW FILLING ZYGOMATICUS MAJOR 09 08 RISORIUS 10 07 04 WRINKLE FILLING PLATYSMA 11 09 15 DEPRESSOR LABII INFERIORIS 12 10 02 RESHAPING DEPRESSOR ANGULI ORIS 13

NASALIS 14 11 12 ORBICULARIS ORIS 15 13 MENTALIS 16 16

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ALGENESS® INJECTION TECHNIQUE

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ALGENESS® IS INDICATED FOR DEEP INJECTION ONLY LINEAR RETRO-TRACING TECHNIQUE

Consists of inserting the needle to almost its entire length, keeping it closely parallel to the skin’s plane and injecting the gel while slowly withdrawing it. This applies much less pressure to the syringe and allows the threads of gel to be deposited more easily in the

CUTANEOUS TISSUE tissues. EPIDERMIS AND DERMIS 05

HYPODERMIS 01 02 03 SUPERFICIAL AND DEEP

DERMIS DERMIS DERMIS

MUSCLE SUPERFICIAL SUPERFICIAL SUPERFICIAL HYPODERMIS HYPODERMIS HYPODERMIS

DEEP DEEP DEEP HYPODERMIS HYPODERMIS HYPODERMIS BONE MUSCLE MUSCLE MUSCLE BONE BONE BONE

1% 1,5% 2,5% 3,5% LD HD VL DF

Tear trough, fine lines, Marionette lines, fine Medium-deep volumizing, Deep volumetric filling, Lip augmentation. lines, Lip augmentation Wrinkles, furrows and folds, Cheeks and jawline and and contouring, Oral Cheeks, jawline and chin, chin, Nasolabial folds, Malar- commissure. Nasolabial folds, zygomatic arch Submalar, Non-surgical rhinoplasty. Non-surgical rhinoplasty.

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PRE-PROCEDURE CONSIDERATIONS

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PRE-PROCEDURE CONSIDERATIONS TIMING OF OTHER AESTHETIC PROCEDURES

Patient has to be informed of the limitations and risks of Algeness® volumizer injection. And its expectations must be realistic. TREATMENT TIME 2 weeks pre or post treatment

Avoid body dysmorphic patient. IPL 1 – 2 weeks pre or post treatment

Chemical peeling 1 – 2 weeks pre or post treatment Review carefully the patient’s medical history including all cosmetic treatments 06 Micro-dermabrasion 1 – 2 weeks pre or post treatment • Previous dermal filler • Any complication Laser resurfacing 3 – 4 weeks interval to treatment • Current medication • Allergies Permanent filler Injection is discouraged • Life style factors Surgical insert, solid implants Proceed with much caution

Other temporary HA fillers 2 weeks interval. Proceed with caution Take always pretreatment photos for assessment and evaluation purposes. Other temporary non HA fillers 2 weeks interval; Proceed with caution

Dental procedures 2 – 3 weeks interval to treatment REMEMBER “MASTER YOUR RESULTS YOUR WORK IS YOUR REPUTATION”

Do not treat patient with:

PRE-PROCEDURE ASSESSMENT • Infected vulnerable skin 1. What does your patient want versus what is realistically achievable • Risk of dental abscess with a needle and within budget and time frame • Currently taking antibiotics 2. Make a mutually agreed plan • Known allergy/hypersensitivity to the material 3. Obtain signed patient consent • History of severe allergy or anaphylaxis • Known bleeding disorders • Known pregnancy or IVF treatment

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PRE-PROCEDURE ASSESSMENT PRE-PROCEDURE ASSESSMENT

Consider your patient needs before the procedure. • Respect the natural proportions of the face. • Make sure the patient understand the concept of correction and beauty enhancement. • Expectations have to be realistic. • Take photos before injecting. 06 07

03 13 01 EAR LOBE CORRECTION 02 UNDEFINED JAWLINE 03 HOLLOW TEMPLES 04 LOSS OF VOLUME IN CHEEKS 04 05 LAUGH LINES 08 14 06 MARIONETTE LINES 01 07 DROOPY EYEBROWS 08 UNDEFINED NOSE OR TIP 09 09 LINES 02 05 10 THIN LIPS 11 CHIN WRINKLES 12 SAGGING CORNERS 12 13 CREASES BETWEEN BROWS 06 10 14 HOLLOWNESS UNDER EYES

11

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PRE INJECTION PROCEDURE; CLEANSING & ANESTHESIA PRE INJECTION PROCEDURE

• The injection sites will be cleansed with an antibacterial agent. • Strict asepsis has to be maintained during the procedure. 01 02 03 Pain at the injection site may be ameliorated by: • The use of a very cold instrument to chill the skin. Prepare the syringe Selection of the needle Mark the skin pre injection • Anesthetic ointment to numb the skin, or Injection of local anesthetic. Thorough mixing or cannula and further photographs 06 • Use sterile gloves. is very important in order to re-homogenise the gel inside the syringe. (about 50 times)

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BEFORE INJECTING;

FACE ANATOMY REMINDER

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FACE ANATOMY REMINDER THERE IS NO SAFE AREA!

You must have a thorough knowledge of facial anatomy and the distribution of the facial • Bones arteries and nerves. • Fat • Muscles • Veines 07 • Arteries • Lymph vessels

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FACIAL NERVES FACIAL ARTERIES

Be aware that patients with a history of dental or facial surgery may have areas of unusual vascular distribution. 07

01  INTERNAL CAROTIDE 02  OPHTALMIC 4 5 03 LACRIMAL 1 04 SUBRAORBITAL 16 3 6 15 05 SUPRAORBITAL 1 2 06  INFRATOCHLEAR 07  INFRAORBITAL 08  ANGULAR 2 01 14 7 09  SUPERIOR LABIAL 8 3 13 10  INFERIOR LABIAL 11  FACIAL 9 4 12  EXTERNAL CAROTID 1 TEMPORAL 13  INTERNAL MAXILARY 2 ZYGOMATIC 5 10 14  TRANSVERSE FACIAL 3 BUCAL 11 15  SUPERFICIAL TEMPORAL 4 MANDIBULAR 16  MIDDLE TEMPORAL 12

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INJECTION PROTOCOLS

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GENERAL CONSIDERATION

® Algeness is an injectable implant and cannot be compared to HA fillers when injected. LIP AUGMENTATION INJECTION PROTOCOL The protocols and injection technique described in this presentation have to be respected. A good understanding of the Algeness® agarose gel’s properties, its unique characteristics and plasticity, and proper injection technique and plane of placement are essential in order to place the correct amount of filler at the appropriate skin depth to provide maximum correction of the tissues while avoiding visibility or nodularity of the filler.

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LIPS AUGMENTATION LIP AUGMENTATION INJECTION PROTOCOL

• What are the patient expectations? Injection technique: • What look does the patient want? Deep linear retrograde - No Bolus • Can you achieve this with a filler? Indicated product: • Keep within Phi ratio 1.618 Algeness® LD 1% or HD 1,5% (very small quantity 0.5 ml) • Remember you can only try to improve what already exists 08 • Check Patient’s pain threshold Warnings: After care: Slow injection - Linear retrograde • herpes, Careful pressure on the syringe plunger because • bruising, low product extrusion force when injecting. • swelling, Careful molding post injection. • discomfort Use little quantities of the product stop and reassess do not rush the lips. Algeness® is not indicated for big lips volumization.

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TEMPLE DEPRESSION INJECTION PROTOCOL

Injection technique: Deep injection supraperiosteal - Bolus technique

Indicated product: VL 2.5% or DF 3.5% 08 Warnings: • Slow injection • Watch for arteries • Thorough massage

TEMPLE DEPRESSION INJECTION PROTOCOL

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ZYGOMAS’ VOLUMIZING INJECTION PROTOCOL

Injection technique: • supraperiosteal on zigomaticomalar region • deep subdermal on submalar and arteromedial area Linear retrograde injection only Indicated product: 08 VL 2,5% and DF 3,5%

Warnings: Slow injection Careful molding post injection

02 01 ZYGOMAS’ VOLUMIZING INJECTION PROTOCOL 01 Zygomaticomalar region 02 Anteromedial cheek region 03 03 Submalar region

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ZYGOMAS’ VOLUMIZING INJECTION PROTOCOL 08 CUTANEOUS TISSUE Epidermis and dermis

01

02 HYPODERMIS 03 02 03 Superficial and deep 01 SUPRAPERIOSTEAL

02 DEEP SUBDERMAL MUSCLE 01 03 DEEP SUBDERMAL BONE

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NASOLABIAL FOLD INJECTION PROTOCOL

Injection technique: Linear retrograde Deep subcutaneous 08 Indicated product: VL 2,5% or DF 3,5%

Warnings: remember your anatomy • Aspirate • Depth is very important • Avoid the danger zone NASOLABIAL FOLD INJECTION PROTOCOL venous occlusion • Slow injection • mold – stop - reassess

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NASOLABIAL INJECTION PROTOCOL BE AWARE! NASOLABIAL ARTERIES Two danger zones during filler injection for nasolabial fold 08

15 mm facial artery without any muscle

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NOSE VEINS AND ARTERIES - ANATOMY REMINDER 08

NOSE CORRECTION INJECTION PROTOCOL

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NERVES ANATOMY REMINDER NOSE INJECTION PROTOCOL

Injection technique: SUPRATROCHLEAR NERVE • Deep Linear retrograde • Supra periosteal 08 Indicated product:

NASAL BONES UPPER LATERAL VL 2,5% or DF 3,5% CARTILAGES INFRATROCHLEAR NERVE Warnings: SEPTUM ALAR CARTILAGE remember your anatomy • Aspirate EXTERNAL • Apply tight pressure on each side BRANCH OF ANTERIOR of the nose during injection to avoid ETHMOIDAL NERVE the vessel occlusion • Slow injection INFRAORBITAL NERVE • mold keeping the pressure on each side of the nose

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MANDIBULAR AND CHIN INJECTION PROTOCOL

Injection technique: • Linear retrograde • No bolus in the jaw line • Small bolus in the chin Deep subcutaneous 08

Indicated product: VL 2,5% or DF 3,5%

Warnings: remember your anatomy • Aspirate • Depth is very important • Avoid the danger zone venous occlusion • Slow injection • mold – stop - reassess

MANDIBULAR AND CHIN INJECTION PROTOCOL

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TEAR TROUGH INJECTION PROTOCOL

TYPOLOGY OF ORBITAL MARGIN DEFORMITIES

TYPE 1 TYPE 2 08 MINIMAL LOWER MINIMAL DESCENT LID AGING OF LID-CHEEK

TYPE 3 TYPE 4

LID-CHEEK MALAR BAG JUNCTION BELOW ORBITAL RIM TEAR TROUGH INJECTION PROTOCOL

NASOLABIAL NASOJUGAL GROOVE GROOVE

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TEAR TROUGH INJECTION PROTOCOL TEAR TROUGH INJECTION PROTOCOL

ORBITAL AGING INDICATIONS The superomedial and inferolateral aspects of the orbit have the tendency to resorb. 1 - Inferior Orbital Margin • Excessively deep inferomedial orbital margin contour (deep orbital part of tear trough). • Excessively deep inferior orbital margin contour­. 08 2 - Superior Orbital Margin • Medial hollowing of upper eyelid (A-frame deformity). • Hollowing of entire upper eyelid.

The first indication to consider are volume deficits in patients with a tendency towards periorbital oedema (malar mounds, eyelid oedema) or a known tendency to develop oedema around the orbital margin after hyaluronic acid injections.

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TEAR TROUGH INJECTION PROTOCOL TEAR TROUGH INJECTION PROTOCOL

INJECTION PLANE INJECTION TECHNIQUE Algeness® LD Charm 1% for tear through might be injected in two different layers Sharp Technique: For experienced injectors at the beginning of their learning curve on the orbital margin. Severe soft tissue atrophy located below the orbital retaining ligament (ORL): For expert injectors who prefer the sharp approach. • Deep injection into the suborbicularis oculi fat (SOOF) layer of the prezygomatic space in 8 order to restore volume. Advantage: maximal control of the position of the tip of the needle. • When the SOOF volume is restored Algeness® might be injected into the subcutaneous Disadvantages: superficial product spread along needle canal, higher chance of bruising. tissue located on the upper part of the orbicularis oculi muscle for fine correction. • If there is not soft tissue atrophy in SOOF Algeness® may be injected into the subcutaneous Compound Algeness® LD Charm 1% with 0,2 ml of lidocaine 2% with adrenaline 1/200.000 tissue above the orbicularis oculi muscle. for pain reduction and vasoconstriction. Perform multiple punctures along the volume deficit. (Fine droplet injections can be injected subcutaneously and well massaged if furrows and Position the tip of the needle under the orbicularis oculi muscle down to the bone. lines in the lower lid.) Gently remodel and massage at the end of the treatment.

Avoid repeated puncturing at the same spot, as reactive oedema and bleeding limits visual control. Remain aware of the cellular response to Algeness® and avoid all subcutaneous or intradermal injection in the periorbital area.

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TEAR TROUGH INJECTION PROTOCOL TEAR TROUGH INJECTION PROTOCOL

CANNULA TECHNIQUE SUPERIOR ORBITAL MARGIN For experienced and expert injectors. Access point at the transition between the eyelid and the eyebrow, superolateral. Cannula 27. All passages are to be made deep to the orbicularis oculi muscle and superficial Advantages: minimal tissue trauma, minimal bruising. to the orbital septum. Disadvantage: more expertise required to position the cannula. One passage into the A-frame area. 8 Important notice: a cannula 27 may work best to fill a hollow close to the medial canthal Aspiration. Slow and careful, retrograde injection of 0,1 to 0,3 ml. tendon insertion or at the lateral condensation, or to reach a submuscular position around a superomedial orbital hollow. Nevertheless, injection risks are higher with a small calibre Gently remodel and massage at the end of the treatment. cannula.

Local anaesthesia and vasoconstriction of cannula entrance points: Luer lock syringe 1 ml. Needle 33 G. Lidocaine 2% with adrenaline 1/200.000. 0,1 to 0,2 ml per point. Immediate subdermal and intradermal injection.

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POST PROCEDURE; CLEAN UP & RECOVERY ALGENESS® AFTER CARE INFORMATION

Once the results are deemed satisfactory, any markings will be cleansed off. Dear Patient Through massage of the injected area to optimize the shaping. Here are some suggestions for the after care of your treatment with Algeness® the all-natural Apply antibiotic oinment on the injection site. dermal filler that is 100% biocompatible and biodegradable. Please read carefully and follow these Remember to take photo post injection. suggestions below. • Immediately after the treatment, you may experience any of these conditions: 08 • Redness, sensivity, swelling, tenderness, and/or itching near the injection site. This is normal and generally disappears within a few hours to a few days. Avoid rubbing, touching the area of injection. • During the 24 hours following the procedure, avoid drinking alcohol or exercise, which may result in additional bruising. Stay out of the sun and avoid activities of sunbathing, tanning, saunas, hot tubs, or hot . Also avoid extreme cold, such as skiing or hiking outdoors. • If you have received the injection in the lip area, avoid lipstick or lip balm for 24 hours and refrain from biting your inner lips, this might lead to temporary swelling and appearance of tiny lumps. • If you experience any swelling apply cold packs, (ice) periodically to reduce the swelling. You may also PATIENT POST-PROCEDURE REQUIREMENTS take pain medications, However, taking Ibuprofen or aspirin may exacerbate bruising, as they have blood thinning properties. • Warn patients that nodules can rarely occur. • To help alleviate any bruising, you can topical application of Arnica ointment. If this is the case, the patient should return to the Physician asap for treatment • Minimize movement of the treated area. However, if there is a visible lump, you can gently massage the before a fully formed occurs area until you do not feel the lump. Always do the massage with clean fingers. Generally Algeness® will soften into the skin naturally within a few days. Should a lump occur and persist for up to 72 hour, call • NO SUN EXPOSURE FOR 72 HOURS your physician for an appropriate corrective action. • Should you experience any swelling with a warm sensation in the injected area 48 hours after the • NO MAKE UP FOR 24 HOURS treatment, please contact your physician to make sure there is no infection. If you have queries or concern, do not hesitate to call your physician at any time. • DO NOT TOUCH OF THE TREATED AREA FOR 12 HOURS

• DO NOT SMOKE FOR 12 HOURS

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TIPS AND PITFALLS

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TIPS AND PITFALLS MASTER YOUR RESULTS ® ALGENESS ® INJECTION GUIDE

Always take photograph pre and post treatment (invaluable). ALGENESS® SUBDERMAL FILLER IS A HYDROCOLLOID, Stings on injection lasts seconds - warn patient. NOT A HYDROPHILIC HA FILLER. Remind patient of possible swelling for up to 72 hours which can be sore. This INJECTION TECHNIQUE IS DIFFERENT FROM ANY OTHER DERMAFILLERS. will all settle. GOOD INJECTION TECHNIQUE WILL PRODUCE BETTER OUTCOMES Can use lidocaine 0.1 ml per syringe AND PATIENT SATISFACTION. 09 Small amounts injection FOLLOW THESE TIPS AND MASTER YOUR RESULTS®. Linear retrograde technique and small aliquots Avoid bolus technique n Cleanse face with antibacterial solution prior to injections. Very slow injection n Mix the filler well between the two (50 cycles). Take your time to massage and mold n To further reduce discomfort can add 0.05% lidocaine to the syringes. Have a post treatment take home card with aftercare reminders. n Inject subdermal for predictable results and to avoid nodules. n Aspirate, before injecting to assure not intra-arterial. EMERGENCY KIT REMINDER n Slow injection with even release of the filler. Don’t rush. PROMPT ACTION PROMPT ACTION n Linear retrograde technique or small aliquots (0,1 ml). Hyaluronidase – Saline solution The injection must be stopped immediately n Avoid large bolus injections only. Warm compress Stimulate blood flow to the affected area n Do not over correct especially with superficial (subdermal) injections. Firm massage Firm massage of the area n Take time to massage the injected filler until you hardly feel the product under your Aspirin Apply 2% nitroglycerin to stimulate fingers insuring smoothness. GTN spray and paste topically vasodilatation n Have a post treatment take home card for aftercare. Antibiotic cover Inject warm saline water or hyaluronidase all over n Always take photographs pre and post treatment (invaluable). Close monitoring 24 hours the affected area Photograph episode for your records Antibiotic (oral and/or topical) Use of hydrocortisone injection into Algeness® site - rare

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AVOID AND TREAT COMPLICATIONS

MASTER YOUR RESULTS ® 10 TRAINING MANUAL P89

AVOID COMPLICATIONS INJECT SLOWLY AND CAREFULLY

ALWAYS KEEP IN MIND THAT THERE IS A POTENTIAL n Inject subdermal for predictable results and to avoid nodules. FOR COMPLICATIONS. n Aspirate, before injecting to assure not intra-arterial. MOST COMPLICATIONS ARE MINOR AND TEMPORARY. n Slow injection with even release of the filler. MAJOR COMPLICATIONS ARE RARE, n Don’t rush. AND SO FAR NONE HAVE BEEN REPORTED AFTER n Avoid large bolus injections. 10 ALGENESS® INJECTIONS. n Do not over correct. n Take time to massage the injected filler until you hardly feel the product under your fingers insuring smoothness. GENERAL CONSIDERATIONS

A good understanding of the agarose gel properties, its unique characteristics AFTER THE PROCEDURE and plasticity, and a proper injection technique are essential to place the correct amount of gel at the appropriate skin depth providing maximal correction of n Remember to take pictures post injection. tissues while avoiding visibility or nodularity of the filler. n Give your Patient an after-care information card. Always remember that Algeness® is an injectable implant and cannot be compared to HA fillers when injected. The Master Your Results® protocols and injection technique have to be respected.

DO NOT TREAT A PATIENT WITH:

n Infected or compromised skin n Dental infection n Currently taking antibiotics n Known allergy/hypersensitivity to similar materials n History of severe allergy or anaphylaxis n Known bleeding disorders. n Known pregnancy or IVF treatment

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ALGENESS® AFTER CARE INFORMATION TREAT COMPLICATIONS

Dear Patient, Here are some suggestions for the after care of your treatment with Algeness® the all-natural dermal filler that is 100% biocompatible and biodegradable. Please read carefully and follow these suggestions below. 10 n Immediately after the treatment, you may experience any of these conditions: n Redness, sensitivity, swelling, tenderness, and/or itching near the injection site. This is normal and TYPES OF COMPLICATIONS generally disappears within a few hours to a few days. Avoid rubbing, touching the area of injection. n During the 24 hours following the procedure, avoid drinking alcohol or exercise, which may result in Early complication delayed complications additional bruising. Stay out of the sun and avoid activities of sunbathing, tanning, saunas, hot tubs, (Occuring to several days post-treatment) (Occuring from 2 to 4 weeks post-treatments) or hot wax. Also avoid extreme cold, such as skiing or hiking outdoors. Infection Infection n If you have received the injection in the lip area, avoid lipstick or lip balm for 24 hours and refrain Edema Edema from biting your inner lips, this might lead to temporary swelling and appearance of tiny lumps. n If you experience any swelling apply cold packs, (ice) periodically to reduce the swelling. You may Erythema Hard / painfull lumps

also take pain medications, However, taking Ibuprofen or aspirin may exacerbate bruising, as they Pain / Tenderness Nodules / Abscesses have blood thinning properties. Bruising Erythematous nodules n To help alleviate bruising, you may apply Arnica ointment to the treated area. n Minimize movement of the treated area. However, if there is a visible lump, you can gently massage Itching the area until you do not feel the lump. Always do the massage with clean. Nodule / abscess

Bumps, asymmetries, contour irregularities caused by errors in technique and level of injections local tissue necrosis caused by vasccular occlusion.

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MINOR COMPLICATIONS MINOR COMPLICATIONS

Even with a proper injection technique, the procedure might induce bruising and swelling. n ERYTHEMA It is, therefore, crucial to explain to the Patient all potential complications. Skin erythema might appear immediately after injection. This is normal and temporary reaction. n BRUISING can be limited by slow and non traumatic injection avoiding visible vessels. In case of hypersensitivity reaction post injection, the erythema might last for more (good lighting is essential) than several days. Make sure there is no infection. 10 • After the session, the Patient might apply an ice pack for 15 minutes. • The erythema can be treated with Vitamin K . If the situation does not improve • Patients taking anticoagulants must be warned that they have an increased risk of bruising. after few days. • If ecchymosis does develop, Patient may also apply Arnica montana 20 percent gel to treat • Treatment with steroids might be considered. the bruising. • Patients with spider veins or rosacea have a higher risk of developing erythema after injection and should be warned of this fact prior to injecting. n DISCOMFORT AND SWELLING The swelling occurs from the volume of Algeness® injected, the trauma of the injection MAJOR COMPLICATIONS procedure itself (inflammatory traumatic reaction) and the massage post injection. The Patient might feel some discomfort during the injection and after the procedure. We n INFECTION recommend to; As with any procedure that penetrates the skin, Algeness® injections can also be • Mix Algeness® with 0.1 ml to 0.2 ml lidocaine. associated with infection. Contamination through the skin likely occurs during injection. • Numb the treated site with numbing ointment 20 minutes prior the injection. • Once the infection is suspected; the physician should prescribe antibiotics as the first If Patient experience minor pain, tenderness, and/or headache after the injection, the line of treatment. physician should prescribe a pain killer such as ibuprophen or acetaminophen on the • If the situation is not better after 48 hours, a culture might be necessary to identify the treatment day. bacteria. Immediate post-injection discomfort should not be dismissed, as it could indicate a more • It might be necessary to incise and drain an abscess that most likely would develop. serious problem.

MASTER YOUR RESULTS ® TRAINING MANUAL P95

n WORSENING OF PATIENT APPEARANCE DELAYED ONSET COMPLICATIONS After the injection is considered a major complication and should be addressed promptly. n LUMPS Algeness® has the advantage of being 100% natural and biodegradable and can be dispersed by There are different types of nodules; cystic, edematous or sclerotic. warm saline solution or dissolved by the injection of hyaluronidase if needed. Lumps or nodules usually appear shortly after treatment in areas of thin soft-tissue coverage. • The physician can inject hyaluronidase and massage the involved area until he obtains the Lumps are more frequent when the product is deposited close to the dermis. expected result. This has to be done few days after the first injection. The lips are an area where this complication is most frequent because the product is 10 • Hyaluronidase can be injected multiple times if needed. inevitably close to the dermis and because of the constant movement and the thin mucosa. Meticulous placement of Algeness® in the deep plane and a thorough massage until the n NODULES perception of the product is lost under the fingers will limit the risk of nodules. Warn patients that nodules can rarely occur. If this is the case, the patient should return to the Physician asap for treatment before a fully n TREATMENT OF LUMPS formed capsule occurs. • The treatment of cystic type nodule is a simple puncture with a needle and drainage. Although Patients are normally able to palpate the filler after injection, there should not be distinct • In case of excess of product, injection of hyaluronidase or warm saline followed with a nodule formation. massage and drainage should resolve the problem. If nodules are detected early on, they should be treated immediately with warm saline solution or • The edematous or sclerosing types lumps, that usually occur because of late detection, hyaluronidase and massaged. can be more resistant and might require intra-lesional steroid injection or a more invasive procedure, such as excision. n VASCULAR COMPROMISE This is a rare complication, however a Prompt actions must be taken. Any concern should be taken seriously and managed swiftly. • The area of concern should be aspirated and massaged. • Hyaluronidase can be injected. • Warm compresses and 2 percent nitroglycerin paste may be applied to assist in vasodilation. • Avoid Ice. • Check that there is no vessel compression by an edema. If so prescribe oral prednisone. • Close monitoring of the Patient daily until situation is back to normal.

MASTER YOUR RESULTS ® If the problem does not solve with the injection of saline or hyaluronidase you can proceed as follow; > Anesthesia with small amount of lidocaine/adrenaline of the area Option 1 Injection (23G needle) of • Triamcinolone 10mg • Lidocaine with adrenaline 1.20 ml • Bidistilled water for injection 1.20 ml • Multiple mechanical capsule fracture with needle and massage • Injection of 200 units of hyaluronidase per nodule

Option 2 1 - Break the capsula with small liposuction cannula 2 - Inject the following mixture in a 1ml luer lock syringe 0.3 ml Triamcinolone 10 0.5 ml 5FU 50mg/ml 0.2 ml 2% Xylocaine with epinephrine

Then, if the nodule is very small refill into 0.3 ml BD syringe and inject with this one, if the nodule is bigger you can use a 1 ml syringe - strictly into the center of the nodule!!!, and massage it yourself thoroughly, and advice the patient to continue. If no improvement, second injection after three to four weeks.

MASTER YOUR RESULTS ® MASTER YOUR RESULTS ® Advanced Aesthetic Technologies, Inc

One Brookline Place, Suite 427 - Brookline, MA 02445

www.algeness.com - [email protected]