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Fraxel Laser

Fractional photothermolysis. - A near infrared laser ; mainly absorbed by aqueous tissue , creates a dense pattern MTZ- The fractional laser also leave part of the skin untouched and it is these islands of normal skin that facillitate rapid healing and create a unique wound healing. Fracti

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Fraxel Laser

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    1. Fraxel ™ Laser

    2. Fractional photothermolysis - A near infrared laser ; mainly absorbed by aqueous tissue , creates a dense pattern MTZ - The fractional laser also leave part of the skin untouched and it is these islands of normal skin that facillitate rapid healing and create a unique wound healing

    3. Fractional Non-Ablative Resurfacing Intact stratum corneum Thousands of microscopic wounds completely surrounded by viable tissue for rapid healing Immediate and delayed therapeutic results Epidermal and dermal coagulation for resurfacing Collagen denaturization for deep remodeling 6/27/2012 Confidential and Proprietary to Reliant Technologies, Inc. 3 DAVE We do not disrupt the stratum corneum. It remains as a biological barrier. Thousands of islands of dead tissue are created per sq cm which are surrounded by seas of health tissue. This enables re-epitheliazation is 24 hours! Non-Ablative Tissue is coagulated, not vaporized The stratum corneum remains intact Fractional Multiple 70-150 micron MicroThermal Zones (MTZs) surrounded by islands of viable tissue Resurfacing Extrusion & replacement of damaged tissue Rapid re-epitheliazation (within 24hrs) Collagen denatured between 300-750 microns Dave We do not disrupt the stratum corneum. It remains as a biological barrier. Thousands of islands of dead tissue are created per sq cm which are surrounded by seas of health tissue. This enables re-epitheliazation is 24 hours! DAVE We do not disrupt the stratum corneum. It remains as a biological barrier. Thousands of islands of dead tissue are created per sq cm which are surrounded by seas of health tissue. This enables re-epitheliazation is 24 hours! Non-Ablative Tissue is coagulated, not vaporized The stratum corneum remains intact Fractional Multiple 70-150 micron MicroThermal Zones (MTZs) surrounded by islands of viable tissue Resurfacing Extrusion & replacement of damaged tissue Rapid re-epitheliazation (within 24hrs) Collagen denatured between 300-750 microns Dave We do not disrupt the stratum corneum. It remains as a biological barrier. Thousands of islands of dead tissue are created per sq cm which are surrounded by seas of health tissue. This enables re-epitheliazation is 24 hours!

    4. Unique epidermal repair Necrotic debris and melanin are eliminated by keratinocyte migration and rapid expulsion

    5. The most prominent effect is the formation of MENDs(as early as 24 hrs after FP) : correlate clinical “bronzing” (high melanin contents in MENDs) MENDs have migrated through epidermis : correlate of flaking Elimination of MENDs from st. corneum more prominent on days 5-7 Thus, the MENDs act as “melanin shuttle”

    6. Fraxel refine 1410 nm Multiple microthermal zone (MTZs) that each affect a fractional volume of tissue Stratum corneum is intact, tissue in the epidermis coagulated; collagen is denatured to 550 microns. Microscopic wound size and viable tissue allow for rapid re-epitheliazation. Extrusion & replacement of damaged tissue ? “Resurfacing”

    7. Day 1. Visible only with magnification Thermally induced Columnar shape Diameters < 250µm 5:1 depth-to-width aspect ratio Approximately one million per tx

    8. Healing time 24-48 hrs. (pink, rough and slightly edematous skin ) Thousands of MTZ created within the skin Eliminated pigment and stimulates collagen remodelling Target to treat early photodamage in younger 20’s -30’s patient.

    9. Fraxel refine

    10. Fraxel Wavelengths

    11. 6/27/2012 Confidential and Proprietary to Reliant Technologies, Inc. 11

    12. 1410 nm vs. 1550 nm 6/27/2012 Confidential and Proprietary to Reliant Technologies, Inc. 12

    13. Balancing Aggressiveness for Efficacy and Safety 6/27/2012 Confidential and Proprietary to Reliant Technologies, Inc. 13 The density of MTZs, relative to the pulse energy, dictate treatment aggressiveness. More aggressive treatments lead to more efficacy. However, too much aggressiveness can precipitate bulk heating. The Fraxel laser is designed to treat 15-25% of the total skin surface in each treatment. It’s always a good idea to do the first treatment with low coverage and increase aggressiveness with subsequent treatments. Also, every patient responds individually. To date, there is no way to predict how a patient will respond to treatment. DAVE The number of MTZs in a treatment dictate treatment aggressiveness. More MTZs translate to greater density and a more aggressive treatment. More aggressive treatments lead to more efficacy. However, too much aggressiveness can lead to bulk heating. In the typical Fraxel laser treatment 15-25% of the total skin surface is effected. The series is generally 3 – 5 treatments, spaced 2 – 4 weeks apart, depending on what is being treated. Typically a full face treatment takes 25 – 30 minutes, Neck, Chest and hands require 10 – 15 minutes. The density of MTZs, relative to the pulse energy, dictate treatment aggressiveness. More aggressive treatments lead to more efficacy. However, too much aggressiveness can precipitate bulk heating. The Fraxel laser is designed to treat 15-25% of the total skin surface in each treatment. It’s always a good idea to do the first treatment with low coverage and increase aggressiveness with subsequent treatments. Also, every patient responds individually. To date, there is no way to predict how a patient will respond to treatment. DAVE The number of MTZs in a treatment dictate treatment aggressiveness. More MTZs translate to greater density and a more aggressive treatment. More aggressive treatments lead to more efficacy. However, too much aggressiveness can lead to bulk heating. In the typical Fraxel laser treatment 15-25% of the total skin surface is effected. The series is generally 3 – 5 treatments, spaced 2 – 4 weeks apart, depending on what is being treated. Typically a full face treatment takes 25 – 30 minutes, Neck, Chest and hands require 10 – 15 minutes.

    14. 6/27/2012 Confidential and Proprietary to Reliant Technologies, Inc. 14 Fraxel laser product family now consists of three different laser system targeted towards different types of physicians performing laser resurfacing procedures. Fraxel re:store laser is the core product that was previously known as Fraxel SR1500 laser system. Fraxel re:fine laser is targeted towards physicians who are not dermatologists or plastic surgeons. This is a very safe laser that provides great results for pigmentation issues and is practically painless. Fraxel re:pair laser is the newest member in the product family which will be launched later part of 2007. This is a fractional but ablative CO2 laser system that produces long lasting results for deeper indications like deep wrinkles, severe sun damage, acne and surgical scars and vascular dyschromia. Fraxel laser product family now consists of three different laser system targeted towards different types of physicians performing laser resurfacing procedures. Fraxel re:store laser is the core product that was previously known as Fraxel SR1500 laser system. Fraxel re:fine laser is targeted towards physicians who are not dermatologists or plastic surgeons. This is a very safe laser that provides great results for pigmentation issues and is practically painless. Fraxel re:pair laser is the newest member in the product family which will be launched later part of 2007. This is a fractional but ablative CO2 laser system that produces long lasting results for deeper indications like deep wrinkles, severe sun damage, acne and surgical scars and vascular dyschromia.

    15. The density of MTZs, relative to the pulse energy, However, too much aggressiveness can precipitate bulk heating. In the typical Fraxel laser treatment 15-25% of the total skin surface is effected. The series is generally 3 – 5 treatments, spaced 2 – 4 weeks apart, depending on what is being treated. Typically a full face treatment takes 25 – 30 minutes, Neck, Chest and hands require 10 – 15 minutes.

    16. re:fine targeted indications Summary 1410nm: Safe- optimized for superficial treatment at lower energies Superficial treatment: laser energy concentrated on the epidermis and papillary dermis Less patient discomfort: reduced fluence due to higher optical absorption Ideal for treating: Pigmented lesions Melasma Periorbital fine lines Texture Tone 6/27/2012 Confidential and Proprietary to Reliant Technologies, Inc. 16

    17. Fraxel re:fine™ laser – Pigmented Lesions 6/27/2012 Confidential and Proprietary to Reliant Technologies, Inc. 17 Patient LR Patient LR

    18. Fraxel restore 1550 nm wavelength – tissue chromophore is water Delivers thousands microscopic low energy (mJ) pulses – creates Microscopic Thermal Zone (MTZ) User selectable Pulse Energy determines MTZ depth & width User selectable Treatment Level determines treatment coverage and aggressiveness Proper laser use eliminates the possibility of bulk-heating

    19. 6/27/2012 Confidential and Proprietary to Reliant Technologies, Inc. 19 Two Main Dials on the Laser Pulse ENERGY (mJ) 4-20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70 energy = MTZ lesion diameter and depth (collagen remodeling) TREATMENT LEVEL (Area Coverage) 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, R1, R2, R3 (5%-48%) Increased TREATMENT LEVEL = increased inflammation and side-effects (intensity and duration)

    20. Same Energy (mJ), Different Treatment Levels 6/27/2012 Confidential and Proprietary to Reliant Technologies, Inc. 20 What we mean by percent coverage. If took all spots and think about them as dimes and quarters you would see your treatment area. The percentage of the pie is the percent coverage. Average level of treatment = level 6 : 20 – 25% treated Untreated skin 75 – 80% is untreated containing viable cells to help wound healing process Size of lesion created in skin during tx level the size of pulse is same but if change Rx level then you can change the density so different treatment levels because more spots in right side then left side. What we mean by percent coverage. If took all spots and think about them as dimes and quarters you would see your treatment area. The percentage of the pie is the percent coverage. Average level of treatment = level 6 : 20 – 25% treated Untreated skin 75 – 80% is untreated containing viable cells to help wound healing process Size of lesion created in skin during tx level the size of pulse is same but if change Rx level then you can change the density so different treatment levels because more spots in right side then left side.

    21. Same Energy, Different Treatment Level 6/27/2012 Confidential and Proprietary to Reliant Technologies, Inc. 21

    22. Different Energy, Same Treatment Level 6/27/2012 Confidential and Proprietary to Reliant Technologies, Inc. 22 Now Rx level the same but apply different energy: One spot has greater diameter then other, treatment level is based on percentage of area treated, tx level same for both of these even though spot size is different Now Rx level the same but apply different energy: One spot has greater diameter then other, treatment level is based on percentage of area treated, tx level same for both of these even though spot size is different

    23. Different Energy, Same Treatment Level 6/27/2012 Confidential and Proprietary to Reliant Technologies, Inc. 23

    24. Fraxel re:storeTM Laser Proven Science Necrotic Debris Act as “Melanin Shuttle” Because the Fraxel® laser does not selectively target tissue, it removes everything in the MTZ, including melanin. proven to remove dermal extracellular material.

    25. Patient Screening: Contraindications Hx of oral Retinoids (e.g., Accutane) or drugs in a similar class 6 months prior to treatment Predisposition to keloid formation or excessive scarring Lesion suspicious for malignancy Unrealistic patient expectations 6/27/2012 Confidential and Proprietary to Reliant Technologies, Inc. 25 Who are the patients that we shouldn’t be treating..contraindicatrions Similar to other ablative treatments Keloids= not an approved indication so do not suggest that fraxel treats Malignancy -> access by derm before treatment (esp. for non derms) If pt. looking for face lift of Co2 result don’t use laser because false expectations Who are the patients that we shouldn’t be treating..contraindicatrions Similar to other ablative treatments Keloids= not an approved indication so do not suggest that fraxel treats Malignancy -> access by derm before treatment (esp. for non derms) If pt. looking for face lift of Co2 result don’t use laser because false expectations

    26. Active tanning/UV exposure within last two weeks Active infection: bacterial, viral, fungal Prophylaxis for oral herpes indicated Predisposition to hyperpigmentation Regimen for prophylaxis indicated Hx of topical retinoids or retinols 2 weeks prior to treatment Compromised ability to heal Pregnancy or breast feeding (topical anesthesia) Be aware that current anticoagulant or medication that can affect coagulation and predispose patient to petechiae Fillers recommended after series of FLT complete No studies on cosmetic tattoos 6/27/2012 Confidential and Proprietary to Reliant Technologies, Inc. 26 Wait 2 wks. For sun tanning / UV exposure (let melanocytes settle down) Why difficulty heal and how does interact with FX tx History of oral herpes should be on prophylatic tx before hand and don’t treat when outbreak (some docs tx everyone b/c pt. may not know have cold sores or may lie due to stigma attached) For hyperpigmentation tendency ask what do you normally do for this? Follow same procedures Can develop patekeyee (sp?) (sp?) or pupura from pt. on anti coag. Retinoids/accutane – 6 months reliant recommends a year Up to physician as to whether to use retinoids (retinoid due promote collagen prod. But on one hand effect hsp but on other hand can assist epidermal regeneration as well as dermal remodeling) Some don’t discontinue some a week to two weeks before you need to make that decision Fillers after FLXT because then you know what fraxel did and then you can see if need fillers Not good idea to fxlt over cosmetic tattoos Fillers usually mid dermal ? will fxlt break down fillers? Reliant doesn't take position b/c haven’t done studies to say yes or no Reliant can’t say you can safely treat silicone implants b/c can melt silicone therefore not recommends to use over silicone which isn’t even FDA approved Wait 2 wks. For sun tanning / UV exposure (let melanocytes settle down) Why difficulty heal and how does interact with FX tx History of oral herpes should be on prophylatic tx before hand and don’t treat when outbreak (some docs tx everyone b/c pt. may not know have cold sores or may lie due to stigma attached) For hyperpigmentation tendency ask what do you normally do for this? Follow same procedures Can develop patekeyee (sp?) (sp?) or pupura from pt. on anti coag. Retinoids/accutane – 6 months reliant recommends a year Up to physician as to whether to use retinoids (retinoid due promote collagen prod. But on one hand effect hsp but on other hand can assist epidermal regeneration as well as dermal remodeling) Some don’t discontinue some a week to two weeks before you need to make that decision Fillers after FLXT because then you know what fraxel did and then you can see if need fillers Not good idea to fxlt over cosmetic tattoos Fillers usually mid dermal ? will fxlt break down fillers? Reliant doesn't take position b/c haven’t done studies to say yes or no Reliant can’t say you can safely treat silicone implants b/c can melt silicone therefore not recommends to use over silicone which isn’t even FDA approved

    27. Fraxel re:store® DUAL: Wavelengths

    28. 1550 nm vs. 1927nm: Lesion depth

    29. 1550 nm vs. 1927nm: Lesion depth

    30. Fraxel re:store DUAL Demonstration Treatments on Face or Body 1927nm: Superficial Treatment: 10 -15 mJ 0.2mm treatment depth High coverage setting for significant clearance of unwanted skin pigmentation Faster pigment clearance More patient comfort, even at higher coverage 1550nm: Dermal Treatment: 35mJ 1.0 mm treatment depth Induces collagen renewal, improves tone and texture, Clears pigmentation Lower coverage setting for improved patient comfort Shorter treatment times (40% faster at 1550nm compared to previous re:store)

    31. Postoperative care Ice compresses to minimize any discomfort Sleep on two to three pillows to decrease edema Application of a board spectrum sunscreen Some patients may experience mild peeling on the 2nd or 3rd day after the treatment

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