Energy- based Vaginal Therapy: Erbium/Er & Diode Current Technology and Evidence

Transcription

1 Energy- based Vaginal Therapy: Erbium/Er & Diode Current Technology and Evidence Nathan Guerette, MD, FPMRS, FACOG, FAAFP Director, The Female Pelvic Medicine Institute of Virginia Associate Professor Director, Virginia Robotic Center of Excellence Division of Urogynecology and Pelvic Reconstructive Surgery Medical College of Virginia, Virginia Commonwealth University

2 Disclosures & Disclaimers Sciton funded the study. Sciton is the manufacturer of, and has a financial interest in, the diva devise. diva treatment may not be eligible for reimbursement under government healthcare programs, such as Medicare or Medicaid, or under private healthcare programs. Some or all uses of the diva device included in this study are not cleared by the FDA. diva has not been cleared or approved by the FDA to treat or improve: female sexual dysfunction, female sexual arousal disorder, female orgasmic disorder, hypoactive sexual disorder, ability to orgasm, urinary incontinence, neural damage, vaginal yeast infections, urinary tract infection, vaginal dryness, vaginal irritation, vaginal itching, vaginal burning, vaginal laxity, vaginal atrophy, genitourinary syndrome of menopause, dyspareunia, vaginismus, or vaginitis. The Joule 2940nm fractional delivery system has been FDA cleared for procedures requiring skin resurfacing, and ablation and coagulation of soft tissue; the Joule 1470nm fractional delivery system has been FDA cleared for skin resurfacing and coagulation of soft tissue. ProFractional, Halo and diva are not FDA cleared for treating scars. Clinical measures for the study included: The vaginal manometer used was the InTone TM (InControl Medical, Brookfield, WI, USA), Female Sexual Function Index (FSFI) questionnaire and International Consultation on Incontinence Short Form (ICIQ SF) questionnaire. The FDA may or may not consider patient questionnaires sufficient for approving or clearing new indications for use. The BBL device is FDA cleared for, but not limited to, mild to moderate inflammatory and pustular inflammatory acne vulgaris, hair reduction, the treatment of benign pigmented lesions including dyschromia, melasma, and freckles, the treatment of cutaneous lesions, and the treatment of benign cutaneous vascular lesions. The BBL device is not FDA cleared or approved for changing gene expression, anti-aging, fine lines and wrinkles, or skin laxity. Video/Image release given solely to Sciton for this presentation. Any reproduction, re-transmission, re-distribution or re-publication of all or part is expressly prohibited. Sciton does not and cannot control, script, or otherwise dictate the sales materials and content utilized by physicians or other clinical practitioners to market their practice. Sciton cannot guarantee returns on investment from any purchase or marketing effort.

3 Disclosures & Disclaimers The study was of 18 adult female patients. The population of this study was majority Caucasian, with a mean age of 41 +/- 4.3 years. Inclusion criteria included having a history of at least one vaginal delivery at least six months prior to enrollment, self-reported vaginal laxity, and regular sexual activity with a monogamous heterosexual partner. The following exclusion criteria were adopted: previous pelvic floor reconstructive surgery, having more than Grade I prolapse using the Baden-Walker Halfway Scoring System in any vaginal compartment, pregnant or lactating, not using a medically approved method of contraception, use of vaginal topical estrogen within one month prior to enrollment, acute or recurrent urinary tract infections, active sexually transmitted diseases, use of vaginal topical antibiotics or antifungal agents within one week prior to enrollment, any medical condition that would interfere with wound healing, known collagen disorder, known vascular disease, scleroderma, history of immunosuppression, history of bleeding disorder, significant concurrent illness such as diabetes, use of medications known to affect sexual function, and clinically significant anxiety, depression, or psychosexual disorder. All patients resided in the Houston, Texas metropolitan area. Patients received three laser treatments performed at 4-6 week intervals, from July to December Johnny Peet, MD, FACOG is an investigator, preceptor, and speaker for Sciton, and was compensated by Sciton for his time conducting the study.

4 Relevant Disclosures Sciton (Palo Alto, CA) Research Consulting

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6 Celebrity Cosmetic Vaginal Surgery

7 Objectives Brief review of medical laser technology Review current potential vulvo-vaginal indications for energy-based treatments Review current evidence for Erbium and Hybrid Erbium energy-based therapies for vulvo-vaginal disorders Provide overview of hybrid platform

8 What is a Laser? Light Amplification by the Stimulated Emission of Radiation In 1959 Originally termed Light Oscillation by the Stimulated Emission of Radiation

9 Light moves in waves Amplitude Wavelength Amplitude: height of wave Frequency: number of wave peaks per second Wavelength: distance from peak to peak

10 White LIGHT WAVEFORM SPECTRUM PRODUCED Filtered Laser

11 Light Interactions with Tissue Absorption: The most important tissue interaction, and is responsible for the thermal affects within the tissue. Absorbed energy is converted to thermal energy and is directly affected by the amount of chromophore in the tissue. Scattering: Occurs when the light energy bounces from molecule to molecule within the tissue. Transmission: Reflection: It distributes the energy over a larger volume of tissue, dissipating the thermal effects. If there is no chromophore, then all of the photons pass through the tissue without producing any effect. Therefore, selection of the proper chromophore in or near the target is the first important step in laser therapy. Reflected light bounces off the tissue with no penetration or interaction at all. It is an undesired effect. Even the smallest the formed angle between the laser beam and the irradiated surface, will result in greater reflection of the beam. This is why it is so important to position your handpiece in a perpendicular way to the tissue.

12 Absorption à Tissue Absorb Each wavelength has unique absorption properties Light is selectively absorbed in tissue by Chromophores, hemoglobin, melanin, and water are the primary targets

13 Where Does the Heat Go? Cooling Heat is carried away in steam and plume Heat Vaporization Absorption Laser energy absorbed, raising temperature Thermal treatment trauma/effect Conduction 13

14 Light Absorption in Tissue The main absorbing chromophores of tissue are: Hemoglobin Melanin Water Water is the dominant chromophore for many dermatological applications

15 Laser Types, Wavelengths and Associated Targets WL (nm) TYPE TARGETS 514 Argon or Dye Melanin, Blood 532 Doubled Nd:YAG KTP Melanin, Blood 578 Copper Vapor Blood Pulsed Dye Blood 694 Ruby Melanin 755 Alexandrite Melanin, Blood, Hair 810, 940 Diode Melanin, Blood, Hair, Fat 1064 Nd:YAG Melanin, Blood, Hair, Fat 1319 Nd:YAG Water, Fat 2940 Erbium YAG Water

16 Laser Light: Depth of Penetration Nd:YAG 1319 Er:YAG CO2 Not Drawn to Scale

17 Energy-based Vaginal Therapy: The need

18 PATIENT CONCERNS o Vaginal Laxity o Dry vagina (vulvovaginal atrophy) o Vaginal Constriction o Urinary Incontinence (Stress or OAB) o Mild Prolapse o Orgasmic Disorders o Vulvar Dystrophy o Dyspareunia o Vulvar Appearance o Labial Appearance

19 Sexual Dysfunction Prevalence Assessment of 440 publications worldwide showed prevalence of Sexual dysfunction in pre- menopausal women estimated to be 40.9% Lubrication difficulties was 20.6% Hypoactive sexual desire disorder was 28.2% 15 Study in 2005 showed prevalence of sexual dysfunction in peri- and post- menopausal women was 40% 16 One study of 83 breast cancer survivors using Female Sexual Function Index qualified 77% for diagnosis of sexual dysfunction 17 Heavy toll on quality of life and relationships Issue is underreported and undertreated

20 Sexual Dysfunction Rates of sexual dysfunction in pre-menopausal women exceed 30% Rates of sexual dysfunction in post-menopausal women exceed 50% Rates of sexual dysfunction in women with urogynecologic issues exceed 60% Rates of sexual dysfunction in women treated for Breast cancer women 60-70% Number similar for other cancers Rates of women dissatisfied with appearance/anatomy > 50% Heavy toll on quality of life and relationships Issue is underreported and undertreated

21 Vaginal Atrophy Treatment Options Non-surgical treatment type Non-hormonal treatments OTC vaginal lubricants Reduce discomfort during intercourse OTC vaginal moisturizers Apply every 2-3 days, effects last a little longer than lubricant Low-dose vaginal estrogen Rings, creams (messy!), suppositories, and tablets Effective at low doses and limits exposure to estrogen; may provide direct relief of symptoms Systemic estrogen therapy Administered orally, vaginally, or transdermally via injection or nasal spray Concerns about long-term potential of estrogen to increase risk of breast and endometrial cancer SERMs DHEA suppository??????????

22 Types Lichen Planus Vulvar Dystrophy Lichen Simplex Lichen Sclerosis Treatments High Potency Steroid ointment (clobetasol) Injectable triamcinolone (debilitating itching) Treat underlying conditions (ie, yeast) Tricyclics Calcineurin inhibitors Manual dilation Estrogen cream Testosterone Cream Progesterone Cream??????????????????

23 Sensory Disorders Hormone replacement Estrogen Progesterone Testosterone Mechanical devices Injection Therapy Plasma-rich protein Fillers Topicals??????????

24 Break

25 Mechanism of Action

26 Energy/Thermal Treatment Transition from Dermatology/Plastic Surgery Improve tissue quality Pigment Tone Hair reduction x-rays cosmic rays Microwaves TV and radio waves UV VISIBLE INFRARED

27 Laser Wavelength (in nanometer) BBL x-rays cosmic rays Microwaves TV and radio waves UV VISIBLE INFRARED

28 Cellular Vaporization/Ablation Vaporization happens with rapid heating of cellular water to 100 C. Cells burst. Laser leaves a hole If cellular temperature rise is less, then coagulation. Laser doesn t leave a hole. Cell death and remodeling ultimately occurs. >200 C can result in carbon buildup

29 Ablative Non- ablative Full or Fractional Full Ablative Resurfacing Fractional Non- ablative Fractional Ablative

30 Fractional

31 Proposed Mechanism of Action Use energy source to create a controlled thermal injury and induce positive wound healing to achieve desired effect

32 Proposed MOA: Neocollagenesis Heating of the skin and mucosa promotes 3 different kinds of effect: Immediate contraction of collagen Immediate collagen remodeling and elasticity Long term stimulation in producing new collagen

33 Proposed MOA: Angiogenesis

34 Proposed Mechanism of Action Thermal injury to epithelium Stimulate epithelial thickening with glycogen-filled cells Increase vaginal lubrication & decreases pain with intercourse Thermal injury to lamina propria Increase collagen density, elastin, & neovascularization Increased vaginal tightness, elasticity, and sensation; improved urinary control

35 Current Data

36 Evidence: Erbium:YAG Ogrinc UB. Novel minimally invasive laser treatment of urinary incontinence in women. Lasers Surg Med Nov;47(9): doi: /lsm Epub 2015 Sep 21. Indications: Stress Urinary Incontinence 175 patients, ICIQ, ISI 12 month follow- up 77% patients with significant improvement at 12 months No adverse events Gaviria JE, Laser Vaginal Tightening (LVT) evaluation of a novel noninvasive laser treatment for vaginal relaxation syndrome, Vol. 2012, No.1; Indication: Laxity 21 patients, non- validated LVT questionnaire, POP- Q, PISQ week follow- up 20 patients (95%) reported significant (moderate and strong) improvement of their vaginal laxity 3/5 patients prolapse improved by 1 stage 3/3 patients with SUI improved No Adverse events Lee MS. Treatment of Vaginal Relaxation Syndrome with an Erbium:YAG Laser Using 90 and 360 Scanning Scopes: A Pilot Study & Short- term Results. Laser Therapy 23.2: Indication: laxity 30 patients 8 week follow- up Perineometer values improved in all patients 70.0% subjective improvement No adverse events

37 Vaginal erbium laser as second- generation thermotherapy for the genitourinary syndrome of menopause: a pilot study in breast cancer survivors Menopause Mar;24(3): doi: /GME Vaginal erbium laser as second- generation thermotherapy for the genitourinary syndrome of menopause: a pilot study in breast cancer survivors. Gambacciani M1, Levancini M. Author information Abstract OBJECTIVE: The aim of this study was to evaluate the efficacy and acceptability of a second generation of vaginal laser treatment, the vaginal erbium laser, as a nonablative photothermal therapy for the management of genitourinary syndrome of menopause in postmenopausal breast cancer survivors. METHODS: The study was performed using an erbium laser crystal yttrium- aluminum- garnet (XS Fotona Smooth, Fotona, Ljubljana, Slovenia) with a wavelength of 2,940 nm. Forty- three postmenopausal breast cancer survivors were treated with three laser applications every 30 days. Symptoms were assessed before the treatment and after 1, 3, 6, 12, and 18 months, using two methods, subjective Visual Analog Scale (VAS) and objective Vaginal Health Index Score (VHIS). The procedures were performed on an outpatient basis without anesthesia or drug use before or after the intervention. RESULTS: From baseline values of 8.5 ± 1.0 cm, vaginal dryness VAS scores were 4.4 ± 1.2 cm after the third treatment and 5.5 ± 1.5 cm 12 months after the treatment (P < 0.01 vs basal values), whereas they were 7.5 ± 1.8 cm after 18 months from the last laser application (NS vs basal values). From baseline values of 7.5 ± 1.5 cm, dyspareunia VAS values decreased to 4.2 ± 0.9 cm after the third treatment and 5.1 ± 1.8 cm 12 months from the last laser application (P < 0.01 vs basal values), whereas they were 6.5 ± 1.8 cm after 18 months from the last laser application (NS vs basal values). VHIS, from baseline values of 8.1 ± 1.3, was 21.0 ± 1.4 after the third treatment and 18 ± months from the last laser application (P < 0.01 vs basal values), whereas they were 14.8 ± 1.5 cm after 18 months from the last laser application (NS vs basal values). No adverse events were recorded during the study. CONCLUSIONS: This study suggests that the vaginal erbium laser is effective and safe for the treatment of genitourinary syndrome of menopause in breast cancer survivors.

38 Efficacy of Erbium:YAG laser treatment compared to topical estriol treatment for symptoms of genitourinary syndrome of menopause Lasers Surg Med Feb;49(2): doi: /lsm Epub 2016 Aug 22. Efficacy of Erbium:YAG laser treatment compared to topical estriol treatment for symptoms of genitourinary syndrome of menopause. Gaspar A1, Brandi H1, Gomez V1, Luque D1. Author information Abstract OBJECTIVES: The objective of this prospective comparative cohort study was to establish the effectiveness and safety of Erbium:YAG (Er:YAG) laser treatment for genitourinary syndrome of menopause and to compare it with an established topical estriol treatment. METHODS: Fifty patients with genitourinary syndrome of menopause were divided into two groups. The estriol group received a treatment of 0.5 mg estriol ovules for 8 weeks and the laser group was first treated for 2 weeks with 0.5 mg estriol ovules 3 times per week to hydrate the mucosa and then received three sessions with 2,940 nm Er:YAG laser in non- ablative mode. Biopsies were taken before and at 1, 3, 6, and 12 months post- treatment. Maturation index, maturation value and ph where recorded up to 12- months post- treatment, while the VAS analysis of symptoms was recorded up to 18 months post- treatment. RESULTS: Statistically significant (P < 0.05), reduction of all assessed symptoms was observed in the laser group at all follow- ups up to 18 months post- treatment. Significant improvement in maturation value and a decrease of ph in the laser group was detected up to 12 months after treatment. The improvement in all endpoints was more pronounced and longer lasting in the laser group. Histological examination showed changes in the tropism of the vaginal mucosa and also angiogenesis, congestion, and restructuring of the lamina propria in the laser group. Side effects were minimal and of transient nature in both groups, affecting 4% of patients in the laser group and 12% of patients in the estriol group. CONCLUSIONS: Our results show that Er:YAG laser treatment successfully relieves symptoms of genitourinary syndrome of menopause and that the results are more pronounced and longer lasting compared to topical estriol treatment. Lasers Surg. Med. 49: , The Authors. Lasers in Surgery and Medicine Published by Wiley Periodicals, Inc.

39 Evidence: Comparative Gaspar A. Evolution of Minimally Invasive Laser Treatments for Vaginal Atrophy. Journal of the Laser and Health Academy ISSN Vol. 2013, No.1; Indication: Atrophy The objective of this study was to compare the efficacy and safety of two minimally invasive laser procedures for treatment of vaginal atrophy Erbium:YAG procedure compared fractional CO2 laser procedure. Patients were treated with two different types of laser technologies: nm of wavelength (CO2) and 2940 nm (Er:YAG). 70 patients (35 per group) Both groups were evaluated with a sexual questionnaire, vaginal cytology and vaginal biopsies. Patient discomfort during the treatment and post- op was assessed with a numerical pain- rating scale. Follow- ups were performed at 3 and 6 months after the treatment. Both groups improved over baseline Er:YAG superior improvement at 6 months Patients reported more discomfort in CO2 group Subjective assessment

40 Vulvar Dystrophy Lee A. et al., Fractional Erbium laser in recalcitrant vulval lichen sclerosus. Australian Journal of Dermatology. March patients undergoing fractional carbon dioxide laser resurfacing Successful in achieving remission Subsequently able to be maintained with topical corticosteroid treatment

41 What is Hybrid Fractional Laser (HFL)? 2 wavelengths 2940 Erbium (Ablation) 1470 Diode (Coagulation) Why is this important? CUSTOMIZATION Different conditions need different treatments BETTER RESULTS 1st treatment settings can be different from 3 rd treatment Distinctions deeper ablation and coagulation 2940nm is used for precise ablation µm 1470 nm is used for coagulation of epithelium and lamina propia µm This unique blend provides customizable treatments for epithelial tissue to heal quickly and the lamina propria to remodel slowly over time, laying down more collagen, vascularity, and elastin. May use independently turn either wavelength off

42 Mechanism of Action Hybrid Fractional Laser Similar to Halo diva delivers both ablative (2940nm) and non-ablative wavelengths (1470nm) to the same treatment zone Angiogenesis diva distinctions deeper ablation and coagulation 2940nm is used for precise ablation µm 1470 nm is used for coagulation of epithelium and lamina propia µm This unique blend provides customizable treatments for epithelial tissue to heal quickly and the lamina propria to remodel slowly over time, laying down more collagen, vascularity, and elastin. May use independently turn either wavelength off

43 Wavelength Absorption Both 1470 nm & 2940 nm wavelengths are strongly absorbed in water, while CO2 is times less than 2940 nm

44 960 µm 208 µm 174 µm 610 µm For u se of p hysician or other clinical p ractitioners authorized to u se p roduct u nder s tate law. Not for p atient dissemination. Read this s lide in conjunction with full d isclaimers, FDA clearances/approvals, and contraindications on slide 2. Source: S citon, Inc.

45 What is High Precision Automation (HPA)? Motorized control system Footswitch controls rotation and automatically delivers laser pulses Advantages Easy to use Limits user and treatment variability Significantly decreases treatment time (5 min) Has 360, 180, & 90 degree delivery in 1 handpiece

46 Strengthened Quartz Dilators (SQDs) Single-use dilators Handle SIZE Expands vaginal canal for increased treatment area - Tip Length of Diameter of 1 HYGIENIC Act as barrier between patient and handpiece Tip

47 Benefit of SQDs Efficient Every pulse delivered through new zone in strengthened quartz tip Less Turnover Time Eliminate min down time between patients if you need to autoclave parts Hygienic No risk of cross contamination Longevity of Equipment Reprocessing can alter the surface of metal, lenses, and mirrors, which can derogate the handpiece.

48 HFL Clinical Research

49 Evaluation of the Safety and Efficacy of Hybrid Fractional 2940 nm and 1470 nm Lasers for Treatment of Vaginal Tissue: Pilot Study Treatment induced the clinical effects of improved vaginal tone, decreased stress urinary incontinence, decreased vaginal laxity, and improved sexual function; specifically, with regard to improved lubrication, enhanced ability to reach orgasm, and decrease in pain with intercourse.

50 Pilot Study Evaluated 18 total patients from 07/2015 to 12/2015 Average Age: 41 ± 4.3 years Clinical Measures Female Sexual Function Index (FSFI) International Consultation on Incontinence Questionnaire Short Form (ICIQ SF) Subject-reported vaginal laxity Sex partner-reported vaginal laxity

51 Clinical Investigator s diva Study Goals Evaluate the effectiveness of laser treatment to treat the vaginal canal for: the improvement of vaginal conditions i.e. tissue firming increased sexual satisfaction improved stress urinary incontinence improved vulvovaginal atrophy symptoms

52 Female Sexual Function Index (FSFI) 19-item questionnaire Brief, multidimensional self-report instrument for assessing the key dimensions of sexual function in women Provides scores on six domains of sexual function Desire Arousal Lubrication Orgasm Satisfaction Pain The FSFI has been validated on clinically diagnosed samples of women with female sexual arousal disorder (FSAD), female orgasmic disorder (FOD), and hypoactive sexual desire disorder (HSDD).

53 ICIQ SF International Consultation on Incontinence Questionnaire Short Form (ICIQ SF) Subjective 4-item measure of severity of urinary loss and quality of life Self-reported survey, screening tool for incontinence Length of Test: < 5 min Cut-Off Scores: Slight = 1-5 Moderate = 6-12 Severe = Very severe = Questionnaire is FDA validated

54 FSFI Average FSFI Score of All Subjects Over Time (n = 18) Average FSFI Score of Subjects with FSD Only Over Time (n = 11) FSFI Score % improvement FSFI Score % improvement Month Month As vaginal laxity decreases and elasticity increases, there is more physical contact, friction and sensation during intravaginal intercourse. Thus, there were improvements in the ability to reach orgasm and in overall sexual function.

55 FSFI Lubrication Sub-Score Lubrication Sub- Score Average Lubrication Sub- Score of All Subjects Over Time (n = 18) 36% improvement Lubrication Sub- Score Average Lubrication Sub- Score of Subjects with FSD Only Over Time (n = 11) 63% improvement Month Month Thickening of the epithelial layer increases cell redundancy and allows for more layers of glycogen- filled cells, which provide lubrication and decrease pain with intercourse. Increased vascularity in the connective tissue layer would bring more blood flow to the tissues, also improving lubrication and sensitivity.

56 FSFI Orgasm Domain Average Orgasm Sub- Score of All Subjects Over Time (n = 18) Average Orgasm Sub- Score of Subjects with FSD Only Over Time (n = 11) Orgasm Sub- Score % improvement Orgasm Sub- Score % improvement Month Month As vaginal laxity decreases and elasticity increases, there is more physical contact, friction and sensation during intravaginal intercourse. Thus, there were improvements in the ability to reach orgasm and in overall sexual function.

57 FSFI Pain With Intercourse Domain Average Pain Sub- Score of All Subjects Over Time (n = 18) Average Pain Sub- Score of Subjects with FSD Only Over Time (n = 11) Pain Sub- Score % improvement Pain Sub- Score % improvement Month Month Thickening of the epithelial layer increases cell redundancy and allows for more layers of glycogen- filled cells, which provide lubrication and decrease pain with intercourse. Increased vascularity in the connective tissue layer would bring more blood flow to the tissues, also improving lubrication and sensitivity.

58 ICIQ SF Average ICIQ Score of Subjects with SUI Only Over Time (n = 12) ICIQ Score Month 54% improvement Cut-Off Scores: Slight = 1-5 Moderate = 6-12 Severe = Very severe = The ablated microchannels located beneath the urethra and bladder neck essentially fill with collagen during the healing process. Collagen provides support for the urethra. With increased vascularity in the tissues, a thicker vaginal epithelium and new collagen formation all beneath the urethra, it follows that patients would experience an improvement in urinary control.

59 Subject Reported Vaginal Laxity Average Subject Reported Vaginal Laxity Score of All Subjects Over Time (n = 18) Slightly loose Neither loose nor tight Slightly tight Moderately tight Very tight Vaginal Laxity Score Month 36% improvement Increases in collagen and elastin in the lamina propia surrounding the vaginal mucosa would ultimately lead to increased vaginal canal tightening and improved elasticity.

60 Sex Partner Reported Vaginal Laxity Average Sex Partner Vaginal Laxity Score of All Subjects Over Time (n = 18) Slightly loose Neither loose nor tight Slightly tight Moderately tight Very tight Vaginal Laxity Score Month 33% improvement

61 Dr. Peet s Clinical Study Review Number of Subjects with Month 0 Month 3 FU 1 Month 8 FU 2 FSD 11:18 5:11 2:11 SUI 12:18 4:12 5:11 severe SUI moderate SUI slight SUI 9 2 4

62 Subject Feedback Average numeric pain rating 3:10 No adverse events High treatment satisfaction 94% reported expectations were met 83% reported improvement in sexual satisfaction 88% reported satisfaction with treatment 89% reported they would repeat the treatment 100% would recommend this treatment

63

64 NOVEL HYBRID FRACTIONAL ERBIUM:YAG LASER: SHORT-TERM OUTCOMES FOR TREATMENT OF GENITOURINARY SYNDROME OF MENOPAUSE AND DYSPAREUNIA - IUGA, Vancouver 2017 (submission) Single center retrospective study 57 patients were treated between July and December met inclusion criteria Sexually active Primary and secondary indication of GSM and dyspareunia Completed 3 treatment protocol Minimum 4 weeks follow-up Mean age 49.6 (27-72) Average parity 2.2 (0-8) Atrophy, Dyspareunia, Dryness and Orgasmic Functionality values collected FSFI scores collected

65 Treatment Protocol 3 treatments 1 month apart 2 week interim follow-up Post-treatment follow-up every month Settings:

66 Data Analysis Atrophy, dyspareunia and dryness: decrease compared to baseline indicates improvement Orgasmic functionality: increase in number equals improvement FSFI calculated in standard fashion Analysis with Paired T- test and Wilcoxon Rank Sum Scale Atrophy, Dyspareunia, Dryness Orgasm 1 none absent 2 mild not satisfactory 3 moderate satisfactory 4 severe very satisfactory

67 Outcomes: Overall Conditions Improvement all significant (p </= 0.05) Atrophy 40% Dyspareunia 45% Dryness 52% Orgasmic Function 29%

68 Outcomes: FSFI Scores

69 Histology H & E Stain Before Treatment Epithelial layer thickness over 100 microns 3 mos Post 3 Treatments 62 / 92

70 Histology Trichrome Stain Before Treatment 3 mos Post 3 Treatments Collagen more dense with horizontal streaming Fibroblasts more dense and activated with open chromatin, larger nuclei Vascularity more notable

71 Future Studies Vaginal Atrophy and Stress Urinary Incontinence - Multi- center - Prospective - All expert sites - Minimum 50 patients each study - Validated QOLs - Histology - Objective measures

72 Easy Touch-Screen Treatment User Interface Depth: microns Set depth for best results Treatment Angles: Able to customize treatments and target specific areas Density: microns Set depth for best results Choose your density for best results. 0%, 7% or 14% Readout Data: For safety and records.

73 3 Treatment Angle Options 360 Degrees You can treat entire 360 degrees of vaginal canal 180 Degrees Additional coagulation on anterior wall if needed 90 Degrees Additional resurfacing to scar tissue on posterior wall if needed

74 Treatment Animation

75 Treatment: Live

76 HFL Laser Pattern Endoscopic view right after Photo right after One Week Post Treatment

77 Recommended Treatment Post-Care Patients: Can immediately return to work and normal life routine, with a few exceptions Should refrain from vaginal penetration for up to 48* hours, included by not limited to Sexual intercourse for 48* hours Douching Use of tampons May experience Spotting, pinkish colored discharge Mild cramping Sunburn-like feeling *This is a variable depending on treatment settings and physician clinical judgement

78 Joule 7 Platform World s Most Expandable Multi-Platform System The Total Women s Health Solution 180 FDA Cleared Indications 27 / 92

79 Added Revenue: The Total Solution External Vulva and Labia divatyte Pigmentation Face and full body Forever Young BBL Hair Removal Ingrown hair that often plagues genital skin, especially from waxing General hair removal, full body Scars Halo HFL and ProFractional options for treating scars Tummy tuck scars, breast augmentation, surgical and skin texture

80 95% Of all Sciton systems ever built since 1997 are still in service The only expandable platform with three delivery modules No artificial consumables for faster ROI

81 divatyte BBL with 695 or 800 filter No downtime Gives patients a firmer, more youthful appearance Available on the JOULE or BBLs Infrared energy with sapphire contact cooling Delivers uniform, deep heating to coagulate vulvar tissue Photos courtesy of Chris Robb, MD

82 Aesthetic: Before and After

83 Additional Considerations Platform Intra- vaginal only Internal and External vulvo- vaginal Wide platform Intravaginal External vulvo- vaginal Other applications Hair removal Skin tightening Pigment Skin resurfacing Scar treatment Quality of Industry Partner Crowded space

84 PATIENT COST COMPARISON COST IS RELATIVE The average cost of hormone creams, patches and tablets range from $600-$5,000+ per year Studies show over 80% of women stop using bladder medications after 1 year due to high costs and side effects* Average woman with bladder leakage spend approximately $750 per year on pads. Management of Stress Urinary Incontinence can cost $2,000-$3,000 out-of-pocket per year.

85 Q & A

86 Sources/References: Slide 3 & 4: Source: 1. Melissa Conrad Stöppler, MD; William C. Shiel Jr., MD, FACP, FACR 2. US 2010 Census Age and Sex Composition May 2011 Slide 5: Source: 1. Sandvik H. Bergen Norway. Dept. of Public Health & Primary Health Care., Univ. of Bergen.1995.Female Urinary Incontinence Studies Epidemiology & Management in General Practice [thesis] 2.Urology Care Foundation Slide 6: Source: 1 & 2 Mayo Clinic Proceedings.2010; 85(1): Simon JA, Komi J. Postmenopausal women s attitudes: vulvovaginal atrophy and its symptoms (abstract LB- 10. Menopause. 2007;14(6): Simons JS, Carey MP. Prevalence of sexual dysfunctions: results from a decade of research. Arch Sex Behav. 2001;30(2): Signorello LB, Harlow BL, et al. Post Partum Sexual functioning and its relationship to perineal trauma. Am J Obstet Gynecol (5): Krychman ML. Vaginal estrogens for the treatment of dyspareunia. J Sex Med.2011;8(3): Reference Johnny Peet, MD, FACOG White Paper included in this presentation Slide 7 Google metrics Slide 8 RealSelf metrics Slide 10 - Source: 1.Leeman LM, Rogers RG. Sex After Childbirth: postpartum sexual function. Obstet Gynecol.2012;119(3): Graphic: Slide 11 Source: 1. Portman DJ, Gass MLS. Climateric 2014; 17: Graphic: Johnston SL Geriatrics & Aging 2002 Reference Johnny Peet, MD, FACOG White Paper included in this presentation Slide 13 Source: Flow chart created by Sciton per Johnny Peet, MD, FACOG White Paper included in this presentation Slide 14 Source: Flow chart created by Sciton per Johnny Peet, MD, FACOG White Paper included in this presentation Slide 15 - Source: Graphic: Johnston SL Geriatrics & Aging 2002, Reference Johnny Peet, MD, FACOG White Paper included in this presentation Slide 16 - Source: 1.Mayo Clinic website atrophy/symptoms, Reference Johnny Peet, MD, FACOG White Paper included in this presentation Slide 17 & 18 Source: ACOG Slide 19 - Source: Graphic: MedFriendly.com. Reference Johnny Peet, MD, FACOG White Paper included in this presentation Slide 20 - Source: Mayo Clinic, Diseases and Conditions, Stress Incontinence, Reference Johnny Peet, MD, FACOG White Paper included in this presentation Slide 24 - Source: 1.Jill Waibel MD, Jama Dermatology. Dec. 2013, 2.Robert Bowen, MD. J Drugs in Dermatology. Aug 2010

87 Sources/References (Cont.): Slide 25 - Source: Patrick Bitter, Jr. MD Slide 26 - Source: Jason Pozner, MD, FACS, Chris Robb, MD, PhD Sciton has been treating tissue with Halo, the world s First Hybrid Fractional Laser since 2014 Slide 27 - Source: The Medical Spa Physician Report Slide 37 Source: Coherent Laser, Inc. Slide 38 & 39 Source: Sciton, Inc. Slide 44 & 45 Source: Videos courtesy of Chad Deal, MD, Southern Surgical Arts, Chattanooga, TN Slide 47 Source: Photos courtesy of Chris Robb, MD, Springhill Dermatology, Springhill, TN Slide Source: Peet J. Evaluation of the Safety and Efficacy of Hybrid Fractional 2940 nm and 1470 nm Lasers for Treatment of Vaginal Tissue: Pilot Study. Sciton Slide 68 - Source: This slide is based on internal data collected by Sciton and includes but is not limited to subjects within Dr. Peet s White Paper. Feedback includes women treated by Dr. Peet and discusses in his White Paper, as well as feedback women treated by the above additional investigators, for which no White Paper has been prepared as of this date. Slide Source: Reference Johnny Peet, MD, FACOG White Paper included in this presentation Slide 74 Source: Endoscopic video and photo courtesy of Johnny Peet, MD, FACOG Slide 76 - Source: Sciton, Inc. Slide 78 - Source: 12XpKk;