THE EFFECTIVE, CUTTING-EDGE, HORMONE-FREE LASER TREATMENT FOR VULVOVAGINAL DISEASES

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1 THE EFFECTIVE, CUTTING-EDGE, HORMONE-FREE LASER TREATMENT FOR VULVOVAGINAL DISEASES VULVOVAGINAL ATROPHY VAGINAL TIGHTENING (DESCENSUS VAGINAE) GENITOURINARY SYNDROME OF MENOPAUSE MILD STRESS URINARY INCONTINENCE

The best alternative to hormonal therapy and surgery Most of the urogenital diseases connected with the menopause follow a reduction in the production of estrogen by the ovaries.

2 The best alternative to hormonal therapy and surgery Most of the urogenital diseases connected with the menopause follow a reduction in the production of estrogen by the ovaries. This involves the gradual thinning of genital epithelial tissues, vaginal and vulvar mucosa, which reduce in thickness and moistness becoming more fragile, irritable and sensitive to trauma. Hormonal therapy has been for a long time the gold standard for postmenopausal symptoms. Urological symptoms such as Stress Urinary Incontinence deriving from childbirth and natural ageing process and affecting the pelvic floor structure have been historically treated by mean of surgery restoring the vaginal anatomy. Juliet represents a minimally invasive, effective and hormone-free treatment option for all women who do not wish invasive and/or hormone based options. MCL31 IV EN 2

Advantages in application and technology Application Fast, painless, discreet and easy to use No anesthesia necessary No surgery, minimal downtime No risk for infection or bleeding Technology Er:YAG

3 Advantages in application and technology Application Fast, painless, discreet and easy to use No anesthesia necessary No surgery, minimal downtime No risk for infection or bleeding Technology Er:YAG wavelength for best results and less side effects Ablative and sub-ablative mode (thermal mode) More than 2,000 Er:YAG lasers worldwide Over 15 years experience in Erbium technology MCL31 IV EN 3

MicroSpot Handpieces Gyn: Steri-Spot, V-Spot 90 *, V-Spot 360 * Additional handpieces: MicroSpot*,

4 Device specifications Laser: MCL31 Dermablate (Er:YAG), Class 4 Wavelength: Fluence: 2,940nm Max. 250 J/cm² Pulse duration: 100 1,000 µs Frequency : Modes: 1 20 Hz Gyn C, Gyn W, Ablation, Therm, MicroSpot Handpieces Gyn: Steri-Spot, V-Spot 90 *, V-Spot 360 * Additional handpieces: MicroSpot*, VarioTEAM* Dimensions: 36 x 60 x 93 cm (W x D x H) Weight: Ca. 75 kg * optional MCL31 IV EN 4

5 Why an Erbium:YAG Laser Deoxyhemoglobin Absorption Coefficient [cm -1 ] Protein Oxyhemoglobin Melanin Water Scattering Wavelength [nm] MCL31 IV EN 5

Why an Erbium:YAG Laser Tissue Er:YAG Ablation (Vaporisation)

absorption peak Ablation layer by layer Controlled thermic

absorption Deep, uncontrolled ablation Uncontrolled thermal

6 Why an Erbium:YAG Laser Tissue Er:YAG Ablation (Vaporisation) Heating Necrosis CO 2 Er:YAG Laser CO 2 Laser 2,940nm: water absorption peak Ablation layer by layer Controlled thermic effect, no thermal damage Cold ablation possible Lower water absorption Deep, uncontrolled ablation Uncontrolled thermal effect, necrosis areas No cold ablation possible MCL31 IV EN 6

7 Intravaginal handpieces V-Spot* With 90 reflecting gold-coated mirror, for SINGLE USE With 90 or 360 reflecting gold-coated mirror, for MULTIPLE USE * optional Handpiece Optic for Steri-Spot Handpieces Optic for V-Spot MCL31 IV EN 7

optional for the treatment of the vulva, it allows for a for different ablative

8 Additional handpieces MicroSpot* VarioTEAM* Fractional handpiece with 13x13 mm spot and variable cover rate Ablative handpiece with variable spot size 1-6 mm * optional for the treatment of the vulva, it allows for a for different ablative treatments complete therapy of vulvovaginal disorders in the vulvar area MCL31 IV EN 8

Micro-Spot Technology Squared spot of 9 x 9mm, consisting of 169 MicroSpots

$Selective treatment of only fractions of the tissue in the form of a grid$ supported by the untreated skin Very low risk of side effects Laser beam

9 Micro-Spot Technology Squared spot of 9 x 9mm, consisting of 169 MicroSpots MicroSpot optic with stable and precise micro lens array technology Selective treatment of only fractions of the tissue in the form of a grid Triggers skin renewal and collagen formation with rapid wound healing supported by the untreated skin Very low risk of side effects Laser beam entrance Micro lens array Fractional laser beam Pattern on the treated area MCL31 IV EN 9

Variable pulse length The adjustable pulse length allows for both cold ablative and thermal treatment This maximizes the results reducing the amount of sessions to two EPITHELIUM LAMINA PROPRIA MAZ*

10 Variable pulse length The adjustable pulse length allows for both cold ablative and thermal treatment This maximizes the results reducing the amount of sessions to two EPITHELIUM LAMINA PROPRIA MAZ* MAZ* MAZ* GYN C Pulse length 300 µs 1,000 µs GYN W Effect on the tissue Cold ablation Sub-ablative thermal treatment MCL31 IV EN 10 * MAZ = Microscopic ablation zone by Dr. Bettina A. Buhren & Dr. Peter A. Gerber, Hautklinik Düsseldorf

itching, painful intercourse, poor lubrication, decreased libido and poor vaginal muscle elasticity and tone This

and is found in 10-40% of post-menopausal women.

and becomes more fragile, irritable and sensitive to trauma Women with untreated vaginal atrophy often suffer from

11 Indications 1. Vulvovaginal Atrophy Women undergoing menopause often experience a number of symptoms including vaginal dryness, itching, painful intercourse, poor lubrication, decreased libido and poor vaginal muscle elasticity and tone This condition is also described as Vaginal Atrophy and it follows a reduction in the production of estrogen by the ovaries and is found in 10-40% of post-menopausal women. It involves the gradual thinning of genital epithelial tissues, vaginal and vulvar mucosa, which reduces in thickness and becomes more fragile, irritable and sensitive to trauma Women with untreated vaginal atrophy often suffer from vaginal paresthesia, a feeling of dryness, itching, burning and even pain during sexual intercourse and can be a contributing factor in urinary incontinence and for many women leads to an overall lack of quality of life Premenopausal vaginal tissue Postmenopausal vaginal tissue MCL31 IV EN 11

12 Indications 2. Vaginal Tightening (First-degree Descensus Vaginae) Descensus of the vagina occurs when, due to factors like vaginal births, weakness of the connective tissue, heavy physical work, ageing processes and hormone deficiencies, the pelvic floor tissue slackens, leading to a bulging of the vaginal walls The mild descensus of the vagina is often experienced as an excessively wide vagina and most women refer to it complaining a loss of vaginal tightness This is directly related to reduction in friction during intercourse and thus to a decrease or loss of sexual gratification. Normal vagina Enlarged vagina MCL31 IV EN 12

13 Indications 3. Genitourinary Syndrome of Menopause (GSM) The term Genitourinary Syndrome of Menopause* refers to a complex of symptoms, which are essentially caused by the post-menopausal hormone deficiency described in case of vaginal atrophy GSM is chronic, if not treated it advances and can interfere with the quality of life It is estimated that one in two women in menopause is affected by this complex of life-quality-impairing disorders such as vaginal dryness, burning, paresthesia, restricted capacity for sexual pleasure due to decreased lubrication or even pain during intercourse, as well as urinary urgency, dysuria and repeated bladder infections. Genital symptoms: vaginal dryness, burning, irritation Sexual symptoms: poor lubrication, dyspareunia Uro-gynecological symptoms: urgency, urge incontinence, dysuria *Genitourinary syndrome of menopause: new terminology for vulvovaginal atrophy from the International Society for the Study of Women's Sexual Health and the North American Menopause Society. Portman et al., Menopause Oct;21(10): MCL31 IV EN 13

Indications 4. Mild Stress Urinary Incontinence The term Stress Urinary Incontinence (SUI) refers to the involuntary loss of urine during coughing, sneezing or physical exertion.

14 Indications 4. Mild Stress Urinary Incontinence The term Stress Urinary Incontinence (SUI) refers to the involuntary loss of urine during coughing, sneezing or physical exertion. The underlying cause of this condition is often the decreased stability of the connective tissue and a loss of support of the urethra It is a quite widespread disease prevalent in women after their first birth (24% to 29%) and in women undergoing menopause because of the reduction in estrogen production. Similarly, frequent exercise in high-impact activities can cause athletic incontinence to develop Women with Stress Urinary Incontinence have an altered connective tissue metabolism, which causes decreased collagen production and which may result in insufficient support of the urogenital tract. Normal pelvic floor muscle Weak pelvic floor muscle MCL31 IV EN 14

Mechanism of action Juliet is a minimally invasive treatment, the goal of which is to restore the original metabolism of connective tissue by stimulating new collagen production As a result of laser

15 Mechanism of action Juliet is a minimally invasive treatment, the goal of which is to restore the original metabolism of connective tissue by stimulating new collagen production As a result of laser irradiation the intermolecular crosslinks of the triple helix of collagen shorten, which leads to the immediate tightening of collagen fibrils by two-thirds of their length This leads to an improvement in the condition of the vaginal skin and in the tone of the pelvic muscle, strengthening the vaginal tissue that contributes to support of the interior tissue and wall The inner mucosa regains elasticity and lubrication, showing improved thickness and softness MCL31 IV EN 15

Mechanism of action The wall of the vagina is composed of the following layers: Epithelium: internal lining of epithelial tissue made up of squamous epithelial cells Lamina propria: connective tissue

16 Mechanism of action The wall of the vagina is composed of the following layers: Epithelium: internal lining of epithelial tissue made up of squamous epithelial cells Lamina propria: connective tissue that supports the mucosa and connects it with the muscularis Muscularis: muscle tissue Adventitia: connective tissue interlaced with elastic fibers, attaches the vagina to surrounding organs Objective of the laser treatment is to reach the Lamina propria, elastic and rich in collagen that can be stimulated. MCL31 IV EN 16

17 Mechanism of action This action continues its beneficial effect even after the treatment is finished: for this reason, many women report further improvements during the first months post-treatment Phase I h Phase II 1 Month Phase III After 1 month Early thermal effect Edema, collagen and elastin shrinking Proliferation Formation of new collagen fibers Remodeling New vascularization, Improved lubrication MCL31 IV EN 17

18 Mechanism of action There are indications in the scientific literature that vaginal laser therapy can lead to an improvement in symptoms of atrophy. Histological studies by Prof. R. Milani of Monza, Italy have already shown how the vaginal epithelium regenerates following laser therapy and further clinical observations support this rationale The rationale for applying laser treatment for mild descensus of the vagina, which is often experienced as an excessively wide vagina and can lead to a decrease in sexual pleasure for a couple, is that it tightens the connective tissue and improves blood circulation in the vaginal epithelium Clinical observations, according to which an improvement of continence occurs following Erbium laser treatment of the vagina, suggest that here a regeneration of connective tissue results in improved urethral closure MCL31 IV EN 18

19 Preparation & Aftercare Inclusion criteria: normal cell cytology (PAP smear), negative urine culture, vaginal canal, introitus and vestibule free of injuries and bleeding Exclusion criteria: pregnancy, injury or/and active infection in the treatment area, undiagnosed vaginal bleeding and active menstruation, intake of photosensitive drugs Immediately before the laser treatment: the patient s vagina (vestibule, introitus and vaginal canal) must be thoroughly washed and the disinfecting solution carefully dried off and removed from the mucosa After the laser treatment: No special post-op therapy needed. No sexual activities for a period of 72 hours after each of the treatment sessions. Cave: with a history of genital herpes for the prevention assign velacyclovir in standard dose for three days before and after the procedure. MCL31 IV EN 19

secondly, a thermal phase, whose goal is to produce a thermal effect, reaching the collagen fibers in the lamina

20 Dual-phase treatment concept The intravaginal Juliet treatment consists of 2 phases: firstly an ablative phase, whose goal is to drill very small holes in the superficial layers of the mucosa by mean of a mechanical effect; secondly, a thermal phase, whose goal is to produce a thermal effect, reaching the collagen fibers in the lamina propria and stimulating the collagenogenesis. The two phases are performed one immediately after the other. MCL31 IV EN 20

$Phase 1: Ablative fractional mode Insert the handpiece in the vagina to the$ treatment by rotating the handpiece by 45⁰ (line to line) between laser pulses When the

treatment by rotating the handpiece by 45⁰ (line to line) between laser pulses When the

until the 2cm indicator on the handpiece is visible outside of the vagina Mode Gyn C

21 Phase 1: Ablative fractional mode Insert the handpiece in the vagina to the cervix/vaginal vault (7 to 10cm) with the mirror in the upward position Perform the treatment by rotating the handpiece by 45⁰ (line to line) between laser pulses When the of 360⁰ rotation is completed (8 pulses), withdraw the handpiece 1 cm Repeat the process until the 2cm indicator on the handpiece is visible outside of the vagina Mode Gyn C Handpiece Steri-Spot or V-Spot 90 Fluence J/cm 2 * Pulse duration 300 µs Interval Rotation angle s (according user s experience) 45 (line to line) * depending on the severity of the condition; general rule is: the thinner the vaginal skin, the lower the fluence MCL31 IV EN 21

Phase 2: Thermal mode Re-insert the handpiece in the vagina to the cervix/vaginal vault (7 to 10cm) with the mirror in

5⁰ (line and dot) between laser pulses When the of 360⁰ rotation is completed (16 pulses), withdraw the handpiece 0.

Steri-Spot or V-Spot 90 Fluence 6 12 J/cm 2 * Pulse duration 1,000 µs Interval Rotation angle 0.

22 Phase 2: Thermal mode Re-insert the handpiece in the vagina to the cervix/vaginal vault (7 to 10cm) with the mirror in the upward position This time, perform the treatment by rotating the handpiece by 22.5⁰ (line and dot) between laser pulses When the of 360⁰ rotation is completed (16 pulses), withdraw the handpiece 0.5cm Repeat the process until the 2cm indicator on the handpiece is visible outside of the vagina Mode Gyn W Handpiece Steri-Spot or V-Spot 90 Fluence 6 12 J/cm 2 * Pulse duration 1,000 µs Interval Rotation angle s (according user s experience) 22.5 (line and dot) * depending on the severity of the condition; general rule is: the thinner the vaginal skin, the lower the fluence MCL31 IV EN 22

Pliaglis from Galderma) is recommended in case of hypersensitive patients Mode N25% Handpiece MicroSpot handpiece Fluence 15 30 J/cm 2

23 Phase 3: Treatment of vestibule and introitus area Treat the area with single spot technique Perform 1 to 3 passes according to patient s condition* Local anesthesia (e.g. Pliaglis from Galderma) is recommended in case of hypersensitive patients Mode N25% Handpiece MicroSpot handpiece Fluence J/cm 2 * Pulse duration 300 µs Interval s (according user s experience) N25% Mode 4 70 N25 8 Hz µm * depending on the severity of the condition; general rule is: the thinner the vaginal skin, the lower the fluence MCL31 IV EN 23

24 Clinical results International studies show the efficacy of the Erbium:YAG technology The Juliet procedure is performed by the MCL31 Dermablate Erbium:YAG laser system. At 2,940 nm, the laser is at the peak for water absorption. And, with the ability for both short and long pulses, studies show that it is more effective than other options. Over 1,000 patients showed excellent improvement with a high level of patient satisfaction (97%) and no adverse effects. Average pelvic floor muscle pressure improved by 60%, vaginal canal shrinkage by 17% and almost 70% of urinary incontinence patients were dry after 120 days (1). In a study of 70 patients, Er:YAG achieved better and more long-lasting results than the CO 2 treated ones. Patient discomfort during the treatment, as well as in the post-op period, was significantly higher in the CO 2 group (2). In a study of 37 patients, 100% of patients reported, 6 months after the treatment, improvement in vaginal tightness. 84% reported better sex. In addition, 84% of patients affected by SUI reported significant improvement in the Q-tip test score (3). 1 Saraçoğlu, F. (2013). Overview of Cosmetic Gynecology, LA&HA, Vol. 2013, (1) 2 Gaspar, A. (2013). Evolution of minimally invasive laser treatments for Vaginal Atrophy. LA&HA, Vol. 2013, No 1. 3 Leshunov EV, Martov AG. (2015). Application of laser technologies for treatment of urinary stress incontinence in women of reproductive age Jan-Feb;(1): MCL31 IV EN 24

25 Clinical results Histological preparation Hematoxylin & Eosin - SETTINGS: Fluence 20 J/cm 2 Pulse duration 300 µs (GYN C) The sample at day 0 shows an altered epithelium stratification with presence of cornification and superficial areas, characterized by very low cellularity. The epithelium appears atrophic and a flattening of the dermal papillae at the dermo-epidermal junction can be recognized. Day 0 before the treatment MCL31 IV EN µm Pictures by courtesy of: University of Milano-Bicocca, San Gerardo Hospital, Monza, Italy - Department of Obstetrics and Gynecology, Chief Prof. Rodolfo Milani

26 Clinical results Histological preparation Hematoxylin & Eosin - SETTINGS: Fluence 20 J/cm 2 Pulse duration 300 µs (GYN C) At day 7 (after one treatment) the pavement epithelium appears well organized, with compact structure and presence of several nuclei, both in the deeper and superficial layers. The depth of the dermal papillae appears moreover increased, showing good tissue vitality. Day 7 after 1 treatment MCL31 IV EN µm Pictures by courtesy of: University of Milano-Bicocca, San Gerardo Hospital, Monza, Italy - Department of Obstetrics and Gynecology, Chief Prof. Rodolfo Milani

27 Clinical results Histological preparation Hematoxylin & Eosin - SETTINGS: Fluence 20 J/cm 2 Pulse duration 300 µs (GYN C) 100 µm 100 µm Day 0 before the treatment Day 7 after 1 treatment Pictures by courtesy of: University of Milano-Bicocca, San Gerardo Hospital, Monza, Italy - Department of Obstetrics and Gynecology, Chief Prof. Rodolfo Milani MCL31 IV EN 27

courtesy of: University of Milano-Bicocca, San Gerardo Hospital, Monza, Italy - Department of Obstetrics and

28 Clinical results Two-photon microscopy image Hematoxylin & Eosin - SETTINGS: Fluence 20 J/cm 2 Pulse duration 300 µs (GYN C) Day 0 before the treatment Day 7 after 1 treatment split epithelium with few and pyknotic nuclei Pictures by courtesy of: University of Milano-Bicocca, San Gerardo Hospital, Monza, Italy - Department of Obstetrics and Gynecology, Chief Prof. Rodolfo Milani multilayered well organized epithelium with presence of nuclei MCL31 IV EN 28

Clinical results Polarized light microscopy image Hematoxylin & Eosin - SETTINGS: Fluence 20 J/cm 2 Pulse duration 300 µs (GYN C) 30 days after 1 treatment Neocollagenogenesis and Angiogenesis

29 Clinical results Polarized light microscopy image Hematoxylin & Eosin - SETTINGS: Fluence 20 J/cm 2 Pulse duration 300 µs (GYN C) 30 days after 1 treatment Neocollagenogenesis and Angiogenesis processes are still visible; a re-gained uniformity of the tissue is the evidence of efficient tissue regeneration. In addition, the new collagen formation can be recognized through the white stripes visible in the deeper layers. 200 µm Day 30 after 1 treatment Pictures by courtesy of: University of Milano-Bicocca, San Gerardo Hospital, Monza, Italy - Department of Obstetrics and Gynecology, Chief Prof. Rodolfo Milani MCL31 IV EN 29

Clinical results Polarized light microscopy image Hematoxylin & Eosin - SETTINGS: Fluence 20 J/cm 2 Pulse duration 300 µs (GYN C) 200 µm Day 7 after 1 treatment 200 µm Day 30 after 1

30 Clinical results Polarized light microscopy image Hematoxylin & Eosin - SETTINGS: Fluence 20 J/cm 2 Pulse duration 300 µs (GYN C) 200 µm Day 7 after 1 treatment 200 µm Day 30 after 1 treatment Pictures by courtesy of: University of Milano-Bicocca, San Gerardo Hospital, Monza, Italy - Department of Obstetrics and Gynecology, Chief Prof. Rodolfo Milani MCL31 IV EN 30

31 Bibliography Application of laser technologies for treatment of urinary stress incontinence in women of reproductive age E.V. Leshunov, A.G. Martov (2015) Urologiia, Jan-Feb;(1): Female intimate surgery: review of methods and trends Ya.A. Yutskovskaia, E.V. Leshunov, V.D.Trufanov Efficacy of Erbium:YAG laser treatment compared to topical estriol treatment for symptoms of genitourinary syndrome of menopause. A. Gaspar, H. Brandi, V. Gomez, D. Luque (2016) Lasers Surg Med. Aug 22. Genitourinary syndrome of menopause: an overview of clinical manifestations, pathophysiology, etiology, evaluation, and management. J. Gandhi, A. Chen, G. Dagur, Y. Suh, N. Smith, B. Cali, S.A. Khan (2016) Am J Obstet Gynecol. Dec;215(6): Evolution of minimally invasive laser treatments for Vaginal Atrophy A. Gaspar (2013) LA&HA, Vol. 2013, No 1. Genitourinary syndrome of menopause and the use of laser therapy J. Hutchinson-Colas, S. Segal (2015), Maturitas, Dec;82(4): Rationale and design for the Vaginal Erbium Laser Academy Study (VELAS): an international multicenter observational study on genitourinary syndrome of menopause and stress urinary incontinence M. Gambacciani, M. G. Torelli, L. Martella et al. (2015), Climacteric, 18:sup1, Vaginal erbium laser: the second-generation thermotherapy for the genitourinary syndrome of menopause M. Gambacciani, M. Levancini & M. Cervigni (2015), Climacteric, 18:5, MCL31 IV EN 31

32 Bibliography Laser Vaginal Tightening (LVT) evaluation of a novel noninvasive laser treatment for vaginal relaxation syndrome E. Jorge, P. Gaviria, A. Jose, L. Lanz (2015), J. LAHA, Vol. 2012, No.1; pp First assessment of short-term efficacy of Er:YAG laser treatment on stress urinary incontinence in women: prospective cohort study N. Fistonić, I. Fistonić, A. Lukanovič, Š. Findri Guštek, I. Sorta Bilajac Turina & D. Franić (2015), Climacteric, 18:sup1, Minimally invasive laser procedure for early stages of stress urinary incontinence (SUI) I. Fistonić, Š. Findri Guštek, N. Fistonić (2012), J. LAHA, Vol. 2012, No.1; pp Treatment of Vaginal Relaxation Syndrome with an Erbium:YAG Laser Using 90 and 360 Scanning Scopes: A Pilot Study & Short-term Results L. Min Seok (2014), Laser Ther. Jul 1;23(2): Novel Minimally Invasive VSP Er:YAG Laser Treatments in Gynecology Z. Vizintin, M. Rivera, I. Fistonić, et al. (2012), J. LAHA, Vol. 2012, No.1; pp Erbium laser in gynecology Z. Vizintin, M. Lukac, M. Kazic & M. Tettamanti (2015) Climacteric, 18:sup1, 4-8. A minimally invasive treatment method for lichen sclerosis E.V. Leshunov, I.V. Kvach, Ya.A. Yutskovskaya MCL31 IV EN 32

The gentle solution to. Vaginal Atrophy Vaginal Tightening Stress Urinary Incontinence

The gentle solution to. Vaginal Atrophy Vaginal Tightening Stress Urinary Incontinence The gentle solution to Vaginal Atrophy Vaginal Tightening Stress Urinary Incontinence Device specifications Laser: MCL31 Dermablate (Er:YAG), Class 4 Wavelength: Fluence: 2,940 nm Max. 250 J/cm² Pulse