MonaLisa Touch Study

Study design: Randomly assigning the intervention can eliminate the influence of unknown or
immeasurable confounding variables that may otherwise lead to biased and incorrect estimate
of treatment effect. Also, randomization eliminates confounding by baseline variables and
blinding eliminates confounding by co-interventions, thus eliminating the possibility that
the observed effects of intervention are due to differential use of other treatments. The
best comparison is placebo control that allows participants, investigators and study staff to
be blinded. The advantage of trial over an observational study is the ability to demonstrate
causality.

Background: Genitourinary syndrome of Menopause is a condition of postmenopausal women due to
estrogen deprivation which results in progressive worsening of the vaginal and vulvar anatomy
with symptoms of vulvar itching or pain during intercourse, vaginal dryness, urinary urgency
and frequency and frequent bladder infections. It could ultimately lead to vaginal bleeding,
petechial hemorrhages, vaginal narrowing or stenosis and hypertonicity of the pelvic muscles
due to anticipation of coital pain. The hypertonicity by itself can cause pelvic pressure or
pain.

Thus, GSM is a chronic progressive disease state that if left untreated could have dire
vaginal and urogynecological consequences.

MonaLisa Touch is a fractional CO2 laser that has been specially designed with the DEKA pulse
to stimulate vaginal tissue. It is delivered in a very precise manner and results in the
synthesis of collagen and stratification of the vaginal epithelium with improvement of the
vaginal pH and moisturization of the vaginal tissue due to increased blood flow and turgidity
of the ground substance from the synthesis of the proteoglycans, hyaluronic acid and
collagen.

Initial trials on MonaLisa Touch have shown promising results with significant improvement in
vaginal exams and patient satisfaction scores.

Inclusion Criteria:

- Postmenopausal dyspareunia or vaginal dryness rated from moderate to severe

- Desirous of sexual function

- Menopausal women with absence of menstruation for at least 12 months or those who have
had bilateral oophorectomy

- Presence of vaginal atrophy symptoms based upon the vaginal health index assessment <
15 and vagina pH >5

- Prolapse stage < III, according to the pelvic organ prolapse quantification (POP-Q)
system

- No pelvic reconstructive surgery within 6 months prior to treatment

- Understanding and acceptance of the obligation to return for all scheduled follow-up
visits

Exclusion Criteria:

- History of vaginal carcinoma or dysplasia, history of vaginal or pelvic radiation

- Acute or recurrent genital infection (e.g. bacterial; vaginosis, herpes genitalis,
candida)

- Any serious disease, or chronic condition such as uncontrolled diabetes, that could
interfere with the study compliance

- Reconstructive pelvic surgery within the past 6 months

- Have used vaginal estrogen cream, ring or tablet within 3 months prior to entering the
study

- Have used vaginal moisturizers, lubricants or homeopathic preparations within 30 14
days of therapy

- Not willing to stop use of any vaginal lubricants or estrogen of any form including
phytoestrogens such as Estroven