Clinical Study of the CO2RE Laser Device Performance for Vaginal Atrophy Treatments

This study is a Prospective clinical study to demonstrate the CO2RE laser device for safety
and efficacy for Vaginal Atrophy.

Up to a total of 60 healthy candidates, seeking vaginal treatment from the participating
investigator will be enrolled at a participating study site. Subjects will receive three (3)
CO2RE treatments.

Each subject will be followed for additional 5 post treatment visits (FU visits) that will be
conducted at:

- One week post first treatment - 1wk FU ± 2 days (Safety).

- 1 month post last treatment - 1m FU ± 2 weeks (efficacy & Safety).

- 3 months post last treatment - 3m FU ± 2 weeks (efficacy & Safety).

- 6 months post last treatment - 6m FU ± 2 weeks (efficacy & Safety).

- 12 months post last treatment - 12m FU ± 2 weeks (efficacy & Safety).

Inclusion Criteria:

1. Subjects seeking treatment of Vaginal Atrophy in the vagina area (External - vestibule
and introitus; Internal - Vaginal canal)

2. Healthy female subjects age greater than or equal to 35 years of age who are post
menopausal for at least one year, for any reason whether surgical , chemical or
natural.

3. Absence of menstruation for at least 12 months

4. Not responding to or satisfied with previous local estrogen therapy

5. Desire to maintain sexual activity

6. Informed consent process completed and subject signed consent

7. Willing to receive the proposed CO2RE treatment and follow-up protocol

8. Post-menopausal or surgically sterilized.

9. Normal cell cytology (PAP smear)

10. Negative urinalysis and a normal vaginal canal (no evidence of dysplasia and occult or
active infection)

11. The external vaginal area (vestibule and introitus) free of injuries and bleeding

12. Subject experienced sexual activity at least once a month

Exclusion Criteria:

1. Subject had surgery or any other procedure for Vaginal Tightening in the last 12
months

2. Use of hormone replacement therapy, either systemic or local within the last 6 months
prior to study

3. Lubricants or any localized preparation in the 30 days prior to enrollment

4. Patient with history of herpes.

5. Acute or recurrent urinary tract infection (UTI) or genital infection (e.g. herpes,
candida)

6. Active malignancy or history of malignancy in the past 5 years

7. Having any active electrical implant anywhere in the body, such as a pacemaker or an
internal defibrillator

8. Suffering from significant concurrent illness, such as cardiac disorders, diabetes
(type I or II), lupus, porphyria, or pertinent neurological disorders (i.e. any
disease state that in the opinion of the Physician would interfere with the treatment,
or healing process)

9. Having a known anticoagulative or thromboembolic condition or taking anticoagulation
medications one week prior to and during the treatment course (to allow inclusion,
temporary cessation of use as per the subject's physician discretion)

10. History of immunosuppression/immune deficiency disorders (including HIV infection or
AIDS) or currently using immunosuppressive medications

11. Suffering from hormonal imbalance, whether related to thyroid, pituitary, or androgen

12. History of significant lymphatic drainage problems

13. History of cancer which required lymph node biopsy or dissection

14. Suffering from significant conditions in the treated areas or inflammatory conditions,
including, but not limited to, open lacerations or abrasions of the treatment area
prior to treatment (duration of resolution as per the Investigator's discretion) or
during the treatment course

15. History of keloid scarring, abnormal wound healing and / or prone to bruising

16. History of epidermal or dermal disorders (particularly if involving collagen or
microvascularity), including collagen vascular disease or vasculitic disorders

17. Use of isotretinoin (Accutane®) within 6 months of treatment or during the study

18. Subject on systemic corticosteroid therapy 6 months prior to and throughout the course
of the study

19. Dysplastic nevi in the area to be treated

20. Participation in a study of another device or drug within 6 month prior to enrollment
or during this study, if treatments of vagina were involved

21. As per the Investigator's discretion, any physical or mental condition which might
make it unsafe for the subject to participate in this study

22. Prolapse staged >_ II, according to the pelvic organ prolapse quantification
(ICS-POP-Q) system

23. Previously undergone pelvic reconstructive surgery