Treatment for Stress and Mixed Urinary Incontinence and Vaginal Vault Prolapse

Urinary incontinence is the involuntary loss of urine and can affect both men and women
throughout their lives. Women are more likely to develop incontinence as a result of
pregnancy and childbirth. There are approximately 11 million cases of incontinence in the US
contributing to several different types of incontinence including :

- Urge - 30% of the market

- Stress - 30% of the market of which 85% are women

- Combination urge and stress - 40%

Despite advances in behavioral therapy, pharmacological advances as well as development of
minimally invasive surgical procedures, only one out of every twelve people affected
actually seek help.

Prolapse

Globally, approximately 1 million women suffer uterovaginal prolapse annually and this
condition can be associated with urinary incontinence. The breakdown of treatments for
uterovaginal prolapse includes:

- 20% - no treatment

- 20% - non surgical management (pessary)

- 60% - receive a surgical procedure of a suture repair or mesh repair

There were greater than 600,000 surgeries performed globally to treat prolapse. These
numbers are projected to increase due to rapid, easy, and less costly methods as well as new
products that facilitate the easier procedures.

Inclusion Criteria:

- Subject must be female and >18 years of age.

- Subject must have genuine stress or mixed incontinence AND/OR evidence of pelvic
organ prolapse.

Exclusion Criteria:

- Any subject with clotting defects, bleeding disorders or receiving anticoagulant
treatments AND is determined to be at risk for minimally invasive surgery as
determined by the investigator

- Subjects who currently have an untreated urinary tract infection

- Subject is unable to comply with the study requirements, follow-up schedule, or to
give valid informed consent.

- Subject is pregnant or desires future pregnancies.