FemPulse Therapy for Overactive Bladder in Women

The FemPulse System is a vaginal ring intended to provide mild electrical stimulation to
nerves that regulate bladder function. It is believed that stimulation of these nerves may
help relieve the symptoms of OAB.

Inclusion Criteria:

- Females 21 years or older with a diagnosis of Overactive Bladder

- If of reproductive age, must use a reliable form of contraception

Exclusion Criteria:

- Pregnant, was recently pregnant or is trying to conceive

- Has a metal pelvic implant or any electrically active implanted medical device

- Had a previous hysterectomy, pelvic radiation or pelvic cancer

- Has significant pelvic organ prolapse

- Had bladder treatment with onabotulinumtoxinA in the previous 12 months

- Has a significant heart condition