Leva

Digital Therapeutic for Pelvic Floor Training

Axena Health’s Leva® Pelvic Health System is FDA-cleared to help treat bladder and chronic bowel leakage. Leva’s motion sensors and app together help you train and strengthen weakened pelvic floor muscles by displaying real-time visualization of your pelvic floor muscle movement. Multiple highly sensitive motion sensors display movement when your pelvic floor muscles lift and contract to help ensure you can perform your pelvic floor muscle training correctly and consistently. The Leva app tracks and records your Leva usage and lift data to help you understand your progress over time. Leva requires a prescription from your healthcare provider.

— Train for 2 ½ minutes, twice daily for 12 weeks.

— Leva is easy to use remotely, in the privacy of your home or on the go.

— Leva provides discreet access to a personal coach to help you reach your symptom improvement goals.

Visit www.levatherapy.com to learn more.

The Leva® Pelvic Health System is intended for (1) strengthening of pelvic floor muscles, (2) rehabilitation and training of weak pelvic floor muscles for the treatment of stress, mixed, and mild to moderate urgency urinary incontinence (including overactive bladder) in women and (3) rehabilitation and training of weak pelvic floor muscles for the first-line treatment of chronic fecal incontinence (>3-month uncontrolled passage of feces) in women. Treatment with the Leva System is by prescription and is not for everyone. Please talk to your prescriber to see if Leva System is right for you. Your prescriber should discuss all potential benefits and risks with you. Do not use Leva System while pregnant, or if you think you may be pregnant, unless authorized by your doctor. For a complete summary of the risks and instructions for the Leva System, see its Instructions for Use available at www.levatherapy.com.

The Leva Pelvic Health System requires the Leva sensor-based device and this app, and is available only in the United States. The U.S. Food & Drug Administration has cleared the Leva Pelvic Health System to be marketed for the above listed intended uses. Axena Health has not pursued approval of the Leva Pelvic Health System, including this app, outside of the United States.