Leva

Renovia's leva® Pelvic Health System is FDA-cleared to help treat bladder leakage. leva and its digital health app helps you train and strengthen weakened pelvic floor muscles by displaying real-time depiction of motion. Multiple highly sensitive motion sensors display movement when your pelvic floor muscles 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.

— Train for 2 ½ minutes, twice daily.
— leva is easy to use in the privacy of your home.
— leva provides discreet access to a personal coach to help you reach your goals.

Visit www.knowleva.com to learn more.

The leva Pelvic Health System is intended for: (i) strengthening of the pelvic floor muscles; and (ii) 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. This product interacts with the user via smartphone technology.

Important Safety Information for leva Pelvic Health System: Do not use leva while pregnant, or if you think you may be pregnant, unless authorized by your doctor. Do not leave leva in your body for longer than necessary to complete the training session. Do not use leva in any other place in your body or have sexual intercourse while leva is inserted. If you experience odor, fever, diarrhea, any signs of infection, or of an allergic reaction, contact your doctor immediately. For a complete summary of the risks and instructions for leva Pelvic Health System, see its Instructions for Use available at Renovia’s website.

Treatment with leva is prescribed by your doctor. This treatment is not for everyone. Please talk to your doctor to see if it is right for you. Your doctor should discuss all potential benefits and risks with you.

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. Renovia has not pursued approval of the leva Pelvic Health System, including this app, outside of the United States