Leva 3.28

Axena Health's Leva® Pelvic Health System, a FDA-cleared medical device, is designed to aid in the treatment of bladder and chronic bowel leakage. The system utilizes motion sensors and an accompanying app to facilitate the training and strengthening of weakened pelvic floor muscles through real-time visualization of muscle movement.

• The Leva system features multiple highly sensitive motion sensors that provide real-time feedback on pelvic floor muscle activity, ensuring correct and consistent muscle training.
• The Leva app conveniently tracks and records usage data, offering valuable insights into progress over time. To utilize the Leva system, a prescription from a healthcare provider is necessary.

The regimen involves training for 2 ½ minutes, twice daily for a period of 12 weeks. Users can comfortably use the Leva system at home or on-the-go with ease. Additionally, the system offers discreet access to a personal coach to support users in achieving symptom improvement goals.

The Leva® Pelvic Health System targets (1) strengthening pelvic floor muscles, (2) rehabilitating weak pelvic floor muscles for urinary incontinence, and (3) treating chronic fecal incontinence in women. This prescription-based treatment is not suitable for everyone and should be discussed with a healthcare provider to assess its appropriateness and potential risks.

For comprehensive information on risks and instructions related to the Leva System, refer to the Instructions for Use available at www.levatherapy.com.

The Leva Pelvic Health System is exclusively available in the United States and has received FDA clearance for its intended uses as listed above. Axena Health has focused its efforts solely on marketing the Leva system within the U.S., including the accompanying app.