24 March 2023 - - US-based medical device company Axena Health, Inc said that Cigna Healthcare (Cigna), one of the largest healthcare insurance providers in the United States with approximately 15m members, has added the Leva Pelvic Health System as a covered treatment for stress, urgency and mixed urinary incontinence in women, the company said.

The Leva Pelvic Health System is a prescription digital therapeutic that guides women through pelvic floor muscle training, offering an easy, convenient way for women to treat UI and chronic fecal incontinence by strengthening their pelvic floor muscles.

The positive coverage decision from Cigna follows Axena Health's recent USD 25m series A fundraising and a new Obstetrics and Gynecology study showing the Leva System's long-term efficacy for female UI.

In its February 15, 2023 coverage policy update, Cigna noted that PFMT is an established treatment option for UI but also cited published evidence indicating that only 25% of women perform PFMT adequately.

UI is a progressive medical condition that can have a severe impact on a woman's quality of life and is associated with significant negative comorbidities.

The Leva System is US Food and Drug Administration -cleared to treat stress, mixed and mild-to-moderate urgency UI (including overactive bladder) in women as well as the first-line treatment of chronic fecal incontinence in women.

It's available by prescription, allowing clinicians to work directly with patients to help them perform PFMT effectively, which level-one evidence shows is most effective. The Leva System requires just five minutes of practice a day, which women can do at home, on their own schedule.

Significant published data support the Leva System, including a randomized controlled superiority trial (RCT), which showed that the Leva System "significantly improved" symptoms of UI in women versus Kegel exercises alone.

The same journal, Obstetrics and Gynecology, published a second study, a one-year longitudinal follow up to the RCT, which showed that women using the Leva System achieved long-term symptom relief that was durable.

In fact, at one-year post-treatment, these women had more than twice the odds of reporting improvement compared to those who did Kegels alone.

The Leva Pelvic Health System offers an innovative, non-invasive, medication-free way for women to train and strengthen their pelvic floor muscles--at home in just five minutes a day--to treat urinary incontinence and chronic fecal incontinence.

Combining a small FDA-cleared vaginal motion sensor connected to a smartphone app, the Leva System offers precise visualization of pelvic movement in real-time, enables progress tracking and allows active physician involvement, all of which support women's success.

Recognizing that level-one evidence shows pelvic floor muscle training is most effective when performed under the supervision of a skilled healthcare provider, the Leva System is available by prescription only, allowing physicians the opportunity to treat UI and chronic FI on a broad scale and with continued involvement in patient success.

The Leva System is the first femtech product included in the Digital Therapeutics Alliance product library and has multiple clinical trials and published data from globally recognized medical centers supporting its efficacy in treating UI, including two studies in Obstetrics and Gynecology (The Green Journal), the official publication of the American College of Obstetricians and Gynecologists.

Axena Health, Inc. is a women-led company dedicated to improving the lives of women with pelvic floor disorders.

Axena Health's flagship product, the Leva Pelvic Health System, offers a novel, effective, first-line treatment for urinary incontinence and chronic fecal incontinence, underreported conditions affecting over 78 m and 12 m women in the US alone.

Axena Health's technology enables non-invasive, drug-free treatment via precise visualization of movement in real time during pelvic floor muscle training, while monitoring usage and progress.