NEWTON, Mass.--(BUSINESS WIRE)--Axena Health, Inc. (Axena Health), a medical device company relentlessly dedicated to women’s health, today announced that Cigna Healthcare (Cigna), one of the largest healthcare insurance providers in the United States with approximately 15 million members, has added the Leva Pelvic Health System as a covered treatment for stress, urgency and mixed urinary incontinence (UI) in women. The Leva Pelvic Health System is a prescription digital therapeutic (PDT) that guides women through pelvic floor muscle training (PFMT), offering an easy, convenient way for women to treat UI and chronic fecal incontinence (FI) by strengthening their pelvic floor muscles. The positive coverage decision from Cigna follows Axena Health’s recent $25 million Series A fundraising and a new Obstetrics and Gynecology study showing the Leva System’s long-term efficacy for female UI.
“This is great news for women,” said S. Mark Cone, MD, FACOG, Market President Privia Health - South Texas. “Pelvic floor muscle training is an effective first-line treatment for urinary incontinence. For our patients, the Leva System makes this training easy, accessible and effective, allowing more women to live leak-free. Insurance coverage for the Leva System ensures that more women can access this new innovative option in the privacy of their own home, allowing them to re-engage confidently with the activities they love.”
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. Cigna’s coverage policy update then states, “a newer at-home biofeedback device and remotely delivered program called Leva® Pelvic Health System was developed to mitigate some of these issues. This device and program includes motion sensor technology with personal coaching and app technology to help patients train and strengthen their pelvic floor muscles correctly and decrease the symptoms of UI. It is physician-prescribed and does not require physical therapist involvement. Given this, the remotely delivered Leva® Pelvic Health System could address potential access issues for patients who cannot easily receive in-person treatment.”
“The National Association for Continence is pleased that Cigna’s positive coverage decision will increase access to a clinically proven treatment option for female urinary incontinence,” said Steven G. Gregg, Ph.D., Executive Director for NAFC. “Patients and their clinicians are always looking for better options for a condition that many think is simply a sign of aging or the result of childbirth. Cigna’s decision affirms that the Leva System should be considered first-line therapy for women with UI, and we applaud them.”
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 U.S. Food and Drug Administration (FDA)-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.
Said CEO Eileen Maus: “Cigna has demonstrated its clear leadership in women’s health, and we’re proud to announce their ‘first mover’ victory for their female members affected by urinary incontinence. With the adult diaper market now exceeding the baby diaper market, it’s time to act, and not with drugs or surgery. Women want to take agency of their pelvic floor, and the Leva System allows this while offering effective, durable relief from UI symptoms. We look forward to hearing many more stories of women who have improved their UI symptoms after just eight weeks of using the Leva System and we are grateful for Cigna’s positive coverage decision for helping to make this possible.”
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.
“PFMT is effective, first-line treatment for urinary incontinence, but it’s been out of reach for most women,” said Axena Health’s Chief Medical Officer Samantha Pulliam, M.D. “FDA clearance for the Leva System made the standard of care more accessible but without insurance coverage, its benefits remained out of reach for many. Cigna’s positive coverage decision marks a fundamental shift in access to the standard of care. Cigna has now set the bar for other payers, and we admire their vision for quality women’s healthcare, which we feel distinguishes them from other health insurance providers.”
About the Leva® Pelvic Health System
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 (UI) and chronic fecal incontinence (FI). 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 (ACOG).
About Axena Health
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 (UI) and chronic fecal incontinence (FI), underreported conditions affecting over 78 million and 12 million women in the U.S. 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. For more information, please visit www.axenahealth.com or www.levatherapy.com and follow Axena Health on LinkedIn.
Important Indication and Other Information for the Leva® Pelvic Health System
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.
