Peer-reviewed analysis demonstrates a reduction in total medical spend and improved patient outcomes, supporting payer coverage of the Leva system
NEWTON, Mass.–(BUSINESS WIRE)–Axena Health, Inc. (Axena Health), a women’s health company redefining the standard of care for pelvic health conditions through clinically proven, non-invasive treatments, today announced the publication of a Budget Impact Model on the company’s Leva Pelvic Health System (Leva) in the Journal of Medical Economics. The publication, titled “U.S. payer budget impact of the Leva Pelvic Health System to improve pelvic floor muscle training as first-line treatment of female urinary incontinence compare to real-world clinical practice,” demonstrated an average of $1.07 per-member-per-month (PMPM) cost savings to health plans when the Leva system was used as a first-line treatment for female urinary incontinence (UI) compared to current clinical practice (CCP).1
The study analyzed 24-month health plan costs associated with treating urinary incontinence in adult women receiving usual care, or CCP, compared to women using Leva as a first-line treatment for UI. The analysis was based on a representative United States commercial health plan with 1 million members.
“This analysis confirms what we have long believed — that the Leva Pelvic Health System offers not only a highly effective first-line treatment for urinary incontinence, but also meaningful cost savings for payers,” said Dr. Samantha Pulliam, MD, FACOG, Chief Medical Officer at Axena Health. “UI can place a heavy financial and clinical burden on health plans when women are not being treated with effective first-line treatment and being escalated to more invasive and costly treatment options. Leva’s ability to deliver better patient outcomes while lowering healthcare costs is a significant step forward.”
Key findings from the analysis include:
- In a United States commercial health plan with 1 million members, 334,191 were adult women, of whom 31,438 (9.4%) were treated for UI over 24 months. 1
- The total estimated 24-month cost per treated patient was $10,447 with Leva versus $11,267 without it. 1 ,2
- This resulted in total projected savings of over $25.7 million over 24 months, or $1.07 PMPM. 1
The results show that patients who used Leva experienced lower utilization of high-cost and invasive treatments, such as medications or surgery, leading to measurable reductions in total medical spend.
For more information about the Leva Pelvic Health System, visit www.levacares.com.
About Axena Health
Axena Health, Inc. is 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 a modern approach to supervised pelvic floor muscle training via precise visualization of movement in real time, while monitoring usage and progress. For more information, please visit www.axenahealth.com or www.levacares.com and follow Axena Health on LinkedIn.
About the Leva® Pelvic Health System
The Leva® Pelvic Health System offers an innovative, non-invasive, medication-free way for women to treat urinary incontinence (UI) and chronic fecal incontinence (FI) — at home in just five minutes a day. Combining a small FDA-cleared vaginal motion sensor with integrated software, the Leva System offers precise, real-time visualization of pelvic movement, progress tracking and active physician involvement, all of which support improved treatment outcomes. The Leva System is available by prescription only, enabling physician engagement in each patient’s success while also offering scalable first-line treatment of UI and chronic FI. The Leva System 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).
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.levacares.com.
1 Hall, E., Sharma, A., Goss, T. F., & Hung, K. (2025). U.S. payer budget impact of the Leva Pelvic Health System to improve pelvic floor muscle training as first-line treatment of female urinary incontinence compare to real-world clinical practice. Journal of Medical Economics, 28(1), 637–647. https://doi.org/10.1080/13696998.2025.2494940
2 The total cost for the Leva group ($10,447) includes the intervention cost of $2,100.
Contacts
Makenna Lukens
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