NEWTON, Mass.–(BUSINESS WIRE)–Axena Health, Inc. (Axena Health), a medical device company focused on female pelvic health, announced today that Highmark Blue Cross Blue Shield (Highmark BCBS) and Blue Cross Blue Shield of North Dakota (BCBS of ND) have both added the Leva® Pelvic Health System as a covered benefit for their members suffering with urinary incontinence. Highmark BCBS is one of the largest Blue Cross Blue Shield Association plans, serving approximately seven million members across Pennsylvania, Delaware, New York and West Virginia. The Leva System was reviewed favorably by Highmark BCBS’s New Technology Assessment Committee. BCBS of ND is the largest Blue Cross Blue Shield plan in North Dakota, serving over 300,000 members. Both positive coverage decisions became effective on April 1, 2024.

“Pelvic floor disorders such as stress urinary incontinence and pelvic organ prolapse can negatively impact the quality of your life and are becoming more common”

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The Leva Pelvic Health System (HCPCS Level II code, S9002) is a small, flexible intra-vaginal probe, embedded with multiple accelerometer motion sensors, that communicates with the patient via integrated software to provide guidance during pelvic floor muscle treatment. Affecting 62% of adult women in the U.S., urinary incontinence (UI) is a progressive disorder that typically worsens without treatment. Untreated, UI can severely impact a woman’s quality of life and lead to 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. It is also FDA-cleared for the first-line treatment of chronic fecal incontinence in women. The Leva System is available by prescription only, ensuring clinicians remain directly engaged with patients’ care. It requires just five minutes of use per day, typically over eight to twelve weeks, which women can do at home, on their own schedule.

“Pelvic floor disorders such as stress urinary incontinence and pelvic organ prolapse can negatively impact the quality of your life and are becoming more common,” stated Vincent Lucente, MD, MBA, FACOG, URPS and the Physician Leader for Urogynecology at The Institute for Female Pelvic Medicine and Reconstructive Surgery an Axia Women’s Health care center. “While pelvic floor muscle strengthening is an effective first-line treatment, properly recruiting, coordinating, and activating the correct muscle can be difficult to perform. However, Leva enables me to prescribe this proven intervention with confidence. Recently published peer-reviewed data show women can use Leva successfully to treat incontinence. Most importantly, they can do it in the privacy of their home, and on their own schedule. Leva also gives me the option to stay involved in their therapy, which further supports success. Insurance coverage is essential to ensuring that more women can access effective treatment, and I applaud Highmark BCBS and BCBS of North Dakota for their commitment to women’s pelvic floor health.”

“On behalf of the millions of women who now have improved access to UI treatment without medications or surgery, I’d like to thank Highmark BCBS and BCBS of North Dakota for recognizing the compelling studies supporting the Leva System’s effectiveness,” said Samantha J. Pulliam, M.D., chief medical officer for Axena Health. “Axena Health is focused on providing evidence-based solutions through both formal clinical trials with world-class academic institutions and published real-world evidence. Women deserve better treatment options, including those who don’t have local access to specialists in pelvic floor care. The Leva System helps enable improved treatment regardless of the location of the patient and their clinician.”

“Insurance coverage equals access for most women in the U.S.,” said Axena Health’s CEO Eileen Maus. “Two more positive coverage decisions for the Leva System means more women can access effective, first-line treatment for UI. No woman living with bladder leaks should feel that her only options are drugs, surgery, or a lifetime of adult incontinence pads. Our most recent published study shows that just eight weeks of at-home treatment with the Leva System results in two years of clinically significant symptom improvement, which makes the Leva System uniquely valuable for women living in rural areas where specialized care is hard to access. Highmark BCBS and BCBS of ND have joined Cigna in demonstrating their clear commitment to women’s health. I am excited for other payers to follow their lead.”

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 with integrated software, 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 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.