Axena Health welcomes 4 distributors for the Leva Pelvic Health System

Effective, at-home treatment for urinary incontinence more accessible to women, clinicians, and healthcare systems

Axena Health, Inc. (Axena Health), a medical device company focused on female pelvic health, has signed agreements with four leading distributors to streamline access to the Leva^® Pelvic Health System. Byram Healthcare Centers, Inc. (“Byram Healthcare”), EVERSANA, J&B Medical and OneSource Medical Group, LLC, now offer the Leva System, recently named to AARP’s 2023 Medical Breakthroughs, making it easier for physicians, healthcare systems and patients to access safe and effective at-home treatment for incontinence supported by multiple clinical trials and published data.

Bladder leaks—called urinary incontinence (UI)—affect 78 million women in the U.S. Accidental bowel leakage, called fecal incontinence (FI), affects 12 million women. While UI and FI are the most prevalent pelvic floor disorders among women, they are vastly undertreated. Shame and embarrassment can keep women from seeking treatment. Left untreated, incontinence can affect women’s mental and physical health, quality of life and relationships. It also leads to higher healthcare costs for both women and insurers. For older women, UI is a leading cause of nursing home placement.

Pelvic floor muscle training (PFMT)—or “Kegels”—is globally recommended first-line treatment for UI and FI. However, data show few women perform Kegels consistently or effectively enough to relieve incontinence symptoms. The Leva System combines a small FDA-cleared vaginal motion sensor device and integrated software that allows women to visualize pelvic movement in real-time, offering an effective, non-invasive, medication-free way for them to train and strengthen their pelvic floor. As a prescription device, the Leva System offers multiple ways for clinicians to connect more women with first-line treatment and support them throughout 12 weeks of therapy.

“Several recent studies show that women do not regularly receive recommended first-line treatment for incontinence,” said Steven G. Gregg, PhD, executive director of the National Association For Continence (“NAFC”). “While concerning, it’s not surprising. While PFMT is effective, first-line treatment for urinary incontinence, doing Kegels correctly and consistently is hard, and most women don’t have access to specialized physical therapy, which can help. The Leva System makes PFMT accessible by supporting a women’s success as she improves her incontinence symptoms. NAFC applauds all efforts to make access to clinically proven treatment options for incontinence more available for women.”

"Women dealing with bladder and bowel leaks are reaching out for support," shared Eileen Maus, CEO of Axena Health. "Pelvic floor muscle training is a globally recommended solution that Leva makes more accessible to women. Through these strategic distributor agreements, we've orchestrated a seamless network, supporting swift access to Leva for patients. We're excited to collaborate with healthcare leaders who share our commitment to offering women non-invasive, drug- and surgery-free options for incontinence treatment."

About the Leva^® Pelvic Health System

The Leva Pelvic Health System is a prescription medical device available in the United States that 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 device and integrated software, the Leva System offers precise visualization of pelvic movement in real-time, enables progress tracking and allows active clinician 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). In May 2023, Axena Health announced a global study to examine the burdens of incontinence for women in low- and middle-income countries. The findings will guide the development of new treatment options based on the Leva System that are culturally acceptable and available within local healthcare pathways.

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, follow Axena Health on LinkedIn and follow Leva Pelvic Health System on Instagram and TikTok.

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 the 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.

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