NEWTON, Mass.--(
BUSINESS WIRE
)--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
.
