NEWTON, Mass.–(BUSINESS WIRE)–Axena Health, Inc. (Axena Health), a FemTech medical device company focused on scalable treatments for female pelvic health, introduced today the Leva® Pelvic Health System for the first-line treatment of chronic fecal incontinence (FI), also called accidental bowel leakage (ABL), in women. The U.S. Food and Drug Administration (FDA) cleared the new indication in 2022 following Breakthrough Device Designation in 2021. New coaching and education support along with updates to the Leva System app combine to support its use for chronic FI, making access to first-line treatment easy and practical.

“Fecal incontinence is a profoundly debilitating condition for which social stigma is high”

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Defined as the uncontrolled passage of feces, chronic FI is a progressive condition that has a significant negative impact on sufferers’ quality of life. Existing treatment options are limited, and few are curative. While pelvic floor muscle training (PFMT) is a first-line treatment, difficulty performing PFMT (“Kegels”) correctly often makes it inaccessible, leaving women to endure the depression, shame, guilt, frustration and social isolation that often accompany FI. Less than 30 percent of women will discuss their FI symptoms with their healthcare provider, which means estimates of those affected are vastly underreported. Despite this, current data show:

• 9 percent of women report monthly FI.
• 19 percent report less frequent FI.
• Less than three percent of women with self-reported FI receive a clinical diagnosis.
• FI is a leading cause of nursing home placement for older women.
• Women with FI are more likely to also have urinary incontinence (UI).

The Leva System is a prescription, at-home medical device that guides women through PFMT, allowing them to improve strength and coordination of their pelvic floor muscles, leading to improvements in FI symptoms. Combining a small vaginal motion sensor with a smartphone app, the Leva System offers an easy, non-invasive, drug-free way for women to perform PFMT to improve symptoms. It requires just five minutes per day, which woman can do privately, at home. In the study, “Use of a motion-based digital therapeutic in women with fecal incontinence: a pilot study,” researchers showed that women using the Leva System for 10 weeks achieved significant improvement in FI severity and symptom-specific quality of life.

“Fecal incontinence is a profoundly debilitating condition for which social stigma is high,” said Milena M. Weinstein, MD, FACOG, FACS, Co-Chair, Massachusetts General Hospital, Center for Pelvic Floor Disorders, Program Director, Female Pelvic Medicine and Reconstructive Surgery Fellowship, Associate Professor of Gynecology and Reproductive Biology, Harvard Medical School, and investigator of the pilot study. “Treatment options are very limited, leaving many women to endure symptoms silently. In our study, we showed that the Leva System had the potential to improve fecal incontinence symptoms, which gives both clinicians and women an easy, practical way to access first-line treatment. I and the study authors continue to advance the data supporting the Leva System’s treatment efficacy for FI as well as the data supporting its efficacy for UI. As these conditions often co-occur, a single, non-invasive treatment option for both could offer significant benefits for patients and clinicians.”

The FDA originally cleared the Leva Pelvic Health System in 2019 for the treatment of stress, mixed and mild-to-moderate urgency urinary incontinence (UI). Since that time, researchers have amassed strong clinical data supporting its efficacy in treating UI, including two studies published in Obstetrics and Gynecology (The Green Journal). The first publication, an eight-week randomized controlled superiority trial (RCT) showed that the Leva System significantly improved symptoms of UI in women compared to PFMT alone. The second Green Journal publication, a one-year longitudinal follow up from the RCT, showed that women who used the Leva System for just eight weeks achieved long-term (12 month) UI symptom relief that was durable.

“Pelvic floor muscle training is a first-line treatment for both urinary and fecal incontinence,” said Samantha Pulliam, MD, FACOG, chief medical officer for Axena Health. “Historically, devices that supported PFMT for FI have relied on anal feedback. The Leva System uses vaginal biofeedback, which we believe makes it more comfortable and tolerable for women. Thousands have used it to relieve symptoms of urinary incontinence, and we aspire to saying the same for women who experience fecal incontinence. As always, we’re committed to advancing the research supporting use of the Leva System for both conditions and will continue to support clinicians with the only device that treats UI and FI and enables clinician-supervised remote or at-home PFMT.”

“Pelvic floor muscle training offers simple, non-invasive treatment for both urinary and fecal incontinence, but accessing it can be hard for many reasons,” said Eileen Maus, CEO of Axena Health. “We believe women deserve non-invasive, drug-free treatment options, and we believe they should be easy to access and backed by the most rigorous data in medicine. We are committed to delivering this for women living with UI, FI or both. With so many unwilling or unable to speak about symptoms with their healthcare provider, the shame factor is clear, and this compels us to do more.”

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 connected to a smartphone app, 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 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, 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 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.