Axena Health Commends New Study Showing the Leva System’s Long-term Treatment Efficacy for Female Urinary Incontinence

NEWTON, Mass.--(BUSINESS WIRE)-- Axena Health, Inc. (Axena Health), a medical device company focused on female pelvic health, announced today that leading pelvic health researchers have published a new study demonstrating the Leva^® Pelvic Health System’s long-term treatment efficacy for female urinary incontinence (UI). The new study published online in the International Urogynecology Journal on January 21, shows UI symptom relief lasts for at least two years following eight weeks of Leva System-assisted pelvic floor muscle training (PFMT), which is a first-line treatment for incontinence. The abstract was named “Best Overall Abstract Presentation,” from the International Urogynecological Association (IUGA) at its 2023 annual meeting.

“There is sparse data regarding the long-term efficacy of pelvic floor muscle training for the treatment of urinary incontinence,” said Lead Author Milena M. Weinstein, MD, FACOG, FACS, division chief of Urogynecology and Reconstructive Pelvic Surgery, Department of Obstetrics and Gynecology, at Massachusetts General Hospital and Associate Professor of Gynecology and Reproductive Biology, Harvard Medical School. “Two years of data showing that UI symptom relief endures following eight weeks of guided-PFMT offers compelling evidence that women can access first-line, conservative treatment successfully. This is critically important for providers with patients hoping to avoid medications, surgery, and the inconvenience of multiple visits to specialists, which remain out of reach for most women.”

The study evaluated the enduring efficacy over 24-months of an initial eight-week, Leva-guided PFMT program versus a standard home program of Kegel exercises. It found that women in the Leva System group experienced durable and significantly greater UI symptom improvement than women in the home program group, even in the absence of continued therapy beyond eight weeks. The study is the second longitudinal analysis of an original randomized controlled clinical trial (RCT) published in Obstetrics and Gynecology (The Green Journal), the official publication of the American College of Obstetricians and Gynecologists (ACOG) in April 2022. The Journal published a one-year longitudinal follow up in January 2023. Study authors include Dr. Weinstein, Dr. Gena Dunivan of the University of Alabama, Dr. Noelani Guaderrama with Kaiser Southern California, and Dr. Holly E. Richter of the University of Alabama.

Additional findings:

Women using the Leva System were twice as likely at 24 months (vs. home PFMT alone) to report persistent symptom improvement as “much better” or “very much better.”

On average, women using the Leva System reported they reached and maintained a “patient acceptable symptom state,” indicating they were likely to consider themselves well. On average the home PFMT (without the Leva System) did not reach this level of improvement.

“Kegels are challenging for many women to do correctly, which can impact how enthusiastically clinicians recommend first-line treatment for urinary incontinence,” said Samantha Pulliam, M.D., Axena Health’s Chief Medical Officer. “This newest published study offers powerful evidence that women can access first-line treatment successfully, and that this treatment has a lasting effect. It bolsters the conclusion from an original randomized controlled clinical trial, the most rigorous type of study in medicine and a published one-year analysis. The cumulative findings provide level-one evidence that the Leva System can help women ‘consider themselves well’ and that this relief lasts. We hope this robust data gives prescribers the confidence to recommend Leva as first-line care, insurers the validation they need to pay for it, and women the assurance that they can relieve incontinence symptoms easily, privately and on their own schedule.”

UI is a progressive disease that, if left untreated, can severely impact women’s quality of life, imposing enormous physical, psychological, and economic burdens and placing her at risk for disability. PFMT, commonly practiced via Kegels, is a first-line treatment, but data show achieving effective, consistent practice is challenging. The Leva System makes PFMT accessible by guiding women through their treatment, enabling supervised PFMT, which level-one evidence shows is most effective. It combines a small vaginal device with motion sensors and integrated software and takes just five minutes of treatment a day. The U.S. Food and Drug Administration (FDA) cleared the Leva System in 2019 for the treatment of stress, mixed and mild-to-moderate urgency UI (including overactive bladder). The Leva System received Breakthrough Device Designation and FDA-clearance for the treatment of chronic fecal incontinence in 2021 and 2022, supporting a single treatment option for the 20 percent of women who experience both conditions.

“Pelvic floor muscle training is globally recommended first-line treatment for urinary incontinence,” said Eileen Maus, CEO of Axena Health. “The women we speak with want to try PFMT and don’t want medications or surgery. Leva offers them an easy, private way to access supervised PFMT with success. We’ve amassed significant data supporting Leva’s effectiveness, and this new study offers rare long-term evidence that relief from bladder leaks lasts. Women deserve to try an effective, non-invasive treatment before surgery, and we hope these data convince more payers to support them.”

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). The Leva System was recently named to AARP’s 2023 Medical Breakthroughs. 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 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). The Leva System was recently named to AARP’s 2023 Medical Breakthroughs. 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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