Newton, Mass.—July 9, 2024— Axena Health, Inc. (Axena Health), a medical device company focused on female pelvic health, announced today that a new published study adds additional real-world evidence supporting women’s effective use of the Leva® Pelvic Health System to access pelvic floor muscle training (PFMT), which is first-line treatment for incontinence. The new Journal of Medical Internet Research: Formative Research study of 947 women concluded that the Leva System was safe, effective and delivered clinically significant symptom improvement for women suffering from urinary incontinence (UI) regardless of age, BMI and UI sub-type. The study follows a 2022 published review showing similar real-world evidence. Together, the studies represent the largest body of real-world evidence supporting an at-home, FDA-cleared treatment for female incontinence.

 The study, “Real-world evidence from a digital health treatment program for female urinary incontinence: Observational study outcomes following user-centered product design,” evaluates 947 women who used the Leva System. 74 percent of participants experienced symptom improvement. Significantly, the study showed 89 percent adherence for the 12-week treatment, revealing that women who used the Leva System 10+ times a week were more likely to achieve symptom improvement. The findings suggest women are likely to succeed at home with clinician monitored first-line incontinence treatment, supporting clinician confidence in prescribing PFMT using the Leva System.

 “Real-world evidence is critically important in women’s health, particularly for behavioral interventions like pelvic floor muscle training where treatment adherence is low,” said Evelyn Hall, MD, Urogynecologist and Female Pelvic Reconstructive Surgeon at Tufts Medical Center, Assistant Professor at Tufts School of Medicine. “These study findings add to the growing body of published data showing that women can access PFMT successfully using the Leva System. Alignment between randomized controlled trial findings and real-world studies underscores the strength of both data sets. We believe the collective findings are unique in urogynecology and offers strong evidence that first-line incontinence treatment is effective, and women can access it using the Leva System.”

 More than 60 percent of adult women experience urinary incontinence, a progressive disorder that can severely impact a woman’s quality of life and lead to significant negative comorbidities. There’s treatment, but it remains largely out of reach. PFMT, commonly called Kegels, is a globally recommended first-line incontinence treatment, but Kegels can be difficult to perform correctly. The Leva System (HCPCS Level II code, S9002) makes first-line treatment accessible by guiding women through PFMT. 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.

 “Women deserve treatments that are validated by the best medical evidence,” said Samantha Pulliam, MD, Axena Health’s Chief Medical Officer. “They also deserve easy access to incontinence treatment that allows them to avoid drugs or surgery. We’re grateful to the researchers who have conducted this study. They have generated what we believe is the largest body of evidence—real world and academic—showing that pelvic floor muscle training is a behavioral intervention for incontinence that can work when women use Leva. We’re grateful to the insurers who recognize the strength of these data and show their commitment to women’s health by paying for access to treatments like Leva that are backed by rigorous medical evidence.” 

 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 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.

 Media:

Shanti Skiffington
617-921-0808