Axena Health’s Leva Pelvic Health System will feature Mayo Clinic’s urogynecology educational content, enhancing educational resources and treatment
NEWTON, Mass.--(BUSINESS WIRE)--Axena Health, Inc. (Axena Health), a medical device company focused on female pelvic health, today announced it has entered into a collaboration with Mayo Clinic to integrate the organization’s educational content on overactive bladder (OAB), into Axena Health’s clinically proven Leva® Pelvic Health System.
The Leva System is designed to provide women with a convenient, non-invasive option for treating urinary incontinence (UI) through a modern approach to supervised pelvic floor muscle training. The physician-prescribed program uniquely combines the FDA-cleared Leva device and smartphone app to provide at-home guided treatment, personalized coaching, educational resources, and progress tracking. Mayo Clinic’s educational content on OAB will be available on the Leva app, further enhancing the Leva program’s comprehensive treatment offering.
“Urinary incontinence impacts millions of women worldwide yet remains underdiagnosed and undertreated due in part to a lack of discussion and education about the condition,” said Randy Pritchard, CEO of Axena Health. “Our collaboration with Mayo Clinic underscores our commitment to empowering women to take control of their pelvic health through clinically proven treatments and accessible, evidence-based education.”
The new content will complement the Leva app’s existing resources on UI and fecal incontinence so users can gain a deeper understanding of their condition, available treatments, and the importance of pelvic floor health. The content will be available to all Leva users beginning Spring 2025.
“Education is a cornerstone of effective care, particularly for conditions like urinary incontinence where stigma and misinformation often hinder treatment,” added Dr. Mandy Pulliam, Chief Medical Officer of Axena Health. “Integrating this important content allows us to provide users of the Leva System with trusted evidence-based information during their training sessions that complements their treatment journey.”
The collaboration includes an investment from Mayo Clinic to further Axena Health’s efforts in advancing women’s pelvic health, opening the door to future innovations, educational initiatives, and evidence-based treatments.
For more information about the Leva Pelvic Health System, visit www.levacares.com.
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 a modern approach to supervised pelvic floor muscle training via precise visualization of movement in real time, while monitoring usage and progress. For more information, please visit www.axenahealth.com or www.levacares.com and follow Axena Health on LinkedIn.
About the Leva® Pelvic Health System
The Leva® Pelvic Health System offers an innovative, non-invasive, medication-free way for women to treat urinary incontinence (UI) and chronic fecal incontinence (FI) — at home in just five minutes a day. Combining a small FDA-cleared vaginal motion sensor with integrated software, the Leva System offers precise, real-time visualization of pelvic movement, progress tracking and active physician involvement, all of which support improved treatment outcomes. The Leva System is available by prescription only, enabling physician engagement in each patient’s success while also offering scalable first-line treatment of UI and chronic FI. 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).
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.levacares.com.
Please note:
Mayo Clinic has a financial interest in the technology referenced in this press release. Any revenue received by Mayo Clinic will be used to support its not-for-profit mission in patient care, education, and research.
Contacts
Makenna Lukens
mlukens@vaultcommunications.com
