Axena Health marks first milestone in long-term collaboration with Mayo Clinic to advance evidence-based care for the treatment of urinary incontinence

Axena Health, Inc. (Axena Health), a medical device company focused on female pelvic health, today announced new educational content on overactive bladder (OAB) from Mayo Clinic is now available to Leva users on the Leva^® Pelvic Health System smartphone app.

The content expands the Leva app’s existing educational resources on UI, now including additional information on the types of UI, tips on controlling urgency, understanding constipation and ways to manage it, and healthy bladder frequently asked questions (FAQs). Leva users can access the content directly while completing their 12-week at-home therapy program. As part of the collaboration, Axena Health expects to provide additional Mayo Clinic educational content to Leva users over time.

“This is an exciting step forward in our mission to redefine the standard of care for women’s pelvic health,” said Randy Pritchard, CEO of Axena Health. “Mayo Clinic is one of the most trusted names in healthcare – and integrating their educational expertise into our Leva System enhances our ability to serve patients with clinically grounded and evidence-based resources they can trust. We are grateful for their support and ongoing collaboration to deliver better patient outcomes.”

Education is a core component of Axena Health’s approach to treating UI. The Leva System is designed to provide women with a convenient, non-invasive option for UI treatment 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.

“A critical part of our Leva therapy is ensuring women feel educated and supported during their treatment,” added Dr. Mandy Pulliam, Chief Medical Officer of Axena Health. “By enhancing our existing educational resources in the Leva app with Mayo Clinic’s content, we are empowering women to better understand their condition and actively engage in their care.”

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.

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Mayo Clinic is one of the most trusted names in healthcare – and integrating their educational expertise into our Leva System enhances our ability to serve patients with clinically grounded and evidence-based resources they can trust.