Axena Health Expands Collaboration to Improve Treatment Options for Women with Pelvic Floor Disorders

Mayo Clinic to support development of new AI-powered treatments

NEWTON, Mass.--(BUSINESS WIRE)--Axena Health, Inc. (Axena Health), a women's health company focused on redefining the standard of care for pelvic health conditions through clinically proven, non-invasive treatments, today announced an expansion of its collaboration with Mayo Clinic to include the development of new offerings that strive to enable improved treatment options as well as greater care pathway adherence for women with pelvic floor disorders. The expanded collaboration builds on the collaboration announced in February 2025.

The expanded collaboration will leverage Mayo Clinic's clinical expertise to develop a new solution separate from Axena Health's flagship Leva® Pelvic Health System. The new product will be developed and owned by Axena Health and aims to integrate advanced artificial intelligence to analyze data and deliver more personalized care pathways for women with pelvic health conditions.

The collaboration seeks to address a critical gap in women's pelvic healthcare: too often, women with pelvic floor disorders fall off the care pathway before completing treatment. Axena Health’s goal is to help keep patients engaged throughout their treatment journey while enabling clinicians to deliver more tailored interventions including, where appropriate, second- and third-line treatments, based on individual symptom profiles, treatment responses, and adherence patterns.

"As a urogynecologist, I see how women with pelvic floor disorders fall off the care pathway before completing treatment—not because they don't want help, but because the system isn't built to meet them where they are," said Dr. Samantha Pulliam, MD, FACOG, Chief Medical Officer and Interim CEO of Axena Health. “This collaboration with Mayo Clinic allows us to work toward tackling that gap head-on by combining Mayo Clinic’s clinical expertise with AI-driven personalization to help clinicians keep patients engaged and deliver more personalized, effective care throughout their treatment journey."

The new product development program is slated to focus initially on urinary incontinence and overactive bladder (OAB), with the platform designed to serve as a framework for additional pelvic floor treatment pathways. Specific product details and timelines remain in early development stages.

"This expanded collaboration is aligned with Axena Health’s commitment to advancing innovative, evidence-based care for women," said Shacey Petrovic, Executive Chair of Axena Health's Board of Directors. "We're striving to build a future where women have access to the personalized care they deserve, and where clinicians have the tools to make that happen."

For more information about Axena Health and the Leva Pelvic Health System, visit www.axenahealth.com or www.levacares.com.

About Axena Health

Axena Health, Inc. is a women's health company redefining the standard of care for pelvic health conditions through clinically proven, non-invasive treatments. Our physician-prescribed Leva® Pelvic Health System empowers women with effective, supervised pelvic floor muscle training at home, combining cutting-edge motion-based technology with evidence-based treatment and personalized coaching. We envision a future where pelvic health is prioritized, destigmatized and effectively treated—because women deserve better. For more information, visit www.axenahealth.com or www.levacares.com and connect with us 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.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.