Axena Health to Present New Preliminary Findings from Nigerian UI Treatment Feasibility Study at FIGO 2025

Audio By Carbonatix

NEWTON, Mass.--(BUSINESS WIRE)--Oct 2, 2025--

Axena Health, Inc., a medical device company focused on female pelvic health, announced today it will present a late-breaking abstract at the International Federation of Gynecology and Obstetrics (FIGO) 2025 World Congress in Cape Town, South Africa from October 5-9. Vice President of Clinical Affairs and Global Health Dr. Jessica McKinney, DScPT, MS and Director of Clinical Strategy and Global Health Dr. Laura Keyser, DPT, MPH will preview preliminary results from the study, titled " Feasibility of Clinic-Based Biofeedback and Digital Home Program for Pelvic Floor Disorders in Nigerian Women."

“We are excited to share this abstract and preliminary results of our feasibility study at FIGO 2025, a premier internal forum for advancing women’s health,” said Laura Keyser, DPT, MPH, Director of Clinical Strategy and Global Health at Axena Health. “Female pelvic floor disorders are not just minor inconveniences – they profoundly impact women’s daily lives and well-being, particularly in low- and middle-income countries. Our study highlights the critical need for accessible, effective solutions that can meaningfully improve every woman’s quality of life. We’re excited to engage with global health leaders at FIGO and continue in our efforts of making pelvic health a priority for women worldwide.”

The feasibility study was conducted in partnership with University of Abuja Teaching Hospital and Lagos State University Teaching Hospital. The 60-woman study treated participants between November 2024 and June 2025 to evaluate the feasibility of implementing clinic-based pelvic floor muscle training (PFMT) using motion-based biofeedback technology combined with a digital home program. This interventional feasibility trial follows Axena Health's prior large-scale qualitative examination into the burden of incontinence among women in Kenya and Nigeria.

“The active patient participation and high satisfaction rates observed in this pilot study suggest a significant unmet need and strong demand for accessible, evidence-based pelvic floor care,” said Dr. Fatimat Akinlusi, Lagos State University Teaching Hospital. “We look forward to sharing how our study’s results demonstrate the potential impact of these solutions.”

The study findings will inform Axena Health's continued development of treatment options based on the Leva ® Pelvic Health System's patented mechanism of action for low- and middle-income countries.

Axena’s global health initiative aligns with United Nation’s Sustainable Development Goals, including "Good Health & Well-Being," "Gender Equality," and "Reduced Inequalities," as part of its mission to deliver clinically proven treatments that redefine the standard of care for women’s pelvic health. For more information about the study, please visit Axena’s website.

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.

View source version on businesswire.com:https://www.businesswire.com/news/home/20251002118606/en/

CONTACT: Media Contact:

Makenna Lukens

[email protected]

KEYWORD: MASSACHUSETTS SOUTH AFRICA AFRICA NIGERIA UNITED STATES KENYA NORTH AMERICA

INDUSTRY KEYWORD: MEDICAL DEVICES WOMEN CONSUMER HEALTH HEALTH TECHNOLOGY

SOURCE: Axena Health, Inc.

Copyright Business Wire 2025.

PUB: 10/02/2025 10:16 AM/DISC: 10/02/2025 10:16 AM

http://www.businesswire.com/news/home/20251002118606/en