NEWTON, Mass.--(BUSINESS WIRE)--Axena Health, Inc. (Axena Health), a newly-formed commercial-stage medical device company focused on women’s pelvic health, today announced a $25 million Series A investment from AXA IM Alts through its Global Healthcare Private Equity Strategy. The investment will support and expand access to the Leva® Pelvic Health System, a prescription digital therapeutic (PDT) that offers easy-to-use, at-home treatment for urinary incontinence (UI) and chronic fecal incontinence (FI) in women. The Leva System is cleared by the U.S. Food and Drug Administration (FDA) to treat stress, mixed and mild-to-moderate urgency UI (including overactive bladder) in women and for first-line treatment of chronic FI in women.
“Pelvic floor disorders affect women globally,” said Zina Affas Besse, PhD, RPh, Deputy Head of Healthcare Private Equity at AXA IM Alts. “We believe the Leva® Pelvic Health System combines high-quality clinical data with novel technology that harnesses the vast opportunity of digital health to offer a breakthrough, at-home treatment for incontinence. Through our Global Healthcare Private Equity Strategy, AXA IM Alts is supporting innovative, affordable healthcare that can provide more accessible solutions to global health challenges. We believe female incontinence is a significant unmet health need for millions of women worldwide and Axena Health will be uniquely able to address this need. We’re thrilled to be a part of it.”
UI and FI are progressive medical conditions that, left untreated, can have a severe impact on a woman’s quality of life and are associated with significant negative comorbidities. Pelvic Floor Muscle Training (PFMT), commonly referred to as Kegel exercises, strengthen a woman’s pelvic floor muscles, offering symptom relief. However, performing PFMT effectively and consistently can be challenging. The Leva System provides treatment by guiding a woman through PFMT, offering an easy, non-invasive, drug-free way for women to improve UI and chronic FI symptoms. Treatment with the Leva System requires just five minutes per day, which women can do at home, on their own schedule.
“Axena Health is a women-founded, women-funded, women-focused company,” said its CEO Eileen Maus. “We’re grateful to extend this solution globally, where an even greater number of women are silently enduring the significant medical, social and economic effects of incontinence. We look forward to working with Dr. Besse and the AXA IM Alts team to support what we believe is a first-of-its-kind commitment to bring an affordable digital health treatment for incontinence to women regardless of geography.”
“We’re intently focused on combining novel technology, rigorous, peer-reviewed data and excellence in patient support to shine a light on what remains a vastly underserved area of women’s health,” said Axena Health’s Chief Medical Officer Samantha Pulliam, M.D. “The Leva Pelvic Health System can help women ease the burden of incontinence at home, on their own schedule, and allow them to re-engage with the activities that make them feel whole. We’re excited to have the opportunity to deliver these benefits to more women here in the U.S. and soon throughout the world.”
“Urinary and fecal incontinence impose an enormous physical, psychological and economic toll for millions—probably hundreds of millions—of women worldwide,” said Shacey Petrovic, Board Member of Axena Health. “With AXA IM Alt’s support, the Leva device is now positioned to help ease this burden and improve outcomes for women dealing with these onerous, often debilitating conditions with an easy to use, effective technology. It’s a privilege to be part of it.”
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 connected to a smartphone app, 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 is the first femtech product included in the Digital Therapeutics Alliance product library and 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 a women-led company 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.
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.
