Axena Health, a newly-formed commercial-stage medical device company focused on women’s pelvic health, has 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.
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.”
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