US start-up lands US$25m investment for female incontinence digital treatment

The US medical device company Axena Health has secured a US$25m investment to expand access to its at-home urinary incontinence treatment.

The Massachusetts-based start-up has developed a prescription digital therapeutic to treat stress, mixed and mild-to-moderate urgency urinary incontinence (UI) and chronic faecal incontinence (FI) and help women train and strengthen their pelvic floor muscles.

According to the company, the Leva System uses a vaginal motion sensor connected to a smartphone app and offers “precise visualisation” of pelvic movement in real-time to track progress and improve symptoms.

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.

“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, Dr Samantha Pulliam.

“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.”

The company says the US$25m investment from AXA IM Alts will support and expand access to the its digital solution.

Zina Affas Besse, deputy head of healthcare private equity at AXA IM Alts, said: “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.

“Female incontinence is a significant unmet health need for millions of women worldwide and Axena Health will be uniquely able to address this need.”

Axena Health CEO, Eileen Maus, said: “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.”

Shacey Petrovic, board member of Axena Health, added: “Urinary and faecal incontinence impose an enormous physical, psychological and economic toll for millions—probably hundreds of millions—of women worldwide.

“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.”