Axena Health, a prescription digital therapeutic for incontinence, raises $25M

The Leva Pelvic Health System allows women to do pelvic floor exercises at home via a sensor and app

Today, 78 million in the U.S. alone live with urinary incontinence and 12 million endure fecal incontinence. While Pelvic Floor Muscle Training (PFMT) is first-line treatment for these conditions, there are two problems: first, it’s difficult to perform correctly and consistently enough to be effective, and, second, it’s most effective when performed under the supervision of a healthcare provider.

"PFMT involves a program of exercises followed regularly for a period of several weeks or months. It’s commonly practiced via Kegel exercises. However, data show performing Kegels consistently and correctly can be challenging," said Eileen Maus, CEO of Axena Health, a newly-formed commercial-stage medical device company focused on women’s pelvic health, told VatorNews. The company announced a $25 million Series A round of funding on Thursday. 

"In fact, only 25% of women who perform Kegels do so effectively. This limits the potential positive impact on UI symptoms. Worse still, if you do Kegels incorrectly you could actually make your symptoms worse."

The typical patient who uses Axena Health’s Leva Pelvic Health System is someone who experiences bladder or accidental bowel leaks and prefers to avoid drugs or surgery to treat it; what Leva allows them to do is perform PFMT to treat urinary incontinence and chronic fecal incontinence in the comfort and privacy of their own home, while also being in contact with their doctor. 

The 12 week long program guides the patient through PFMT by providing precise visualization of movement in real time; it this does by combining a small vaginal motion sensor that detects movement, which it conveys to a smartphone app. This technology, combined with personal coaching, helps women perform PFMT correctly and consistently. 

A prescription digital therapeutic (PDT), the Leva System supports the partnership between clinicians and patients by keeping clinicians involved in treatment, Maus explained, as the Leva System monitors usage and progress, which women and their clinicians can use to track results. 

"We make first-line treatment for incontinence easy and accessible by offering providers a reliable way to offer it to a broad group of women confidently. We support women’s success with a solution that combines published clinical evidence, patented technology and excellence in patient support to help them be successful with PFMT," she said. 

The company estimates that nearly 3,000 women are currently using, or have used, the Leva System successfully, and a study in Obstetrics and Gynecology, the official publication of the American College of Obstetricians and Gynecologists, showed that pelvic floor muscle training using the Leva System was statistically and clinically superior to Kegels alone for improving symptoms of stress and stress-dominant mixed urinary incontinence in women.

"In the eight-week clinical study, we found that women using Leva experienced fewer leaking episodes and significantly greater symptom improvement. Leva users saw a decrease in leaking episodes from nearly two leaks per day to about two leaks per week," said Maus.

The new funding, which came from AXA IM Alts, through its Global Healthcare Private Equity Strategy, will be used support and expand access to the Leva Pelvic Health System, with the ultimate goal for every woman, regardless of geography, to live without the social, emotional, financial, and psychological effects of incontinence.

"We want every woman in the U.S. and eventually, globally, to have access to Leva regardless of financial situation and geography. To that end, insurance reimbursement is essential. We continue to work with a select group of payers who are committed to the health of their female members and look forward to sharing positive coverage decisions soon," Maus explained.

"We will also use our funding to educate clinicians serving women. For too long, these clinicians haven’t had a drug- and surgery-free solution to incontinence to offer. That’s changing, and we’re pleased to share that many physicians groups are already offering Leva and sharing their outstanding results with their peers."

(Image source: levatherapy.com)