Axena Health

Axena Health, Inc. operates as a commercial-stage medical device company with a sharp focus on advancing women's pelvic health. Founded in 2023, the Newton, Massachusetts-based firm was established following a $25 million Series A investment from AXA IM Alts, which acquired the company's flagship product from the previous developer, Renovia, Inc. The company is led by CEO Randy Pritchard, a MedTech executive with extensive experience in commercializing novel technology, who works alongside a women-led executive team. This leadership includes individuals with deep backgrounds in women's health, such as former Renovia CEO Eileen Maus, who had a pivotal role in growing Cytyc Corporation from $8 million to over $700 million.

The company's business centers on the Leva® Pelvic Health System, a prescription-only digital therapeutic device designed to treat urinary incontinence (UI) and chronic fecal incontinence (FI). These conditions affect over 78 million and 12 million women in the U.S., respectively. Axena Health's revenue model is based on the sale of this prescription device, which is increasingly covered by payers and made accessible through distribution agreements with major healthcare suppliers like Byram Healthcare and EVERSANA. The company targets clinicians, such as OB/GYNs and urologists, who prescribe Leva® to their patients, creating a partnership between healthcare providers and the women using the at-home treatment.

The Leva® Pelvic Health System provides a non-invasive, drug-free approach to strengthening pelvic floor muscles. The system consists of a small vaginal motion sensor that connects to a smartphone app, guiding women through pelvic floor muscle training (PFMT) for five minutes a day. Its key feature is providing real-time biofeedback, which allows users to visualize their pelvic movements to ensure they are performing the exercises correctly and consistently—a common challenge with unguided Kegels. The Leva® system received FDA 510(k) clearance for treating UI in 2019 and was granted a subsequent clearance for chronic FI in 2022. The device's efficacy is supported by multiple clinical trials, including studies published in peer-reviewed journals and a multi-center trial with the National Institutes of Health (NIH), demonstrating its clinical superiority over traditional exercises alone.

Keywords: Axena Health, Leva Pelvic Health System, female incontinence, pelvic floor disorders, digital therapeutic, FemTech, medical device, urinary incontinence, fecal incontinence, pelvic floor muscle training, women's health, biofeedback device, prescription digital therapeutic, at-home medical device, OB/GYN solutions, urology device, MedTech, venture capital, AXA IM Alts, Randy Pritchard, Eileen Maus, Renovia Inc