About Axena Health
As a company lead by women for women, Axena Health is focused on providing innovative new treatments in women’s pelvic health with a guiding mission to ensure that everything we do supports the critical partnership between clinicians and patients. We are dedicated to combining excellence in patient support and advancements in technology to shine a light on underserved areas of women’s health. We also understand that changes in clinical practice must be supported by strong clinical evidence and are committed to offering treatments backed by peer reviewed research and real-world data.
We strive to provide solutions to help the millions of women who suffer from urinary and fecal incontinence improve their quality of life, because, while leaking is very common, it does not have to be normal. Our flagship product, 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 Gynecology1 (The Green Journal), the official publication of the American College of Obstetricians and Gynecologists (ACOG).
1 Weinstein, Milena M. MD; Dunivan, Gena MD; Guaderrama, Noelani M. MD; Richter, Holly E. PhD, MD. Digital Therapeutic Device for Urinary Incontinence: A Randomized Controlled Trial. Obstetrics & Gynecology 139(4):p 606-615, April 2022. | DOI: 10.1097/AOG.0000000000004725; Weinstein, Milena M. MD; Dunivan, Gena C. MD; Guaderrama, Noelani M. MD; Richter, Holly E. PhD, MD. Digital Therapeutic Device for Urinary Incontinence: A Longitudinal Analysis at 6 and 12 Months. Obstetrics & Gynecology 141(1):p 199-206, January 2023. | DOI: 10.1097/AOG.0000000000005036