Axena Health

Axena Health is a private, commercial-stage digital health and medical device company based in Newton, Massachusetts, founded in 2019. It has successfully launched the Leva Pelvic Health System, a prescription digital therapeutic that uses a vaginal motion sensor and smartphone app to guide pelvic floor muscle training for incontinence. The company emphasizes strong clinical evidence, real-world data, and strategic access initiatives, such as securing coverage for female veterans through the VA. Axena is positioned in the large and growing market for women's pelvic health, aiming to redefine the standard of care with its non-drug, non-surgical solution.

The Leva® Pelvic Health System: an FDA-cleared, prescription digital therapeutic platform combining a vaginal motion sensor (medical device) with a smartphone application. It provides guided, biofeedback-enabled pelvic floor muscle training for at-home treatment of urinary and fecal incontinence.

Axena Health competes in the pelvic floor digital therapeutic and device market. Competitors include other prescription digital therapeutics for UI (e.g., Renovia's leva system, now part of Hologic), various pelvic floor training apps, and traditional medical device companies offering in-office biofeedback systems. Axena's differentiation hinges on its specific FDA clearances, clinical evidence package, and its integrated hardware-software approach designed for the home setting.