Axena Health develops the Leva® Pelvic Health System, an FDA‑cleared, prescription at‑home device that uses a vaginal motion sensor and integrated software to visualize pelvic movement and support pelvic floor muscle training. The Leva System is positioned as a non-invasive, medication‑free first-line treatment for urinary incontinence (UI) and chronic fecal incontinence (FI) and is supported by multiple clinical trials and published data, including studies in Obstetrics and Gynecology. Proceeds from the recent fundraise will support Axena’s continued U.S. commercial launch, where the company reports rising prescriber adoption and expanding payer coverage, and will accelerate work to scale treatments in low- and middle-income countries, including efforts in sub‑Saharan Africa. The system enables physician involvement, progress tracking, and remote monitoring to improve patient outcomes. Axena cites U.S. prevalence figures of over 78 million women affected by UI and 12 million by FI. The company is based in Newton, Massachusetts. Axena Health commercializes the Leva® Pelvic Health System, a prescription digital therapeutic that guides pelvic floor muscle training for urinary incontinence (UI) and chronic fecal incontinence (FI). The Leva System pairs a small FDA-cleared vaginal motion sensor with a smartphone app to provide real-time visualization, progress tracking, and physician involvement. Treatment is non-invasive, drug-free, performed at home in about five minutes per day, and is FDA-cleared for stress, mixed and mild-to-moderate urgency UI and first-line treatment of chronic FI in women. Axena highlights multiple clinical trials and peer-reviewed publications supporting Leva’s efficacy, including studies in Obstetrics and Gynecology (The Green Journal). The company is women-founded, women-funded and women-focused and describes itself as a newly-formed commercial-stage business based in Newton, Mass. The firm cites the large addressable need—affecting over 78 million and 12 million women in the U.S. for UI and FI respectively—and is positioning Leva as an accessible, scalable prescription treatment.

Total raised

$34M

Funding rounds

2

Latest round

Series A

Latest activity

Jun 2024