Company Overview
About Avation Medical
Avation Medical is a neuromodulation and digital health company focused on making wearable peripheral nerve stimulation accessible for patients with chronic conditions. The company''s flagship product, the Vivally System, received FDA 510(k) clearance in April 2023 for treating urinary urgency and urge urinary incontinence (UUI) caused by overactive bladder (OAB) syndrome. Vivally is the only closed-loop, non-invasive neuromodulation device cleared for at-home use for bladder control in the U.S. market.
Business Model & Competitive Advantage
The Vivally System uses percutaneous-contact-less tibial nerve stimulation (TTNS) combined with an EMG-based closed-loop feedback mechanism that continuously monitors nerve activation and adjusts therapy parameters in real time. This closed-loop design distinguishes Vivally from simpler TENS-based devices and in-office tibial nerve stimulation procedures. In a prospective, multi-center clinical study (the FREEOAB Study, n=96), 69% of subjects responded for urinary urgency and 63% for urge incontinence at 6 months. Avation Medical raised $22M in a growth funding round to accelerate commercialization of the Vivally System.
Competitive Landscape 2025–2026
Avation Medical competes with in-office peripheral tibial nerve stimulation (PTNS) procedures, Medtronic''s InterStim sacral neuromodulation implant, and pharmaceutical treatments for OAB. Its at-home wearable model creates a significant market access advantage — enabling patients to treat OAB without clinic visits or surgery. The company targets the estimated 33 million Americans with OAB, a chronic condition that is frequently undertreated due to the inconvenience and invasiveness of existing options.
Key Differentiators
Emerging Innovator
Avation Medical is an emerging player bringing innovative solutions to the Healthcare market.
Frequently Asked Questions
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