Avation Medical

Avation Medical develops and commercializes Vivally®, an FDA-cleared wearable at-home treatment system for overactive bladder (OAB) symptoms, including urgency urinary incontinence and frequency. The Vivally System combines a wearable ankle wrap, a wireless CliQ™ control module, and a mobile application to deliver physiologic closed-loop controlled transcutaneous tibial nerve stimulation (PCL TTNS) with continuous EMG sensing. The treatment regimen consists of 30-minute sessions administered three times weekly, allowing patients to manage therapy on their own schedule at home. Clinical evidence from multicenter prospective trials demonstrates that 84% of enrolled patients were responders experiencing significant improvement in OAB symptoms and quality of life, with sustained reductions in void, incontinence, and urgency episodes observed through 12 months of use. The system features high patient satisfaction rates and no significant device-related adverse events. Vivally targets a large addressable market: approximately 42 million Americans suffer from OAB and urge urinary incontinence. The platform supports remote monitoring and digital health capabilities, enabling providers to prescribe and calibrate therapy during a single office visit, then track patient progress remotely. Avation Medical provides comprehensive patient support including coverage coordination with major commercial payors, customer care services, and claims and billing assistance. The company markets the system to both patients seeking non-pharmacological OAB management and healthcare providers seeking to offer advanced therapeutic options.