Pelvital USA, Inc.

Pelvital USA (operating as Flyte Therapy) manufactures Flyte®, an FDA-cleared at-home intravaginal mechanotherapy device designed to treat stress urinary incontinence (SUI) and strengthen the pelvic floor. The device delivers mechanical oscillations during 5-minute daily sessions over a 6-week treatment protocol. Clinical evidence demonstrates 82% continence achievement in patients previously referred for surgery, with 77% durability at 2 years—comparable to or exceeding surgical outcomes without surgical risk. Flyte consists of a medical-grade silicone wand, proprietary motion-sensing controller, optional mobile app for progress tracking, and complimentary access to pelvic health physical therapy experts for patient guidance. Backed by leading urologists, gynecologists, and pelvic floor specialists, the device represents a non-invasive, patient-controlled alternative to pessaries, pelvic floor physical therapy alone, or surgical intervention.