Vivally® System, wearable closed-loop neuromodulation system and mobile application for urge incontinence and urinary urge, recognized by MedTech Breakthrough Awards program for 2023.
Columbus, Ohio – May 3, 2023 – Avation Medical, Inc., the innovator in patient-friendly, closed-loop neuromodulation therapies to treat life-altering medical conditions, announced today that its Vivally System has received the 2023 MedTech Breakthrough Award for Healthcare Wearables Innovation. The MedTech Breakthrough Award program recognizes the world’s most outstanding digital health and medical technology products, services, and companies. This year’s competition received 4,000 nominations from some of the largest and most innovative medical device companies in the world.
Vivally directly addresses the negative impacts of urge incontinence and urinary urge, improving health and well-being for millions of sufferers, and it does so as a wearable therapeutic used in the home, eliminating the need for surgery, permanent implants, or drugs.
“As the first FDA cleared closed-loop, non-invasive neuromodulation system to treat incontinence and urinary urge, we are honored to receive the Healthcare Wearables Innovation Award from MedTech Breakthrough,” said Jill Schiaparelli, Avation CEO. “We listened carefully to patients and designed Vivally as a wearable neuromodulation therapy that does not require surgery or an implant and can be used in the home for 30 minutes as little as once per week. We also paired it with a mobile application to provide each patient with a full system of therapy and support.”
The Vivally System delivers an electrical signal to the tibial nerve near a patient’s ankle to calm the nerves that control the muscle around the bladder. Vivally utilizes a proprietary closed-loop control algorithm calibrated to the patient’s EMG signal to confirm activation of the target nerve, personalize a therapeutic treatment range for each patient, and continuously adjust and optimize the therapy output.
About Avation Medical and the Vivally System
Avation Medical is an innovative neuromodulation and mobile app company with a mission to make wearable peripheral neuromodulation accessible to patients across a variety of clinical conditions. The Company’s Vivally System combines a patient-friendly, closed-loop neuromodulation system with a mobile application, offering a complete therapy and support system. Prescribed by a physician, the Company’s smart ankle wearable objectively confirms activation of the target nerve, sets a personalized therapeutic range for each patient, and delivers clinically effective therapy in just 30 minutes as little as once per week. Vivally is FDA cleared to treat the conditions of urinary incontinence and urinary urge caused by overactive bladder (OAB) syndrome. Learn more at Avation.com.