Maker of the Vivally® System wearable neuromodulation system for bladder issues
passes rigorous standards for safety and quality
Columbus, OH March. 4, 2024 Avation Medical, an innovative neuromodulation and digital health company on
a mission to make wearable peripheral neuromodulation accessible to patients across a variety of
clinical conditions, announced today that it is now an official member of the League of Exemplary
Providers®. Avation Medical’s membership accreditation verifies that the company has established
processes that meet the requirements of The Compliance Team™ Exemplary Provider Durable Medical
Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) Quality Standards
Avation Medical recently launched its Vivally System, the only non-invasive, FDA-cleared, wearable
neuromodulation system for home use that delivers closed-loop, autonomously adjusted electrical
stimulation to treat patients with urge urinary incontinence (UUI) and urinary urgency caused by
overactive bladder (OAB) syndrome, which affects more than 46 million people in the U.S. Using
proprietary algorithms and electromyographical sensors, the System detects and calibrates the
stimulation energy being delivered to the tibial nerve to ensure optimal, customized therapeutic output
in a true real-time, closed-loop operation. Worn on the ankle, Vivally is used at home for therapy
sessions lasting only 30 minutes, as little as once per week. Unlike implantable neuromodulation
approaches for bladder treatment, Vivally requires no surgery and no drugs.
Avation Medical underwent a rigorous review by The Compliance Team to earn the Exemplary Provider
accreditation, which is granted to healthcare companies that demonstrate outstanding patient care
practices and compliance to The Compliance Team’s comprehensive Safety-Honesty-Caring® quality
standards. The Compliance Team is deemed by CMS to accredit all DMEPOS products and services. Their
comprehensive standards meet and exceed CMS quality standards.
About Avation Medical and the Vivally System
Avation Medical is an innovative neuromodulation and digital health company with a mission to make
wearable peripheral neuromodulation accessible to patients across a variety of clinical conditions. The
Company’s Vivally System is the only FDA-cleared, closed-loop, at-home wearable neuromodulation
device system. Combined with a companion mobile application, Vivally offers a comprehensive therapy
and support system for patients suffering from urge urinary incontinence and urinary urgency caused by
overactive bladder syndrome (OAB). Vivally is prescribed by a clinician following a brief clinical
evaluation which includes personalized calibration. Personalization establishes an EMG target and range
of neuromodulation energy associated with the detection of an EMG signal to indicate nerve activation.
Vivally delivers clinically effective therapy in just 30 minutes, as little as once per week. Vivally is
available by prescription in select geographies in the United States. Learn more at Avation.com.
