Avation Medical, a neuromodulation and digital health company, has named Michael Hoffman, a veteran of bringing medical technologies to market, as vice president of market access and payer relations for its newly launched Vivally System.
The company said Vivally is the first FDA-cleared, non-invasive closed-loop neuromodulation system to treat symptoms of overactive bladder (OAB) in adults. Hoffman will play a pivotal role in formulating, executing, and optimizing market access strategies and reimbursement for Vivally, and establishing and expanding coverage with commercial and government payers, and employer groups in the U.S.
Using proprietary algorithms and electromyographical sensors, Vivally detects and automatically calibrates the level of energy being delivered to a patient’s tibial nerve during stimulation to ensure optimal, customized therapeutic output in a true real-time, closed-loop system. Worn on the ankle, Vivally is used by patients at home for therapy sessions lasting only 30 minutes, as little as once per week. Unlike other approaches for bladder treatment, Vivally requires no surgery, drugs, or needles, which is a major advancement in the treatment of urinary urge incontinence and OAB.
In two multi-center clinical trials, the Vivally System was shown to significantly reduce daily void, incontinence, and urgency episodes and improve patient quality of life while facilitating an 89-percent therapy compliance rate. Symptom reduction was demonstrated out to one year, even with a decrease in therapy frequency. Vivally was recently featured on the cover of Urology, the Gold Journal.
The Vivally System is a convenient, next-generation, at-home wearable neuromodulation therapy that is discreet, comfortable, and easy to use. Urology teams collaborate with their patients through online diaries and individualized data to validate, treat, and monitor symptoms for optimal success. Clinicians can increase the number of patients they are able to effectively treat while reducing the cost of care, thus positively impacting both patients and the healthcare system.
