Avation Medical Hires Vice President of Market Access

Avation Medical has named Michael Hoffman as vice president of market access and payer relations for its newly launched Vivally System.

Vivally is the first U.S. Food and Drug Administration-cleared, non-invasive closed-loop neuromodulation system to treat overactive bladder (OAB) symptoms 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 U.S. commercial and government payers, and employer groups.
 
“Adding Michael to the Avation leadership team is our next step in launching Vivally,” Avation Medical Founder/CEO Jill Schiaparelli said. “Patients have been crystal clear that they want a surgical-free, non-invasive treatment option for their OAB symptoms. Our focus now is to ensure that Vivally is easily accessible to the 46 million patients suffering from OAB in this country.”
 
Hoffman has more than two decades of experience in the healthcare industry and, specifically, helping to gain and expand access and coverage for products, including multiple sclerosis treatment at Octave Bio and novel autoimmune diagnostics from ExaGen.
 
“I’m excited to work with Vivally because it is the only closed-loop non-invasive wearable neuromodulation system for OAB and eliminates the need for surgery and drugs,” Hoffman stated. “The market is always looking for first-of-its-kind innovation that meets an unmet need of a large market. I look forward to working with my payer contacts on expanding coverage and access for Vivally.”
 
Schiaparelli said the OAB patient population is unhappy with current options, and noted that while OAB is a chronic condition, nearly 90% of patients drop out of the care pathway after just two years of any treatment. “Before Vivally, patients had to choose between drugs and their side effects or the risks, and the scars of surgery; the choices are so unappealing that most patients would rather live with OAB, a chronic condition that requires the use of diapers and catheters,” Schiaparelli explained. “We’re already seeing great interest from clinicians, and patients and look forward to Michael helping to pave the way toward market access for our treatment option.”
 
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% therapy compliance rate. Symptom reduction was demonstrated out to one year, even with a decrease in therapy frequency. 
 
The Vivally System is a 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.
 
Avation Medical is a neuromodulation and digital health company with a mission to make wearable peripheral neuromodulation accessible to patients with various  conditions. 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. 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.