Avation Medical, an innovative neuromodulation and digital health company on a mission to make non-invasive peripheral neuromodulation accessible to patients across a variety of clinical conditions, has named Michael Hoffman, a veteran of bringing innovative medical technologies to market, as vice president of market access and payer relations for its newly launched Vivally System. 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.
“Adding Michael to the Avation leadership team is our next step in launching Vivally,” said Jill Schiaparelli, founder and CEO of Avation Medical. “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 innovative products including for medical treatment for multiple sclerosis at Octave Bio and for 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,” said Hoffman. “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 adds that the OAB patient population is unhappy with current options, noting that while OAB is a chronic condition, nearly 90 percent 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,” said Schiaparelli. “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-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.
