Theranica Announces Results from Pivotal Study of Device for Treating Acute Migraine
Nerivio Usage Grows Significantly Following Indication Expansion to Adolescents
MONTCLAIR, N.J., November 15, 2018 /PRNewswire/ — Theranica, a prescribed digital therapeutics company developing advanced electroceuticals for migraine and other pain conditions, today announced it has seen consistent growth in the usage of Nerivio, marking more than 100,000 treatments in the USA.
“We are at a crossroads for acute migraine treatment, where traditional drug-based solutions are being challenged by FDA-authorized, novel digital therapeutics such as Nerivio,” said Ronen Jashek, co-founder and COO of Theranica. “We are pleased to see that Nerivio patients are showing both adherence to the treatment program and an increased level of comfort with the device itself. 100,000 treatments hold significance to Theranica, as does our recent 33% growth in monthly active users, because these numbers demonstrate that Nerivio users consistently see the benefits of this prescribed therapy to their well-being.”
This milestone follows a recent study, published in Headache, the official peer-reviewed journal of the American Headache Society, that evaluated the efficacy of Nerivio in episodic and chronic migraine patients between the ages of 12 and 17. At two hours post treatment, 71% of participants reported pain relief and 35% reported pain freedom. Pain relief and pain freedom were sustained for 24 hours in 90% of the cases.
“Over the last couple of years our toolbox for treating migraine has been enriched with several new types of FDA-authorized therapies, including a few drug-free neuromodulation devices,” said Christopher Gottschalk, MD, a Yale Medicine neurologist and director of Yale Medicine’s Headache and Facial Pain Center, who also serves as the president of the Alliance for Headache Disorders Advocacy (AHDA), a non-profit organization advocating for equitable policies for people with headache disorders. “These non-pharmacological therapies present an important alternative for people with migraine, especially those who do not respond well to or have reasons not to take medications,” commented Dr. Gottschalk. “Affordable access to these devices is essential for the community of people with migraine.”
Nerivio is eligible for insurance coverage. While the device list price (Wholesale Acquisition Cost, or WAC) is $599 for a twelve-treatment unit, the combination of the company’s Nerivio Patient Savings Program plus coverage by Payers may result in an out-of-pocket patient payment of as low as zero dollars per unit – depending on the specific health insurance plan.
Nerivio is a prescribed digital therapeutic wearable that deploys Remote Electrical Neuromodulation (REN) to activate the body’s native conditioned pain modulation mechanism to treat pain, aura, and other symptoms associated with migraine. It is worn on the upper arm and controlled through an App on a patient’s smartphone that also serves as a migraine diary, possibly shareable with a caregiver.