Theranica: Journal of Expert Review of Medical Devices Publishes Profile of Nerivio™
Review Highlights Efficacy and Safety of Smartphone-Controlled Prescribed Wearable for the Acute Treatment of Migraine
NETANYA, Israel, Dec. 3, 2019 /PRNewswire/ — Theranica Bio-Electronics (Theranica), a bio-medical technology company developing advanced electroceuticals for migraine and other pain disorders, announced today that the journal of Expert Review of Medical Devices has published a device profile of its novel smartphone-controlled, prescription migraine wearable device, Nerivio™. The article explores the safety and efficacy of the product, demonstrating the promise of the FDA-cleared remote electrical neuromodulation (REN) device among traditional pharmacological therapies as a highly effective and affordable wearable that has a favorable safety and tolerability profile.
“There is an unmet treatment need in the acute care of migraine attacks and Nerivio represents an emerging field in the acute treatment of migraine and the desired shift in paradigm to non-pharmacological treatments,” said Alan M. Rapoport, M.D. author of the article and Clinical Professor of Neurology at UCLA in Los Angeles. “Nonsteroidal anti-inflammatory medications (NSAIDs), triptans, ergots including dihydroergotamine (DHE) and other commonly used pharmacological options may prevent optimal migraine care due to poor tolerability, contraindications and lack of efficacy. When taken in excess, these medications may result in medication overuse headache (MOH) and migraine chronification.”
Reviewing the clinical studies demonstrating the safety and efficacy of Nerivio the article highlights the unique mechanism of action of REN, in which neuromodulation is applied to peripheral nerves in the upper arm to invoke CPM (Conditioned Pain Modulation). Nerivio underwent two randomized trials demonstrating favorable efficacy and documenting that the wearable is non-inferior to traditional care and to acute pharmacological treatments. A summary of both studies can be found in the article.
“The new frontier for acute treatment of migraine is non-invasive neuromodulation,” said Alon Ironi, CEO and co-founder of Theranica. “Nerivio integrates clinically meaningful efficacy with a high safety profile. We are proud of the drug-free, low side-effect alternative that Nerivio offers to individuals around the world living with this condition.”
Nerivio is the first smartphone-controlled wearable device for the acute treatment of migraine. Placed on the upper arm, it uses smartphone-controlled electronic pulses to wirelessly and remotely stimulate a Conditioned Pain Modulation response to mitigate pain and keep track of migraine episodes. The product received De Novo approval to market from the U.S. Food and Drug Administration (FDA) in May 2019 and was most recently recognized by TIME Magazine’s Best Inventions 2019 in its Health Care category.