Theranica announced the presentation of three comprehensive real-world evidence studies at the 2025 American Headache Society (AHS) 67th Annual Scientific Meeting, demonstrating the sustained clinical benefits of its FDA-cleared Nerivio® REN wearable for migraine treatment. The studies, presented in Minneapolis, Minnesota, provide compelling evidence for the device's long-term efficacy and versatility across different migraine subtypes.
Long-Term Efficacy Without Treatment Fatigue
The most significant finding comes from a long-term study demonstrating that the REN wearable maintains consistent efficacy for migraine treatment over three years of use, with no signs of tachyphylaxis or "treatment fatigue." Throughout the study period, patients experienced consistent pain relief, functional recovery, and freedom from migraine-associated symptoms including photophobia, phonophobia, and nausea/vomiting.
"These findings speak to a critical need in migraine treatment: durability with continued use," said Stephanie J. Nahas, MD, MSEd, FAHS, FAAN, Assistant Director, Headache Medicine Fellowship Program, Jefferson Headache Center and Professor, Department of Neurology, Thomas Jefferson University. "Migraine disease is complex and non-curable, yet too often patients struggle to find safe, well-tolerated treatments with sustained efficacy over time, something that is necessary to mitigate chronification and maintain quality of life."
Dr. Nahas emphasized that seeing ongoing patient adherence with consistent results over a three-year span, without the risk of treatment fatigue, rebound symptoms, or gradually degraded response confirms the REN wearable as a sustainable, non-drug option for long-term migraine management.
Comparable Efficacy Across Migraine Subtypes
A second poster compared REN's impact in treating migraine with and without aura (MWA and MWoA) in nearly 32,000 patients. Despite patients with aura having more severe baseline symptoms, they experienced treatment outcomes that were comparable, and in some measures slightly better than patients without aura. Pain relief, functional recovery, and freedom from migraine-associated symptoms were evident in both groups, reinforcing the REN wearable's reliable performance across these two major migraine subtypes.
Clinical Significance and Real-World Impact
"These studies represent some of the most comprehensive real-world analyses to date on the use of REN in migraine treatment," said Alit Stark-Inbar, Ph.D., VP Medical Information and Research at Theranica. "Together, they demonstrate that REN is not only effective when used early for acute treatment—but also durable over time and beneficial across different migraine subtypes."
The clinical data reinforce the REN wearable's unique position as a non-drug treatment of migraine, clinically proven to work both acutely and preventively. For patients facing intolerability or lack of efficacy with medications, or seeking non-pharmacological alternatives, Nerivio delivers safe, effective, and non-disruptive relief without compromising outcomes.
Device Technology and Mechanism
The Nerivio® REN wearable is an acute and preventive prescription migraine treatment that works without drugs, needles, or invasive procedures. FDA-cleared for patients 8 and above, it uses gentle electrical pulses on the arm to activate the brain's natural pain regulation system, relieving migraine symptoms during an attack and reducing the frequency and burden of future episodes when used preventively. Controlled by a smartphone app, the device offers a safe, effective, and easy-to-use way to manage migraine without the risk of systemic side effects or drug interactions.
Market Position and Patient Access
Theranica's flagship product has been used in more than one million treatments across the U.S., providing options for migraine patient populations with unique needs, including children, veterans, individuals managing comorbidities, and women of childbearing age. The company positions itself as a pioneer in drug-free neuromodulation treatments for idiopathic pain conditions, dedicated to modernizing pain management without drugs or needles.
