Theranica's Nerivio® REN Wearable Validated in Landmark 55,000-Patient Study Published in Cephalalgia

Peer-reviewed real-world evidence confirms that starting treatment within the first hour of migraine symptom onset nearly doubles relief, positioning the REN wearable as an innovative, drug-free alternative in acute migraine care.

BRIDGEWATER, N.J. and NETANYA, Israel, Oct. 28, 2025 /PRNewswire/ -- Theranica, a neuromodulation therapeutics company developing drug-free treatments for neuroplastic pain conditions, today announced the publication of a landmark real-world evidence study in Cephalalgia, one of the world's leading peer-reviewed journals dedicated to headache research. The study from Ailani, et al., The effect of treatment onset time on acute efficacy in migraine patients treating with remote electrical neuromodulation (REN), evaluated data from more than 55,000 patients and demonstrated that early treatment with the Nerivio^® REN wearable significantly improves migraine outcomes.

The study revealed that initiating treatment with the Nerivio REN wearable within one hour of migraine onset nearly doubled the likelihood of achieving pain relief, pain freedom, and freedom from associated symptoms compared to delayed treatment (p<0.001). These findings underscore the clinical importance of timely intervention and mark one of the largest prospective studies in migraine research.

While the value of early acute treatment makes a lot of sense and has been known to healthcare providers, this is the first time that its advantage is demonstrated rigorously, in a non-pharmacological treatment", said lead author of the study paper, Jessica Ailani, MD, Director, Department of Neurology, Medstar Georgetown University Hospital, Headache Center, Washington, DC. "What's especially impressive about this study is the huge sample size, which makes it the largest prospective study in migraine, ever".

"Validation of this real-world evidence study is a breakthrough moment for migraine treatment because the study confirms what clinicians have long suspected: timing matters," "When the REN wearable is used early on, patients are nearly twice as likely to achieve relief or freedom—not just from pain, but from the disability that derails their lives" said Alon Ironi, CEO of Theranica. "Adding the high safety profile of this therapy, the practical conclusion for prescribed patients is not to hesitate, once they feel the initial signs of a migraine attack and treat as early as possible."

"The study further iterates that timely acute treatment is key in optimizing clinical results and reducing the overall burden of migraine, including the impact on quality of life, medication overuse headache, and disease chronification," said Alit Stark-Inbar, PhD, Vice President of Medical Information and Research at Theranica. "Moreover, timely intervention is expected to increase treatment adherence, as patients who treat early and experience meaningful relief are more likely to continue using the REN wearable as part of their care plan."

Learn more about the Nerivio REN wearable at www.Theranica.com.

About Nerivio
The Nerivio^® REN wearable is an acute and preventive (dual-use) 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 Nerivio REN wearable offers a safe, effective, and easy-to-use way to manage migraine—without the risk of systemic side effects or drug interactions.

About Theranica
Theranica  is a neuromodulation therapeutics company pioneering drug-free treatments for idiopathic pain conditions. Its FDA-cleared flagship product, Nerivio^®, is the first-and-only prescribed REN wearable for both acute and preventive migraine care. Used in more than one million treatments across the U.S., Nerivio provides a much-needed option for migraine patient populations with unique qualities, including children, veterans, individuals managing comorbidities, and women of childbearing age. Dedicated to modernizing pain management without drugs or needles, Theranica continues to develop cutting-edge neuromodulation therapies that reshape the way pain is treated.

Theranica Contact:
Ronen Jashek
[email protected]
+972-72-390-9750

Media Contact:
Grey Matter Marketing
[email protected]

SOURCE Theranica