The U.S. Food and Drug Administration (FDA) granted a De Novo request for its smartphone-controlled electroceutical, Nerivio Migra®, utilizing Remote Electrical Neuromodulation for the acute treatment of migraine.
News & Events
We are excited to inform: FDA Grants Theranica De Novo to Market First Smartphone-controlled Acute Migraine-relief Wearable Device
HEADACHE Journal: Remote Electrical Neuromodulation (REN) Relieves Acute Migraine - A Randomized, Double‐Blind, Placebo‐Controlled, Multicenter Trial
There is a significant unmet need for novel effective well‐tolerated acute migraine treatments. REN is a novel acute migraine treatment that stimulates upper arm peripheral nerves to induce conditioned pain modulation – an endogenous analgesic mechanism in which conditioning stimulation inhibits pain in remote body regions. A recent pilot study showed that REN can significantly reduce headache. We have conducted a randomized, double‐blind, sham‐controlled study to further evaluate the efficacy and safety of REN for the acute treatment of migraine.
Read more here: https://onlinelibrary.wiley.com/doi/full/10.1111/head.13551
Drs. Alan Rapoport and Lars Edvinsson: Aspects on the pathophysiology of migraine and a review
of device therapies for migraine and cluster headache
An article published by Drs. Rapoport and Edvinsson discusses aspects on the pathophysiology of migraine as well as reviews device therapies for migraine and cluster headache, including the Nerivio Migra – Remote modulation device for the upper arm using CPM (conditioned pain modulation).
Read more here (additional subscription required): https://link.springer.com/article/10.1007/s10072-019-03828-0
Brian Grosberg, MD: Nerivio Migra Device for Acute Migraine Treatment
The director of the Hartford Healthcare Headache Center in Connecticut and lead investigator on the trial provided some insight into the study’s findings. Click on the NeurologyLive image to see the interview:
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Theranica in the news:
GeekTime – Theranica Raises $6m to Develop a Patch for Treating Migraines
Electric Stim Armband May Reduce Migraine Pain
Industry News: Effectiveness of Preventive Medicines for Pediatric Migraines
A recent study published by the New England Journal of Medicine re-affirms that, unfortunately there is no effective solution for pediatric migraine.
On the other hand, the population of kids and adolescents suffering from migraine continues to grow (6M patients in the US alone), and the toll on the US economy is estimated at $36B.
Theranica is vowed to have its risk-free, effective Nerivio Migra cleared for adolescents and kids, and provide them with a comfortable, affordable, easy-to-use, rapid solution for acute migraine.
Industry News: The American Migraine Foundation Launches Initiative to Mobilize the 36 Million Americans Living with Migraine
The American Migraine Foundation (AMF) announced that it is launching an initiative – Move Against Migraine – to empower the more than 36 million Americans living with migraine to advocate for themselves to find the support and treatment they need. Given the lack of awareness of the varied symptoms that can occur during migraine attacks and the long-standing stigma associated with this disease, less than 5% of those with the most debilitating form of migraine have sought help, received a diagnosis and been treated.
Theranica in the News: Coverage of the AAN publication regarding pilot study results
CBS News: Migraine “smart” patch tested to help ease pain.
New Atlas: Wireless armband may be a headache for migraines.
Neurology Advisor: Self-Controlled Electric Stimulation a Good Alternative to Drug Therapy for Migraine.