- The CE mark for Nerivio® extends its indication to the preventive and acute treatment of migraine in adolescents and adults
The company is preparing to bring the prescribed wearable device to Europe next year
NETANYA, Israel, Aug. 9, 2023 /PRNewswire/ -- Theranica, a digital prescription therapy company developing advanced neuromodulation devices for migraine and other pain disorders, today announced that it has received expanded CE mark approval (Conformité Européenne) in accordance with the European MDR standard for Nerivio® as a dual-use therapy for the acute and preventive treatment of migraine in adults and adolescents. The extension of the CE mark for Nerivio is a critical milestone in accelerating the availability to the European market of this novel, drug-free anti-migraine device.
Migraine is a major global neurological disorder affecting more than one billion people worldwide, with a prevalence of more than one in ten people in Europe. Research shows that it is one of the most prevalent disorders, with high morbidity, especially among young adults and women.
Nerivio has been available by prescription in the United States since 2020, initially for acute treatment and since April of this year also as a preventive treatment.
"Migraine is the leading cause of disability worldwide, including in adolescents and young adults, and early intervention with preventive treatment is necessary to prevent the disease from worsening," said Simona Sacco, PhD, Professor of Neurology at the University of L'Aquila (Italy) and second vice-president of the European Federation of Headaches. "It is important to broaden the therapeutic options with a non-drug treatment, especially one that can treat and prevent migraine."
"With more than 50,000 patients prescribed Nerivio in the United States, we receive numerous weekly requests to bring the device to Europe," said Alon Ironi, CEO and co-founder of Theranica. "We have been awaiting approval of the prevention indication, and with that we are preparing to make Nerivio available to people with migraine in Europe from 2024. Our goal is to empower underserved populations, particularly adolescents, to prevent and treat migraines safely and effectively, and be fully present in everyday life.
Controlled by a smartphone app and self-administered, Nerivio wraps around the upper arm and uses sub-painful Remote Electrical Neuromodulation (REN) to activate nociceptive nerve fibers in the arm to send signals that trigger a pain management mechanism. descending pain in the brain called conditioned pain modulation (CPM), which turns off migraine pain and associated symptoms without medication. In simpler terms, the upper arm is stimulated to trigger a natural process in the brain that aborts or alleviates the migraine and other associated symptoms. Each treatment lasts 45 minutes and is applied every other day for prevention or at the onset of a migraine attack for acute treatment.
About Theranica Theranica is a digital prescription therapy company dedicated to creating effective, safe, affordable, and low-side effect therapies for idiopathic ailments. Nerivio®, the company's award-winning flagship wearable device, is the first FDA-cleared and CE-marked prescription migraine bioband for the acute and/or preventative treatment of migraine with or without aura in individuals age 12 and older. years. Nerivio already serves more than 50,000 migraineurs in the United States, including teens and veterans. Theranica is expanding its proprietary technology to develop solutions for other idiopathic ailments. Learn more on our websites, theranica.com and nerivio.com, and follow us on LinkedIn, Twitter, Instagram, and Facebook.
Theranica Contact Ronen Jashekronenj@theranica.com 972-72-390-9750
Media ContactV.A. LopesGrey Matter Marketingvlopes@greymattermarketing.com
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