09.08.2023 – 15:08
Theranica
Netanja, Israel (ots/PRNewswire)
The company is gearing up to bring the prescription wearable to the European market next year
Theranica, a prescription-only digital therapeutics company developing advanced neuromodulation devices for migraine and other pain conditions, today announced it was granted an Enhanced Conformité Européenne (CE) Mark for Nerivio® as a dual-use therapy for the acute and preventive treatment of Migraine in adults and adolescents under the EU Medical Devices Regulation (MDR). The extension of the CE mark for Nerivio is an important milestone in accelerating the availability of the novel drug-free migraine device in the European market.
Migraine is a common global neurological disorder affecting more than 1 billion people worldwide. In Europe, their prevalence exceeds one in ten. Studies have shown that migraines are among the most common diseases and have a high morbidity, especially in young adults and women.
Nerivio has been available by prescription in the US since 2020, initially limited to acute treatments and, since April this year, also as a preventive treatment.
“Migraine is the leading cause of disability worldwide, including in adolescents and young adults. Early intervention with preventative treatments is critical to prevent disease progression,” said Dr. Simona Sacco, Professor of Neurology at the University of L’Aquila, Italy, and Second Vice-President of the European Headache Federation. “It is important to expand treatment options to include a non-pharmacological treatment, particularly one that can both treat and prevent migraines.”
“With Nerivio being prescribed for more than 50,000 patients in the US, we receive numerous requests every week to bring the device to Europe,” said Alon Ironi, CEO and co-founder of Theranica. “We have awaited approval of the indication as a prevention treatment and are now preparing to make Nerivio available to people living with migraines in Europe from 2024. Our focus is to enable underserved populations, particularly youth, to be able to manage migraines safely.” and to prevent and treat effectively and to be fully present in everyday life.”
Nerivio is controlled via a smartphone app and used by the patient himself. The device wraps around the upper arm and uses non-painful remote electrical neuromodulation (REN) to activate nociceptive nerve fibers in the arm and send signals that trigger a descending pain-coping mechanism in the brain. This conditioned pain modulation (CPM) can switch off migraine pain and associated symptoms without the use of medication. Put simply, the upper arm is stimulated to trigger a natural process in the brain that ends or relieves migraine headaches and other associated symptoms. Each treatment lasts 45 minutes and is used every other day for prevention or at the onset of a migraine attack for acute treatment.
Information about Theranica
Theranica is a prescription-only digital therapeutics company dedicated to developing effective, safe, affordable and low-adverse therapies for idiopathic pain disorders. The company’s award-winning flagship wearable device, Nerivio®, is the first FDA-cleared and CE-marked prescription BioBand for the treatment of acute or preventive migraine headaches, with or without aura, in people ages 12 and older. Nerivio is already being used by more than 50,000 people with migraines in the US, including youth and veterans. Theranica is expanding its proprietary technology to develop solutions for additional idiopathic pain indications. Visit our websites theranica.com and nerivio.com for more information. Follow us on LinkedIn, TwitterInstagram and Facebook.
Theranica – Contact
Ronen Jashek [email protected]
+972-72-390-9750
Media contact:
VA Lopes
Grey Matter Marketing [email protected]
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Original content from: Theranica, transmitted by news aktuell