The launch in
Augsburg;
The current best estimate of global migraine prevalence is 14–15%, and, in terms of burden, migraine accounts for 4.9% of global ill health, quantified as years lived with disability1. Around 8 to 10 million people in
Nerivio® is a prescription-based, non-invasive device intended for acute and prophylactic (preventive) treatment of migraine with or without aura3 for adults and adolescents aged 12 years and older. Nerivio® can be worn on the upper arm and controlled by a smartphone app. Each device has an in-built capability for providing 18 treatment sessions, each 45 minutes long. It is to be used within 60 minutes of the onset of headache or aura for acute treatment of migraine or every alternate day for prevention of migraine. The device uses the Remote Electrical Neuromodulation (REN) mechanism to activate conditioned pain modulation (CPM), specifically by stimulating nociceptive neural receptors under the skin of the arm. This initiates a natural pain-relieving process in the brainstem, causing a global effect of pain inhibition that affects the source of migraine pain in the brain4.
n“Neuromodulation offers a significant advancement in migraine treatment,” says Dr.
Clinically proven in multiple clinical trials6, the drug-free REN wearable is suitable for a wide range of migraine patients, especially those who seek an individual treatment opportunity, a drug-free therapy, failed to control their migraine with medications, or with poor tolerance or contraindication to medications. In addition, sensitive populations such as adolescents, women of childbearing age groups, and patients at risk of medication overuse headaches could benefit from Nerivio®7. Studies show that Nerivio® is well tolerated with no systemic side effects or concern for medication overuse. It has been evaluated in robustly designed pivotal studies conducted in the
In
The product has already been presented in
The prescribed Nerivio® REN wearable is indicated for acute and/or preventive treatment of migraine with or without aura in patients 12 years and older. Patients are advised to consult their physician or neurologists on the use of the device and management of migraine. More information (in German only) can be found on www.nerivio.de
n n n1 Steiner, T.J., Stovner, L.J. Global epidemiology of migraine and its implications for public health and health policy. Nat Rev Neurol 19, 109–117 (2023). https://doi.org/10.1038/s41582-022-00763-1
2 Porst et al. J Health Monitoring 2020 5(S6):2–26
3 Symptoms or sensations, such as flashing lights or zigzag lines or loud sound, which typically precede migraine headache
4 Nir R-R, Yarnitsky D. Conditioned pain modulation. Curr Opin Support Palliat Care 2015; 9:131-137 https://doi.org/doi:10.1097/SPC.0000000000000126; Yarnitsky D et al. Remote Electrical Neuromodulation (REN) Relieves Acute Migraine: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial. Headache 2019; 59:1240-1252 https://doi.org/doi:10.1111/head.13551
5 Marmura: Incorporating Remote Electrical Neuromodulation (REN) Into Usual Care Reduces Acute Migraine Medication Use: An Open-Label Extension StudyFront. Neurol., 07 April 2020 Sec. Headache and Neurogenic Pain Volume 11 - 2020 | https://doi.org/10.3389/fneur.2020.00226
6 Migraine Headache Treatment - Nerivio | Clinical Trials
7 Babaei M, Rapoport AM. Expert Review of Medical Devices. 2023 May 12:1-5.
8 CE mark: https://www.prnewswire.com/news-releases/nerivio-ce-mark-indication-expanded-to-preventive-and-acute-treatment-of-migraine-for-adolescents-and-adults-301896254.html
| Europe agreement: https://www.prnewswire.com/news-releases/theranica-enters-into-agreement-with-dr-reddys-for-commercializing-nerivio-in-europe-301986214.html
| India agreement: https://www.prnewswire.com/news-releases/theranica-enters-into-agreement-with-dr-reddys-for-commercializing-nerivio-in-india-301715697.html
nnDisclaimer: This press release may include statements of future expectations and other forward-looking statements that are based on the management's current views and assumptions and involve known or unknown risks and uncertainties that could cause actual results, performance or events to differ materially from those expressed or implied in such statements. In addition to statements which are forward-looking by reason of context, the words "may", "will", "should", "expects", "plans", "intends", "anticipates", "believes", "estimates", "predicts", "potential", or "continue" and similar expressions identify forward-looking statements. Actual results, performance or events may differ materially from those in such statements due to without limitation, (i) general economic conditions such as performance of financial markets, credit defaults , currency exchange rates, interest rates, persistency levels and frequency / severity of insured loss events, (ii) mortality and morbidity levels and trends, (iii) changing levels of competition and general competitive factors, (iv) changes in laws and regulations and in the policies of central banks and/or governments, (v) the impact of acquisitions or reorganization, including related integration issues, and (vi) the susceptibility of our industry and the markets addressed by our, and our customers', products and services to economic downturns as a result of natural disasters, epidemics, pandemics or other widespread illness, including coronavirus (or COVID-19), and (vii) other risks and uncertainties identified in our public filings with the Securities and Exchange Commission , including those listed under the "Risk Factors" and "Forward-Looking Statements" sections of our Annual Report on Form 20-F for the year ended March 31, 2023 . The company assumes no obligation to update any information contained herein.
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