The US Food and Drug Administration’s (FDA) has granted the clearance of Theranica Bioelectronics’ smartphone-controlled non-invasive neuromodulation device – Nerivio Migra – for the treatment of acute migraine coupled with further clinical development for expansion of indications will drive the adoption of the device in the US from 2020, says GlobalData, a leading data and analytics company.
Migraine is ranked as the third most common disease in the world with an estimated global prevalence of 14.7% of the world’s population. According to the American Migraine Foundation, about 36 million people suffer from migraine in the US.
GlobalData’s latest report ‘United States Neuromodulation Devices Market Outlook to 2025’ reveals that the US neuromodulation device market is set to grow at a compound annual growth rate (CAGR) of 7.4% from US$3.1bn in 2018, to US$5.1bn in 2025. It also states that high prevalence of neurological conditions among aging population; increasing user adoption rates for new technologies and increasing patient awareness about neurological disorders are set to drive the US neuromodulation device market.
Vamsee Krishna, Medical Device Analyst at GlobalData, says: “The high unmet need of the migraine population, who are currently using ineffective, contra-indicated triptans and ergots having non-tolerable side effects, can be achieved by the availability of smartphone wearable device Nerivio Migra. The high quality, low cost device developed by Theranica, an Israeli medical technology company is set to hit the US market later this year”.
Currently, GammaCore (handheld) and Cefaly (headband) are some of the other neuromodulation devices available at high prices for the treatment of migraine. These high cost associated treatment options, triptans and latest medications including over-the-counter drugs, do not meet the patients’ satisfaction in treating the acute migraine condition.
Nerivio Migra, a breakthrough electronic device has received Food and Drug Administration (FDA) market authorization through De Novo pathway based on the results of a double-blind, placebo-controlled study conducted at 12 headache clinics in the US and Israel involving 252 migraine patients. The medical device demonstrated a high efficacy ratio for single and multiple attacks, and relieved pain in patients at two and 48 hours after treatment.
Over the next four months, a series of clinical studies will be carried out at 30 headache clinics in the US where the patient selection and correct usage of Nerivio Migra will be evaluated.
Krishna concludes: “Nerivio Migra is bound to demonstrate a strong shift in the patient pool from oral medications and other treatment options to the smartphone wearable device for acute treatment of migraine.”