A small technology company based in southern Belgium is set to take on the giant US market with its crowning achievement: an anti-migraine headband.
The device, created after years of medical and technological research, is a diadem fitted with electrodes designed to take the edge off migraines before they develop into acute blinding pain.
Migraine, a deep headache that develops behind the eyes and can last for days, is estimated to affect about one in seven adults around the world, World Health Organisation data shows.
It appears to be less common in East Asia, but overall it affects up to three times more women than men because of differences in hormonal activity.
The band, developed by the Belgian company Cefaly Technology, is worn across the forehead, and sends electric currents to facial nerves. Although the device is not a cure, the manufacturers believe it could stop the transition from "episodic" migraines to the "chronic" category.
The WHO says that migraine is one of the top 20 causes of disability in terms of years of healthy life lost.
The battery-powered headband, approved by the US Food and Drug Administration (FDA) in March, will be the first device with this design available in the United States.
The headband is already on the European market, but Cefaly Technology's managing director Pierre Rigaux said the FDA approval would open the way to a 25 per cent boost in sales over the next five years.
The device will hit the US market at a time when medical experts are putting more trust in non-pharmaceutical responses to migraines.
Giles Elrington, medical director of the National Migraine Centre, a British charity, said that techniques targeting the patient's head, in contrast to the use of drugs affecting the whole body, would be a "huge area of development in coming years".
One of the creators of the migraine headband said international technological developments in the field mean that "the course had been set" for the use of electrical stimulation to treat a number of pathologies, including headaches and insomnia.
Before the FDA approval, Cefaly Technology's short-term prospects in Europe had been reasonable, with healthy sales of its anti-migraine devices, but its turnover was only €3 million (HK$32 million) in 2013.
That has now changed. The small company, based outside the town of Liege and with just 10 employees, expects to sell 10,000 units a month in the US market.
Founded in 2004 by a 58-year-old medical doctor and an engineer, Cefaly Technology began by researching sports medicine, a field in which electrical stimulation of muscles was common. The challenge was to apply those techniques to the external stimulation of nerves.