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.
A product of years of medical and technological research, the device 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 the Far East, 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 for severe headaches, the manufacturers believe it could stop the transition from "episodic" migraines to the more severe "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, which was approved by the US Food and Drug Administration (FDA) in March, will be the first device with this design available in the US.
According to Cefaly Technology's managing director Pierre Rigaux, while the headband is already on the European market, the long-awaited FDA approval will 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, the medical director of the National Migraine Centre, a British charity research centre, said that techniques targeting the patient's head, in contrast to the use of drugs affecting the whole body, will be a "huge area of development in coming years".