Neurovalens startup from Belfast has received approval from the FDA for its new treatment device that is aimed to help people suffering with anxiety. This is with respect to the change in rule in 2019 to encourage innovations focused on problems like insomnia and anxiety.
The company is using noninvasive electrical stimulation technology to target the brain and nervous system. They are working on it for past 10 years and lately their second head-mounted device has been cleared by the FDA.
The approval means that doctors in the U.S. can now prescribe the medical devices of Neurovalens. These are two in number. One is for the treatment of generalized anxiety disorder (GAD) and the other is for tackling insomnia. The GAD device was approved last week and the insomnia device was approved last October.
Neurovalens said they working on more products and one is to deal with obesity-related health risks. They are mainly focused on creating medical devices for specific conditions, which requires them to conduct clinical trials to prove their effectiveness.
The devices are worn on the head and delivers electrical stimulation to the skin from behind the ear. These mainly target specific areas of the brain which are responsible for stress response, metabolic control and other such functions. The approach is distinct from other neurostimulation methods like transcranial direct current stimulation (TDCS).
Neurovalens is the first company that is working on noninvasive direct stimulation of the vestibular nerve, which plays a critical role in regulating various bodily functions. They have received additional funding to commercialize their new anxiety treatment device in the U.S. market and plan to raise more funds for further development.
