Neurovalens, a pioneering neurotechnology startup based in Belfast, has achieved a significant milestone with the recent clearance of its second head-mounted medical device by the U.S. Food and Drug Administration (FDA). This clearance marks a key advancement in the company’s mission to provide innovative noninvasive treatments for various neurological and metabolic conditions.

The FDA’s approval allows Neurovalens to offer two prescription-based devices for specific medical conditions in the United States: one targeting generalized anxiety disorder (GAD) and the other addressing insomnia. These devices utilize noninvasive electrical stimulation of the brain and nervous system to deliver therapeutic effects. The GAD device received FDA clearance just last week, following the approval of the insomnia treatment device in October of the previous year.

Neurovalens, under the leadership of CEO Dr. Jason McKeown, is now focusing on expanding its product portfolio to include treatments for other prevalent conditions. The company is currently developing a device designed to address obesity-related cardiometabolic risk, which targets brain messaging influencing the storage of visceral fat. Another product aimed at treating post-traumatic stress disorder (PTSD) is also in the pipeline.

Dr. McKeown emphasized the importance of adhering to rigorous regulatory standards and conducting clinical trials to demonstrate the safety and efficacy of their devices for specific medical indications. Neurovalens has opted for a strategy focused on selling FDA-cleared medical devices tailored for precise conditions, differentiating themselves from wellness-focused consumer devices that cannot make medical claims.

The regulatory challenges in Europe differs, allowing consumers to purchase Neurovalens’ devices directly. However, the company is actively pursuing medical device clearances in the U.K. and EU markets, anticipating approval for its insomnia treatment device later this year.

Neurovalens’ technology involves head-mounted devices that apply electrical neurostimulation to the skin behind the ear, targeting the vestibular nerve to stimulate key brain regions responsible for metabolic control, stress response, and circadian regulation. This approach represents a novel avenue in the field of noninvasive neurostimulation, distinct from other methods such as transcranial direct current stimulation (TDCS) or magnetic stimulation.

The company’s recent funding boost of £2.1 million ($2.65 million) suggests that there is a strong investor confidence in Neurovalens’ innovative approach and potential for commercial success. With plans to raise additional capital in a Series B funding round, Neurovalens aims to accelerate the commercialization and accessibility of its groundbreaking medical devices, offering hope for individuals suffering from a range of chronic conditions that have historically been challenging to treat with conventional methods.