Neurovalens announced that it received FDA de novo approval for Modius Spero, a post-traumatic stress disorder (PTSD) therapy.
Belfast, Northern Ireland-based Neurovalens designed its Modius technology to use low-level electrical signals to non-invasively stimulate areas of the brain known to regulate key functions. This method is known as electrical vestibular system stimulation (VSS).
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Modius Spero specifically targets the symptoms of PTSD. It stimulates deep parts of the brain, using small, safe electrical pulses delivered to the skin behind the ear. The treatment period lasts 30 minutes daily, while patients can perform other activities, like watching TV or reading, during therapy.
Neurovalens says a large, U.S.-based clinical study demonstrated a significant and clinically meaningful improvement in symptoms in two-thirds of participants, supporting the device’s effectiveness as a non-invasive treatment option for PTSD. The company plans to offer the device through prescriptions to veterans through the U.S. VA, starting in July 2026.
FDA approval for a PTSD treatment marks the latest in a long line of milestones for Neurovalens. The company’s Modius Sleep for insomnia is already available in the U.S., having earned FDA approval in 2023 and launched the following year. Neurovalens received approval for Modius sleep in Europe and the UK in March, making it the company’s first nod in the geography.
he company also won FDA approval for Modius Calm, its anxiety-treating device, in 2024, then picked up de novo approval for Modius Lean, its weight management technology, in December 2025.
The company has also raised approximately £20 million (nearly $27 million) to date, including $8.1 million last year.
Dr. Jason McKeown, Neurovalens CEO, said:
“Neurovalens remains on a mission to offer low risk, non-invasive treatments for chronic health issues such as PTSD. By focusing on a treatment that addresses the underlying cause, we know this can have a transformative impact on the lives of patients. Being granted medical device regulatory approval for Modius Spero from the FDA validates it as a treatment for patients who suffer from PTSD, and is a significant milestone for the company. As a business founded in Northern Ireland, a post-conflict society, it has always felt incredibly meaningful that our device is being used to treat people who have experienced severe trauma. We’re delighted that our technology will shortly be available to veterans in the USA and look forward to Modius Spero being prescribed by doctors to the many more people suffering from PTSD across the world in future.”
