Other devices developed by the Northern Irish company for the treatment of insomnia, anxiety and weight management have previously received various levels of FDA approval.

Belfast health-tech company Neurovalens has received ‘de novo’ approval from the US Food & Drug Administration (FDA) for its prescribed treatment for symptoms associated with post-traumatic stress disorder (PTSD).

The treatment, a non-invasive medical device named ‘Modius Spero’, is specifically designed to help treat the symptoms of PTSD, according to the company.

It works by stimulating deep parts of the brain, associated with stress response and regulation of mental health, using small and safe electrical pulses – known as electrical vestibular system stimulation – delivered to the skin behind each ear for a period of 30 minutes daily, its maker said.

The device will become available on prescription from July to US military veterans, through their affiliated government department, following US clinical trials in which two-thirds of participants with PTSD using Modius Spero reported a significant and clinically meaningful improvement in symptoms, supporting the device’s effectiveness as a non-invasive treatment option for PTSD, Neurovalens said.

The Northern Irish company’s CEO Dr Jason McKeown 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.” Neurovalens also has European medical device regulation compliance certification to sell its products in the EU.

Other ‘Modius’ devices developed by Neurovalens for the treatment of insomnia, anxiety and weight management have previously received various levels of FDA approval, and use the same non-invasive approach to neurostimulation in targeting relevant areas of the brain.

The approach “allows the device[s] to operate non-invasively, and therefore we can avoid the need for surgical implantation”, McKeown told SiliconRepublic.com in 2024. “This allows the devices to be considered as much lower risk, and therefore can be offered much earlier in the treatment pathway.”

Neurovalens has been operating for more than a decade and is led by McKeown, chief project officer Iain Hendrick, chief regulatory officer Sinead Watson and chief technology officer Chris McCabe.

It said that to date, it has raised approximately £20m in equity and debt funding from UK investors including Wharton Asset Management, IQ Capital, Techstart Ventures, ACF Investors, Beltrae Partners, Investment Fund for Northern Ireland, Clarendon Fund Managers, Whiterock, Innovation Ulster Limited and the British Business Bank.

Don’t miss out on the knowledge you need to succeed. Sign up for the Daily Brief, Silicon Republic’s digest of need-to-know sci-tech news.