'Significant milestone': Northern Ireland medical tech manufacturer granted FDA De Novo approval for PTSD treatment device

Neurovalens, a global leader in non-invasive neuro-technology, has been granted medical device De Novo approval from the US Food & Drug Administration (FDA) for Modius Spero, its prescribed treatment for symptoms associated with Post-traumatic Stress Disorder (PTSD).

Based in Belfast, Neurovalens is a pioneering medical device company which specialises in leveraging the power of neuroscience and advanced technology to address a variety of global mental health challenges.

The company’s Modius technology uses low-level electrical signals to non-invasively stimulate areas of the brain that are known to influence stress response and regulate mental health. This technology is known as electrical vestibular system stimulation (VSS).

Modius Spero is specifically designed to help treat the symptoms of PTSD. It works by stimulating deep parts of the brain using small and safe electrical pulses delivered to the skin behind each ear for a period of 30 minutes daily, during which users can do other activities, such as watching TV or reading.

In a large, US-based clinical study, 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.

The device will be available on prescription to Veterans, through the US Department of Veterans Affairs (VA) from July 2026.

The VA estimates that approximately 13 million Americans have PTSD, with women more likely to develop PTSD at some point in their lives than men.

Dr Jason McKeown, MD, PhD, CEO of Neurovalens, 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.”

Neurovalens has previously obtained medical device clearance from the US FDA for its Modius Sleep device for insomnia, as well as its Modius Calm device for managing anxiety.

This year, Neurovalens became one of only a few Northern Ireland companies to achieve EU Medical Device Regulation compliance certification to sell its products in the EU, placing it alongside some of the world's leading medical device manufacturers.

To date, Neurovalens 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 British Business Bank.

The company continues to run clinical trials on the effectiveness of its drug-free non-invasive technology in treating other conditions.