Neurovalens, a global leader in non-invasive neuro-technology, has announced the publication of peer reviewed research in the prestigious Nature Mental Health journal which demonstrates the impact of Modius Spero, its prescribed treatment for symptoms associated with Post-traumatic Stress Disorder (PTSD).
Based in Belfast, Northern Ireland, 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 pulses to non-invasively stimulate areas of the brain that are known to regulate stress response. This technology is known as electrical vestibular system stimulation (VSS).
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Modius Spero is specifically designed to help treat symptoms associated with 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.
The company was granted medical device De Novo approval from the US Food & Drug Administration (FDA) for Modius Spero earlier this year and the device is now available on prescription to Veterans, through the US Department of Veterans Affairs (VA).
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.
The research published in Nature Mental Health, reports findings from a large clinical study of 383 US adults aged 22 and over with PTSD, carried out by the University of California, San Diego.
The paper, 'Electrical vestibular system stimulation versus sham for treatment of post-traumatic stress disorder: a double-blind, randomized clinical trial', found that Modius Spero produced statistically and clinically significant reductions in both PTSD symptom severity and insomnia severity. It provides evidence of its potential as a non-invasive, at-home treatment option for people living with PTSD.
Dr. Peter Colvonen, Associate Clinical Professor of Psychiatry at the University of California, San Diego, designed and conducted the clinical trial and published the manuscript in Nature Mental Health. Findings from this trial supported the manufacturer’s subsequent FDA De Novo approval for treatment of symptoms associated with PTSD.
Dr. Colvonen said: “For Modius Spero to demonstrate a statistically and clinically significant reduction in PTSD symptom severity in a large, nationwide, randomized controlled trial like this is an exciting development for the treatment of PTSD across the US.
“I am now studying how the Modius Spero can support Veterans seeking care for their PTSD - including whether it can help stabilize symptoms while Veterans wait for trauma-focused treatment, and whether it can be studied as an adjunct to existing evidence-based therapies.
“How we use the device at the VA can be a guide for how it will be used for civilians seeking care for PTSD.”
Dr Jason McKeown, MD, PhD, CEO of Neurovalens, said: “Our mission at Neurovalens is to offer low risk, non-invasive treatments for chronic health issues like PTSD. We believe that by focusing on treatments that address the underlying cause of these conditions, we can have a transformative impact on the lives of patients.
“The publication of the peer reviewed clinical trial paper is another meaningful step for the company in demonstrating the significance of this world-first non-invasive, neuromodulation device to treat the symptoms of PTSD. It is an FDA-authorised medical device and we are excited by the feedback from patients suffering from PTSD who have already been prescribed the treatment by their doctors.”
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Neurovalens also has medical device clearance from the US FDA for its Modius Sleep device for insomnia, as well as its Modius Calm device for anxiety, with all three Modius devices currently available to Veterans through the US Department of Veterans Affairs (VA).
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 research paper can be accessed at https://www.nature.com/articles/s44220-026-00714-5
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