The U.S. Food and Drug Administration has granted medical device approval to a breakthrough treatment that could transform the lives of veterans suffering from Post-Traumatic Stress Disorder (PTSD).
The official FDA De Novo approval for Modius Spero makes it the world’s first neuromodulation device to receive authorization by the FDA to treat symptoms associated with PTSD, a condition that affects an estimated 13 million Americans a year.
The wearable medical device, developed by Neurovalens and approved following clinical testing, uses low-level electrical stimulation to target specific areas of the brain to address the symptoms of PTSD.
PTSD significantly impacts mental health and frequently disrupts sleep, relationships, daily functioning, and emotional wellbeing, yet access to effective treatment remains an ongoing challenge, particularly for treatments that can be used outside a clinical setting.
Veterans are disproportionately affected by the condition as a result of increased exposure to combat or life threatening situations.
Dr Jason McKeown, CEO of Neurovalens, said: “The effects of PTSD can be devastating to people living with the condition. This medical device approval marks a turning point for the millions of people living with the condition who deserve better access to safe, effective, and non-invasive care.
“We are especially proud that Modius Spero’s first patients will be Veterans, supported through the U.S. Department of Veterans Affairs, and we are committed to working alongside clinicians and Veteran support networks to expand that access responsibly, and help more people in need of support.”
Designed for adults aged 22 and older, the Modius Spero device delivers non-invasive gentle nerve stimulation in 30-minute daily sessions, prescribed and overseen by a healthcare professional as part of a comprehensive care plan.
Designed for easy use at home and to fit around daily life, users can carry out other activities, such as watching TV or reading, while the treatment is under way.
The approval comes after a pivotal clinical trial was carried out in the US, led by Peter Colvonen PhD, Associate Clinical Professor at the University of California, San Diego.
The trial included 383 adults across the country with clinical PTSD diagnoses, with participants given either the Modius Spero headset or active sham device. In this clinical study, two-thirds of participants using Modius Spero reported a clinically meaningful improvement in PTSD symptoms.
Following the FDA’s de novo approval, Modius Spero will be available to Veterans through the U.S. Department of Veterans Affairs from this summer onwards. The device is intended for use alongside – not as a replacement for – a clinician-directed treatment plan.
Modius Sleep (indicated for chronic insomnia) and Modius Calm (indicated for Generalized Anxiety Disorder), are currently available exclusively to US Veterans through the Department of Veterans Affairs.
Modius Spero has been approved under the FDA’s De Novo classification, a pathway designed for new medical devices that have been proven safe and effective for their intended use through clinical testing.
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