This week, Neurovalens‘ Modius Spero became the first neuromodulation device to earn FDA approval to treat PTSD.
Veterans, who face disproportionately high PTSD rates, will be the first to gain access to this treatment through the VA this summer — marking a rare bit of good news in a field where treatment options have long been limited to antidepressants and talk therapy.
To prove the device’s efficacy, Belfast-based Neurovalens conducted a clinical trial involving 383 adults, two-thirds of whom reported meaningful symptom improvement using Modius Spero.
Modius Spero stimulates deep parts of the brain that are known to regulate stress response by delivering small electrical pulses to the skin behind each ear.
The device targets the vestibular cranial nerve, which sits very close to the skin behind each ear and therefore can be activated non-invasively by a small electrical pulse, explained Neurovalens CEO Jason McKeown.
“It is a user-friendly headset, worn for 30 minutes daily, usually in the evening, while the patient watches TV, browses the internet or reads a book,” McKeown said.
The trial showed that daily sessions over 12 weeks can lead to clinically meaningful improvements in PTSD and insomnia.
McKeown pointed out that PTSD is a serious and complex condition that needs to be managed closely by a clinician who has experience treating it. Modius Spero was designed as a therapy that can be integrated into a patient’s personalized treatment plan rather than a standalone treatment, he said.
“Modius Spero can be used alongside standard-of-care treatments such as psychological therapies or medication, depending on the individual’s needs,” McKeown remarked.
Access begins with veterans, but Neurovalens expects Modius Spero to be widely reimbursed and available to all PTSD soon.
“It is important to us as a company that all PTSD patients have access to Modius Spero, and therefore we are actively navigating the reimbursement process to have nationwide coverage in place later 2027,” McKeown stated.
Photo: LordHenriVoton, Getty Images
