This week, Neurovalenes“Modius Spero became the first neuromodulation device to gain FDA approval to treat PTSD.
Veterans, who face disproportionately high rates of PTSD, will be the first to gain access to this treatment through the VA this summer — which is rare good news in an area where treatment options have long been limited to antidepressants and talk therapy.
To prove the effectiveness of the device, Belfast-based Neurovalens conducted a clinical trial involving 383 adults, two-thirds of whom reported significant improvement in their symptoms using Modius Spero.
Modius Spero stimulates deep parts of the brain known to regulate the stress response by delivering small electrical pulses to the skin behind each ear.
The device targets the vestibular cranial nerve, which lies very close to the skin behind each ear and therefore can be activated non-invasively by a small electrical pulse, explained Jason McKeown, CEO of Neurovalens.
“This is a user-friendly headset, worn daily for 30 minutes, 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 emphasized that PTSD is a serious and complex illness that must be closely managed by a clinician experienced in its treatment. Modius Spero was designed as a therapy that could be integrated into a patient’s personalized treatment plan rather than a stand-alone treatment, he said.
“Modius Spero can be used alongside standard treatments such as psychological therapies or medications, depending on the needs of the individual,” noted McKeown.
Access starts with veterans, but Neurovalens expects that Modius Spero will soon be widely reimbursed and available to all PTSD patients.
“It is important to us as a company that all PTSD patients have access to Modius Spero, and that is why we are actively pursuing the reimbursement process to achieve national coverage by 2027,” McKeown said.
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