Neurovalens Receives FDA De Novo Approval for Modius Spero PTSD Treatment
Neurovalens, a biotechnology company specializing in non-invasive neuro-technology, has announced the publication of peer-reviewed research in Nature Mental Health detailing the effectiveness of its Modius Spero device for treating symptoms associated with Post-traumatic Stress Disorder (PTSD). The device, which uses low-level electrical pulses to stimulate areas of the brain regulating stress response, recently received De Novo approval from the U.S. Food & Drug Administration (FDA). This approval allows Modius Spero to be prescribed to veterans through the U.S. Department of Veterans Affairs (VA). The clinical trial, conducted by the University of California, San Diego, involved 383 U.S. adults with PTSD and demonstrated statistically and clinically significant reductions in both PTSD symptom severity and insomnia. This marks a significant development in providing a non-invasive, at-home treatment option for individuals living with PTSD. 
