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GrayMatters Health Receives FDA Clearance for Flagship Digital Therapy for PTSD
(Courtesy GrayMatters Health)

GrayMatters Health Receives FDA Clearance for Flagship Digital Therapy for PTSD

GrayMatters Health, an Israeli company that develops digital self-neuromodulation therapies for mental disorders, announced on Tuesday that its flagship product, Prism for PTSD, has received a 510(k) clearance from the US Food and Drug Administration (FDA). This is the first noninvasive, self-neuromodulation adjunct digital therapy for PTSD on the market.

Prism for PTSD is designed to help patients lower the amygdala-derived-EFP biomarker, which is associated with the amygdala and emotion regulation system, using self-neuromodulation techniques through neurofeedback. The therapy is expected to augment standard-of-care PTSD therapy, treating the underlying mechanisms of the condition and enhancing clinical outcomes.

The FDA 510(k) clearance is based on the results of a study evaluating 79 patients with chronic PTSD, at least one year since experiencing trauma. The study demonstrated high rates of symptom improvement, low rates of adverse events, and a low attrition rate.

The company plans to further clinical development and evaluate Prism for additional mental disorders such as major depressive disorder, attention deficit hyperactivity disorder, general anxiety disorder, and borderline personality disorder. It will also use de-identified data collected throughout Prism treatments to develop treatment predictors, patient management tools, and treatment personalization.

GrayMatters Health is the first to use advanced statistical models fusing EEG and fMRI data to develop biomarkers of brain-mechanism-specific activity associated with mental disorders. The company’s products use these biomarkers with an interactive audio/visual interface to help patients regain control over the relevant brain activity.

The technology used in the product was developed by Dr. Talma Hendler, a professor of neuroscience and psychiatry at Tel Aviv University and director of the Sagol Brain Institute at the Tel Aviv Souraski Medical Center. The company has just initiated a large-scale PTSD study with some of the top mental health institutions in Germany, through a European Union grant.

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