GrayMatters Health (GMH), a company that develops digital self-neuromodulation therapies for mental disorders, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its flagship product, Prism for PTSD. The non-invasive, self-neuromodulation adjunct digital therapy is the first of its kind for post-traumatic stress disorder (PTSD). Prism for PTSD trains patients to lower the amygdala-derived-EEG-fMRI-Pattern (EFP) biomarker associated with the amygdala and emotion regulation system using self-neuromodulation techniques through neurofeedback.
GMH is the first to use advanced statistical models to fuse EEG and fMRI data to develop biomarkers of brain-mechanism-specific activity associated with mental disorders, which it calls EFP. The company’s products use these biomarkers with an interactive audio/visual interface to help patients regain control (agency) over the relevant brain activity.
GMH’s Prism for PTSD will augment standard PTSD therapy, treating the proven underlying mechanisms of the condition and enhancing clinical outcomes. The FDA 510(k) clearance is based on results of a study evaluating 79 patients with chronic PTSD, at least one year since experiencing trauma.
“Gaining FDA clearance affirms the value of bringing this innovative and clinically proven, non-invasive technology to mental disorder treatment. We are eager to place Prism in the hands of mental healthcare professionals, in the US and abroad to help patients across the world living with PTSD,” said Oded Kraft, Co-founder and CEO of GrayMatters Health.
The company has initiated a large-scale PTSD study with some of the top mental health institutions in Germany, through a European Union grant, after receiving a direct equity investment from the European Innovation Council (EIC). The EIC Fund, in collaboration with the European Investment Bank (EIB) acting as the investment advisor, has expanded its involvement in GMH after granting the company €2.5 million euros in September 2022. The funds will be used to continue developing Prism for PTSD, as well as a large-scale study in the EU.
“GMH plans to expand clinical development to evaluate Prism for additional mental conditions, such as Major Depressive Disorder, Attention Deficit Hyperactivity Disorder, General Anxiety Disorder, and Borderline Personality Disorder,” added Kraft. “Looking ahead, the company also plans to use deidentified data collected throughout Prism treatments to develop treatment predictors, patient management tools, and treatment personalization. This important milestone, only three years after raising our seed round, would have been impossible to achieve without Professor Talma Hendler, the inventor of the technology, and our many clinical and business partners in the US, Israel, Germany, and Japan.”
GrayMatters Health is making progress in improving the outcome of PTSD treatment, recognized as a company bringing breakthrough technology and game-changing innovations to the field of mental health. The company’s innovative technology and clinically proven approach to treatment has the potential to improve the lives of the millions of people living with PTSD and other mental disorders worldwide.