U.S. FDA Grants GrayMatters Health 510(k) Clearance to Market Prism for PTSD

Non-Invasive, Self-Neuromodulation, Adjunct to Standard of Care Therapy Using Amygdala Derived EEG-fMRI Pattern Biomarkers to Help Patients with PTSD

GrayMatters Health (GMH), developer of digital self-neuromodulation therapies for mental disorders, has received a 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its flagship product, Prism for PTSD, the first non-invasive, self-neuromodulation adjunct digital therapy for post-traumatic stress disorder (PTSD).

GMH 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, named EEG-fMRI-Pattern (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.

Prism for PTSD trains patients to lower the amygdala-derived-EFP biomarker, which is associated with the amygdala and emotion regulation system, using self-neuromodulation techniques (through neurofeedback).

Prism for PTSD has the potential to improve the lives of the millions of Americans living with PTSD,” said Oded Kraft, Co-founder and CEO of GrayMatters Health. “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.”

Prism for PTSD augments standard of care 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.

“The study leading to Prism for PTSD’s 510(k) clearance resulted in high quality clinical data that exemplifies the efficacy and safety of this innovative device,” said Professor Charlie Marmar, Principal Investigator of the study at NYU Langone. “Results demonstrated a high rate of symptom improvement, a low rate of adverse event and a low attrition rate. I am encouraged that Prism, as an adjunctive therapy, will significantly benefit patients with PTSD and allow clinics to offer more options and better outcomes.”

“This is a first step in making Prism for PTSD available globally, as the company has just initiated a largescale PTSD study with some of the top mental health institutions in Germany, through a European Union grant,” said Rani Cohen, Co-Founder and Executive Chairman of GrayMatters Health. “Just a few days ago, the European Innovation Council (EIC) made a direct equity investment in GrayMatters Health, demonstrating a vote of confidence in the company. Additionally, we are furthering our collaboration to Japan with our Otsuka Medical Devices Co., Ltd. investors and partners.”

“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.”