Neuromodulation device for PTSD treatment from GrayMatters snags FDA nod

Post-traumatic stress disorder (PTSD) treatment typically takes a two-pronged approach: talk therapy and medications combined to help manage symptoms. Now, a newly FDA-cleared device adds a third option in the form of self-guided neuromodulation.

The regulatory clearance went to GrayMatters Health, an Israeli startup developing a noninvasive neurostimulation device aimed at helping PTSD patients retrain their brain to minimize and control the condition’s symptoms. In its announcement this week, GrayMatters said its Prism technology is now the first such neuromodulation system to receive the FDA’s blessing as an adjunct PTSD treatment.

The Prism system relies on what GrayMatters has termed its EEG-fMRI-Pattern mechanism, or EFP. The Prism technology performs a series of electroencephalograms—focusing specifically on activity in the amygdala, the brain's emotional center—to build what the company calls an EFP biomarker.

During each 30-minute session, while interacting with audio-visual software that GrayMatters developed, patients are repeatedly instructed to find a mental strategy—such as thinking of a specific memory or focusing on a certain emotion—that will calm down a noisy and chaotic scene they're viewing.

The process, which compares the patients’ real-time EEG data to the EFP biomarker to continuously adjust the onscreen situations, is known as neurofeedback. The theory behind the technology is that by seeing visual proof of how certain mental strategies can alter a virtual scene, patients will be able to learn how to consciously control their brain waves in real-life situations, too.

The FDA’s clearance came after GrayMatters submitted results from a study of 79 chronic PTSD patients. Though the company hasn’t yet published those results, Charlie Marmar, M.D., principal investigator at the study’s NYU Langone site, said in this week’s release that the trial's findings confirmed the safety and efficacy of the neuromodulation system.

“Results demonstrated a high rate of symptom improvement, a low rate of adverse event and a low attrition rate,” Marmar noted. “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 first FDA clearance is just the beginning, according to GrayMatters. For one thing, the company is continuing its studies of the PTSD treatment—including with the recent launch of a large study in Germany backed by a grant from the EU, noted co-founder Rani Cohen in the press release.

For another, it’s planning to expand the Prism system into other conditions such as depression, anxiety, attention deficit hyperactivity disorder and borderline personality disorder, CEO Oded Kraft said in the announcement. Plus, Kraft added, “Looking ahead, the company also plans to use deidentified data collected throughout Prism treatments to develop treatment predictors, patient management tools and treatment personalization.”