New Adjunctive Digital Therapy for PTSD Gains FDA Clearance

A new product aimed at helping to treat post-traumatic stress disorder (PTSD) has been cleared for the United States market by the FDA.

GrayMatters Health, an Israeli digital health startup focused on mental health disorders, said last month that it had received a 510(k) clearance from the FDA to market Prism for PTSD, a self-neuromodulation product designed as an adjunct to standard-of-care therapy.

The product uses neurofeedback to help train patients to use self-neuromodulation techniques to alleviate symptoms of PTSD.

The technology is based on biomarkers of brain mechanisms associated with mental disorders, which the company developed using electroencephalogram and functional MRI data. These biomarkers are referred to as EEG-fMRI-patterns, or EFPs. Prism then uses those biomarkers, along with an interactive audiovisual interface, to help patients lower an amygdala-derived EFB biomarker associated with the emotional regulation system.

The approval opens up a major market for the company. According to the U.S. Department of Veterans Affairs, about 6% of Americans will experience PTSD at some point in their lives. Globally, the company said, about 250 million people have PTSD.

Oded Kraft, MBA, the company’s CEO, said the FDA clearance is an affirmation of the efficacy of their noninvasive 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,” he said, in a press release.

The approval was based on a study involving 79 people with chronic PTSD who were at least one year out from their traumatic experience.

“Results demonstrated a high rate of symptom improvement, a low rate of adverse events, and a low attrition rate,” said Charles Marmar, M.D., of New York University’s Langone Medical Center, who was the study’s principal investigator. “I am encouraged that Prism, as an adjective therapy, will significantly benefit patients with PTSD and allow clinics to offer more options and better outcomes.”

The concept of expanded options is important because the U.S. continues to have a significant shortage of mental health practitioners. A report published earlier this year by the US Department of Health and Human Services found nearly 8,000 mental health providers would be needed nationally in order to eliminate existing mental healthcare “deserts” — areas in which residents have inadequate access to mental healthcare.

Though GrayMatters’ announcement of FDA clearance is a major step forward for the company, the firm says it has bigger plans to use its technology for other mental health indications, and to expand its footprint globally.

The company is targeting conditions such as major depressive disorder, attention deficit hyperactivity disorder, general anxiety disorder, and borderline personality disorder, Kraft said.

“Looking ahead, the company also plans to use deidentified data collected throughout Prism treatments to develop treatment predictors, patient management tools, and treatment personalization,” Kraft said.

News of the FDA clearance came just days after the European Innovation Council had expanded its initial investment in the company following an initial investment of 2.5 million euros. The company has also worked closely with Otsuka Medical Devices Co., Ltd., who acts as an investor and partner in Japan, GrayMatter said.