GrayMatters Health Earns FDA Clearance for PTSD Neuromodulation Device – MedCity News
The Food and Drug Administration recently cleared the first non-invasive, self-neuromodulation digital therapy for post-traumatic stress disorder. GrayMatters Health, an Israeli company that makes neuromodulation devices to treat mental disorders, announced on Tuesday that it received 510(k) clearance from the FDA to market its flagship product, called Prism for PTSD.
PTSD affects nine million Americans, and standard treatments center on drugs and psychotherapy. These treatments fail to address the proven underlying mechanisms of mental disorders, and many PTSD drugs have adverse side effects, GrayMatters CEO Oded Kraft pointed out in a recent interview. The U.S. also has a major shortage of mental healthcare professionals, he added.
Founded in 2018, GrayMatters seeks to address these deficiencies through its self-neuromodulation therapy. To create Prism, the company focused on certain brain mechanisms associated with PTSD. It developed a brain mechanism-specific biomarker by fusing electroencephalogram (EEG) data of electrical activity measured on the scalp with blood flow signals of relevant brain mechanisms, which were measured using fMRI scanners.
“Prism for PTSD is using a specific biomarker called amygdala-derived-EFP, which is using data of the emotion regulation mechanism, which is referred to as the fight-flight-freeze instinct,” Kraft explained.
Prism therapy comprises 15 sessions spread over eight weeks, with each session lasting about 30 minutes. During each session, a mental healthcare professional places the EEG on the patient’s head and the patient sits in front of a screen showing a virtual scene of a reception room. In this virtual room, the avatars huddle around a reception desk and shout.
The screen then instructs the patient to find a mental strategy, such as a memory, emotion, or experience, that would make the avatars sit down.
“This method is known as neurofeedback — only here, we are doing it on a specific biomarker,” Kraft said. “As the patient practices different mental strategies, Prism reads the EEG signal, uses it to compute the amygdala-derived-EFP, and uses that value to change what is happening in the user interface (i.e., reception room).”
As patients find the mental strategy that lowers the biomarker, the avatars sit and the reception room calms down. Patients practice this new skill over the course of the 15 sessions, and they often improve with time.
The therapy can be thought of as “placing a mirror in front of this specific brain activity,” Kraft declared.
Ultimately, Prism is designed to help patients develop mental strategies that can be utilized outside the clinic so they can regain agency in their daily life, he said. The therapy empowers patients to take an active role in their treatment journey by allowing them to identify and utilize their own strategy for lowering their emotional response.
“This is as personalized as treatment can get,” Kraft said. “For example, one patient might find that thinking of a happy childhood memory helps lower their biomarker. Another patient might begin counting numbers and reach the same result.”
Later this year, GrayMatters will begin selling Prism to outpatient and private mental health clinics. Psychologists and psychiatrists in these clinics will be able to prescribe and administer Prism as an adjunct therapy, allowing patients to continue with their existing PTSD treatment regimens. And GrayMatters has “already begun laying the groundwork” for insurance coverage for Prism by reaching out to U.S. payers, Kraft said.
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