First FDA-Approved Self-Neuromodulation Device for PTSD Officially Launches in the US

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GrayMatters Health, a developer of digital self-neuromodulation therapies for mental health care, announced today that it has officially launched Prism for posttraumatic stress disorder (PTSD) in the United States.

Prism for PTSD—the first self-neuromodulation device to receive US Food & Drug Administration (FDA) clearance as a prescribed adjunct to standard of care (SOC) for PTSD—is now accessible at 2 US clinics, with several more clinics currently in the process of installing and training with Prism for PTSD.¹

Clinics adopting Prism for PTSD have the added value of being able to leverage existing business models, which provides opportunities to add revenue-generating services while enhancing treatment outcomes.¹ “It is exciting that the response from psychiatrists and mental health care professionals is so positive,” said Kirk Thelander, chief commercial officer at GrayMatters Health, in a press release. “Notably, Prism for PTSD’s easy installation facilitates training and treatment the very same day, and its user-friendly interface allows non-MDs to operate Prism, expanding access to care and reducing costs.”

With an estimated 13 million Americans grappling with PTSD stemming from various causes, finding effective treatments can be challenging. Many patients face obstacles such as adverse effects from medications, revisitation of traumatic experiences in psychotherapy, and societal stigma. Prism for PTSD aims to address these challenges by utilizing a computer simulation and electroencephalography (EEG) cap to provide a unique experience that complements standard therapies in order to improve patient outcomes.¹

During Prism therapy, a computer simulation and EEG headset create an immersive environment to train individuals to gain control over amygdala-based biomarker activity associated with PTSD. The core GrayMatters Health technology, the world’s first digital EEG-fMRI-Pattern (EFP) biomarker of brain-area-specific activity, plays a pivotal role in Prism for PTSD. Developed through advanced statistical models, this technology registers fMRI amygdala data with EEG. The therapy focuses on an amygdala-based biomarker, as research has indicated that PTSD is associated with hyperactivity of the amygdala.¹

“In the clinical study, Prism for PTSD demonstrated clinically significant symptom improvement in the majority of patients with a high safety profile and low attrition,” said Aron Tendler, MD, chief medical officer at GrayMatters Health, in a press release. “This first-in-kind adjunct therapy can help empower someone who has experienced significant trauma with a sense of agency.”

Prism for PTSD is now available at the Center for Neuropsychiatry and Brain Stimulation, an ARC Health practice in North Carolina, and Bespoke Treatment in California. Several more US clinics are also in varying stages of the process of incorporating Prism for PTSD by the end of this month.¹

Stay up-to-date on news related to research on promising new interventions and developments in the treatment of a wide variety of psychiatric disorders at psychiatrictimes.com.

Note: This article was prepared with the assistance of ChatGPT.

Reference

1. GrayMatters Health launches new FDA-cleared self-neuromodulation PTSD therapy in the United States. PR Newswire. News release. January 4, 2024. Accessed January 4, 2024. https://www.prnewswire.com/il/news-releases/graymatters-health-launches-new-fda-cleared-self-neuromodulation-ptsd-therapy-in-the-united-states-302026265.html#:~:text=Prism%20for%20PTSD%20is%20the,and%20Bespoke%20Treatment%20in%20California.