GrayMatters Health Launches New FDA-Cleared Self-Neuromodulation PTSD Therapy in the United States
GrayMatters Health (GMH), developer of digital self-neuromodulation therapies for mental health care, announces the official launch of Prism for PTSD in the United States. Prism for PTSD is currently being used to treat patients at two centers, with additional clinics in various phases of readiness.
13 million Americans struggle with post-traumatic stress disorder (PTSD) following assault, abuse, military combat, illness, accident, or natural disasters. Many patients seeking remission are challenged with medication side effects, revisiting traumatic experiences in psychotherapy and societal stigma. Prism for PTSD uses a computer simulation and EEG cap to create a novel, rich experience that augments standard therapies to improve patient outcomes.
Prism for PTSD is the first self-neuromodulation device to receive FDA clearance as a prescribed adjunct to standard-of-care (SOC) for PTSD and 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 clinics are in line for Prism for PTSD installation and training this month.
"It is exciting that the response from psychiatrists and mental healthcare professionals is so positive," said Kirk Thelander, Chief Commercial Officer at GrayMatters Health. "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."
GMH's core technology is the world's first digital EEG-fMRI-Pattern (EFP) biomarker of brain-area-specific activity, developed by applying advanced statistical models to register fMRI amygdala data with EEG. Prism for PTSD utilizes an amygdala-based biomarker since research has shown that PTSD is associated with hyper-activity of the amygdala.
"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 Dr. Aron Tendler, Chief Medical Officer at GMH. "This first-in-kind adjunct therapy can help empower someone who has experienced significant trauma with a sense of agency."
During Prism therapy, a computer simulation and EEG headset create an immersive environment for training individuals to gain control over amygdala-based biomarker activity associated with PTSD. For clinics, Prism for PTSD is covered by existing business models, thereby providing clinics with opportunities to add revenue-generating services while augmenting existing treatment outcomes.
About GrayMatters Health
GrayMatters Health (GMH) develops self-neuromodulation therapies to enhance mental health care outcomes. GMH is the first company to develop a treatment based on digital biomarkers of brain-mechanism-specific activity associated with mental disorders. GMH's flagship FDA-cleared product, Prism for PTSD, is an award-winning digital therapy offering providers a neuroscience-based technology that augments standard-of-care therapies while improving patient outcomes. The company is collaborating with leading mental health institutions to evaluate Prism for additional mental disorders.

Optimize Your trial insights with Clival Database.
Are you exhausted from the uncertainty of trial insights pricing? Clival Database ensures the clarity in the midst of the global scenario for clinical trials to you.Clival Database is one of the best databases that offers an outstanding number of clinical trial data in terms of 50,000+ molecules and from primary regulatory markets as well as new entrants like Indian and Chinese markets.
With Clival, you get accurate positioning of historical sales data, patent database, company profiling, safety & efficacy, and prediction of launch of new innovative molecules helping you to align your research and driving down the cost.
To add value, we further break down our analytics for you so that improving your operational effectiveness; optimizing your clinical trials; and offering you accurate and high-quality data at lowest possible prices becomes possible.
Elevate your trial success rate with the cutting-edge insights from Clival database.
Check it out today and make more informed sourcing decisions! Learn More!