Novel technology paves the way for objective brain function measurement to support precision psychiatry and accelerate CNS drug development

Universal Brain, a neurotechnology company pioneering objective brain-function measurement for mental health, today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for its proprietary UB ERP System, which measures brain function using electroencephalography (EEG) and event-related potentials (ERPs). The clearance marks an important step toward bringing objective, neuroscience-based brain function assessment into routine psychiatric care and clinical research.

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Universal Brain EEG headset (Photo credit: Universal Brain)

Psychiatry has historically relied on symptom-based evaluations and trial-and-error treatment selection, with few objective tools available to measure the underlying biology of mental illness. Universal Brain's platform combines a proprietary dry-electrode EEG wearable with its Neurotique™ ERP software to rapidly capture objective measures of brain function, reducing the time and complexity associated with conventional EEG systems. From device setup to analyzed results, clinicians can complete a single neural assessment in under five minutes.

“This FDA clearance represents a major milestone towards bringing objective brain function measurement into everyday psychiatric care,” said Kazu Okuda, M.D., Founder and CEO, Universal Brain. “By measuring neural responses across cognitive and emotional tasks, we can begin to understand how each patient's brain is functioning rather than relying solely on symptoms. Our vision is to enable more personalized treatment decisions and accelerate the development of better therapies for patients with mental health disorders.”

Universal Brain's platform enables clinicians and researchers to rapidly measure brain function in both clinical practice and psychiatric clinical trials. The Company is advancing the technology to support treatment selection, monitor therapeutic response and develop objective biomarkers that improve the precision of CNS drug development.

As part of this expansion for clinical use, the company has initiated two new studies to further validate its platform in patients with depression:

• United States: A multicenter study with Adams Clinical sites in Boston and New York evaluating brain function and clinical outcomes before and after first-line antidepressant treatment to develop biomarkers predictive of treatment response.
• Japan: A multicenter longitudinal study across leading hospitals evaluating patients over 24 weeks following treatment initiation to develop objective brain function markers associated with antidepressant response.

The company also announced that K. Luan Phan, Chair of Psychiatry at The Ohio State University College of Medicine, has joined Universal Brain as Chief Medical Advisor.

“Objective brain-function measurement has the potential to fundamentally change how we diagnose and treat psychiatric disorders,” said Dr. Phan. “Universal Brain’s rapid ERP platform brings rigorous neuroscience into everyday clinical practice in a way that has never been possible. With this technology, we can move beyond symptom checklists and begin to understand the underlying brain systems driving each patient’s illness, and how those systems change with treatment.”

Universal Brain has also secured a $2 million grant from the Japan Agency for Medical Research and Development as part of its “Next-Generation Medical Device Development Project,” supporting multi-site clinical studies and commercialization efforts.

The company is preparing for a commercial market launch later this year, with ongoing studies aimed at generating large-scale datasets to further advance its platform for predicting treatment response across a range of psychiatric interventions. Universal Brain aims to make rapid and reliable brain function assessment routine across psychiatric and neurological conditions.

About Universal Brain

Universal Brain is a neurotechnology company developing the first scalable platform for objective brain function measurement in psychiatry. Using rapid EEG acquisition and validated neuroscience-based assessments, the company’s platform enables rapid and reliable assessment of brain function. Universal Brain is working to support brain-based monitoring, patient classification (“neurotyping”), and personalized treatment decisions for psychiatric and neurological conditions. Founded in 2022, Universal Brain is headquartered in San Francisco. For more information, visit www.universal-brain.com.

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