Texas A&M Health and Wave Neuroscience Announce FDA Clearance of MeRT for PTSD
Wave Neuroscience, in partnership with the Institute of Biosciences and Technology (IBT) at Texas A&M University, announced that the U.S. Food and Drug Administration (FDA) has granted clearance for the company's MeRT System for post-traumatic stress disorder (PTSD). MeRT, or Magnetic EEG-guided Resonance Therapy, is a personalized, biomarker-guided neuromodulation platform that uses a patient's own brain data to inform treatment.
IBT-Led Clinical Research
The clinical evidence submitted for FDA clearance included a double-blind, randomized, sham-controlled, parallel-group clinical trial designed to evaluate electroencephalogram (EEG)-guided MeRT in people with PTSD. Dr. Kenneth S. Ramos, MD, PhD, distinguished professor and executive director of IBT, served as principal investigator of the study.
The trial included a pilot phase and a test phase. The pilot phase randomized 74 active-duty and retired military participants and evaluated persistent post-concussion symptoms and PTSD symptoms in PTSD-positive participants. The test phase randomized 158 participants in a general-public population that included military subjects recruited at one or more study sites, with PTSD symptom reduction as the primary outcome.
Results demonstrated significant and clinically meaningful reductions in PTSD symptom severity after treatment using the MeRT platform.
What FDA Clearance Means
The clearance establishes the first FDA-cleared indication for the MeRT platform for PTSD and follows Breakthrough Device designation in 2024. For patients, families, and clinicians, it represents a non-invasive, personalized treatment option for a condition that affects veterans, active-duty service members, first responders, trauma survivors, and civilians.
A Partnership Built for Translation
The study combined Wave Neuroscience's technology advances with investigator expertise at IBT to complete a multisite trial evaluating the safety and effectiveness of MeRT in PTSD. FDA clearance positions the platform within the growing field of precision brain healthcare and neurotechnology.
For more information about Wave Neuroscience, visit waveneuro.com. Media inquiries regarding Texas A&M University Health may be directed to media@tamu.edu.