Wave Neuroscience has received FDA clearance for its MeRT System, making it the first personalised, biomarker-based treatment for post-traumatic stress disorder to clear the US regulatory pathway. The decision follows closely behind Neurovalens, which recently became the first company to win clearance for a PTSD-focused neuromodulation device. Together, the two milestones point to a more active regulatory path for brain-based approaches in PTSD, alongside therapy and medication.
The clearance builds on the FDA Breakthrough Device designation Wave received in 2024. PTSD affects an estimated 13 million Americans at any given time, while current care still relies mainly on trauma-focused psychotherapy and medication. Outcomes remain uneven, particularly in veteran populations, where many patients retain a PTSD diagnosis after psychotherapy and drop-out rates can be high. Wave’s MeRT System enters that gap with a personalised neuromodulation approach guided by patient-specific brain activity.
MeRT stands for Magnetic EEG-guided Resonance Therapy. Treatment begins with a quantitative EEG, a recording that maps brainwave activity and flags where neural networks are out of sync. This data feeds into Wave’s AI-powered BrainCare platform, which analyses the biomarkers and builds a stimulation protocol specific to that person’s brain.
The therapy itself uses transcranial magnetic stimulation, delivering magnetic pulses to targeted brain regions. Unlike standard TMS, which applies the same protocol to each patient, MeRT adjusts frequency and timing based on each person’s EEG data. The company describes this as a “read-then-treat” approach that shapes treatment around the brain receiving it, rather than a fixed template.
“The idea that neuromodulation therapies can be personalised using measurable neurophysiologic data was once viewed as aspirational,” said Dr Erik Won, Wave’s Chief Medical Officer. “Today, it has become part of FDA-cleared clinical care for PTSD.” That personalisation is especially relevant in PTSD, where symptoms and treatment response can vary widely across individuals.
The clearance rests on the MeRT-005-B trial, a double-blind, randomised, controlled study run in partnership with the Texas A&M Health Institute of Biosciences and Technology across multiple sites, involving 158 patients diagnosed with PTSD and co-occurring traumatic brain injury. Patients treated with the MeRT System showed significant and clinically meaningful reductions in symptom severity.
PTSD alongside traumatic brain injury is among the hardest presentations to treat, and it is especially common among veterans and active military personnel, a population Wave has built its clinical network around. The trial’s focus on this group was deliberate, mapping directly onto where existing treatments have proven least adequate. The sample size is meaningful for this stage of the field, though the peer-reviewed publication is still forthcoming. Broader real-world data will be needed to confirm how well the results hold up outside a controlled trial.
PTSD is also a relevant test case for this kind of biomarker-guided approach. Although the condition is still diagnosed through symptoms and self-report, research over the past two decades has identified measurable disruptions in brainwave coherence and communication between the prefrontal cortex, amygdala, and hippocampus. These disruptions can vary between people, which is where a personalised approach has a clearer rationale.
Wave’s CEO, Fred Walke, said, “Healthcare for mental conditions has historically evolved through distinct eras: first psychotherapy, then pharmacologic innovation. We believe the next era will be defined by precision-based, biomarker-guided technologies capable of personalising treatment to the unique neurophysiology of each patient.”
Neurofounders spoke to Wave CEO Fred Walke about non-invasive neuromodulation to treat mental health disorders. Watch the talk below.
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