California-based Wave Neuroscience, in collaboration with researchers at the Texas A&M Health Institute of Biosciences and Technology, has received FDA clearance for its Magnetic e-Resonance Therapy (MeRT) system. The technology combines electroencephalogram (EEG) brain activity measurements with targeted transcranial magnetic stimulation (TMS), guided by an AI-assisted algorithm that customizes treatment protocols to each patient's brain activity.
Early clinical trial results, which have not yet been published in full, indicate a 52% reduction in PTSD symptoms and a 68% remission rate. The company contrasted these figures with a 2020 review of PTSD medications that found symptom improvements of 6.8 to 10.1 points on assessment scales and remission rates of at most 10.9%.
“In comparison to that study, our FDA trial reported a 52% reduction in symptoms, so more than a four-fold increase in efficacy,” said Erik Won, the company's chief medical officer. “And more importantly, we saw 68% remission in our clinical trial. So, it's really a quantum change, an inflection point in what we can offer to patients.” The results come from different studies and should not be interpreted as a direct comparison.
The need for more effective PTSD treatments is substantial. In the United States, approximately 17.5 veterans die by suicide each day, and about 7% of veterans receive a PTSD diagnosis annually. Current standard treatments include psychotherapy and selective serotonin reuptake inhibitors (SSRIs) such as sertraline and fluoxetine, which have limited efficacy for many patients.
The regulatory process for MeRT included receipt of an FDA Breakthrough Device designation in 2024, which can streamline review while preserving scientific and medical standards. Dr. Rick Silva, executive director of clinical trials at Texas A&M Health, noted that medical device development often takes around 10 years to reach clearance, but this project completed the relevant process in just over two years.
Dr. Israel Liberzon, lead psychiatrist and PTSD specialist on the study, said MeRT will become the only FDA-cleared nonmedication treatment specifically for PTSD once it reaches patients. “Right now, the FDA has approved only two medications for PTSD,” Liberzon said. “This is the first time that in addition to the medication, we have a non-medication option.”
Wave Neuroscience CEO Fred Walke said the company plans to make the therapy available to an estimated 13 million people who may be struggling with PTSD.