FDA Clears Personalized Magnetic Therapy for PTSD Showing 68% Remission in Trial

The U.S. Food and Drug Administration has granted 510(k) clearance to Wave Neuroscience’s Magnetic e-Resonance Therapy (MeRT) System as an adjunct treatment for adult patients with post-traumatic stress disorder (PTSD), according to a company announcement (prnewswire.com). The clearance, dated June 3, 2026, marks the first FDA-cleared personalized, biomarker-guided neuromodulation technology specifically for PTSD.

MeRT combines electroencephalogram (EEG) measurements of a patient’s brain activity with artificial intelligence-assisted analysis to generate individualized protocols for transcranial magnetic stimulation (TMS). A magnetic coil placed against the scalp delivers pulses tuned to the patient’s unique neural patterns, typically over 20 to 25 sessions of about 30 minutes each, five days a week for five to six weeks (sciencedaily.com).

The clearance was supported by data from the MeRT-005-B trial (NCT02990793), a prospective, double-blind, randomized, sham-controlled, multisite study conducted in partnership with investigators at the Texas A&M Health Institute of Biosciences and Technology. The intention-to-treat population included 158 adults with a CAPS-5 PTSD diagnosis and PCL-5 score of at least 30, with 77 assigned to active MeRT and 81 to sham (acuity.news).

Active-arm patients showed a 27-point improvement on the self-reported PCL-5 primary endpoint (p < 0.046), exceeding the Department of Veterans Affairs threshold of 8.5 to 12.5 points for clinically meaningful change. The clinician-administered CAPS-5 secondary endpoint reached p < 0.0006. According to Wave Neuroscience, patients experienced a 52% reduction in PTSD symptoms, with 68.2% achieving remission at follow-up (p < 0.008). Improvements continued or held through a two- to four-month window rather than decaying, and no serious adverse events were reported (fda.innolitics.com; sciencedaily.com).

Erik Won, DO, chief medical officer at Wave Neuroscience, stated that the trial results represented a substantial advance, noting a more than four-fold increase in symptom reduction efficacy compared with previously reported medication outcomes in other studies, alongside the 68% remission rate (sciencedaily.com). Israel Liberzon, M.D., of Texas A&M, described it as providing a unique non-medication alternative to the two FDA-approved SSRIs for PTSD and to psychotherapies that many patients find difficult to complete (sciencedaily.com).

The system received FDA Breakthrough Device designation in 2024. It is cleared for prescription use in clinical settings as an adjunct, allowing it to be added to existing medications or psychotherapy without requiring patients to discontinue them. Conventional TMS has been cleared for depression, but MeRT personalizes the stimulation frequency (typically 8-13 Hz) based on EEG and ECG data rather than using fixed protocols (medicaldevice-network.com).

PTSD affects an estimated 6% of U.S. adults lifetime and about 7% of veterans annually, with limited options beyond psychotherapy and the two SSRIs approved more than two decades ago. Wave Neuroscience and partners are working on expanding access, insurance coverage, and a Category III CPT code for the EEG analysis component effective in 2027 (acuity.news). Full peer-reviewed publication of the trial results was pending at the time of the ScienceDaily report.