BrainsWay Deep TMS data show 70% cut in suicidal ideation in MDD

BrainsWay has published peer-reviewed data showing a marked reduction in suicidal ideation among patients with major depressive disorder (MDD) treated with its Deep Transcranial Magnetic Stimulation (Deep TMS) platform, adding to a growing body of evidence around the technology's potential in one of psychiatry's most urgent unmet needs.

The secondary analysis, published in the Journal of Affective Disorders, drew on data from BrainsWay's previously completed multisite randomised non-inferiority trial. Of 89 enrolled patients, the proportion exhibiting signs of suicidal ideation on the Scale for Suicide Ideation fell from 22.5% at baseline to 6.7% after six weeks of treatment, a 70% relative reduction. Both the company's SWIFT accelerated protocol and its standard once-daily Deep TMS regimen produced reductions, though the SWIFT group reached meaningful improvement in a median of 10 days against 13 days for standard treatment, a statistically significant difference.

It is important to note that Deep TMS is FDA-cleared for MDD, but carries no clearance for the treatment or prevention of suicidal ideation or suicidal behaviour. The results reported here stem from a secondary analysis of a trial designed primarily to compare two stimulation protocols rather than to evaluate suicidality as a primary endpoint, a distinction that limits the strength of causal inference that can be drawn.

Regulatory and clinical context

BrainsWay's SWIFT protocol received FDA clearance in September 2025 following the multisite non-inferiority trial from which this analysis is derived, giving the company a commercial and regulatory foundation on which the new data build. The publication sits alongside two other 2026 studies cited in the release: a randomised sham-controlled trial in hospitalised patients with active suicidality that showed reductions with active Deep TMS but not with sham treatment, and a broader review of 108 studies concluding that TMS was associated with durable reductions in suicidal ideation.

Chief executive Hadar Levy said that "multiple independent publications converging around the potential of Deep TMS to meaningfully reduce suicidal ideation is highly encouraging," and characterised the work as reinforcing BrainsWay's commitment to advancing science in an area of profound unmet need.

Market landscape

The noninvasive neurostimulation market for treatment-resistant depression has grown considerably since the first TMS systems received FDA clearance over a decade ago. BrainsWay competes with Neuronetics, whose NeuroStar platform holds the largest installed base in the United States, as well as with Magnus Medical, whose SAINT Neuromodulation System uses an accelerated, MRI-guided TMS protocol that received FDA clearance for MDD in 2022. Electroconvulsive therapy remains a clinical option in severe and suicidal presentations, and ketamine-based treatments including esketamine nasal spray have grown their footprint in treatment-resistant depression, providing further competitive pressure.

For BrainsWay, accumulating published evidence on suicidality is strategically significant even in the absence of a specific FDA clearance for the indication. Payer coverage decisions and clinical adoption increasingly follow real-world and publication-based evidence, and a convincing evidence base could support expanded use in high-acuity settings such as inpatient psychiatry units, where the company currently has limited penetration. Whether BrainsWay seeks a dedicated FDA clearance for suicidality reduction will be a closely watched question; the existing data, while encouraging, are likely insufficient on their own to support a de novo or supplemental submission without a prospectively powered primary-endpoint trial.