BrainsWay: Deep TMS linked to 70% suicidal ideation drop
Rhea-AI Filing Summary
BrainsWay Ltd. (BWAY) reported new peer-reviewed data on its Deep Transcranial Magnetic Stimulation (Deep TMS™) technology showing reduced suicidal ideation in patients with Major Depressive Disorder. A secondary analysis of a multisite randomized non-inferiority trial, comparing the SWIFT™ accelerated protocol to standard once-daily Deep TMS, found that patients with suicidal ideation by the Scale for Suicide Ideation (SSI>0) fell from 22.5% (20/89) at baseline to 6.7% (6/89) after 6 weeks, a 70% relative reduction. Median time to improvement, defined as at least a one-point SSI reduction, was 10 days with SWIFT and 13 days with standard Deep TMS, a statistically significant difference. The company notes that Deep TMS is FDA-cleared for Major Depressive Disorder, but not for treatment or prevention of suicidal ideation or behavior.
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Filing Explained
The August 27 Form 6-K incorporates the report by reference into four existing registration statements—two Form S-8s and two Form F-3s—making the disclosure part of those filings without documenting a new share issuance or offering.
Key Figures
Patients with suicidal ideation at baseline: 22.5% (20/89)
Patients with suicidal ideation after 6 weeks: 6.7% (6/89)
Relative reduction in patients with suicidal ideation: 70%
+3 more
6 metrics
Patients with suicidal ideation at baseline
22.5% (20/89)
Patients with Major Depressive Disorder, before Deep TMS treatment in the analyzed trial
Patients with suicidal ideation after 6 weeks
6.7% (6/89)
After 6 weeks of Deep TMS treatment in the analyzed trial
Relative reduction in patients with suicidal ideation
70%
Change in proportion of patients with SSI>0 from baseline to 6 weeks
Median time to improvement with SWIFT
10 days
Median time to at least a one-point SSI reduction in SWIFT group
Median time to improvement with standard Deep TMS
13 days
Median time to at least a one-point SSI reduction in standard protocol group
Number of studies in 2026 suicidality treatment review
108 studies
Review examining treatments for suicidality that reported TMS-associated reductions
Key Terms
Deep Transcranial Magnetic Stimulation, Major Depressive Disorder, non-inferiority clinical trial, sham-controlled, +2 more
6 terms
Deep Transcranial Magnetic Stimulation medical
"treated with Deep Transcranial Magnetic Stimulation (Deep TMS™)"
A noninvasive medical therapy that uses focused magnetic pulses to stimulate brain regions deeper than standard transcranial magnetic stimulation; think of it as a magnetic “tuning fork” placed outside the head to gently nudge deeper neural circuits. It matters to investors because its clinical effectiveness, regulatory approvals, device manufacturing, and insurance coverage determine market size and revenue potential for companies that make or sell the equipment and treatment services.
Major Depressive Disorder medical
"patients with Major Depressive Disorder (MDD) treated with Deep TMS"
A clinical condition characterized by persistent, severe low mood, loss of interest in daily activities, and reduced ability to function at work or home, lasting weeks or longer. It matters to investors because it drives demand for treatments and mental health services, affects workforce productivity and absenteeism, influences health-care and insurance costs, and shapes risks and opportunities for companies developing drugs, therapies or workplace programs—like a long-lasting storm that lowers economic output.
non-inferiority clinical trial medical
"previously published multisite randomized non-inferiority clinical trial"
A non-inferiority clinical trial is a type of study that tests whether a new drug or medical treatment is not unacceptably worse than an existing approved treatment by more than a pre-set margin. Think of it as checking that a new product performs at least close enough to the current standard while possibly offering other benefits like fewer side effects, easier use, or lower cost. Investors watch these trials because meeting a non-inferiority goal can allow regulatory approval and market entry when outright superiority is not required.
sham-controlled medical
"A separate randomized, sham-controlled study of hospitalized patients"
A sham-controlled trial compares a real medical procedure or device to a fake version that looks and feels the same but has no therapeutic effect, much like a sugar pill for surgery or implants. For investors, sham control is a sign of rigorous testing because it helps separate true treatment benefits from placebo effects or patient expectations, making clinical results and regulatory prospects more reliable when assessing commercial potential.
Scale for Suicide Ideation medical
"using the Scale for Suicide Ideation (SSI), the number of patients"
A scale for suicide ideation is a standardized questionnaire or clinician-rated tool used in clinical trials and patient care to measure the presence, severity, and change over time in thoughts about harming oneself. Think of it like a thermometer for suicidal thoughts: it translates subjective feelings into scores that regulators, clinicians and researchers use to track safety, compare treatments, and make decisions about drug labeling, monitoring and risk management, which can affect clinical trial outcomes and regulatory approval.
suicidal ideation medical
"reduction in patients experiencing Suicidal Ideation"
Suicidal ideation is when a person thinks about, plans, or imagines ending their own life; it ranges from fleeting thoughts to specific plans. For investors, reports of suicidal ideation matter because they can signal serious safety, regulatory, legal, workforce or reputational risks for healthcare products, services or employers—like a dashboard warning light that can prompt investigations, product changes, recalls, litigation or shifts in public trust.
FAQ
What did BrainsWay (BWAY) announce in this Form 6-K?
BrainsWay announced publication of peer-reviewed data showing that its Deep TMS™ treatment for Major Depressive Disorder was associated with significant reductions in suicidal ideation in a secondary analysis of a multisite randomized non-inferiority clinical trial.
What were the key suicidal ideation results reported by BWAY?
Among 89 patients, those with suicidal ideation (SSI>0) decreased from 22.5% (20/89) at baseline to 6.7% (6/89) after 6 weeks of Deep TMS treatment, representing a 70% relative reduction in patients exhibiting suicidal ideation.
How did the SWIFT™ accelerated protocol perform compared with standard Deep TMS in the BrainsWay study?
Both SWIFT™ accelerated and standard once-daily Deep TMS showed reductions in suicidal ideation. The median time to improvement was 10 days for SWIFT-treated patients versus 13 days for those on the standard protocol, a statistically significant difference in this analysis.
Is BrainsWay’s Deep TMS FDA-cleared to treat suicidal ideation?
No. Deep TMS is FDA-cleared for Major Depressive Disorder, including reduction of anxiety symptoms, as well as obsessive-compulsive disorder and smoking addiction. It is not FDA-cleared for the treatment or prevention of suicidal ideation or suicidal behavior.
How do these BrainsWay results relate to other 2026 suicidality research?
BrainsWay cites a randomized, sham-controlled study where active Deep TMS (H1 or H7) reduced suicidal-ideation intensity, and a 2026 review of 108 studies that found TMS was associated with reduced suicidal ideation and comparatively durable effects after treatment.
AI-generated analysis. How Rhea-AI works. Not financial advice.
