BrainsWay Deep TMS™ Study Shows 70% Reduction in Patients Experiencing Suicidal Ideation

BURLINGTON, Mass. and JERUSALEM, Aug. 27, 2026 — BrainsWay Ltd. (NASDAQ & TASE: BWAY), a global leader in advanced noninvasive neurostimulation treatments for mental health disorders, today announced the publication of new peer-reviewed data demonstrating significant reductions in suicidal ideation among patients with Major Depressive Disorder (MDD) treated with Deep Transcranial Magnetic Stimulation (Deep TMS™).

The publication, entitled “Effects of H-coil TMS on suicidality in major depression: A secondary analysis of data from a multisite randomized trial comparing accelerated to once-a-day stimulation,” was published in the Journal of Affective Disorders. The analysis evaluated suicidality outcomes from BrainsWay’s previously published multisite randomized non-inferiority clinical trial which had compared its SWIFT™ accelerated protocol with its standard once-daily Deep TMS protocol and which had resulted in the FDA’s September 2025 clearance of SWIFT.

Key Findings

• Patients receiving Deep TMS demonstrated significant reductions in suicidal ideation over the course of treatment. Of the 89 patients enrolled in the study, using the Scale for Suicide Ideation (SSI), the number of patients exhibiting signs of suicide ideation (SSI>0) decreased from 22.5% (20/89) at baseline to 6.7% (6/89) after 6 weeks of treatment, a 70% relative reduction.
• Reductions were observed with both the SWIFT accelerated protocol and standard once-daily Deep TMS treatment. The median time to improvement in suicidality (i.e. defined in the study as a reduction of at least one point on the SSI) was 10 days in the group of patients treated with SWIFT, and 13 days in the group treated with the standard Deep TMS protocol, a statistically significant difference.

The results add to a growing body of research published in 2026 on the potential role Deep TMS can play in reducing suicidality, a devastating symptom associated with Major Depressive Disorder (MDD). A separate randomized, sham-controlled study of hospitalized patients with MDD and active suicidality found that patients receiving active H1 or H7 Deep TMS showed reductions in suicidal-ideation intensity, while those receiving sham treatment did not. In addition, a 2026 review of 108 studies examining treatments for suicidality concluded that TMS was associated with reductions in suicidal ideation and noted comparatively durable effects following TMS treatment.

“Suicidal ideation remains one of the most serious and urgent challenges in major depression. Seeing multiple independent publications converge around the potential of Deep TMS to meaningfully reduce suicidal ideation is highly encouraging and reinforces our commitment to advancing the science in an area of profound unmet need” said Hadar Levy, Chief Executive Officer of BrainsWay.

Deep TMS is FDA-cleared for the treatment of Major Depressive Disorder. It is not FDA-cleared for the treatment or prevention of suicidal ideation or suicidal behavior.

About BrainsWay

BrainsWay is a global leader in advanced noninvasive neurostimulation treatments for mental health disorders. The Company is advancing neuroscience with its proprietary Deep Transcranial Magnetic Stimulation (Deep TMS™) platform technology to improve health and transform lives. BrainsWay is the first and only TMS company to obtain three FDA-cleared indications backed by pivotal clinical studies demonstrating clinically proven efficacy. Current indications include major depressive disorder (including reduction of anxiety symptoms, commonly referred to as anxious depression), obsessive-compulsive disorder, and smoking addiction. The Company is dedicated to leading through superior science and building on its unparalleled body of clinical evidence. Additional clinical trials of Deep TMS in various psychiatric, neurological, and addiction disorders are underway. Founded in 2003, with operations in the United States and Israel, BrainsWay is committed to increasing global awareness of and broad access to Deep TMS. For the latest news and information about BrainsWay, please visit www.brainsway.com.

Contacts

BrainsWay:

Ido Marom Chief Financial Officer [email protected]

Investors:

Brian Ritchie LifeSci Advisors [email protected]