BrainsWay Reports Positive Results from Multicenter Randomized Study of Accelerated Deep TMS for Major Depressive Disorder (MDD)

Rhea-AI Summary

BrainsWay (NASDAQ: BWAY) has announced promising results from a major multicenter randomized trial evaluating an accelerated Deep Transcranial Magnetic Stimulation (Deep TMS) protocol for Major Depressive Disorder (MDD). The study, involving 104 adult patients across eight sites, compared accelerated Deep TMS using intermittent theta burst stimulation to standard treatment. The accelerated protocol showed comparable efficacy with significant advantages: patients received five 10-minute sessions daily over six days plus eight continuation sessions, versus traditional daily sessions over six weeks. Key results showed depression score reductions of 18.9 points for accelerated treatment versus 19.9 for standard treatment, with response rates of 87.8% versus 87.5%. The accelerated group achieved median remission in 21 days compared to 28 days for standard treatment. The protocol demonstrated strong safety with no serious adverse events.

Positive

• Accelerated Deep TMS showed comparable efficacy to standard treatment with significantly reduced time commitment
• High response and remission rates: 87.8% response and 78.0% remission in accelerated group
• Faster time to remission: 21 days vs 28 days for standard treatment
• Shorter treatment sessions: under 10 minutes vs 20 minutes for standard sessions
• Protocol demonstrated excellent safety profile with no serious adverse events

Negative

• The accelerated protocol is not yet FDA-cleared and remains investigational
• Results are preliminary and still subject to additional analysis and peer review

Insights

Medical Device Researcher

BrainsWay's accelerated Deep TMS protocol shows comparable efficacy to standard protocol while significantly reducing treatment burden for depression patients.

BrainsWay's multicenter randomized controlled trial delivers compelling evidence that their accelerated Deep TMS protocol achieves comparable clinical outcomes to the standard protocol while dramatically reducing the treatment burden for patients with major depressive disorder (MDD). The accelerated protocol condenses treatment into just 5 sessions per day over 6 days plus 8 continuation sessions, compared to the standard protocol that requires daily visits over several weeks.

The efficacy results are particularly impressive, with the accelerated protocol achieving 87.8% response and 78.0% remission rates, statistically comparable to the standard protocol's 87.5% for both metrics. Depression scores showed substantial improvements with reductions of 18.9 points in the accelerated group versus 19.9 points in the standard group on the HDRS-21 scale.

Two operational advantages stand out: the accelerated protocol's shorter 10-minute sessions (versus 20 minutes for standard treatment) and the faster median time to remission (21 days versus 28 days). Importantly, this protocol achieved these results without requiring expensive fMRI neuronavigation equipment, using BrainsWay's existing H1 Coil with standard targeting.

This advancement addresses a critical barrier to TMS adoption - the logistical challenge of attending frequent clinic visits over extended periods. By maintaining efficacy while improving accessibility, BrainsWay could potentially expand the addressable patient population for Deep TMS therapy. However, it's worth noting this protocol remains investigational and not yet FDA-cleared, with results still subject to additional analysis and peer review.

Psychiatric Treatment Specialist

The clinical significance of BrainsWay's accelerated Deep TMS protocol cannot be overstated. The non-inferiority design of this study establishes that the accelerated protocol delivers comparable therapeutic benefit to the standard approach while addressing one of the most significant barriers to TMS adoption: the treatment burden.

With 104 patients across eight sites, this represents the largest randomized controlled trial of accelerated Deep TMS for depression to date. The protocol's ability to maintain efficacy while condensing treatment into just six days of intensive sessions plus minimal follow-up represents a paradigm shift in treatment delivery. For context, standard TMS protocols typically require 20-30 sessions over 4-6 weeks, creating substantial scheduling barriers for many patients.

The comparable efficacy metrics are clinically meaningful - both protocols produced substantial reductions in HDRS-21 scores (18.9 vs 19.9 points), far exceeding the typical threshold for clinical significance. The 87.8% response rate in the accelerated group is particularly notable, as typical response rates for first-line antidepressant medications hover around 50-60%.

The faster median time to remission (21 vs 28 days) could translate to quicker relief for suffering patients. Additionally, the accelerated protocol's implementation without specialized neuronavigation equipment means it could be readily adopted by existing TMS providers without additional capital investment.

This advance addresses a crucial clinical need, as described by the participating psychiatrist - many motivated patients simply cannot commit to the traditional schedule. By reducing this barrier while maintaining efficacy and safety, BrainsWay's accelerated protocol could significantly expand access to this effective non-medication treatment for depression.

Improvement in depression scores, response and remission were all found to be comparable with standard Deep TMS in non-inferiority trial

BURLINGTON, Mass. and JERUSALEM, June 11, 2025 (GLOBE NEWSWIRE) -- BrainsWay Ltd. (NASDAQ & TASE: BWAY), a global leader in advanced noninvasive neurostimulation treatments for mental health disorders, today announced preliminary results from a multicenter, randomized controlled trial titled, “Accelerated Deep TMS for Depression: Results from a Multisite, Randomized Non-Inferiority Trial.” The results suggest that the accelerated Deep Transcranial Magnetic Stimulation (Deep TMS™) protocol using intermittent theta burst stimulation (iTBS) to treat patients with major depressive disorder (MDD) resulted in outcomes that are comparable to the standard once-daily TMS protocol — while requiring considerably fewer visits to the clinic.

The trial, which enrolled 104 adult patients diagnosed with depression across eight sites, is the largest randomized, controlled, blinded, multicenter trial of an accelerated Deep TMS protocol. Patients from the study were divided into two active treatment groups, with one group receiving treatment under the standard Deep TMS protocol and the other group receiving treatment under the accelerated Deep TMS protocol.

Patients in the accelerated group completed five sessions per day over six treatment days, followed by a brief continuation phase of eight sessions over the subsequent four weeks. This protocol was designed to significantly reduce treatment burden. The primary endpoint of the study was the change in depressive symptoms as measured using the HDRS-21 scale, and secondary endpoints included response and remission rates.

Key Points from the Study:

• Comparable Efficacy: The accelerated Deep TMS group achieved significant improvement that was comparable to the standard Deep TMS group: 
  • HDRS depression scores were reduced by 18.9 and 19.9 points in the accelerated and standard Deep TMS groups, respectively; and
  • Response and remission rates were 87.8% and 78.0%, respectively, for the accelerated group, compared to response and remission rates of 87.5% and 87.5%, respectively, for the standard group.
• Shorter Sessions: Accelerated Deep TMS sessions lasted less than 10 minutes, compared to 20 minutes for standard treatment sessions.
• Time to Remission: Median time to remission was 21 days for the accelerated group v. 28 days for the standard group.
• Safety and Tolerability: The accelerated protocol was well-tolerated, with no reported serious adverse events. Side effects, such as headache and site discomfort, were mild and consistent with standard TMS treatments.
• No Reliance on fMRI Imaging: The study was conducted using BrainsWay’s H1 Coil with standard targeting, without reliance on any neuronavigation equipment.
  

“Throughout psychiatry, we see patients who are motivated to get better but simply cannot make it to a clinic five days a week for six weeks straight,” said Dr. Russ Voltin, a board-certified psychiatrist at PsyCare, a participating site in the study. “This accelerated treatment approach appears to preserve efficacy while making the logistics far more manageable. For many patients, it could be the difference between getting treated and not receiving the treatment.”

“Innovation in mental health care is not only about new technology, it is also about advancing how care is delivered,” noted Dr. Colleen Hanlon, Vice President of Medical Affairs at BrainsWay. “This study reflects our commitment to expanding access to Deep TMS and driving the field forward through compelling scientific research.”

The accelerated protocol tested in the study is investigational in nature and not yet FDA-cleared. The preliminary results remain subject to additional analysis and peer-review.

About BrainsWay

BrainsWay is a global leader in advanced noninvasive neurostimulation treatments for mental health disorders. The Company is boldly 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.

Forward-Looking Statement

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words, and also includes any financial guidance and projections contained herein. These forward-looking statements and their implications are based on the current expectations of the management of the Company only and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. In addition, historical results or conclusions from scientific research and clinical studies – especially preliminary data which remains subject to peer-review – do not guarantee that future results would suggest similar conclusions or that historical results referred to herein would be interpreted similarly in light of additional research or otherwise. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: the failure of our investments in management services organizations and/or other clinic-related entities to produce profitable returns; inadequacy of financial resources to meet future capital requirements; changes in technology and market requirements; delays or obstacles in launching and/or successfully completing planned studies and clinical trials; failure to obtain approvals by regulatory agencies on the Company’s anticipated timeframe, or at all; inability to retain or attract key employees whose knowledge is essential to the development of Deep TMS products; unforeseen difficulties with Deep TMS products and processes, and/or inability to develop necessary enhancements; unexpected costs related to Deep TMS products; failure to obtain and maintain adequate protection of the Company’s intellectual property, including intellectual property licensed to the Company; the potential for product liability; changes in legislation and applicable rules and regulations; unfavorable market perception and acceptance of Deep TMS technology; inadequate or delays in reimbursement from third-party payers, including insurance companies and Medicare; inability to commercialize Deep TMS, including internationally, by the Company or through third-party distributors; product development by competitors; inability to timely develop and introduce new technologies, products and applications, which could cause the actual results or performance of the Company to differ materially from those contemplated in such forward-looking statements.

Any forward-looking statement in this press release speaks only as of the date of this press release. The Company undertakes no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by any applicable securities laws. More detailed information about the risks and uncertainties affecting the Company is contained under the heading “Risk Factors” in the Company’s filings with the U.S. Securities and Exchange Commission.

Contacts: 
BrainsWay:
Ido Marom
Chief Financial Officer
Ido.Marom@BrainsWay.com

Investors:
Brian Ritchie
LifeSci Advisors LLC
britchie@lifesciadvisors.com

FAQ

What are the main results of BrainsWay's accelerated Deep TMS trial for depression?

The trial showed that accelerated Deep TMS achieved comparable efficacy to standard treatment, with depression score reductions of 18.9 vs 19.9 points, response rates of 87.8% vs 87.5%, and faster remission time of 21 vs 28 days.

How does BWAY's accelerated Deep TMS protocol differ from standard treatment?

The accelerated protocol delivers five 10-minute sessions daily over six days plus eight continuation sessions, compared to standard treatment's daily 20-minute sessions over six weeks.

What were the safety results of BrainsWay's accelerated Deep TMS trial?

The accelerated protocol was well-tolerated with no serious adverse events reported. Side effects were mild and consistent with standard TMS treatments, including headache and site discomfort.

Is BrainsWay's accelerated Deep TMS protocol FDA-approved?

No, the accelerated protocol is still investigational and not yet FDA-cleared. The preliminary results are subject to additional analysis and peer review.

What was the size and scope of BrainsWay's Deep TMS clinical trial?

The trial enrolled 104 adult patients diagnosed with depression across eight sites, making it the largest randomized, controlled, blinded, multicenter trial of an accelerated Deep TMS protocol.