Landmark Data Validate BrainsWay’s SWIFT™ Deep TMS, Beginning a New Era in Depression Treatment

Rhea-AI Summary

BrainsWay (NASDAQ: BWAY) published two peer-reviewed manuscripts showing its FDA-cleared SWIFT™ accelerated Deep TMS reduced the acute depression treatment phase by ~70%, delivering an 87.8% response rate, 78.0% remission rate, and median remission in 21 days versus 28 for standard treatment.

Patient-reported quality of life rose ~32 percentage points and ~60% regained normal-range functioning, improving access and retention for non-drug depression therapy.

Positive

• Response rate of 87.8% in randomized non-inferiority trial
• Remission rate of 78.0% on HDRS-21
• Median time to remission reduced to 21 days vs 28 days
• Acute visits cut by ~70% (20 visits to 6 half days)
• Quality of life improved ~32 percentage points by 6 weeks
• ~60% of patients reached normal-range functioning after treatment

Negative

• None.

News Market Reaction – BWAY

+7.42% 2.0x vol

14 alerts

+7.42% News Effect

+3.6% Peak in 6 hr 16 min

+$34M Valuation Impact

$497M Market Cap

2.0x Rel. Volume

On the day this news was published, BWAY gained 7.42%, reflecting a notable positive market reaction. Argus tracked a peak move of +3.6% during that session. Our momentum scanner triggered 14 alerts that day, indicating notable trading interest and price volatility. This price movement added approximately $34M to the company's valuation, bringing the market cap to $497M at that time. Trading volume was above average at 2.0x the daily average, suggesting increased trading activity.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

Response rate: 87.8% Remission rate: 78.0% Median time to remission: 21 days vs 28 days +5 more

8 metrics

Response rate 87.8% SWIFT accelerated Deep TMS protocol for MDD

Remission rate 78.0% SWIFT accelerated Deep TMS protocol for MDD

Median time to remission 21 days vs 28 days SWIFT vs standard daily Deep TMS protocol

Acute phase duration 20 visits vs 6 half days Standard protocol vs SWIFT accelerated protocol

Reduced severe QoL impairment ~70% of participants Patients no longer with severe quality of life impairment after treatment

Normal-range functioning Approximately 60% Patients reaching normal-range functioning by end of treatment

QoL score improvement ≈32 percentage points Increase in quality-of-life scores by 6 weeks vs baseline

MDD burden 20 million adults; $333 billion U.S. adults with MDD and estimated annual economic burden

Market Reality Check

Price: $12.34 Vol: Volume 57,249 is below th...

low vol

$12.34 Last Close

Volume Volume 57,249 is below the 20-day average of 87,809, indicating subdued pre-news activity. low

Technical Shares at $23.18 are trading above the $16.18 200-day moving average, reflecting a pre-news uptrend.

Peers on Argus

With BWAY down 2.15% pre-news and only two peers screened (one up, one down), mo...

1 Up 1 Down

With BWAY down 2.15% pre-news and only two peers screened (one up, one down), moves appear stock-specific rather than a coordinated medical devices sector trend.

Historical Context

5 past events · Latest: Feb 25 (Neutral)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Feb 25	Earnings date notice	Neutral	+0.2%	Announcement of Q4 and full-year 2025 earnings release and call details.
Feb 23	Conference participation	Neutral	+0.0%	Management participation in Citi 2026 Unplugged MedTech and Life Sciences Access Day.
Feb 19	Strategic investment	Neutral	-8.2%	Minority-stake equity financing in Canadian provider BrainStim Health Inc.
Feb 18	Reimbursement access	Positive	+4.3%	Evernorth Behavioral Health removing prior authorization for TMS coverage.
Feb 17	ADS ratio change	Neutral	+8.6%	Change in ADS-to-ordinary share ratio equivalent to 2-for-1 forward split of ADSs.

Pattern Detected

Recent BWAY news has generally led to modest price moves, with one notable negative reaction to a minority-stake investment and a positive reaction to a capital markets action.

Recent Company History

Over the past few weeks, BrainsWay has issued several operational and corporate updates. An ADS ratio change on Feb 17 coincided with a 8.61% move, while news that Evernorth would eliminate prior authorization for TMS coverage on Feb 18 was followed by a 4.29% gain. A minority-stake investment in BrainStim Health on Feb 19 saw shares decline 8.22%. More routine items, including a conference appearance and an earnings date announcement, had minimal impact, suggesting investors differentiate sharply between strategic and routine updates.

Market Pulse Summary

The stock moved +7.4% in the session following this news. A strong positive reaction aligns with the...

Analysis

The stock moved +7.4% in the session following this news. A strong positive reaction aligns with the robust clinical profile highlighted here. The SWIFT protocol delivered an 87.8% response rate and 78.0% remission rate, while cutting acute treatment from 20 visits to 6 half days. Earlier remission at 21 days vs 28 days and quality-of-life gains of about 32 percentage points support a substantive efficacy and convenience story. Investors might still weigh execution, adoption pace, and reimbursement dynamics when assessing durability.

Key Terms

deep transcranial magnetic stimulation, major depressive disorder, non-inferiority trial, hamilton depression rating scale, +4 more

8 terms

deep transcranial magnetic stimulation medical

"BrainsWay’s exclusive FDA-cleared SWIFT™ accelerated 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

"...protocol for the treatment of Major Depressive Disorder (MDD) achieved comparable remission..."

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 trial medical

"In a large, randomized, multisite non-inferiority trial, patients treated with..."

A non-inferiority trial is a clinical study designed to show that a new treatment or drug is not meaningfully worse than an existing standard therapy by a pre-set amount. For investors, these trials matter because they can enable regulatory approval and market entry when a new product offers similar benefit with other advantages (lower cost, easier use, fewer side effects); think of it like proving a new smartphone’s battery lasts nearly as long as the market leader so buyers will consider it.

hamilton depression rating scale medical

"...a 78.0% remission rate on the clinician-rated Hamilton Depression Rating Scale (HDRS-21)..."

A clinician-administered questionnaire that rates the severity of a person’s depressive symptoms across mood, sleep, appetite and physical signs, producing a numeric score used to track change over time. Investors pay attention because these scores are often primary endpoints in clinical trials and can determine whether a treatment is seen as effective, influencing regulatory approval, prescribing use and the commercial value of mental-health therapies — like a standardized thermometer showing whether a treatment lowers the ‘fever’ of depression.

patient-reported outcomes medical

"Manuscript 2: Patient-Reported Outcomes Following Accelerated vs. Standard Deep TMS..."

Reports provided directly by patients about their symptoms, daily functioning, and quality of life—collected through surveys, apps, or interviews—reflecting how a treatment affects real people rather than lab measures. Investors care because these firsthand accounts help regulators, doctors and payers judge a product’s real-world value and can influence approval, pricing, adoption and long-term sales; think of them as customer reviews that show whether a medical product truly improves everyday life.

quality of life medical

"Daily patient assessments confirmed substantial improvements in quality of life, functioning..."

Quality of life is a measure of how a medical condition and its treatment affect a person’s daily well‑being, functioning, comfort, and ability to do routine activities — essentially a patient’s own “product review” of how life feels. Investors watch it because improvements in quality of life can influence regulatory approvals, medical guidelines, prescription uptake, insurance coverage, and a treatment’s market value, much like customer satisfaction drives sales for a consumer product.

multisite randomized trial medical

"...Patient-Reported Outcomes Following Accelerated vs. Standard Deep TMS...: A Multisite Randomized Trial"

A multisite randomized trial is a clinical study run at several hospitals or clinics where participants are assigned by chance to different treatments or a control group. Running the same, randomly assigned test in many locations helps ensure results aren’t driven by one place’s practices or patient types, much like trying a recipe in multiple kitchens to see if it works broadly; for investors, such trials give stronger, more reliable evidence that can affect regulatory approval, market size estimates and a company’s risk profile.

noninvasive medical

"...a significantly faster, noninvasive way to treat depression without compromising the efficacy..."

Noninvasive describes medical tests, devices, or procedures that do not break the skin or enter the body, working from outside the body such as scans, external sensors, or topical treatments. For investors, noninvasive options often mean lower development and regulatory hurdles, faster adoption, and broader market appeal because patients and providers prefer less discomfort and simpler logistics—similar to using a forehead thermometer instead of a blood draw—which can reduce costs and speed revenue.

AI-generated analysis. Not financial advice.

World’s only FDA-cleared Deep TMS™ accelerated treatment reduces the acute phase of treatment by 70%

BURLINGTON, Mass. and JERUSALEM, March 04, 2026 (GLOBE NEWSWIRE) -- BrainsWay Ltd. (NASDAQ & TASE: BWAY) unveiled new clinical data showing a significantly faster, noninvasive way to treat depression without compromising the efficacy of one of psychiatry’s most impactful treatments. The milestone advances BrainsWay’s brain health vision and sets the stage for a neuromodulation platform that transforms lives.

Two new peer-reviewed manuscripts in Brain Stimulation found that BrainsWay’s exclusive FDA-cleared SWIFT™ accelerated Deep Transcranial Magnetic Stimulation (Deep TMS™) protocol for the treatment of Major Depressive Disorder (MDD) achieved comparable remission and response rates when compared to the traditional standard protocol. The accelerated protocol reduces the traditional 20-visit acute treatment phase to just 6 half days, followed by weekly maintenance visits for 4 weeks.

Widespread adoption of the SWIFT approach, which reduces the number of clinic visits in the acute phase by ~70%, could alter how interventional psychiatry is delivered, improving patient retention and expanding clinical options at a time when demand for non-drug depression therapies is rising.

In a large, randomized, multisite non-inferiority trial, patients treated with BrainsWay’s accelerated protocol achieved:

• 87.8% response rate
• 78.0% remission rates
• Median time to remission of 21 days, compared with 28 days under the standard daily protocol
  

“SWIFT demonstrates that we can substantially reduce treatment burden without compromising on outcomes, which fundamentally changes what access looks like for patients,” said Colleen A. Hanlon, Ph.D., Vice President of Medical Affairs at BrainsWay.

Why SWIFT™ Matters: The Cost of Time

Over 20 million U.S. adults live with MDD, at an estimated $333 billion annual economic burden. Yet logistical barriers – time away from work, caregiving responsibilities, and travel – reduce the number of people who initiate access to this life-saving treatment. SWIFT™ lowers one of the most persistent barriers in interventional psychiatry: Time.

The second published manuscript, focusing on the patients’ own ratings of perceived impact of the treatment on their lives, highlights the human impact of that efficiency. Key secondary outcomes in this study include:

• ~70% of the participants no longer suffered from severe quality of life impairment
• Approximately 60% returned to normal-range functioning after treatment

Patients also reported earlier symptom improvement across a range of measures, consistent with clinician-rated outcomes, suggesting not only statistical success, but lived recovery.

“Patients are reconnecting with work, relationships, and routines,” said Hanlon. “That’s the human outcome that matters most.”

As clinical innovation improves access, payers are also reducing administrative barriers, including the previously announced move by Evernorth® Behavioral Health to eliminate prior authorization requirements for Deep TMS.

“We believe this marks the beginning of a new era for BrainsWay,” said Hadar Levy, Chief Executive Officer of BrainsWay. “Innovation in mental health cannot stop at clinical efficacy – it must address accessibility and scalability. SWIFT demonstrates that we can advance neuroscience while expanding real-world reach. That is the future of interventional psychiatry.”

Study Design and Results

The trial incorporated input from both patients and providers in both urban and rural areas, reflecting a patient-centric approach uncommon in studies of this type. Each manuscript highlights different but complementary findings from the same clinical trial.

Manuscript 1: Accelerated TMS with the H1-coil for Depression: A Multisite, Randomized Non-Inferiority Trial

In the randomized non-inferiority comparison, the accelerated SWIFT protocol achieved an 87.8% response rate and a 78.0% remission rate on the clinician-rated Hamilton Depression Rating Scale (HDRS-21), establishing efficacy comparable to the standard once-daily protocol while requiring substantially fewer treatment days. (The standard protocol consists of an acute phase of 5 daily sessions over 4 weeks, followed by 2 daily sessions per week for 2 weeks.) Median time to remission was 21 days for SWIFT versus 28 days for the standard protocol. Outcomes were consistent across diverse patient subgroups, including individuals with moderate-to-severe depression and comorbid anxiety symptoms.

Manuscript 2: Patient-Reported Outcomes Following Accelerated vs. Standard Deep TMS with the H1 coil for Major Depression: A Multisite Randomized Trial

Clinician-rated measures remain the gold standard in depression trials; however, patient-reported outcomes provide critical insight into real-world experiences. Daily patient assessments confirmed substantial improvements in quality of life, functioning, and symptom burden among patients receiving accelerated treatment. By 6 weeks, quality-of-life scores improved by approximately 32 percentage points from those measured at baseline. The proportion of patients reporting severe functional impairment declined from 85–100% at baseline to 15–17% at the end of treatment, and approximately 60% reached normal-range functioning by the end of treatment. Patients receiving SWIFT also reported earlier perceived symptom improvement across a range of symptoms, consistent with clinician-rated findings.

For more information, visit BrainsWay.com.

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 Statements
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,” “targets,” “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 to realize anticipated synergies and other benefits of the proposed transaction; 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
britchie@lifesciadvisors.com

FAQ

What were the key efficacy results for BrainsWay's SWIFT accelerated Deep TMS (BWAY) announced March 4, 2026?

SWIFT achieved an 87.8% response rate and 78.0% remission rate on clinician-rated HDRS-21. According to BrainsWay, the randomized multisite non-inferiority trial showed comparable efficacy to standard protocol with faster median remission.

How much did SWIFT (BWAY) shorten the acute depression treatment schedule compared with standard Deep TMS?

The accelerated SWIFT protocol reduced the acute phase by about 70%, from 20 visits to 6 half days. According to BrainsWay, this compressed schedule aims to improve patient retention and access to care.

What was the median time to remission for patients using SWIFT versus standard Deep TMS in BrainsWay's trial?

Median time to remission was 21 days for SWIFT versus 28 days for the standard daily protocol. According to BrainsWay, this faster remission aligns with clinician-rated and patient-reported improvements.

What patient-reported outcomes did BrainsWay report for SWIFT accelerated Deep TMS (BWAY)?

Patient reports showed ~32 percentage-point quality-of-life improvement and a drop in severe impairment to 15–17%. According to BrainsWay, about 60% of participants reached normal-range functioning by treatment end.

What payer or access changes accompanied BrainsWay's SWIFT Deep TMS results that could affect BWAY investors?

Payer barriers are easing, with Evernorth Behavioral Health removing prior authorization for Deep TMS. According to BrainsWay, reduced administrative friction may support broader adoption and clinical scalability for SWIFT.