BrainsWay Announces First Coverage Policy for Accelerated Deep TMS™

Rhea-AI Summary

BrainsWay (NASDAQ: BWAY) announced that Premera Blue Cross Blue Shield has adopted a final medical policy expanding coverage for BrainsWay’s accelerated SWIFT Deep TMS protocol to patients ages 15 and older with moderate to severe major depressive disorder. Premera covers about 2.8 million lives across Alaska and Washington.

The SWIFT protocol features an acute phase of five 10-minute sessions per day for six days, then two sessions per day once weekly for four weeks, totaling 38 sessions. The protocol requires no functional MRI or expensive neuronavigation. Company statements referenced clinical trial and real-world evidence showing comparable response and remission versus standard Deep TMS.

Positive

• Coverage expanded to patients age 15+
• Premera policy affects ~2.8 million covered lives
• SWIFT protocol uses 38 sessions with fewer clinic days
• No functional MRI or neuronavigation required

Negative

• Coverage currently limited to Premera members in Alaska and Washington

Key Figures

Premera covered lives over 2.8 million Premera Blue Cross Blue Shield membership

Eligible age cutoff 15 and older Patients with moderate to severe MDD covered for SWIFT protocol

Daily acute sessions 5 sessions per day SWIFT protocol acute phase treatment schedule

Session duration 10 minutes each Length of each SWIFT Deep TMS session

Acute phase length 6 days Initial intensive SWIFT treatment period

Maintenance sessions 2 sessions per day SWIFT maintenance phase frequency

Maintenance duration 4 weeks Length of weekly SWIFT maintenance phase

Total sessions 38 sessions Full SWIFT accelerated Deep TMS treatment course

Market Reality Check

$23.11 Last Close

Volume Volume 122,209 vs. 20-day average 79,376 (relative volume 1.54) suggests elevated interest ahead of this news. high

Technical Price 21.35 is trading above the 200-day MA of 13.42, reflecting a pre-existing uptrend.

Peers on Argus

Peers show mixed moves: STIM +20.71%, OM +12.89%, CATX +4.07%, while VMD and NNOX were flat. Momentum scanner did not flag a coordinated sector move, indicating the BWAY setup appears more company-specific.

Historical Context

Date	Event	Sentiment	Move	Catalyst
Dec 22	Coverage expansion	Positive	+10.1%	Optum expanded Deep TMS coverage for adolescents 15+ with MDD.
Nov 25	Investor event	Positive	+2.5%	Announcement of virtual Analyst & Investor Day on growth strategy.
Nov 17	Clinical trial launch	Positive	-3.7%	Launched first Deep TMS 360 trial for Alcohol Use Disorder.
Nov 13	FDA label expansion	Positive	+1.5%	FDA cleared Deep TMS as adjunct therapy for adolescent MDD.
Nov 11	Earnings update	Positive	-5.8%	Strong Q3 2025 growth and raised full-year revenue guidance.

Pattern Detected

Positive regulatory and coverage news for Deep TMS has often seen aligned positive price reactions, while strong earnings and some clinical updates have coincided with negative divergence.

Recent Company History

Over the past few months, BrainsWay reported multiple milestones linked to Deep TMS. On Nov 11, 2025, Q3 2025 results showed revenue of $13.5M with higher margins, yet shares fell 5.83%. Subsequent FDA clearance for adolescent MDD on Nov 13 and expanded adolescent coverage on Dec 22 both saw positive price reactions of 1.46% and 10.05%. A new Deep TMS 360 AUD trial launch on Nov 17 coincided with a 3.68% decline. Today’s coverage expansion for the accelerated SWIFT protocol fits this payer-access progression theme.

Market Pulse Summary

This announcement highlights the first payer policy specifically covering BrainsWay’s accelerated SWIFT Deep TMS protocol for patients aged 15 and older, from a plan with over 2.8 million covered lives. It follows recent FDA label expansion and broader adolescent coverage, reinforcing a trend of improved access for Deep TMS. Investors may track further payer decisions, real-world outcomes compared with standard protocols, and how these influence procedure volumes and system utilization.

Key Terms

major depressive disorder medical

"include patients ages 15 and older with moderate to severe major depressive disorder (MDD)"

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.

mdd medical

"include patients ages 15 and older with moderate to severe major depressive disorder (MDD)"

Major depressive disorder (MDD) is a medical condition characterized by persistent low mood, loss of interest in daily activities, and impaired functioning similar to carrying a heavy backpack that makes ordinary tasks much harder. For investors, MDD matters because treatments and therapies for it are a large market regulated by health authorities; clinical trial outcomes, approvals, or safety concerns can strongly affect a drugmaker’s sales prospects, valuation, and risk profile.

deep tms medical

"treated with BrainsWay’s accelerated SWIFT™ (Short-course with Intrinsic Field Targeting) Deep TMS™ protocol"

A non-invasive medical treatment that uses focused magnetic fields to stimulate deeper brain regions through a specialized coil, aiming to change brain activity linked to conditions like depression or obsessive-compulsive disorder. It matters to investors because regulatory approval, clinical evidence, and insurance coverage determine how widely clinics adopt the technology and how much revenue device makers and treatment providers can generate—think of it as a more powerful, targeted ‘wireless signal’ to the brain whose commercial success depends on proven benefits and payor support.

functional mri medical

"There is no need for any functional MRI or other expensive neuronavigational equipment."

Functional MRI (fMRI) is a noninvasive brain imaging technique that maps changes in blood flow to show which brain regions are active during tasks or at rest, like a heat map that lights up parts of the brain. For investors, fMRI matters because it is a key tool in developing and testing neurological and psychiatric drugs, medical devices, and diagnostics; positive fMRI findings can de‑risk programs, support regulatory submissions, and influence the perceived value of related companies.

neurostimulation therapies medical

"to expand access to advanced neurostimulation therapies."

Neurostimulation therapies are medical treatments that apply controlled electrical or magnetic pulses to nerves or brain regions to alter abnormal signals and relieve symptoms such as chronic pain, movement problems or mood disorders. For investors, they matter because they combine durable hardware sales, recurring follow-up care and potential long-term patient dependence, so clinical trial results, regulatory approval and insurance coverage can strongly affect market size and company revenue prospects.

h-coil technology medical

"continues to lead the field with its proprietary H-coil technology, robust clinical research"

A type of medical device coil used in transcranial magnetic stimulation that creates magnetic fields shaped to reach deeper and broader brain regions than standard coils, often used to treat conditions like depression and obsessive-compulsive disorder. Investors care because adoption, regulatory approval, clinical evidence, and insurance coverage for this deeper-stimulating technology affect market size, sale growth, and recurring service or device revenue—think of it as a specialized tool that can open access to a larger patient pool if proven effective.

AI-generated analysis. Not financial advice.

New Premera Blue Cross Blue Shield® policy extends to both adolescent and adult depression patients

BURLINGTON, Mass. and JERUSALEM, Jan. 07, 2026 (GLOBE NEWSWIRE) -- BrainsWay Ltd. (NASDAQ & TASE: BWAY) (“BrainsWay” or the “Company”), a global leader in advanced noninvasive brain stimulation technologies, today announced that Premera Blue Cross Blue Shield^®, a company with over 2.8 million covered lives serving Alaska and Washington state, has adopted a new final medical policy which, among other developments, expands coverage to include patients ages 15 and older with moderate to severe major depressive disorder (MDD) treated with BrainsWay’s accelerated SWIFT™ (Short-course with Intrinsic Field Targeting) Deep TMS™ protocol.

“We are elated at Premera’s decision to formally adopt a policy covering our SWIFT depression protocol, which marks a first among payers. SWIFT entails significantly fewer days spent in the clinic, allowing patients to achieve meaningful improvement more quickly than our standard Deep TMS protocol,” stated Hadar Levy, Chief Executive Officer of BrainsWay.

BrainsWay’s SWIFT depression protocol consists of an acute phase of five treatment sessions (ten minutes each) per day for six days, followed by two sessions per day once a week for four weeks, for a total of 38 sessions. There is no need for any functional MRI or other expensive neuronavigational equipment.

“BrainsWay’s clinical trial and real-world evidence demonstrates comparable response and remission outcomes for its SWIFT accelerated depression protocol when compared to the standard Deep TMS protocol. We are committed to continuing our efforts to educate stakeholders within our space on the compelling data supporting additional favorable coverage of this novel protocol,” stated Colleen Hanlon, PhD, Vice President of Medical Affairs for BrainsWay.

BrainsWay continues to lead the field with its proprietary H-coil technology, robust clinical research, and ongoing collaboration with providers and policymakers to expand access to advanced neurostimulation therapies.

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 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 did BrainsWay announce on January 7, 2026 regarding Premera and BWAY?

BrainsWay announced Premera adopted a final policy covering its SWIFT Deep TMS protocol for patients age 15+ with MDD.

Which patients are covered under Premera's new policy for BWAY SWIFT Deep TMS?

Patients ages 15 and older with moderate to severe major depressive disorder are included.

How many treatment sessions does the BrainsWay SWIFT Deep TMS protocol require?

The SWIFT protocol totals 38 sessions: five 10‑minute sessions/day for six days, then two sessions/day weekly for four weeks.

Does BrainsWay's SWIFT protocol require fMRI or neuronavigation according to the announcement?

No; the announcement states there is no need for functional MRI or expensive neuronavigational equipment.

How many lives does Premera cover under the policy mentioned by BrainsWay (BWAY)?

Premera covers about 2.8 million lives in Alaska and Washington.

Did BrainsWay claim clinical evidence supports SWIFT outcomes versus standard Deep TMS?

Yes; BrainsWay said clinical trial and real‑world evidence demonstrate comparable response and remission outcomes to standard Deep TMS.