BrainsWay Announces Draft Coverage Policy from Highmark® for Accelerated Deep TMS™

BrainsWay (NASDAQ: BWAY) said Highmark Blue Cross Blue Shield released a draft medical policy expanding coverage to adolescent and adult major depressive disorder (MDD) patients for the company’s accelerated Deep TMS SWIFT protocol.

Rhea-AI Summary

BrainsWay (NASDAQ: BWAY) said Highmark Blue Cross Blue Shield released a draft medical policy expanding coverage to adolescent and adult major depressive disorder (MDD) patients for the company’s accelerated Deep TMS SWIFT protocol.

The policy covers an acute course of five 10-minute sessions/day for six days, then two sessions/day weekly for four weeks (38 sessions total), and is expected to take effect in February 2026 after an open comment period. Highmark serves over 7 million covered lives in Pennsylvania, Delaware, West Virginia and parts of New York.

The company noted FDA clearance for the accelerated protocol in September 2025 and cited a multisite randomized non-inferiority trial reporting an 87.8% response rate and 78.0% remission rate.

Positive

• Draft payer coverage expands to adolescents and adults
• Policy expected effective February 2026 after comment period
• Highmark footprint covers over 7 million lives
• FDA cleared accelerated protocol in September 2025
• Trial showed 87.8% response and 78.0% remission

Negative

• Coverage is currently a draft and not final until post-comment
• Highmark coverage is geographically limited to its regional footprint

Argus Jan 21 session

+4.74% close to close Open Argus

Details

News Market Reaction – BWAY

On Jan 21, the day this news came out, BWAY closed 4.74% above the previous close.

Data tracked by StockTitan Argus for the Jan 21 session.

Key Figures

Highmark covered lives: over seven million Total sessions: 38 sessions Acute phase frequency: 5 sessions/day for 6 days +5 more

Highmark covered lives

over seven million

Highmark Blue Cross Blue Shield coverage base

Total sessions

38 sessions

Full accelerated SWIFT Deep TMS protocol

Acute phase frequency

5 sessions/day for 6 days

Initial accelerated Deep TMS treatment phase

Session duration

10 minutes

Length of each acute-phase treatment session

Maintenance frequency

2 sessions/day once a week

Maintenance phase of accelerated protocol

Maintenance duration

4 weeks

Length of maintenance phase

Response rate

87.8%

Multisite randomized non-inferiority trial for accelerated Deep TMS

Remission rate

78.0%

Multisite randomized non-inferiority trial for accelerated Deep TMS

Historical Context

5 past events · Latest: Jan 12

5 events

1. Jan 12

   FDA approval link

   24h Move

   +4.7%

   FDA PMA for Proliv™Rx as adjunctive MDD treatment tied to BrainsWay investment.

2. Jan 07

   Coverage expansion

   24h Move

   +3.6%

   Premera policy expanding coverage for accelerated SWIFT Deep TMS from age 15.

3. Dec 22

   Coverage expansion

   24h Move

   +10.1%

   Optum expanded Deep TMS coverage for adolescents with MDD across large member base.

4. Nov 25

   Investor day

   24h Move

   +2.5%

   Announcement of virtual Analyst & Investor Day on Deep TMS and growth strategy.

5. Nov 17

   Clinical trial launch

   24h Move

   -3.7%

   Launch of multicenter Deep TMS 360 trial for Alcohol Use Disorder with >200 patients.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

major depressive disorder, deep tms, functional mri, noninvasive brain stimulation, +4 more

8 terms

major depressive disorder medical

"include adolescent and adult patients with 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.

deep tms medical

"treated with the company’s accelerated 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

"does not entail the use of any functional MRI or other expensive neuronavigational"

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.

noninvasive brain stimulation medical

"a global leader in advanced noninvasive brain stimulation technologies"

Noninvasive brain stimulation uses external devices to change brain activity without surgery, typically by applying magnetic pulses or gentle electrical currents to the scalp. Investors pay attention because these devices aim to treat neurological and psychiatric conditions with lower procedural risk and often shorter development times than implanted devices or drugs; commercial potential depends on clinical trial results, regulatory approval, insurance coverage and user convenience—think of it as a medical 'tuning' tool for the brain.

multisite, randomized non-inferiority trial medical

"submission of data from a Multisite, Randomized Non-Inferiority Trial demonstrating"

A multisite, randomized non-inferiority trial is a clinical study run at several locations where participants are randomly assigned to either a new treatment or a standard one, with the goal of showing the new option is not meaningfully worse than the standard. Think of it like testing a budget version of a popular product across many stores to prove it performs nearly as well; results matter to investors because they influence regulatory approval, market acceptance, and commercial risk.

response rate medical

"demonstrating an 87.8% response rate and 78.0% remission rate"

Response rate is the percentage of participants in a study or recipients of an intervention who meet a predefined positive outcome—such as tumor shrinkage, symptom improvement, or a completed action—after treatment or outreach. For investors, it provides a direct signal of a product’s or campaign’s effectiveness and helps forecast regulatory success, future sales, and valuation; think of it like the share of seeds that actually sprout after planting, which predicts the size of the eventual harvest.

remission rate medical

"demonstrating an 87.8% response rate and 78.0% remission rate"

The remission rate is the percentage of patients in a clinical study whose disease symptoms disappear or fall below a defined level after treatment. Investors use it as a simple measure of how well a therapy works — similar to the share of customers who stop needing a product — and higher remission rates can signal stronger commercial potential, regulatory support, and reduced ongoing costs of care.

neuromodulation medical

"Proliv™Rx neuromodulation system on January 12, 2026, as a Class III"

Neuromodulation is the use of devices or targeted treatments to change how nerves or brain circuits send signals, much like adjusting the volume or tuning on an audio system to alter what you hear. For investors, it matters because these therapies can treat chronic conditions (pain, movement disorders, depression) where existing medicines fall short, creating potential markets, regulatory milestones, and durable revenue streams if technologies prove safe and effective.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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New draft policy from Highmark Blue Cross Blue Shield extends to both adolescent and adult depression patients

BURLINGTON, Mass. and JERUSALEM, Jan. 21, 2026 (GLOBE NEWSWIRE) -- BrainsWay Ltd. (NASDAQ & TASE: BWAY) (“BrainsWay” or the “Company”), a global leader in advanced noninvasive brain stimulation technologies, today announced that Highmark Blue Cross Blue Shield^®, a company with over seven million covered lives that primarily serves Pennsylvania, Delaware, West Virginia, and parts of New York, has released a draft medical policy which, among other developments, expands coverage to include adolescent and adult patients with major depressive disorder (MDD) treated with the company’s accelerated Deep TMS™ protocol.

The policy, which is anticipated to go into effect in February 2026 after an open comment period, will provide coverage of BrainsWay’s accelerated SWIFT™ (Short-course with Intrinsic Field Targeting) protocol, which 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. Accelerated Deep TMS does not entail the use of any functional MRI or other expensive neuronavigational equipment.

“We believe this news from Highmark, together with our recently reported adoption by another payer of a medical policy covering our accelerated protocol, will help usher in a new era in Deep TMS depression treatment. This trend affords patients increased flexibility by giving them access to a treatment option requiring considerably fewer visits to the clinic,” stated Scott Blackman, Director of Market Access for BrainsWay.

The Company’s accelerated depression protocol for Deep TMS was cleared by the FDA in September 2025. This clearance followed BrainsWay’s submission of data from a Multisite, Randomized Non-Inferiority Trial demonstrating an 87.8% response rate and 78.0% remission rate for patients treated with the accelerated Deep TMS protocol, which was comparable to outcomes achieved via standard Deep TMS.

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 of the draft coverage policy referenced herein to advance to formal adoption by the payer following the open comment period; 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

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What does Highmark's January 21, 2026 draft policy mean for BrainsWay (BWAY)?

Highmark's draft expands coverage to adolescent and adult MDD patients for BrainsWay's accelerated Deep TMS SWIFT protocol, potentially increasing payer access.

When would Highmark's coverage for accelerated Deep TMS become effective for BWAY patients?

The draft policy is anticipated to go into effect in February 2026 after an open comment period.

What is the treatment schedule for BrainsWay's accelerated SWIFT protocol covered by Highmark?

The protocol is five 10-minute sessions per day for six days, then two sessions per day once weekly for four weeks (38 sessions total).

Does BrainsWay's accelerated Deep TMS have FDA clearance (BWAY)?

Yes; BrainsWay's accelerated depression protocol received FDA clearance in September 2025.

What clinical results support BrainsWay's accelerated Deep TMS for BWAY?

A multisite randomized non-inferiority trial reported an 87.8% response rate and 78.0% remission rate for the accelerated protocol.

How many people could be affected by Highmark's draft coverage in BrainsWay regions?

Highmark covers over 7 million lives across Pennsylvania, Delaware, West Virginia and parts of New York.