BrainsWay Reports Expansion of Adolescent Depression Coverage Applicable to Deep TMS™

Rhea-AI Summary

BrainsWay (NASDAQ: BWAY) announced that Optum Behavioral Health expanded its medical policy to cover Deep TMS for adolescents aged 15 and older with confirmed major depressive disorder (MDD). Optum serves over 48 million covered lives.

BrainsWay said the move aligns Optum with other payers that collectively cover about 180 million lives. The company noted Deep TMS is FDA cleared as an adjunct therapy for adolescents and highlighted an estimated 5 million U.S. adolescents aged 15–21 who experience major depression.

Positive

• Optum coverage expanded to include adolescents 15+
• Optum network reaches >48 million covered lives
• Payer alignment adds to payers covering ~180 million lives
• FDA clearance for Deep TMS as adjunct adolescent therapy

Negative

• Policy applies only to patients aged 15 and older, excluding younger adolescents
• Coverage remains payer-specific and is not yet universal across all insurers

Key Figures

Optum covered lives over 48 million Lives covered by Optum Behavioral Health network

Payers covering Deep TMS approximately 180 million lives Aggregate lives covered by listed insurers for adolescent MDD Deep TMS

Adolescent age range aged 15 and older Coverage expansion criteria for Deep TMS in MDD

US adolescents with depression an estimated 5 million Adolescents aged 15–21 with major depression in the U.S.

Adolescent real-world cohort 1,120 adolescents Patients in Deep TMS MDD data set across 35 U.S. centers

Depression score improvement 12.1-point PHQ-9 improvement Average change after 36 Deep TMS sessions in adolescents

Response rate 66.1% response rate Adolescent Deep TMS MDD real-world data

Q3 2025 revenue $13.5M Q3 2025, 29% year-over-year growth

Market Reality Check

$19.29 Last Close

Volume Volume 68,445 is slightly above the 20-day average of 62,435. normal

Technical Price 17.11 is trading above the 200-day MA at 12.94, reflecting a pre-news uptrend.

Peers on Argus

Peers show mixed moves, with names like CATX up 2.23% and STIM down 1.41%, suggesting today’s positive move in BWAY is more stock-specific than sector-driven.

Historical Context

Date	Event	Sentiment	Move	Catalyst
Nov 25	Investor day announcement	Positive	+2.5%	Announced virtual Analyst & Investor Day on growth strategy and Deep TMS.
Nov 17	Clinical trial launch	Positive	-3.7%	Initiated randomized trial of Deep TMS 360 for Alcohol Use Disorder.
Nov 13	FDA clearance youth MDD	Positive	+1.5%	FDA cleared Deep TMS as adjunct therapy for adolescents with MDD.
Nov 11	Q3 2025 earnings	Positive	-5.8%	Reported strong Q3 growth, higher margins, and raised 2025 guidance.
Nov 04	NIH grant news	Positive	-3.9%	NIH granted ~$2.5M for accelerated Deep TMS AUD study.

Pattern Detected

Recent history shows mixed alignment: positive news has sometimes led to selloffs, particularly around earnings and grant/trial announcements.

Recent Company History

Over the last two months, BrainsWay reported strong Q3 2025 financials with revenue of $13.5M and raised full-year guidance, yet the stock fell after that release. The company then secured FDA clearance for Deep TMS as adjunct therapy for adolescents with MDD and launched new clinical work in Alcohol Use Disorder, supported by an NIH grant of about $2.5M. It also scheduled an Analyst & Investor Day to outline growth strategy. Today’s coverage expansion by a major payer builds on November’s adolescent MDD clearance and broadening clinical adoption themes.

Market Pulse Summary

The stock surged +10.1% in the session following this news. A strong positive reaction aligns with the pre-existing uptrend, with BWAY trading near its 52-week high and about 118.24% above its 52-week low before this announcement. The news extends payer coverage for adolescent MDD, building on prior FDA clearance and real-world efficacy data. However, historical patterns show that even favorable earnings and grant news sometimes preceded declines, so investors have previously reassessed enthusiasm after initial strength.

Key Terms

deep tms medical

"has expanded its medical policy applicable to Deep TMS™ therapy to include coverage"

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.

major depressive disorder medical

"coverage for adolescents aged 15 and older with a confirmed diagnosis of major depressive disorder"

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

"young people affected by MDD,” said Hadar Levy, Chief Executive Officer"

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.

fda cleared regulatory

"BrainsWay’s Deep TMS is FDA cleared as an adjunct therapy for adolescent patients"

FDA cleared means the U.S. Food and Drug Administration reviewed a medical device and agreed it is similar enough to an already allowed product to be marketed in the United States. Think of it like a new car model using largely the same, proven parts as an earlier model — the regulator gives a green light for sales but does not imply the more extensive testing required for full approval. For investors, clearance signals regulatory access to the U.S. market and typically lowers commercialization risk compared with no clearance.

adjunct therapy medical

"Deep TMS is FDA cleared as an adjunct therapy for adolescent patients with depression"

An adjunct therapy is an additional treatment used alongside a primary medical therapy to improve effectiveness, reduce side effects, or extend benefits — like a sidekick that supports the lead treatment. For investors, adjunct therapies matter because they can expand a product’s market, increase combined treatment sales, affect pricing and reimbursement decisions, and change a drug or device’s competitive position and long‑term revenue potential.

neurostimulation therapies medical

"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.

AI-generated analysis. Not financial advice.

Optum Behavioral Health, a Health Services Company with Over 48 Million Covered Lives, Joins Growing List of Insurers Now Covering Deep TMS Depression Therapy for Adolescents Aged 15 and Older

BURLINGTON, Mass. and JERUSALEM, Dec. 22, 2025 (GLOBE NEWSWIRE) -- BrainsWay Ltd. (NASDAQ & TASE: BWAY) (“BrainsWay” or the “Company”), a global leader in advanced noninvasive brain stimulation technologies, today announced that Optum Behavioral Health, a leading health services company with over 48 million covered lives through its network of professionals and a part of UnitedHealth Group, has expanded its medical policy applicable to Deep TMS™ therapy to include coverage for adolescents aged 15 and older with a confirmed diagnosis of major depressive disorder (MDD).

“Optum’s policy expansion marks an important step forward in expanding access to a more effective, clinically proven, and non-drug treatment option for young people affected by MDD,” said Hadar Levy, Chief Executive Officer of BrainsWay. “Deep TMS has already changed the trajectory of care for adults facing depression, and extending access to younger patients reflects a shared commitment to early intervention, innovation, and meaningful clinical impact.”

“Optum’s decision to expand its coverage brings it in line with several other leading insurers that already cover Deep TMS for adolescents with MDD, including Evernorth Health Services, CVS/Aetna, Medi-Cal, PacificSource Health Plans, TRICARE, and several Blue Cross and Blue Shield companies, including Health Care Service Corporation, Highmark, Regence, Florida Blue, Blue Cross Blue Shield of Michigan and Blue Cross Blue Shield of North Carolina, among others. These payers, in the aggregate, cover approximately 180 million lives. We believe this decision reflects a growing recognition of Deep TMS as an essential component of modern mental health care,” concluded Mr. Levy.

An estimated 5 million adolescents aged 15–21 in the United States experience major depression, representing a significant and growing public health challenge. For these young individuals, depression can disrupt critical developmental milestones, affecting academic achievement, family relationships, social functioning and emotional growth during formative years. Treatment options for MDD remain limited, particularly for adolescents who cannot tolerate or do not respond to medication. Those who fail to achieve relief with first-generation treatments face prolonged suffering, higher healthcare costs, and a higher risk of comorbid conditions, such as substance abuse and suicide. Together, these challenges highlight what has historically been a critical gap in access to effective, well-tolerated treatment options for this vulnerable population.

BrainsWay’s Deep TMS is FDA cleared as an adjunct therapy for adolescent patients with depression based on clinical evidence demonstrating meaningful response and remission rates, providing renewed hope at a pivotal stage of life. 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 – 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 change did BrainsWay (BWAY) announce about adolescent Deep TMS coverage on December 22, 2025?

Optum Behavioral Health expanded its medical policy to cover Deep TMS for adolescents aged 15 and older with confirmed major depressive disorder.

How many covered lives does Optum Behavioral Health represent in the BrainsWay (BWAY) announcement?

Optum represents over 48 million covered lives.

Is Deep TMS FDA cleared for adolescent depression according to BrainsWay (BWAY)?

Yes. BrainsWay states Deep TMS is FDA cleared as an adjunct therapy for adolescent patients with depression.

How many people do BrainsWay (BWAY) say other payers cover in aggregate for Deep TMS adolescent coverage?

BrainsWay cites that several payers together cover approximately 180 million lives.

What age range did BrainsWay (BWAY) cite for the estimated 5 million U.S. adolescents with major depression?

The company cited an estimate for adolescents aged 15–21 experiencing major depression.

What limitation should investors note about Optum's Deep TMS policy in the BrainsWay (BWAY) release?

The policy covers only adolescents aged 15 and older, so younger teens are not included under this change.