BrainsWay Expands U.S. Insurance Coverage for Deep TMS™ Treatment of OCD to Over 118 Million Lives

Additional U.S. medical policies now provide access to Deep TMS for OCD as an adjunct treatment for adults.

Rhea-AI Summary

BrainsWay (BWAY) expanded U.S. insurance coverage for its Deep TMS treatment for obsessive compulsive disorder to more than 118 million Americans. The expansion reflects additional medical policies providing access to the treatment.

Deep TMS, a noninvasive brain stimulation therapy, is FDA-indicated as an adjunct treatment for adults with obsessive compulsive disorder (OCD). BrainsWay plans to continue working with insurers and healthcare providers to broaden coverage and reduce treatment barriers. The expansion follows a recently announced coverage increase for its accelerated SWIFT protocol for major depressive disorder.

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Hollow bars mark forward-looking points. How the balance works

Positive

• Moderate pointExpanded OCD insurance coverage provides Deep TMS access for more than 118 million Americans.
• Minor pointAccelerated SWIFT protocol coverage for major depressive disorder also recently increased.
• Minor point. Forward-looking: it has not happened yet and may not happen.BrainsWay plans continued work with insurers and providers to expand coverage and reduce treatment barriers.

Negative

• None.

Key Figures

Covered lives: More than 118 million

Covered lives

More than 118 million

U.S. insurance policies providing access to Deep TMS for OCD

Key Terms

obsessive compulsive disorder, placebo-controlled, fda clearance, adjunct treatment

4 terms

obsessive compulsive disorder medical

"patients suffering from obsessive compulsive disorder (OCD)"

A chronic psychiatric disorder marked by obsessions—recurrent, unwanted thoughts, images, or urges that cause anxiety or distress—and compulsions—repetitive behaviors or mental acts the person feels driven to perform to reduce that distress or prevent a feared event. Symptoms are time-consuming or cause significant distress or impairment in daily life, and the compulsive acts are performed in response to the obsessions (not for pleasure) and are not better explained by another mental disorder or a medical condition.

placebo-controlled medical

"a randomized, placebo-controlled multicenter pivotal study"

"Placebo-controlled" describes a testing method where one group receives the actual treatment or intervention, while another group receives a harmless, inactive version called a placebo. This approach helps determine whether the real treatment has genuine effects beyond psychological expectations. For investors, understanding this ensures confidence that reported benefits are real and not influenced by bias or false perceptions.

fda clearance regulatory

"the first company to receive FDA clearance"

FDA clearance is the U.S. Food and Drug Administration’s official permission to market certain medical devices or diagnostic tests after reviewing evidence that they are as safe and effective as similar products already on the market. For investors, it’s like a product passing a required safety inspection — it reduces regulatory uncertainty, speeds commercial rollout, and can directly affect sales prospects, valuation, and partnership opportunities.

adjunct treatment medical

"indicated by the FDA as an intended adjunct treatment"

An adjunct treatment is an additional therapy used alongside a main treatment to improve outcomes, reduce side effects, or address aspects the primary therapy does not cover. Think of it as a supporting player or assistant coach that can enhance the effectiveness of the lead approach. For investors, adjunct treatments matter because they can expand a product’s market, create new revenue streams, influence regulatory decisions, and affect adoption rates and long‑term value.

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BURLINGTON, Mass. and JERUSALEM, Oct. 26, 2026 (GLOBE NEWSWIRE) -- BrainsWay Ltd. (NASDAQ & TASE: BWAY) (“BrainsWay” or the “Company”), a global leader in advanced noninvasive brain stimulation technologies, today announced further expansion in the number of medical policies across the U.S. providing coverage for the use of BrainsWay Deep TMS™ in the treatment of patients suffering from obsessive compulsive disorder (OCD).

With this latest expansion, more than 118 million Americans are now covered under insurance policies that provide access to BrainsWay Deep TMS for OCD, marking another important milestone in the Company's ongoing efforts to broaden patient access to innovative, evidence-based mental health treatments.

“As the first company to receive FDA clearance for a non-invasive brain stimulation treatment for OCD, and the only TMS company to have published data from a randomized, placebo-controlled multicenter pivotal study on its device demonstrating efficacy and safety for this indication, we have established a strong foundation of clinical evidence and leadership in this field,” stated Hadar Levy, Chief Executive Officer of BrainsWay. “Reaching more than 118 million covered lives represents meaningful progress in expanding access to Deep TMS for patients living with this challenging condition. We believe our differentiated clinical evidence, supported by growing real-world experience, continues to strengthen the case for broader payer adoption. We remain committed to working with insurers, healthcare providers, and other stakeholders to expand coverage, reduce barriers to treatment, and make this important therapy available to more patients,” concluded Mr. Levy.

The announcement comes within the broader context of continued momentum in BrainsWay’s reimbursement landscape generally, including the Company’s recent announcement regarding the increase in coverage for its accelerated SWIFT™ protocol in the treatment of major depressive disorder (MDD) patients.

BrainsWay Deep TMS is indicated by the FDA as an intended adjunct treatment for adult patients suffering from OCD. BrainsWay remains the only TMS company to have published data from a randomized, placebo-controlled multicenter study conducted on its device demonstrating the efficacy and safety of the treatment for OCD.

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,” “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: risks relating to the Company’s ability to consummate, finance and close proposed or potential investments, 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

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

How many Americans have insurance coverage for BrainsWay Deep TMS for OCD?

More than 118 million Americans are covered under insurance policies providing access to BrainsWay Deep TMS for OCD following the latest expansion in U.S. medical policies.

What is BrainsWay Deep TMS FDA-indicated to treat in OCD patients?

BrainsWay Deep TMS is FDA-indicated as an adjunct treatment for adult patients with OCD, meaning treatment used alongside other care.