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

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New draft policy from Highmark Blue Cross Blue Shield extends to both adolescent and adult depressio...

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AI Summary

Highmark Blue Cross Blue Shield's draft policy expanding coverage for BrainsWay's Deep TMS protocol aims to increase patient access among those with major depressive disorder. If finalized, this could significantly boost BrainsWay's market share and revenue from its innovative treatment options.

Sentiment Rationale

Previous coverage expansions by payers have led to strong stock performances in similar healthcare companies, suggesting that BWAY could benefit from increased market access.

Trading Thesis

Investors should consider BWAY bullish in the near term as new coverage expands market access.

Market-Moving

  • Successful adoption of the policy could lead to significant revenue growth for BWAY.
  • Increased patient access may drive higher demand for BrainsWay's Deep TMS treatments.
  • Positive clinical trial results previously reported bolster confidence in BWAY's product efficacy.
  • Potential for expanded payer adoption following Highmark's policy could impact stock sentiment.

Key Facts

  • Highmark Blue Cross Blue Shield expands coverage for BrainsWay's Deep TMS protocol.
  • Coverage extends to adolescent and adult patients with major depressive disorder.
  • Accelerated Deep TMS shows 87.8% response and 78.0% remission rates.
  • Draft policy expected to be effective by February 2026.
  • Treatment protocol requires fewer clinic visits, enhancing patient access.

Companies Mentioned

  • Highmark Blue Cross Blue Shield (N/A): Expanding coverage could lead to significant patient recruitment for BWAY's treatment.

Corporate Developments

This news falls into 'Corporate Developments' as it pertains to an insurance policy change affecting BrainsWay's business model, enhancing patient access to its treatments and potentially impacting revenue projections.

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

BURLINGTON, Mass. and JERUSALEM, Jan. 21, 2026 (GLOBE NEWSWIRE) – BrainsWay Ltd. (NASDAQ & TASE: BWAY), a leader in noninvasive brain stimulation technologies, has announced a pivotal development with Highmark Blue Cross Blue Shield®.

Expansion of Coverage for Depression Treatment

The newly proposed medical policy from Highmark, affecting over seven million members across Pennsylvania, Delaware, West Virginia, and parts of New York, seeks to expand coverage for both adolescent and adult patients suffering from major depressive disorder (MDD) via BrainsWay's accelerated Deep TMS™ protocol.

Expected to take effect in February 2026 following a public comment period, this policy includes support for BrainsWay's accelerated SWIFT™ (Short-course with Intrinsic Field Targeting) protocol, which involves:

  • Five treatment sessions (ten minutes each) daily for six days.
  • Two sessions per day, once weekly for four weeks.
  • A total of 38 treatment sessions

This method offers a non-invasive alternative without the necessity for functional MRI or other high-cost neuronavigational tools.

Implications for Patients

Scott Blackman, Director of Market Access for BrainsWay, emphasized that this initiative by Highmark could signify a transformative shift in depression treatment through Deep TMS. He stated, “This trend affords patients increased flexibility by giving them access to a treatment option requiring considerably fewer visits to the clinic.”

The accelerated protocol for Deep TMS received FDA clearance in September 2025, following positive outcomes from a Multisite, Randomized Non-Inferiority Trial, which reported an impressive 87.8% response rate and 78.0% remission rate for patients using this method, comparable to traditional Deep TMS results.

About BrainsWay and Deep TMS Technology

Founded in 2003, BrainsWay remains at the forefront of noninvasive neurostimulation treatments for mental health disorders, showcasing innovative applications of their Deep Transcranial Magnetic Stimulation (Deep TMS™) technology.

With three FDA-clearances for various indications, including MDD, obsessive-compulsive disorder, and smoking addiction, BrainsWay continually aims to enhance global access to Deep TMS while conducting additional clinical trials across various psychiatric and neurological conditions.

Forward-Looking Statements

This announcement includes forward-looking statements under the Private Securities Litigation Reform Act of 1995. These statements reflect the Company's management expectations and may involve risks and uncertainties. Potential challenges could affect actual results, which may differ materially from those projected.

For detailed information regarding the risks and uncertainties, please refer to the “Risk Factors” section in the Company's filings with the U.S. Securities and Exchange Commission.

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