Brainsway (BWAY) Company Report

BrainsWay Ltd. (BWAY) announced that Cigna's Evernorth Behavioral Health will eliminate prior authorization requirements for transcranial magnetic stimulation (TMS) coverage for contracted providers.
This policy change, effective March 6, 2026, is anticipated to accelerate patient access to TMS treatment for conditions like major depressive disorder (MDD) and obsessive-compulsive disorder (OCD), which Evernorth currently covers.
BrainsWay's CEO, Hadar Levy, stated that this decision is an important step in expanding patient access to effective therapy by reducing administrative hurdles for providers.

Feb 18, 2026, 12:30 PM

6-K

BrainsWay Announces Change in ADS-to-Ordinary Share Ratio

BWAY

BrainsWay Ltd. announced a change in its American Depositary Shares (ADSs) to ordinary share ratio from 2-to-1 to a new 1-to-1 structure, effective March 3, 2026.
This adjustment will result in each existing ADS holder receiving one additional ADS for each ADS held, which has the same effect as a 2-for-1 forward split of the ADSs.
The Company expects the trading price of its ADSs to be divided in half after the ratio change.
The change aims to simplify share price comparisons between NASDAQ and the Tel Aviv Stock Exchange, enhance liquidity, and improve accessibility for U.S. investors.

Feb 17, 2026, 12:30 PM

6-K

BrainsWay Announces Draft Coverage Policy for Accelerated Deep TMS

BWAY

New Projects/Investments

BrainsWay announced that Highmark Blue Cross Blue Shield has released a draft medical policy to cover the company's accelerated Deep TMS protocol.
This policy expands coverage to include adolescent and adult patients with major depressive disorder (MDD), impacting over seven million covered lives.
The accelerated Deep TMS protocol, which was FDA-cleared in September 2025, demonstrated an 87.8% response rate and 78.0% remission rate in clinical studies.
The policy is anticipated to go into effect in February 2026 following an open comment period.

Jan 21, 2026, 12:30 PM

6-K

BrainsWay Announces First Coverage Policy for Accelerated Deep TMS Protocol

BWAY

Product Launch

New Projects/Investments

BrainsWay Ltd. announced that Premera Blue Cross Blue Shield®, which covers over 2.8 million lives in Alaska and Washington state, has adopted the first coverage policy for BrainsWay’s accelerated SWIFT™ Deep TMS™ protocol.
This new medical policy expands coverage to include patients ages 15 and older with moderate to severe major depressive disorder (MDD).
The SWIFT protocol consists of an acute phase of five 10-minute treatment sessions per day for six days, followed by two sessions per day once a week for four weeks, for a total of 38 sessions.

Jan 7, 2026, 12:30 PM

6-K

BrainsWay Reports Strong Q3 2025 Results and Outlines Growth Strategy

BWAY

Earnings

Guidance Update

New Projects/Investments

BrainsWay reported Q3 2025 revenue of $13.5 million, a 29% year-over-year increase, with a 75% gross margin and $1.6 million net profit, up 137%.
The company is transitioning to a recurring revenue model, with 70% of new deals being multi-year leases, and recurring revenue growing 34% year-over-year. Remaining performance obligation reached $65 million, up 37% year-over-year.
Key clinical milestones include FDA clearance for the accelerated protocol for MDD and adolescent MDD. BrainsWay is also expanding into new indications and developing a home-use neuromodulation system through an investment in Neuralif.
BrainsWay maintains a strong financial position with $71 million in cash and 10 consecutive quarters of positive free cash flow, reaffirming its 2025 revenue guidance of $52 million.

Dec 1, 2025, 3:00 PM

Transcript

Brainsway Reports Strong Q3 2025 Performance and Outlines Strategic Growth Drivers

BWAY

Revenue Acceleration/Inflection

New Projects/Investments

Guidance Update

Brainsway reported strong Q3 2025 revenue of $13.5 million, an increase of 29% year-over-year, with a 75% gross margin, $2 million in adjusted EBITDA (up 81%), and $1.6 million in net profit (up 137%).
The company is shifting towards a recurring revenue business model, with recurring revenue growing 34% year-over-year and a remaining performance obligation of $65 million, up 37% year-over-year.
Key strategic initiatives include FDA clearance for the accelerated protocol for MDD, a $2.5 million NIH grant supporting Deep TMS for alcohol use disorder, and strategic minority investments in mental health networks, alongside a partnership with Nuwolif for a home-use neuronal dilation system.
Brainsway maintains a strong financial position with $71 million in cash and no debt, and reaffirms its 2025 revenue guidance of $52 million, anticipating 2026 to be a "breakout year".

Dec 1, 2025, 3:00 PM

Transcript

BrainsWay Analyst & Investor Day 2025 Highlights Strategic Growth and Strong Q3 Performance

BWAY

Revenue Acceleration/Inflection

New Projects/Investments

Guidance Update

BrainsWay reported Q3 2025 revenue of $13.5 million, a 29% year-over-year increase, with a 75% gross margin, $2 million in Adjusted EBITDA (up 81%), and $1.6 million in net profit (up 137%).
The company is transitioning to a recurring revenue model, with $65 million in remaining performance obligation (up 37% year-over-year) and recurring revenue growing 34% year-over-year. BrainsWay maintains a strong financial position with $71 million in cash and no debt, and reaffirms its 2025 revenue guidance of $52 million.
Key strategic initiatives include FDA clearance for the accelerated protocol for MDD and adolescent MDD, strategic minority investments in mental health clinics, and expansion into home use with its investment in Neuralif.
BrainsWay is also pursuing new clinical indications such as PTSD, addiction, and cognitive decline, and developing its next-generation Deep TMS 360 platform.

Dec 1, 2025, 3:00 PM

Transcript

BrainsWay receives FDA clearance for Deep TMS in adolescent MDD

BWAY

Product Launch

New Projects/Investments

On November 13, 2025, BrainsWay Ltd. announced that its Deep TMS™ system received FDA clearance as an adjunct therapy for Major Depressive Disorder (MDD) in adolescents aged 15 to 21.
This clearance positions Deep TMS™ as the first and only TMS device approved for treating depression in patients across the age range of 15 to 86.
The 510(k) clearance was supported by real-world data from 1,120 adolescents treated between 2012 and 2024, showing an average improvement of 12.1 points on the PHQ-9 rating scale and a 66.1% response rate after 36 treatment sessions.
BrainsWay's CEO, Hadar Levy, stated that this clearance allows the company to address a significant market segment, with approximately 5 million adolescents in the U.S. estimated to have experienced a major depressive episode within the past year.

Nov 13, 2025, 11:00 AM

6-K

BrainsWay Ltd. Reports Strong Q3 2025 Financial Results and Strategic Progress

BWAY

Earnings

Guidance Update

Product Launch

BrainsWay Ltd. reported strong Q3 2025 financial results, with revenue of $13.5 million (+29% year-over-year), a gross margin of 75%, and Adjusted EBITDA of $2.0 million (+81%). The company also achieved a net profit of $1.6 million (+137%) for the quarter ended September 30, 2025.
The company is transitioning to a high-margin Annual Recurring Revenue (ARR) model, with 70% of recent customer engagements structured as multi-year lease agreements. Remaining Performance Obligations (RPO) stood at $65 million as of June 2025.
BrainsWay received FDA clearance for an accelerated Deep TMS protocol for Major Depressive Disorder (MDD) on September 16, 2025. As of September 30, 2025, the company held ~$71 million in cash with no debt. For Fiscal Year 2025, the company provides revenue guidance of $51 - 52 million.

Nov 12, 2025, 12:00 PM

6-K

BrainsWay Reports Strong Q3 2025 Financial Results and Raises Full-Year Guidance

BWAY

Earnings

Guidance Update

Revenue Acceleration/Inflection

BrainsWay reported revenue of $13.5 million in Q3 2025, marking a 29% increase compared to Q3 2024.
Operating income for Q3 2025 was $1.3 million, and Adjusted EBITDA increased 81% to $2.0 million compared to the prior year period.
The company raised the midpoint of its full-year 2025 revenue guidance to $51 million – $52 million and its Adjusted EBITDA guidance to 13% – 14%.
Remaining performance obligations increased to $65 million, and the FDA cleared an accelerated protocol for Deep TMS treatment of major depressive disorder (MDD).
As of September 30, 2025, cash, cash equivalents, and restricted cash totaled $70.7 million.