Welcome to our dedicated page for Brainsway Ltd. news (Ticker: BWAY), a resource for investors and traders seeking the latest updates and insights on Brainsway Ltd. stock.
BrainsWay Ltd. (BWAY) generates a steady flow of news centered on its Deep TMS™ neurostimulation technology, regulatory developments, clinical research, and financial performance. As a company focused on noninvasive brain stimulation for mental health disorders, BrainsWay frequently announces updates related to major depressive disorder, obsessive-compulsive disorder, smoking addiction, and emerging indications such as Alcohol Use Disorder.
News items for BrainsWay often cover FDA clearances and label expansions, including accelerated Deep TMS protocols for MDD and indications that extend treatment to adolescent patients aged 15 to 21. The company also reports on payer coverage decisions, such as new or expanded medical policies from insurers that reimburse Deep TMS depression therapy for adults and adolescents, and coverage of its SWIFT™ accelerated protocol. These updates provide insight into how access to Deep TMS is evolving across different patient populations and geographies.
Investors following BWAY can also expect clinical research and grant-related announcements, including NIH-funded studies evaluating accelerated Deep TMS protocols for Alcohol Use Disorder and stimulant use disorders, as well as company-sponsored trials using the Deep TMS 360™ multichannel system. In addition, BrainsWay issues news on strategic investments, such as its minority-stake investment in Neurolief and stakes in mental health providers, and on financial results that highlight revenue trends, installed base growth, and multi-year customer agreements.
The BrainsWay news page on Stock Titan aggregates these updates so readers can track regulatory milestones, payer coverage changes, clinical trial progress, strategic partnerships, and quarterly financial disclosures related to BWAY stock. This makes it a useful reference for monitoring how the company’s Deep TMS platform and broader neuromodulation strategy are developing over time.
BrainsWay (NASDAQ & TASE: BWAY) announced on October 27, 2025 two additional minority-stake investments in U.S. mental health providers, bringing its 2025 total to four strategic minority investments. One agreement with Tangient ATX (Heading Health) includes an initial $1.5 million equity investment and up to $2.5 million more via three milestone-based tranches, for a total potential investment of $4.0 million. BrainsWay will receive a minority position in Heading Health as a preferred, annually compounding security, and the agreement includes a redemption mechanism. The company says the transactions aim to accelerate patient access to Deep TMS therapy and support long-term shareholder value.
BrainsWay (NASDAQ: BWAY) has received FDA clearance for an accelerated Deep Transcranial Magnetic Stimulation (Deep TMS) protocol to treat Major Depressive Disorder (MDD). The new protocol significantly reduces treatment time from 4 weeks to just 6 days in the acute phase.
The clearance is based on a multicenter clinical study showing the accelerated protocol achieved comparable results to the standard treatment. Key outcomes include depression score reductions of 19.02 points for accelerated treatment versus 19.79 for standard protocol, with response and remission rates of 87.8% and 78.0% respectively.
The accelerated protocol features 5 sessions per day over 6 days, followed by twice-weekly sessions for 4 weeks. Each session now takes under 10 minutes, compared to 20 minutes in the standard protocol. Notably, the median time to remission decreased to 21 days from 28 days with the standard treatment.
BrainsWay (NASDAQ: BWAY) has made a strategic investment in Neurolief, a brain stimulation company developing non-invasive neuromodulation therapies. The investment comes as Neurolief awaits FDA approval for its Proliv™Rx system, designed to treat Major Depressive Disorder (MDD).
The Proliv™Rx system represents a breakthrough in depression treatment, offering at-home brain neuromodulation therapy for patients who haven't responded adequately to traditional antidepressants. BrainsWay's commercial expertise and global presence, with Deep TMS systems in over 1,500 clinics worldwide, positions Neurolief for significant market penetration post-FDA approval.
The partnership aims to address a critical gap in mental health care, particularly for patients who have limited access to clinic-based treatments due to factors such as childcare, employment, or geographical constraints.
BrainsWay (NASDAQ: BWAY) has made a strategic investment in Neurolief Ltd. through a $5 million convertible loan with an option to acquire the company. Neurolief is developing the first wearable, non-invasive, multi-channel brain neuromodulation platform for at-home use.
The agreement includes potential additional milestone-based funding: a $6 million convertible loan upon FDA approval of Neurolief's Proliv Rx system for Major Depressive Disorder (MDD), and a $5 million equity investment upon reaching specific revenue targets. BrainsWay has also secured a call option to acquire Neurolief's outstanding equity during defined exercise windows.
Neurolief's Proliv™Rx device is currently pending FDA Premarket Approval and, if granted, will become the first FDA-cleared medical device for MDD treatment that can be administered outside clinical settings. The company's Relivion®MG therapy is already approved in the U.S., Europe, and Japan for migraine treatment.
BrainsWay (NASDAQ & TASE: BWAY), a leader in noninvasive neurostimulation treatments, has announced a strategic equity investment in Axis Integrated Mental Health, a Colorado-based mental health clinic management services organization. The investment consists of an initial $2.3 million with a potential additional $1 million milestone-based investment for a minority stake in Axis.
This investment follows BrainsWay's previous stake in Stella and aligns with the company's strategy to accelerate access to innovative mental health treatments, including their Deep TMS Therapy. The investment will be structured as a preferred, annually compounding security with a redemption mechanism, enabling Axis to expand its services and grow from a regional platform to a larger footprint.
BrainsWay (NASDAQ: BWAY), a leader in noninvasive neurostimulation treatments, reported strong Q2 2025 financial results. The company achieved record quarterly revenue of $12.6 million, up 26% year-over-year, with a net profit of $2.0 million, representing a 233% increase.
Key operational highlights include shipping 88 Deep TMS™ systems (35% YoY increase), reaching a total installed base of 1,522 systems. The company maintained a strong 75% gross margin and increased Adjusted EBITDA by 16% to $1.5 million. Notably, 70% of new customer engagements are structured as multi-year lease agreements, with remaining performance obligations of $62 million.
Based on strong performance, BrainsWay raised its full-year 2025 guidance to revenues between $50-52 million, with operating income of 4-5% and Adjusted EBITDA of 12-13%. The company also entered a strategic equity financing transaction with Stella MSO, LLC, expanding its mental health provider network.
BrainsWay (NASDAQ:BWAY), a leader in noninvasive neurostimulation treatments, has announced the sponsorship of two free Continuing Medical Education (CME) courses focused on Transcranial Magnetic Stimulation (TMS). The courses, worth 0.5 AMA PRA Category 1 Credits™ each, are led by prominent psychiatry experts.
The first course, presented by Dr. David Feifel, covers evidence-based TMS data and technology distinctions. The second course, led by experts from Brown University, Harvard Medical School, and Sheppard Pratt, focuses on practical patient application strategies. BrainsWay's Deep TMS™ technology is uniquely FDA-cleared for treating depression, anxious depression, late-life depression, OCD, and smoking addiction.
BrainsWay (NASDAQ & TASE: BWAY), a leader in noninvasive neurostimulation treatments for mental health disorders, has scheduled its second quarter 2025 financial results announcement for August 13, 2025, before U.S. markets open.
The company will host a conference call and webcast at 8:30 AM Eastern Time to discuss financial results and operational highlights. The call will be accessible via multiple dial-in numbers and will be available for replay on the company's investor relations website for 30 days.
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