Brainsway Ltd. Stock Price, News & Analysis

BrainsWay (NASDAQ: BWAY) launched a multicenter, randomized, double-blind, sham-controlled clinical trial using its next-generation Deep TMS 360 system to treat Alcohol Use Disorder (AUD). The study will enroll >200 adults aged 18–86 with moderate-to-severe AUD, run for approximately six months with an intensive 3–5 week phase and weekly maintenance, and uses the FDA-recognized primary endpoint of no heavy drinking days (NHDD) during the initial four-month treatment period.

Sites span multiple US states and select international locations in Israel and Sweden; each visit includes two sessions per day and behavioral education components.

BrainsWay (NASDAQ: BWAY) announced on Nov 13, 2025 that the FDA has expanded the Deep TMS™ label to permit use as an adjunct therapy for adolescents aged 15–21 with major depressive disorder (MDD). The clearance followed real-world data from 1,120 adolescents treated across 35 U.S. centers (2012–2024), showing a 12.1-point average PHQ-9 improvement after 36 sessions and a 66.1% response rate. The system remains indicated for adults who failed prior antidepressant treatment and now covers the broadest age range for a TMS system.

BrainsWay (NASDAQ: BWAY) reported strong Q3 2025 results: revenue +29% to $13.5M, adjusted EBITDA +81% to $2.0M, operating income $1.3M, and net profit $1.6M. Gross margin was 75% and cash totaled $70.7M as of Sept 30, 2025.

The company shipped 90 Deep TMS systems in Q3 (installed base >1,600), holds $65M of remaining performance obligations, and notes ~70% of new engagements are multi-year leases. FDA cleared an accelerated Deep TMS protocol for MDD. Full-year 2025 guidance midpoint was raised to $51M–$52M revenue with higher margin and EBITDA ranges.

BrainsWay (NASDAQ: BWAY) announced that the U.S. National Institutes of Health awarded a grant of approximately $2.5 million over five years to a Stanford-led team to study an accelerated Deep TMS protocol for Alcohol Use Disorder (AUD). The randomized, double-blind, sham-controlled trial will enroll 100 adults and deliver an accelerated schedule of three Deep TMS sessions per day for 10 business days (30 sessions) using BrainsWay’s H7 Coil.

The mechanistic study will use neuroimaging to assess target engagement in regions such as the dorsal anterior cingulate cortex and link brain changes to clinical outcomes including percentage days abstinent and heavy drinking days. This is the second major NIH grant to this team in two years and follows recent FDA clearance for BrainsWay’s H1 Coil for accelerated MDD treatment.

BrainsWay (NASDAQ: BWAY) will report third quarter 2025 financial results and operational highlights before U.S. market open on Tuesday, November 11, 2025. The company will host a conference call and webcast at 8:30 AM ET to discuss results and business updates.

Dial-in numbers, conference ID 10203968, and a live webcast will be available; the replay will be posted on the investor website for 30 days. Investors are asked to register at least 10 minutes early.

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.