BrainsWay Ltd. reports developments in noninvasive neurostimulation treatments for mental health disorders. The company markets its proprietary Deep TMS platform, with FDA-cleared indications that include major depressive disorder, obsessive-compulsive disorder, and smoking addiction, and derives revenue from leases and sales of Deep TMS systems.
Recurring updates include financial results, operating guidance, system placements, reimbursement and payer coverage for TMS therapy, clinical data for Deep TMS protocols such as SWIFT, and additional regulatory clearances. Company news also covers strategic minority-stake and milestone-based investments in mental health providers and related neurostimulation technologies, along with investor conference participation and operational updates across its U.S. and Israel-based business.
BrainsWay (NASDAQ & TASE: BWAY) announced a strategic minority-stake equity financing in Canadian provider BrainStim Health on Feb 19, 2026.
BrainsWay will invest an initial $1.0 million, with up to an additional $1.5 million via two milestone-based investments, in a preferred, annually compounding security; the deal includes a redemption mechanism and marks BrainsWay's fifth minority-stake clinical investment.
BrainsWay (NASDAQ: BWAY) commented on Evernorth Behavioral Health's decision to remove prior authorization for transcranial magnetic stimulation (TMS) for contracted providers, effective March 6, 2026. Evernorth serves over 18 million covered lives across 12 states and covers TMS for major depressive disorder and OCD. BrainsWay said the change should reduce administrative barriers and accelerate patient access to its Deep TMS systems.
BrainsWay (NASDAQ: BWAY) will change its ADS-to-ordinary share ratio from 2-to-1 to 1-to-1, effective prior to trading on March 3, 2026. Each ADS holder will receive one additional ADS per ADS held, equivalent to a 2-for-1 forward split of ADSs.
The ADSs will continue trading under the symbol BWAY; ordinary shares on the Tel Aviv Stock Exchange are unaffected. Because each ADS will represent half the ordinary shares after the change, the ADS trading price is expected to be roughly divided in half.
BrainsWay (NASDAQ: BWAY) said Highmark Blue Cross Blue Shield released a draft medical policy expanding coverage to adolescent and adult major depressive disorder (MDD) patients for the company’s accelerated Deep TMS SWIFT protocol.
The policy covers an acute course of five 10-minute sessions/day for six days, then two sessions/day weekly for four weeks (38 sessions total), and is expected to take effect in February 2026 after an open comment period. Highmark serves over 7 million covered lives in Pennsylvania, Delaware, West Virginia and parts of New York.
The company noted FDA clearance for the accelerated protocol in September 2025 and cited a multisite randomized non-inferiority trial reporting an 87.8% response rate and 78.0% remission rate.
BrainsWay (NASDAQ: BWAY) announced that the U.S. FDA granted Premarket Approval (PMA) to Neurolief's Proliv™Rx neuromodulation system on January 12, 2026, as a Class III adjunctive treatment for adults with major depressive disorder (MDD) who failed to improve after at least one antidepressant.
The approval makes Proliv™Rx the first and only FDA‑labeled at‑home neuromodulation therapy for treatment‑refractory MDD and follows BrainsWay's strategic investment in Neurolief, which includes an option to acquire the company and plans for commercial and research synergies.
BrainsWay (NASDAQ: BWAY) announced that Premera Blue Cross Blue Shield has adopted a final medical policy expanding coverage for BrainsWay’s accelerated SWIFT Deep TMS protocol to patients ages 15 and older with moderate to severe major depressive disorder. Premera covers about 2.8 million lives across Alaska and Washington.
The SWIFT protocol features an acute phase of five 10-minute sessions per day for six days, then two sessions per day once weekly for four weeks, totaling 38 sessions. The protocol requires no functional MRI or expensive neuronavigation. Company statements referenced clinical trial and real-world evidence showing comparable response and remission versus standard Deep TMS.
BrainsWay (NASDAQ: BWAY) announced that Optum Behavioral Health expanded its medical policy to cover Deep TMS for adolescents aged 15 and older with confirmed major depressive disorder (MDD). Optum serves over 48 million covered lives.
BrainsWay said the move aligns Optum with other payers that collectively cover about 180 million lives. The company noted Deep TMS is FDA cleared as an adjunct therapy for adolescents and highlighted an estimated 5 million U.S. adolescents aged 15–21 who experience major depression.
BrainsWay (NASDAQ: BWAY) will host a virtual Analyst & Investor Day on Monday, December 1, 2025 at 10:00 AM ET to outline its growth strategy and provide an overview of its patented Deep TMS™ treatment.
Management will feature Dr. Owen Scott Muir discussing clinical experience and unmet needs for conditions treated with Deep TMS, and Michael Gershenzon discussing BrainsWay’s strategic minority-stake investment in Stella and clinical operations experience. The program will cover Deep TMS, its accelerated protocol, and include a live Q&A. Registration details are available via the company.
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.