Brainsway Ltd. Stock Price, News & Analysis

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.

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.