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 reported Q1 2021 revenues of $6.1 million, marking a 47% year-over-year increase. The operating loss was $2.1 million, including a $2.0 million one-time stock compensation expense. The company ended the quarter with $58.5 million in cash after raising $45.2 million through a public offering. BrainsWay successfully launched its Deep TMS system for smoking cessation and received FDA clearance for its new depression treatment protocol. The installed base of Deep TMS systems grew by 19% to 652 units.
BrainsWay announced that President and CEO Christopher von Jako, Ph.D., will present at the Oppenheimer MedTech, Tools & Diagnostics Summit on May 26, 2021. The company will also conduct one-on-one investor meetings during the event. BrainsWay is a leader in advanced noninvasive treatments for brain disorders, utilizing its proprietary Deep TMS technology. The FDA has cleared three indications for its treatments: major depressive disorder, obsessive-compulsive disorder, and smoking addiction. Additional clinical trials are ongoing to expand the reach of Deep TMS.
BrainsWay Ltd. (NASDAQ: BWAY) will report its first quarter 2021 financial results on May 20, 2021, before U.S. markets open. A conference call and webcast will follow at 8:30 AM ET to discuss these results and provide operational updates. BrainsWay is known for its advanced neurostimulation treatments, holding three FDA-cleared indications for mental health disorders including major depressive disorder. The company aims to expand awareness and access to its Deep Transcranial Magnetic Stimulation technology worldwide.
BrainsWay Ltd. (NASDAQ: BWAY) announced the appointment of R. Scott Areglado as Senior Vice President and Chief Financial Officer, effective immediately. This leadership change aims to strengthen financial operations as the company expands its commercial efforts in noninvasive neurostimulation treatments for mental health disorders. Areglado brings over 25 years of experience in finance within the medical technology sector, previously serving as CFO at iCAD, Inc. His leadership is expected to drive long-term growth and value for stakeholders amid increasing mental health awareness.
BrainsWay Ltd (NASDAQ: BWAY) has announced the distribution of its first 10 Deep Transcranial Magnetic Stimulation (Deep TMS) devices aimed at aiding short-term smoking cessation. This FDA-cleared treatment employs electromagnetic pulses to stimulate brain areas linked to addiction. A 2019 study of 262 smokers showed significant improvements in quit rates and reduction in cravings. The treatment is now accessible in multiple states, including clinics in Florida, New York, and Texas. BrainsWay aims to provide an effective noninvasive option for those struggling with tobacco addiction.
BrainsWay Ltd. announced FDA 501(k) clearance for its Theta Burst three-minute protocol using the Deep TMS system for treating major depressive disorder (MDD). This shorter treatment option aims to enhance patient access to care and improve flexibility for providers and patients. Clinical data from 146 subjects indicated significant reductions in depression scores for both the standard and three-minute protocols. The new protocol will be available immediately on all existing BrainsWay systems.
BrainsWay Ltd. announces that its noninvasive Deep TMS technology has treated 100,000 patients globally for depression, OCD, and smoking addiction. This technology, FDA-cleared for MDD since 2013 and OCD since 2018, now also aids short-term smoking cessation. With over 600 Deep TMS systems installed worldwide, BrainsWay emphasizes the potential to help millions in the future. The company has conducted over 30 clinical trials demonstrating the efficacy of its treatment, showcasing its commitment to enhancing mental health care.
BrainsWay Ltd. (NASDAQ: BWAY) reported its fourth quarter 2020 results, with revenues of $7.1 million, marking a 17% sequential increase and a 12% year-over-year rise. The company achieved a gross margin of 78% and an operating loss reduction to $0.4 million from $2.0 million in Q4 2019. Despite a full-year revenue decline of 5% to $22.1 million, net loss improved to $5.4 million, down from $10.3 million in 2019. Cash equivalents increased to $17.2 million at year-end, bolstered by a $45.2 million follow-on equity offering in March 2021.
BrainsWay Ltd. (NASDAQ: BWAY) will announce its fourth quarter and full year 2020 financial results on March 24, 2021, after market close. A conference call to discuss these results and provide business updates is scheduled for March 25, 2021, at 8:30 AM ET. The call can be accessed via phone or webcast, with replay available for 30 days post-event. BrainsWay is recognized for its non-invasive Deep Transcranial Magnetic Stimulation technology, FDA-approved for various disorders including major depressive disorder and obsessive-compulsive disorder.
BrainsWay Ltd. (NASDAQ: BWAY) has announced that Christopher von Jako, CEO, will present at the Oppenheimer 31st Annual Healthcare Conference from March 16-18, 2021. The presentation is scheduled for 10:00 AM ET on March 16, 2021. Investors can also participate in one-on-one meetings during the event. BrainsWay specializes in non-invasive neurostimulation products, having received FDA marketing authorization for treatments targeting major depressive disorder, obsessive-compulsive disorder, and smoking addiction.