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 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.
BrainsWay Ltd. (NASDAQ: BWAY) has successfully closed its underwritten public offering of 5,315,300 American Depositary Shares (ADSs), including 693,300 ADSs from underwriters’ full exercise of their option to purchase additional ADSs, priced at $8.50 per ADS. The offering generated approximately $45.2 million in gross proceeds. Oppenheimer & Co. Inc. led the offering, with Ladenburg Thalmann and Northland Capital Markets as co-managers. The funds will aid in expanding BrainsWay's non-invasive neurostimulation products aimed at treating various brain disorders.
BrainsWay Ltd. (NASDAQ: BWAY) announced a public offering of 4,622,000 American Depositary Shares at $8.50 each, aiming to raise about $39.3 million. The share offering includes a 30-day option for underwriters to purchase an additional 693,300 ADS. Proceeds will support commercial expansion and general corporate purposes, including R&D and marketing. The offering is under SEC registration. Closing is expected on February 25, 2021. Oppenheimer & Co. acts as the sole book-running manager, with Ladenburg Thalmann and Northland Capital as co-managers.
BrainsWay Ltd. (NASDAQ: BWAY) announced plans for an underwritten public offering of American Depositary Shares (ADS), each representing two ordinary shares. The company may grant underwriters a 30-day option for an additional 15% of ADS sold. Proceeds will support commercial expansion and general corporate purposes, including R&D and regulatory matters. The offering is subject to market conditions and is registered under an existing SEC statement. Oppenheimer & Co. Inc. is the sole book-running manager for this offering.
BrainsWay Ltd (NASDAQ & TASE: BWAY) announced the appointment of Fran Hackett as Vice President of North American Sales, effective February 16, 2021. Hackett, a seasoned sales executive with over 30 years of experience, is expected to enhance the company's growth trajectory in the non-invasive treatment of brain disorders. His previous roles include Senior VP of Global Sales at Alter G and CEO of RTI Group. The company aims to expand awareness and access to its Deep Transcranial Magnetic Stimulation (Deep TMS) technology, which has FDA approval for several conditions.
BrainsWay Ltd. (NASDAQ & TASE: BWAY) reported strong preliminary Fourth Quarter Financial Results, with quarterly revenues between $6.8 million and $7.1 million, marking a sequential rise of up to 18.3% and a year-over-year increase of up to 12.7%. Full-year revenues were approximately $21.8 million to $22.1 million, reflecting a decline of 4.3% to 5.6% due to COVID-19 impacts. BrainsWay's installed base of Deep TMS systems grew by 18.7% year-over-year, totaling 629 systems. The company maintains a debt-free status with $17.1 million in cash as of December 31, 2020.