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 on August 18, 2021, that it received 510(k) clearance from the FDA for its Deep Transcranial Magnetic Stimulation (Deep TMS™) System. This allows BrainsWay to market its system for reducing anxiety symptoms in adults with depression, enhancing its existing depression indication. The company presented data from 573 patients across 11 studies, showing clinically meaningful treatment effects. This clearance broadens its reach in the mental health market, potentially impacting millions suffering from anxious depression, as 60-90% of depressed patients exhibit anxiety symptoms.
BrainsWay Ltd. reported a strong Q2 2021 performance, achieving total revenues of $7.0 million, a 45% increase year-over-year. The installed base of Deep TMS™ systems rose to 682, marking a 20% growth. The company is gaining traction in OCD reimbursement, with key coverage policies from Centene and HCSC impacting 42 million covered lives. Operating loss was $1.5 million, up from $215 thousand in Q2 2020, while cash reserves increased to $55.9 million.
BrainsWay Ltd. (NASDAQ: BWAY) announced it will report its second quarter 2021 financial results and operational highlights on August 11, 2021, before U.S. markets open. A conference call will follow at 8:30 AM ET to discuss these results and business updates. BrainsWay is recognized for its advanced noninvasive neurostimulation treatments for mental health disorders, utilizing its proprietary Deep TMS™ technology. The company has achieved FDA clearance for three indications, including major depressive disorder, and continues expanding clinical trials for additional disorders.
On July 13, 2021, MindPath Care Centers announced an open house on July 15 to showcase BrainsWay’s Deep Transcranial Magnetic Stimulation (Deep TMS) treatment for major depressive disorder (MDD) and obsessive-compulsive disorder (OCD) in Charlotte, NC. The event will allow local mental health clinicians to witness live demonstrations of the Deep TMS device, which administers magnetic waves via a helmet. It is FDA-cleared for MDD since 2013 and OCD since 2018. Patients can return to normal activities post-treatment, enhancing access to care for those with treatment-resistant conditions.
BrainsWay Ltd. (NASDAQ: BWAY) announced that Christopher von Jako, Ph.D., President and CEO, will present at the Ladenburg Thalmann 2021 Healthcare Conference on July 14, 2021, at 2:30 PM ET. The company will also facilitate one-on-one investor meetings during the conference. BrainsWay specializes in advanced noninvasive neurostimulation treatments for mental health disorders and is recognized for its FDA-cleared indications including major depressive disorder and obsessive-compulsive disorder.
BrainsWay (NASDAQ: BWAY), a leader in noninvasive neurostimulation, announced CEO Christopher von Jako will present at the Raymond James Human Health Innovation Conference on June 21, 2021, at 10:00 AM ET. The event will include one-on-one investor meetings. BrainsWay is recognized for its proprietary Deep TMS technology, with FDA clearance for major depressive disorder, obsessive-compulsive disorder, and smoking addiction. The company aims to expand awareness and access to its innovative treatments, leveraging clinical evidence to advance mental health care.
BrainsWay (NASDAQ: BWAY) announced participation in two significant global medical conferences: the Clinical TMS Society Annual Meeting from June 10-12 and the Psych Congress Elevate from June 11-13, 2021. At the Clinical TMS Society event, BrainsWay will present seven posters showcasing the benefits of Deep TMS™ for mental health disorders, along with two showcase presentations. Dr. David Feifel will present at the Psych Congress discussing evidence for Deep TMS in OCD and smoking cessation. The company is focused on advancing innovative treatments for mental health issues.
BrainsWay Ltd. (NASDAQ: BWAY) announced a positive coverage policy from Health Care Service Corporation (HCSC) for its Deep TMS™ system, effective June 15, 2021, for treating obsessive-compulsive disorder (OCD). HCSC, covering approximately 17 million members, is a significant health insurer in the U.S. This coverage marks a milestone for BrainsWay, following other recent coverage announcements for OCD. The company aims to expand positive coverage from additional systems. OCD affects 2.3% of the U.S. population, resulting in a healthcare burden exceeding $7 billion annually.
BrainsWay Ltd. announced the publication of a draft Local Coverage Determination (LCD) by Palmetto GBA for its Deep TMS™ system, aimed at treating obsessive-compulsive disorder (OCD). This coverage proposal affects over 9 million Medicare patients across seven states. BrainsWay's management expressed optimism about improved access to treatment for patients unresponsive to standard therapies. The draft LCD aligns with clinical guidelines and follows a recent positive coverage decision from Centene. A formal meeting for public comments will take place before a final policy is issued.
BrainsWay Ltd. (NASDAQ: BWAY) announced that Centene Corporation will provide coverage for its Deep Transcranial Magnetic Stimulation (TMS) treatment for obsessive-compulsive disorder (OCD). This policy covers approximately 25 million members across the U.S. The decision follows a thorough review of clinical evidence supporting the safety and efficacy of Deep TMS. Centene’s coverage marks a significant development in expanding access to this treatment, particularly for patients resistant to standard therapies. The economic burden of OCD treatments exceeds $7 billion annually in the U.S.