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BrainsWay Ltd (BWAY) delivers innovative neurostimulation solutions through its FDA-cleared Deep TMS technology, offering noninvasive treatment for mental health disorders. This news hub provides investors and healthcare professionals with essential updates on clinical advancements, regulatory milestones, and corporate developments.
Access timely information about earnings reports, research collaborations, and therapeutic applications of Deep TMS technology. Our curated collection features official press releases and verified news covering treatment efficacy studies, global expansion efforts, and strategic partnerships.
Discover updates on BrainsWay's progress in addressing major depressive disorder, OCD, and addiction treatment through its patented magnetic stimulation platform. The resource serves investors monitoring neurotechnology trends and clinicians seeking evidence-based therapeutic innovations.
Bookmark this page for structured access to BWAY's latest developments in neuromodulation science and mental health treatment advancements. Stay informed about breakthrough clinical data and operational updates from this leader in noninvasive brain stimulation solutions.
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.