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BrainsWay Ltd. reports developments in noninvasive neurostimulation treatments for mental health disorders. The company markets its proprietary Deep TMS platform, with FDA-cleared indications that include major depressive disorder, obsessive-compulsive disorder, and smoking addiction, and derives revenue from leases and sales of Deep TMS systems.
Recurring updates include financial results, operating guidance, system placements, reimbursement and payer coverage for TMS therapy, clinical data for Deep TMS protocols such as SWIFT, and additional regulatory clearances. Company news also covers strategic minority-stake and milestone-based investments in mental health providers and related neurostimulation technologies, along with investor conference participation and operational updates across its U.S. and Israel-based business.
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.
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.