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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 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.
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.