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BrainsWay Ltd. (NASDAQ & TASE: BWAY) is a leading global neurostimulation company headquartered in Jerusalem and the U.S., specializing in advanced noninvasive treatments for mental health disorders. With its proprietary Deep Transcranial Magnetic Stimulation (Deep TMS) technology, BrainsWay has revolutionized the field of brain disorder treatment, offering hope to millions of patients worldwide.
The company's innovative solutions target major depressive disorder (MDD), obsessive-compulsive disorder (OCD), and smoking addiction. BrainsWay's Deep TMS is FDA-cleared for its efficacy in treating these conditions. Clinical trials are ongoing for additional indications, including various psychiatric, neurological, and addiction disorders, aiming to expand the reach of this cutting-edge technology.
BrainsWay's treatments are non-invasive, safe, and convenient, typically requiring only brief daily sessions over a few weeks. This approach has already treated over 10,000 patients, delivering significant improvements without long-term side effects. The company leases and sells its Deep TMS systems, generating revenue while expanding its global footprint.
Recent collaborations, such as the partnership with Katie’s Way for providing mental health care to U.S. servicemembers, veterans, and their families, highlight BrainsWay's commitment to addressing critical mental health needs. This partnership underscores the transformative impact of Deep TMS technology in treating depression, particularly within the military community, where mental health issues are on the rise.
BrainsWay has also achieved significant milestones, such as being the first TMS company to receive three FDA-clearances for different indications, backed by pivotal clinical studies. The company's financial health is robust, with a reported 37% year-over-year revenue growth in the first quarter of 2024 and positive net income for consecutive quarters.
Looking ahead, BrainsWay continues to pursue innovations, including a clinical trial comparing accelerated Deep TMS protocols with standard treatments. This trial aims to enhance the convenience and appeal of Deep TMS, potentially broadening its market reach.
For more information about BrainsWay and its latest news, visit the company's website or follow their updates on StockTitan.
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.
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.
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