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About BrainsWay Ltd. (BWAY)
BrainsWay Ltd. is a global leader in the field of non-invasive neurostimulation, dedicated to advancing mental health care through its proprietary Deep Transcranial Magnetic Stimulation (Deep TMS™) technology. With headquarters in Jerusalem, Israel, and Burlington, Massachusetts, BrainsWay leverages cutting-edge neuroscience to provide innovative solutions for psychiatric, neurological, and addiction disorders. The company's mission is to improve health and transform lives by offering safe, effective, and clinically validated treatments for conditions that have historically been challenging to manage.
Core Technology and FDA-Cleared Indications
BrainsWay’s Deep TMS platform utilizes a patented coil design to deliver targeted magnetic pulses to specific brain regions involved in mental health disorders. This technology is the first and only TMS system to receive FDA clearance for three distinct indications: major depressive disorder (MDD), obsessive-compulsive disorder (OCD), and smoking addiction. The system has also demonstrated efficacy in reducing anxiety symptoms associated with depression, commonly referred to as anxious depression.
Unlike traditional TMS, which offers more superficial stimulation, Deep TMS is designed to penetrate deeper and broader brain regions, making it particularly effective for patients who may not respond to other treatments. The therapy is non-invasive, requires no anesthesia, and is free from systemic side effects, making it a highly convenient option for patients. Treatment protocols typically involve brief daily sessions over several weeks, followed by maintenance phases as needed.
Business Model and Revenue Streams
BrainsWay generates revenue through the sale and leasing of its Deep TMS systems to mental health care providers, hospitals, and clinics worldwide. Additionally, the company benefits from recurring revenue streams through the sale of consumables and maintenance services associated with its systems. This hybrid model ensures both upfront and long-term revenue generation, supporting the company’s growth and operational sustainability.
Clinical Efficacy and Ongoing Research
BrainsWay’s commitment to advancing mental health care is underscored by its robust clinical research program. The company has conducted numerous clinical trials demonstrating the efficacy of Deep TMS in treating a wide range of conditions, including MDD, OCD, and smoking addiction. Recent studies have also explored its potential applications in late-life depression, Parkinson’s disease, and substance use disorders such as alcohol addiction. These efforts aim to expand the indications for Deep TMS, further solidifying its position as a transformative treatment option in mental health care.
Market Context and Competitive Landscape
The global mental health crisis, exacerbated by rising rates of depression, anxiety, and addiction, has created a significant demand for effective, non-invasive treatment options. BrainsWay addresses this unmet need by offering a scientifically validated alternative to traditional pharmacological therapies, which often come with limited efficacy and adverse side effects. Within the competitive landscape, BrainsWay differentiates itself through its patented Deep TMS technology, extensive clinical evidence, and global reach. The company’s focus on underserved populations, such as older adults and veterans, further enhances its market appeal.
Global Reach and Strategic Partnerships
BrainsWay’s international presence spans North America, Europe, South America, and the Middle East, reflecting its commitment to increasing global access to advanced mental health care. The company has established strategic partnerships with mental health networks, hospitals, and specialized care providers, enabling it to expand the reach of its Deep TMS systems. Notable collaborations include initiatives to address the unique mental health challenges faced by veterans and military personnel, as well as efforts to make treatment accessible in underserved regions.
Future Outlook
With ongoing clinical trials, a growing portfolio of FDA-cleared indications, and a strong commitment to innovation, BrainsWay is well-positioned to lead the neurostimulation market. The company’s focus on addressing critical mental health challenges, combined with its scalable business model and global footprint, underscores its potential to transform the landscape of mental health care.
Conclusion
BrainsWay Ltd. represents a unique convergence of advanced neuroscience, innovative technology, and a mission-driven approach to improving mental health. By offering safe, effective, and non-invasive treatment options, the company is redefining the standard of care for mental health disorders and paving the way for a healthier future.
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.
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.
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