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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.
BURLINGTON, Mass. and JERUSALEM, Feb. 01, 2022 – BrainsWay (NASDAQ: BWAY), a leader in noninvasive neurostimulation for mental health disorders, announced its CEO, Christopher von Jako, will present at the BTIG MedTech, Digital Health, Life Science & Diagnostic Tools Conference from February 15-17, 2022. A fireside chat is scheduled for February 15 at 9:30am ET. The company aims to enhance awareness and access to its Deep TMS technology, which treats conditions like major depressive disorder and smoking addiction. Investors interested in meetings should contact their BTIG representative.
BrainsWay Ltd. (NASDAQ: BWAY) announced that the Medicare Administrative Contractor, Palmetto GBA, will cover the Deep TMS™ system for treating Obsessive-Compulsive Disorder (OCD) in seven states, effective March 13, 2022. This coverage expands access to over 9 million additional Medicare patients, bringing the total to approximately 60 million covered lives. The decision underscores the clinical efficacy of Deep TMS for OCD treatment, aligning with the Clinical TMS Society's recommendations.
BrainsWay Ltd. (NASDAQ: BWAY) has appointed Professor Markus Heilig, an expert in addiction and anxiety treatment, to its scientific advisory board. Professor Heilig, who has a notable background in neuroscience and previously directed clinical research at the National Institute on Alcohol Abuse and Alcoholism, will guide BrainsWay's research strategies, particularly in Deep TMS™ therapy. This appointment underscores BrainsWay's commitment to advancing neuroscience amid urgent mental health needs and aims to enhance treatment efficacy for mental health disorders.
BrainsWay Ltd. (NASDAQ: BWAY) announced promising research data validating the durability and cost-effectiveness of Deep TMS for treating Obsessive-Compulsive Disorder (OCD). Key findings from studies published in peer-reviewed journals indicate that 86.7% of patients experienced treatment durability of over one year, with significant reductions in functional disability. Additionally, Deep TMS was shown to be a cost-effective alternative compared to other treatment methods, addressing a significant healthcare burden exceeding $7 billion annually in the U.S.
BrainsWay Ltd. has published findings from a randomized, placebo-controlled pilot study on its Deep TMS™ System aimed at reducing alcohol consumption and cravings in adults with Alcohol Use Disorder (AUD). Conducted with 46 subjects, results showed a significant decrease in heavy drinking days—2.9 for the treatment group compared to 10.6 for placebo. The study highlights the potential of Deep TMS in addressing AUD, particularly amidst rising cases exacerbated by the pandemic. No serious adverse events were reported, marking a promising step for future treatments in this area.
BURLINGTON, Mass. and JERUSALEM, Nov. 30, 2021 – BrainsWay (NASDAQ: BWAY), a leader in noninvasive neurostimulation treatments for mental health disorders, announced that CEO Christopher von Jako, Ph.D., will present at the Sidoti December Micro-Cap Investor Conference on December 9, 2021, at 10 am EST. The event, occurring December 8-9, will also feature one-on-one investor meetings. BrainsWay's Deep TMS technology is FDA-cleared for major depressive disorder, OCD, and smoking addiction. For more details, visit www.brainsway.com.
BrainsWay Ltd. (BWAY) reported a 34% revenue growth year-over-year, reaching $8.1 million for Q3 2021, driven by high demand for its Deep TMS therapy. The company achieved a total revenue of $21.2 million for the first nine months, marking a 41% increase compared to the same period in 2020. The installed base of Deep TMS systems rose by 22% to 717 units. Regulatory clearance was obtained for Deep TMS therapy for treating anxious depression, adding to its portfolio. Despite a net loss of $1.8 million in Q3, cash reserves increased to $55.3 million.
BrainsWay Ltd. (NASDAQ: BWAY), a leader in noninvasive neurostimulation for mental health, will report its Q3 2021 financial results on November 17, 2021, before U.S. market opening. The company plans to host a conference call at 8:30 AM ET to discuss the results and update on operations. BrainsWay is recognized for its Deep TMS™ technology, which is FDA-cleared for major depressive disorder, obsessive-compulsive disorder, and smoking addiction. The call will be available for replay for 30 days.
BrainsWay Ltd. (NASDAQ: BWAY) has appointed Dr. Zafiris Daskalakis to its scientific advisory board, enhancing its expertise in brain stimulation. Dr. Daskalakis, Chair of Psychiatry at UCSD, brings extensive research knowledge and over 450 publications in neurophysiology and psychiatric disorders. This strategic addition aims to strengthen BrainsWay’s growth and clinical impact as it seeks to expand the application of its Deep TMS™ technology for mental health treatment. CEO Christopher von Jako emphasized the importance of Dr. Daskalakis’s insights in navigating the company's future.
BrainsWay Ltd. (NASDAQ: BWAY) has released promising data from a pivotal clinical trial published in World Psychiatry, supporting its Deep TMS™ treatment for smoking addiction. Conducted across 12 U.S. and 2 Israeli sites with 262 chronic smokers, the trial showed over 25% of patients achieving a minimum of 4 weeks of abstinence. The treatment, which is FDA-cleared, demonstrated significant reductions in smoking behavior. BrainsWay is engaged in a controlled market release to refine its business model and gather post-marketing data.
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