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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 (NASDAQ & TASE: BWAY) reported strong Q2 2024 financial results, with 28% year-over-year revenue growth to $10 million. The company achieved positive net income for the third consecutive quarter and positive Adjusted EBITDA for the fourth consecutive quarter. Key highlights include:
- Gross margin increased to 75% from 73% in Q2 2023
- Operating income of $0.6 million, compared to a $1.3 million loss in Q2 2023
- Net income of $0.6 million, compared to a $1.7 million loss in Q2 2023
- Adjusted EBITDA of $1.2 million, compared to a $0.6 million loss in Q2 2023
- Cash and equivalents of $48.1 million as of June 30, 2024
BrainsWay raised its full-year 2024 revenue guidance to $38.5-$40 million, representing 21-25% growth over 2023. The company expects continued profitability and positive cash generation in H2 2024.
BrainsWay (NASDAQ & TASE: BWAY), a leader in noninvasive neurostimulation treatments for mental health disorders, has announced its plan to report second quarter 2024 financial results on August 6, 2024, before U.S. financial markets open. The company will host a conference call and webcast at 8:30 AM Eastern Time to discuss results and provide operational updates.
Investors can access the call via phone or webcast. The webcast will be available for replay for 30 days on BrainsWay's investor relations website. This announcement provides shareholders and analysts with a scheduled opportunity to review the company's financial performance and engage with management about recent developments and future prospects.
BrainsWay has announced an exclusive multi-year distribution agreement to market its Deep Transcranial Magnetic Stimulation (Deep TMS) system in Canada. The agreement involves a specialty distributor serving acute and non-acute healthcare sectors, and includes minimum quantity orders, starting with 11 systems in 2024. BrainsWay’s CEO, Hadar Levy, emphasized the significance of expanding into Canada to address the country's mental health crisis. The Deep TMS system, which uses a patented coil design to stimulate brain neural networks, is currently approved in Canada for treating major depressive disorder and obsessive-compulsive disorder.
BrainsWay has launched a new clinical trial to evaluate an accelerated treatment protocol for its Deep Transcranial Magnetic Stimulation (Deep TMS) system, targeting major depressive disorder (MDD). This multicenter, randomized, controlled trial will compare a novel accelerated protocol to the FDA-cleared standard-of-care protocol. Over 100 patients will participate, with one group receiving an acute treatment phase over several days and the other over several weeks. The trial aims to determine if the accelerated protocol is as effective as the traditional method. Recruitment is ongoing across multiple U.S. sites.
BrainsWay has announced that the FDA has expanded the indication for its Deep Transcranial Magnetic Stimulation system (Deep TMS™) to treat major depressive disorder (MDD) in patients aged 22 to 86, extending beyond the previous age limit of 68. This marks the company's 10th FDA clearance, making their Deep TMS the only TMS device approved for depression treatment in patients over 68. The expanded labeling is supported by clinical data showing significant response and remission rates in older patients. BrainsWay sees this as a promising business opportunity, given the rising life expectancy and the need for effective depression treatments in the elderly.
BrainsWay reported a 37% year-over-year revenue growth in Q1 2024, achieving positive net income for the second consecutive quarter. The company also recorded positive Adjusted EBITDA and cash flow from operations for the third consecutive quarter. Revenues reached $9.1 million, with a gross margin of 75%. Operating income was $0.1 million compared to a loss of $3.7 million in the same period last year. Net income was $0.1 million, an improvement from a net loss of $2.4 million in Q1 2023. The Company's cash, cash equivalents, and short-term deposits stood at $47.8 million as of March 31, 2024. BrainsWay shipped 57 Deep TMS™ systems in Q1 2024, bringing the total installed base to 1,158 systems. Collaboration with partner Katie’s Way Plus expanded, and the Company installed its 11th Deep TMS system in Israel. With strong Q1 results, BrainsWay reaffirmed its full-year 2024 revenue guidance of $37 million to $40 million, expecting continued growth and profitability throughout the year.
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