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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. announces positive coverage from Highmark BCBS for its Deep TMS™ treatment of obsessive-compulsive disorder (OCD), effective May 2, 2022. This coverage benefits 6.8 million members across New York, Pennsylvania, West Virginia, and Delaware. With existing coverage from Health Care Service Corporation, nearly 70 million lives are now eligible for Deep TMS OCD treatment. BrainsWay remains the only TMS company with FDA clearance for OCD, backed by positive clinical data. The firm aims to enhance reimbursement for Deep TMS through continued engagement with major payors.
BrainsWay Ltd. (NASDAQ: BWAY) reported a 30% year-over-year revenue growth in Q1 2022, achieving total revenues of $8.0 million, up from $6.1 million in Q1 2021. The company's gross margin improved to 77%, while operating expenses increased to $7.6 million, leading to an operating loss of $1.5 million. Despite operational challenges due to the Omicron surge, the firm saw a 21% increase in its Deep TMS installed base, totaling 790 systems as of March 31, 2022. Leadership changes were also made to support long-term growth.
BrainsWay Ltd. has appointed Eric Hirt as Vice President of U.S. Sales, bringing over 20 years of medical device sales and marketing experience. Hirt's role will focus on promoting the company's Deep Transcranial Magnetic Stimulation (Deep TMS™) system, aimed at expanding its market presence and increasing demand for its FDA-cleared treatment indications. The company highlights its commitment to advancing mental health solutions through innovative technology, backed by robust clinical evidence.
BrainsWay Ltd. (NASDAQ: BWAY) will showcase its Deep TMS™ technology for treating major depressive disorder at the Clinical TMS Society Annual Meeting in Chicago. An analysis of real-world data from 1,750 patients supports the efficacy of Deep TMS. The company aims to enhance noninvasive neurostimulation through innovative technologies and research. Alongside depression, BrainsWay's treatment includes indications for obsessive-compulsive disorder and smoking addiction. The company has multiple upcoming presentations at psychiatric conferences throughout May and June 2022.
BrainsWay Ltd. (NASDAQ: BWAY) announced it will report its first-quarter financial results and operational highlights on May 11, 2022, before U.S. markets open. The company will host a conference call at 8:30 AM ET to discuss the results and provide business updates. BrainsWay specializes in advanced noninvasive neurostimulation treatments for mental health disorders and is known for its FDA-cleared Deep Transcranial Magnetic Stimulation (Deep TMS™) technology, with indications for major depressive disorder, obsessive-compulsive disorder, and smoking addiction.
BrainsWay Ltd. (NASDAQ: BWAY) appoints Dr. Joachim Seidel as the new Vice President of Corporate Development and Strategy, effective March 28, 2022. With over 20 years in the medical device sector, Dr. Seidel aims to drive strategic opportunities and enhance corporate development initiatives globally. His background includes leadership roles at Covidien, Medtronic, and PAREXEL, with a proven track record in market expansion and M&A. The company's focus on expanding its Deep TMS therapy aligns with its commitment to maximize stakeholder value.
BrainsWay Ltd. (NASDAQ: BWAY) announced a KOL webinar on Deep TMS™ Therapy for anxious depression set for March 22, 2022, at 10:30 am ET. KOL Shan H. Siddiqi, M.D. from Harvard Medical School will discuss the treatment landscape for anxious depression, where 60-90% of patients with major depressive disorder also experience anxiety. BrainsWay’s patented therapy is proven to reduce anxiety symptoms in depressed patients. Interested participants can register here.
BrainsWay Ltd. (NASDAQ: BWAY) reported a 34% revenue growth in 2021, reaching $29.7 million, compared to $22.1 million in 2020. Fourth-quarter revenues rose 20% to $8.5 million. The company improved its cash position to $57.3 million, reflecting positive operational cash flow. Notably, BrainsWay received a Local Coverage Determination from Medicare, expanding coverage for Deep TMS therapy to 60 million patients. Gross margins remained steady at 77%, while operating expenses increased to $8.0 million. The net loss for the year was $6.5 million.
Burlington, Mass., and Jerusalem, March 01, 2022 - BrainsWay Ltd. (NASDAQ: BWAY) announced that CEO Christopher von Jako, Ph.D., will present at the 32nd Annual Oppenheimer Healthcare Conference. The event will take place from March 15 to March 17, 2022, with BrainsWay's presentation scheduled for March 16 at 2:40 PM ET. The company specializes in noninvasive neurostimulation treatments for mental health disorders, including major depressive disorder and obsessive-compulsive disorder. Investors interested in meetings should contact their Oppenheimer representative.
BURLINGTON, Mass. and JERUSALEM, Feb. 28, 2022 – BrainsWay Ltd. (NASDAQ: BWAY) will report its fourth quarter and full year 2021 financial results on March 9, 2022, before U.S. markets open. A conference call and webcast, scheduled for 8:30 AM ET, will discuss the results and operational updates. BrainsWay is a leader in noninvasive neurostimulation for mental health, with FDA-cleared treatments for major depressive disorder, obsessive-compulsive disorder, and smoking addiction. The company aims to raise awareness and access to its Deep TMS technology, supported by robust clinical evidence.
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