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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. (NASDAQ: BWAY) announced positive results from a post-marketing study on its Deep TMS device for obsessive-compulsive disorder (OCD). The study demonstrated that 73% of participants showed a positive response to treatment, with 58% achieving a significant reduction in OCD symptoms after a full course of therapy. Additionally, 52% of patients sustained their improvement for at least one month. The results, published in the Journal of Psychiatric Research, will support reimbursement efforts for Deep TMS in OCD.
BrainsWay Ltd. (NASDAQ: BWAY) announced that it will release its third quarter 2020 financial results on November 18, 2020, before U.S. markets open. A conference call is scheduled for 8:30 AM ET to discuss these results and provide business updates. The Company specializes in non-invasive treatments for brain disorders using its Deep Transcranial Magnetic Stimulation technology, with FDA approvals for conditions like major depressive disorder and smoking addiction. More details will be available via webcast following the call.
BrainsWay, a leader in non-invasive brain disorder treatments, announced that CEO Dr. Christopher von Jako will present at the H.C. Wainwright 6th Annual Israel Conference on November 12 at 7:00 AM ET. The company will also engage in one-on-one investor meetings at the Oppenheimer Fall MedTech Summit on the same day.
BrainsWay specializes in Deep Transcranial Magnetic Stimulation (Deep TMS) and has received FDA approvals for treating major depressive disorder, obsessive-compulsive disorder, and smoking addiction. They are currently conducting clinical trials for various brain disorders.
BrainsWay Ltd (NASDAQ: BWAY) announced its #TheRealOCD campaign during OCD Awareness Week (October 11-17, 2020), aimed at educating the public on the misrepresentation of Obsessive-Compulsive Disorder (OCD). The campaign features a video with mental health influencers discussing the realities of living with OCD, as well as sharing stories from treated patients. BrainsWay's Deep Transcranial Magnetic Stimulation (Deep TMS) is highlighted as the only FDA-cleared noninvasive treatment for OCD. The initiative underscores the importance of accurate understanding and treatment of this mental health condition.
BrainsWay (NASDAQ: BWAY) announces the presentation of 10 posters at the annual Clinical TMS Poster session, emphasizing the advantages of Deep TMS in treating mental disorders. These presentations showcase a range of topics, including major depressive disorder and obsessive-compulsive disorder, demonstrating real-world applications. The company expressed optimism for future studies and the growing evidence supporting Deep TMS. The session remains accessible until December 31, 2020, enabling ongoing education despite the challenges posed by COVID-19.
BrainsWay, a leader in non-invasive brain disorder treatments, announced that CEO Christopher von Jako will present at the Oppenheimer Fall Healthcare Life Sciences & MedTech Summit on September 22, 2020, at 1:40 PM ET. The company specializes in Deep Transcranial Magnetic Stimulation (Deep TMS) technology, which has received FDA approval for various disorders, including major depressive disorder in 2013, obsessive-compulsive disorder in 2018, and smoking addiction in 2020. BrainsWay is actively conducting clinical trials across multiple psychiatric and neurological conditions.
BrainsWay, a leader in non-invasive brain disorder treatments, announced that CEO Christopher von Jako will present at two key conferences on September 15, 2020. The H.C. Wainwright 22nd Annual Global Investment Conference will take place at 2:00 PM ET, followed by the Cantor Fitzgerald Virtual Global Healthcare Conference at 10:00 AM ET on the same day. BrainsWay specializes in Deep Transcranial Magnetic Stimulation technology, with FDA approvals for conditions like major depressive disorder, obsessive-compulsive disorder, and smoking addiction.
BrainsWay Ltd. (NASDAQ: BWAY) achieved a significant milestone by receiving FDA 510(k) clearance for its Deep TMS system to assist in short-term smoking cessation in adults. This clearance marks the first FDA approval for a TMS device in the addiction sector. Based on a randomized study of 262 subjects, the Deep TMS group demonstrated a 17.1%-28.4% continuous quit rate compared to a 7.9%-11.7% rate in the sham group. With plans for a controlled U.S. market launch in early 2021, this advancement solidifies BrainsWay's leadership in the non-invasive treatment of brain disorders.
BrainsWay Ltd. (NASDAQ: BWAY) reported Q2 2020 revenues of $4.8 million, down 15% from Q2 2019 due to COVID-19-related disruptions. The installed base of Deep TMS systems rose 24% year-over-year to 567 systems, with significant reimbursement progress made for major depressive disorder treatments. The company achieved a 79% gross margin and reduced operating expenses to $4.0 million, down from $7.0 million in the previous year, leading to a smaller operating loss of $0.2 million compared to $2.7 million in 2019.
BrainsWay Ltd. (NASDAQ: BWAY) will announce its Q2 2020 financial results on August 12, 2020, before U.S. markets open. A conference call will take place at 8:30 AM ET to discuss the results and business updates. BrainsWay specializes in non-invasive treatments for brain disorders through its Deep TMS technology, which has FDA approval for treating major depressive disorder and obsessive-compulsive disorder. The company is currently conducting clinical trials for various neurological and psychiatric disorders. Forward-looking statements involve risks and uncertainties.
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