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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 & TASE: BWAY) has announced a significant leadership change, with Ami Boehm appointed as Chairman of the Board, succeeding co-founder David Zacut, M.D., who will now serve as a Director. Zacut co-founded the company in 2003 and played a crucial role in its development into a leader in noninvasive neurostimulation treatments for mental health disorders. Boehm, a seasoned professional in capital markets, brings extensive experience, having notably served as a partner at FIMI Opportunity Funds. This transition is expected to enhance shareholder value as BrainsWay pursues growth opportunities in its sector.
BrainsWay announced the publication of a comparative study validating the efficacy of its Deep Transcranial Stimulation (Deep TMS™) H1 and H7 coils for treating depression, published in The Journal of Clinical Investigation (JCI) Insight. The study involved 169 patients with treatment-resistant depression and showed that the H7 Coil demonstrated non-inferiority to the H1 Coil. Additionally, preliminary predictors for treatment optimization were identified. Notably, patients with high symptom severity had a 95% response rate with the H1 Coil. These findings emphasize the potential for personalized treatment approaches in mental health.
BrainsWay Ltd. (BWAY) announced that a major private insurance company in Washington state will extend coverage for its Deep Transcranial Magnetic Stimulation (Deep TMS™) for obsessive-compulsive disorder (OCD) starting February 3, 2023. This expansion affects approximately 2.2 million members and reduces the coverage criteria for major depressive disorder (MDD) from four to three failed medication trials. Since 2021, BrainsWay has significantly expanded its coverage, now reaching 90.5 million lives for OCD treatment, a substantial increase from 52.6 million.
BrainsWay Ltd. (NASDAQ: BWAY) announced the settlement of litigation with Neuronetics, Inc. in the District of Delaware. The settlement terms remain confidential, and BrainsWay did not admit liability. CEO Christopher von Jako emphasized the company's focus on advancing its Deep TMS™ therapy for patients. BrainsWay is recognized for its innovative neurostimulation treatments for various mental health disorders, holding three FDA clearances for its technology. The company remains committed to expanding the use of Deep TMS and conducting further clinical trials.
BrainsWay Ltd. (NASDAQ: BWAY) announced that independent Director Yossi Ben Shalom purchased 147,500 ADRs, totaling $277,300, at an average price of $1.88 each. This investment underscores his confidence in BrainsWay's strategic vision and its Deep TMS technology, which has proven effective in treating multiple mental health disorders. Other board members have also made similar open market purchases, reflecting a collective bullish outlook. BrainsWay continues to expand its research and clinical trials to enhance its market position in non-invasive neurostimulation treatments.
BURLINGTON, Mass. and JERUSALEM, Nov. 28, 2022 – BrainsWay Ltd. (NASDAQ: BWAY) reported significant open market stock purchases by its Chairman, Dr. David Zacut, and independent Director, Avner Hagai. Dr. Zacut acquired 431,797 shares for 1,607,676 NIS (approximately 3.72 NIS per share), increasing his stake to 6.71%. Mr. Hagai purchased 403,312 shares for 1,581,048 NIS (approximately 3.92 NIS per share), raising his ownership to 6.49%. Both purchases reflect confidence in the company's growth prospects and favorable industry trends.
BrainsWay (BWAY) reported a 36% revenue decline in Q3 2022, with total revenues of $5.2 million versus $8.1 million in Q3 2021. The company reported a gross margin of 74%, down from 76% the previous year, attributed to rising shipping costs and inventory obsolescence. Operating expenses increased to $8.7 million, leading to an operating loss of $4.9 million compared to a $1.2 million loss in 2021. Despite challenges, BrainsWay acknowledged positive reimbursement developments and a strong balance sheet, with cash reserves of $49.6 million.
BrainsWay Ltd. (NASDAQ: BWAY) announced that Premera Blue Cross will extend coverage for Deep TMS therapy for OCD starting February 3, 2023. This addition will benefit over 2.6 million members in the Pacific Northwest, increasing access to mental health treatments. With this announcement, the total number of insured lives for Deep TMS rises to approximately 90 million. The policy change for major depressive disorder (MDD) requires only three medication trials instead of four, reflecting evolving trends in mental health coverage.
BrainsWay Ltd. (NASDAQ: BWAY) will release its third quarter financial results and operational highlights on November 16, 2022, before U.S. market opening. A conference call scheduled for 8:30 AM ET will provide insights into the company’s performance and updates on business operations. BrainsWay specializes in noninvasive neurostimulation treatments for mental health disorders, with FDA-cleared technologies to treat major depressive disorder, obsessive-compulsive disorder, and smoking addiction. The call will be accessible via dial-in and webcast.
BrainsWay Ltd. has appointed Colleen A. Hanlon, Ph.D., a seasoned expert in brain stimulation research, as Vice President of Medical Affairs. Dr. Hanlon, with nearly 20 years of experience, will enhance the integration of medical intelligence for TMS providers and advance patient safety protocols. Previously a professor at Wake Forest University, she has secured over $12 million in NIH funding and published extensively in her field. BrainsWay is a leader in noninvasive neurostimulation treatments, focusing on major depressive disorder, OCD, and addiction.
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