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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) will announce its fourth quarter and full year 2020 financial results on March 24, 2021, after market close. A conference call to discuss these results and provide business updates is scheduled for March 25, 2021, at 8:30 AM ET. The call can be accessed via phone or webcast, with replay available for 30 days post-event. BrainsWay is recognized for its non-invasive Deep Transcranial Magnetic Stimulation technology, FDA-approved for various disorders including major depressive disorder and obsessive-compulsive disorder.
BrainsWay Ltd. (NASDAQ: BWAY) has announced that Christopher von Jako, CEO, will present at the Oppenheimer 31st Annual Healthcare Conference from March 16-18, 2021. The presentation is scheduled for 10:00 AM ET on March 16, 2021. Investors can also participate in one-on-one meetings during the event. BrainsWay specializes in non-invasive neurostimulation products, having received FDA marketing authorization for treatments targeting major depressive disorder, obsessive-compulsive disorder, and smoking addiction.
BrainsWay Ltd. (NASDAQ: BWAY) has successfully closed its underwritten public offering of 5,315,300 American Depositary Shares (ADSs), including 693,300 ADSs from underwriters’ full exercise of their option to purchase additional ADSs, priced at $8.50 per ADS. The offering generated approximately $45.2 million in gross proceeds. Oppenheimer & Co. Inc. led the offering, with Ladenburg Thalmann and Northland Capital Markets as co-managers. The funds will aid in expanding BrainsWay's non-invasive neurostimulation products aimed at treating various brain disorders.
BrainsWay Ltd. (NASDAQ: BWAY) announced a public offering of 4,622,000 American Depositary Shares at $8.50 each, aiming to raise about $39.3 million. The share offering includes a 30-day option for underwriters to purchase an additional 693,300 ADS. Proceeds will support commercial expansion and general corporate purposes, including R&D and marketing. The offering is under SEC registration. Closing is expected on February 25, 2021. Oppenheimer & Co. acts as the sole book-running manager, with Ladenburg Thalmann and Northland Capital as co-managers.
BrainsWay Ltd. (NASDAQ: BWAY) announced plans for an underwritten public offering of American Depositary Shares (ADS), each representing two ordinary shares. The company may grant underwriters a 30-day option for an additional 15% of ADS sold. Proceeds will support commercial expansion and general corporate purposes, including R&D and regulatory matters. The offering is subject to market conditions and is registered under an existing SEC statement. Oppenheimer & Co. Inc. is the sole book-running manager for this offering.
BrainsWay Ltd (NASDAQ & TASE: BWAY) announced the appointment of Fran Hackett as Vice President of North American Sales, effective February 16, 2021. Hackett, a seasoned sales executive with over 30 years of experience, is expected to enhance the company's growth trajectory in the non-invasive treatment of brain disorders. His previous roles include Senior VP of Global Sales at Alter G and CEO of RTI Group. The company aims to expand awareness and access to its Deep Transcranial Magnetic Stimulation (Deep TMS) technology, which has FDA approval for several conditions.
BrainsWay Ltd. (NASDAQ & TASE: BWAY) reported strong preliminary Fourth Quarter Financial Results, with quarterly revenues between $6.8 million and $7.1 million, marking a sequential rise of up to 18.3% and a year-over-year increase of up to 12.7%. Full-year revenues were approximately $21.8 million to $22.1 million, reflecting a decline of 4.3% to 5.6% due to COVID-19 impacts. BrainsWay's installed base of Deep TMS systems grew by 18.7% year-over-year, totaling 629 systems. The company maintains a debt-free status with $17.1 million in cash as of December 31, 2020.
BrainsWay has announced an exclusive distribution agreement with Gaelan Medical Trade LLC to market its Deep TMS treatment in the United Arab Emirates. Following the historic Abraham Accords, this deal allows BrainsWay to expand its reach for treating major depressive disorder and obsessive-compulsive disorder in the UAE. The agreement is a significant step in enhancing access to this innovative non-invasive therapy. BrainsWay's technology has already received FDA approval for various conditions, and clinical trials are ongoing in additional areas.
BrainsWay Ltd. (NASDAQ: BWAY) reported strong third-quarter financial results for 2020, with revenues reaching $6.0 million, a 25% increase from Q2 2020 and a 1% rise year-over-year. The company has installed a total of 593 Deep TMS systems, up 22% from 2019. Recently, it received 510(k) clearance from the FDA for its Deep TMS system to aid smoking cessation. Gross margin stood at 75%, down from 81% in Q3 2019. Operating expenses decreased to $5.1 million from $7.0 million in 2019, leading to an operating loss of $0.6 million, improved from a loss of $2.2 million a year earlier.
BrainsWay Ltd. (NASDAQ: BWAY) announced a KOL call on November 23, 2020, about Deep Transcranial Magnetic Stimulation (Deep TMS) for psychiatric disorders. Dr. Owen Muir from Brooklyn Minds will discuss treatment landscapes for conditions like major depressive disorder (MDD) and obsessive-compulsive disorder (OCD). The management will also update on the company's commercial efforts and Deep TMS technology, authorized by the FDA for various conditions since 2013. This non-invasive treatment activates deep brain structures using electromagnetic fields.
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