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Overview of BrainsWay Ltd
BrainsWay Ltd (BWAY) is a pioneering global company specializing in advanced noninvasive neurostimulation treatments for brain disorders. With its headquarters located both in Jerusalem and the United States, the company has established a robust international presence and a growing portfolio of clinical evidence that supports its innovative approach to treating mental health conditions.
Innovative Technology and Core Business
At the heart of BrainsWay's offering is its proprietary Deep Transcranial Magnetic Stimulation (Deep TMS) platform technology. This breakthrough device delivers non-invasive magnetic pulses that stimulate neural circuits, offering a novel therapeutic alternative for patients who are inadequately served by traditional pharmacological treatments. The technology is designed to address a range of indications such as major depressive disorder, including anxious depression, obsessive-compulsive disorder, and smoking addiction. The Deep TMS system is engineered to be safe and convenient, requiring only brief daily sessions over a few weeks, thereby providing an accessible treatment option with minimal systemic or long-term side effects.
Clinical Validation and Industry Impact
BrainsWay's technology has been the subject of extensive research and multiple clinical trials, yielding pivotal data that supports its efficacy. The company’s approach not only addresses mental health conditions with rigorous clinical backing but also underscores the company’s commitment to advancing neurostimulation science. By integrating advanced coil designs and sophisticated software protocols, BrainsWay's Deep TMS offers targeted stimulation of specific brain regions. This precision in treatment delivery has established a new therapeutic paradigm in neuropsychiatry, especially for patients who have not responded optimally to medication.
Market Position and Revenue Model
BrainsWay operates at the intersection of medical device innovation and clinical neuroscience. The company generates revenue primarily through the sale and leasing of its Deep TMS systems to hospitals, mental health clinics, and research institutions worldwide. Its business model is reinforced by a series of strategic regulatory clearances, including several indications approved by the FDA, which not only validate the safety and efficacy of its technology but also serve as powerful market differentiators.
Global Reach and Expansion Strategy
With installations across multiple continents, including North America, Europe, and South America, BrainsWay has positioned itself as a key player in the global neurostimulation market. The company’s consistent focus on clinical excellence and technological innovation has bolstered its international footprint, making its life-changing therapy accessible to a diverse patient population. Its growth strategy emphasizes expanding its geographical presence and strengthening ties with healthcare providers, who are increasingly seeking alternatives to traditional treatment modalities.
Operational Excellence and Evidence-Based Approach
BrainsWay’s operational strategy is deeply rooted in rigorous scientific research and evidence-based medicine. Every aspect of its Deep TMS technology—from the design of its coils to the delivery protocols—has been optimized through clinical trials and post-market studies. The company’s transparent communication of clinical outcomes, patient benefits, and operational milestones reinforces its reputation for reliability and safety. BrainsWay provides clear, factual insights into the mechanics of its therapies, addressing both the technical and human elements of treatment, which is crucial in building trust with patients, practitioners, and investors alike.
Key Differentiators in the Competitive Landscape
In an industry marked by rapid innovation and evolving treatment paradigms, BrainsWay distinguishes itself through a blend of superior science, a strong clinical evidence base, and a commitment to patient-centric solutions. Unlike many conventional treatment methods, Deep TMS provides a non-invasive, well-tolerated, and efficient treatment alternative without the risks associated with invasive procedures. Furthermore, the company’s strategic focus on conditions with high unmet medical need sets it apart from competitors, cementing its role as an expert facilitator in advancing therapeutic outcomes for mental health disorders.
Operational and Strategic Highlights
- Noninvasive Approach: The Deep TMS system offers a modern and patient-friendly alternative to invasive neurosurgical procedures, reducing both operational risk and recovery time.
- Robust Clinical Evidence: The technology is supported by an extensive array of clinical studies that document significant improvements in symptomatology among patients with major depressive disorder, OCD, and smoking addiction.
- Global Installations: With a growing number of installed systems around the world, BrainsWay has proven its ability to meet diverse market needs while contributing to improved patient outcomes on a global scale.
- Revenue Generation: Through the leasing and sale of its Deep TMS systems to healthcare facilities and mental health centers, the company maintains a stable commercial base built on proven clinical benefits.
Understanding the Scientific and Clinical Rationale
The application of magnetic stimulation to the brain is based on sound neuroscience principles. Deep TMS targets specific neural networks associated with mood regulation and behavior, offering a precision-based treatment that can be finely tuned to individual patient needs. This meticulous approach to neurostimulation is a cornerstone of BrainsWay’s operational philosophy, ensuring that every treatment session is both clinically meaningful and scientifically substantiated.
Conclusion
BrainsWay Ltd stands as a beacon of innovation in the field of noninvasive neurostimulation, combining advanced technology with rigorous clinical science to offer effective treatment options for complex brain disorders. Its comprehensive approach—from state-of-the-art device design to extensive clinical validations—underscores the company’s authority and trustworthiness within the medical community. For anyone seeking a deep understanding of modern neuromodulation technologies and their applications in mental health treatments, BrainsWay represents a remarkable convergence of cutting-edge science, clinical precision, and a patient-focused operational model.
BrainsWay Ltd. announces that its noninvasive Deep TMS technology has treated 100,000 patients globally for depression, OCD, and smoking addiction. This technology, FDA-cleared for MDD since 2013 and OCD since 2018, now also aids short-term smoking cessation. With over 600 Deep TMS systems installed worldwide, BrainsWay emphasizes the potential to help millions in the future. The company has conducted over 30 clinical trials demonstrating the efficacy of its treatment, showcasing its commitment to enhancing mental health care.
BrainsWay Ltd. (NASDAQ: BWAY) reported its fourth quarter 2020 results, with revenues of $7.1 million, marking a 17% sequential increase and a 12% year-over-year rise. The company achieved a gross margin of 78% and an operating loss reduction to $0.4 million from $2.0 million in Q4 2019. Despite a full-year revenue decline of 5% to $22.1 million, net loss improved to $5.4 million, down from $10.3 million in 2019. Cash equivalents increased to $17.2 million at year-end, bolstered by a $45.2 million follow-on equity offering in March 2021.
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.