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Brainsway Ltd. - BWAY STOCK NEWS

Welcome to our dedicated page for Brainsway Ltd. news (Ticker: BWAY), a resource for investors and traders seeking the latest updates and insights on Brainsway Ltd. stock.

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.

Rhea-AI Summary

BrainsWay Ltd. (NASDAQ: BWAY) has achieved a significant milestone with the Israeli Ministry of Health approving its Deep TMS™ treatment for depression, now included in Israel's health basket of essential medical services. This means qualifying patients over 21, who have not responded to prior antidepressants, can receive up to 40 sessions free of charge. Dr. Christopher von Jako emphasized the importance of access to this Israeli innovation, as the company aims to expand insurance coverage globally, focusing on improving mental health treatment accessibility.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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FAQ

What is the current stock price of Brainsway Ltd. (BWAY)?

The current stock price of Brainsway Ltd. (BWAY) is $9.08 as of April 3, 2025.

What is the market cap of Brainsway Ltd. (BWAY)?

The market cap of Brainsway Ltd. (BWAY) is approximately 170.4M.

What is the core technology behind BrainsWay Ltd?

BrainsWay utilizes its proprietary Deep Transcranial Magnetic Stimulation (Deep TMS) technology, a noninvasive method that stimulates neural circuits to alleviate brain disorders such as major depressive disorder, OCD, and smoking addiction.

How does BrainsWay generate its revenue?

The company earns revenue primarily through the sale and leasing of its Deep TMS systems to hospital networks, clinical centers, and research facilities worldwide.

Which mental health conditions does BrainsWay target with its technology?

BrainsWay’s Deep TMS technology is indicated for major depressive disorder (including anxious depression), obsessive-compulsive disorder, and smoking addiction, with ongoing clinical trials exploring additional psychiatric and neurological applications.

What makes Deep TMS different from other brain stimulation therapies?

Unlike invasive procedures, Deep TMS is a noninvasive treatment that is both safe and convenient, offering targeted stimulation of neural networks with minimal side effects, which makes it a compelling alternative for patients unresponsive to traditional therapies.

How is BrainsWay positioned within the neurostimulation market?

BrainsWay is recognized for its robust clinical evidence, innovative technology, and global reach. Its regulatory clearances and focus on high unmet medical needs distinguish it in a competitive field of neuromodulation treatment providers.

What evidence supports the efficacy of BrainsWay's technology?

The company’s numerous clinical trials and pivotal studies have demonstrated significant improvements in patient symptomatology for various conditions, reinforcing the clinical efficacy and safety profile of the Deep TMS system.
Brainsway Ltd.

Nasdaq:BWAY

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170.39M
15.56M
6.42%
32.12%
0.29%
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