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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) 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.

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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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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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FAQ

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

The current stock price of Brainsway Ltd. (BWAY) is $8.76 as of April 9, 2025.

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

The market cap of Brainsway Ltd. (BWAY) is approximately 157.4M.

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.

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